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Breast Cancer clinical trials at UC Health

223 in progress, 101 open to eligible people

Showing trials for
  • A Culturally Sensitive Social Support Intervention

    open to eligible females ages 18 years and up

    This study is a randomized controlled trial (RCT) to assess the impact of a culturally based social support program (i.e. Joy Luck Academy, JLA) among Chinese American breast cancer survivors.

    at UCLA

  • A Phase 2 Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors

    open to eligible people ages 18 years and up

    This phase II trial studies cediranib maleate in combination with olaparib in treating patients with solid tumors that have spread to other parts of the body (advanced/metastatic) or cannot be removed by surgery (unresectable), including breast cancer, non-small cell lung cancer, small cell lung cancer, and pancreatic cancer. Cediranib maleate and olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may also block the flow of oxygen to the tumor, and may help make the tumor more sensitive to olaparib.

    at UC Davis UCSD UCSF

  • A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma

    open to eligible people ages 18 years and up

    The purpose of this phase 2 study is to evaluate the efficacy and safety of NIR178 in combination with PDR001 in multiple solid tumors and diffuse large B-cell lymphoma (DLBCL) and further explore schedule variations of NIR178 to optimize immune activation through inhibition of A2aR.

    at UCLA

  • A Safety Study of SGN-LIV1A in Breast Cancer Patients

    open to eligible females ages 18 years and up

    This study will examine the safety and tolerability of SGN-LIV1A (ladiratuzumab vedotin) in patients with metastatic breast cancer. SGN-LIV1A will be given alone or in combination with trastuzumab.

    at UCLA UCSF

  • A Safety, Pharmacokinetic, Pharmacodynamic and Anti-Tumor Study of PF-06873600 as a Single Agent and in Combination With Endocrine Therapy

    open to eligible people ages 18 years and up

    Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06873600 administered as a single agent and then in combination with endocrine therapy. The study contains two parts, a Part 1 single agent dose escalation and combination endocrine therapy dose finding component and a Part 2 dose expansion as both a single agent and in combination with endocrine therapy.

    at UCLA UCSF

  • A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic or Inoperable Locally Advanced Triple-Negative Breast Cancer

    open to eligible people ages 18 years and up

    This is a Phase Ib/II, open-label, multicenter, randomized umbrella study evaluating the efficacy and safety of multiple immunotherapy-based treatment combinations in patients with metastatic or inoperable locally advanced TNBC. The study will be performed in two stages. During Stage 1, two cohorts will be enrolled in parallel in this study: one cohort will consist of Programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line [1L] PD-L1+ cohort), and one cohort will consist of participants who had disease progression during or following 1L treatment with chemotherapy (e.g., paclitaxel, nab-paclitaxel, carboplatin) and have not received cancer immunotherapy (CIT) (second-line [2L] CIT-naive cohort). In addition, participants in the 2L CIT-naive cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination (Stage 2), provided Stage 2 is open for enrollment.

    at UCSD

  • A Study Evaluating the Efficacy, Safety, and Pharmacokinetics of GDC-9545 Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer

    open to eligible females ages 18 years and up

    This is a randomized, multicenter, open-label, two-arm, Phase II study to evaluate the efficacy, safety, and pharmacokinetics of GDC-9545 versus anastrozole (in the window-of-opportunity phase) and GDC-9545 plus palbociclib compared with anastrozole plus palbociclib (in the neoadjuvant phase) in postmenopausal women with untreated, estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, early breast cancer. The study consists of a screening period of up to 28 days, a window-of-opportunity phase for 14 days, followed by a neoadjuvant treatment phase for 16 weeks (four 28-day cycles), surgery, and an end of study visit (28 days after the final dose of study treatment).

    at UCLA

  • A Study of Experimental Pembrolizumab (MK-3475) in Combination With Chemotherapy & Endocrine Therapy for Breast Cancer

    open to eligible people ages 18 years and up

    The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS.

    at UC Davis

  • A Study of Experimental Tucatinib vs. Placebo Combined With Ado-trastuzumab Emtansine (T-DM1) for HER2+ Breast Cancer

    open to eligible people ages 18 years and up

    This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.

    at UC Davis UC Irvine UCLA

  • A Study of LGK974 in Patients With Malignancies Dependent on Wnt Ligands

    open to eligible people ages 18 years and up

    This primary purpose of this study is to find the recommended dose of LGK974 as a single agent and in combination with PDR001 that can be safely given to adult patients with selected solid malignancies for whom no effective standard treatment is available.

    at UCLA

  • A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms

    open to eligible people ages 18 years and up

    The primary goal of this Phase 1 study is to characterize the safety and tolerability of MGD013 and establish the maximum tolerated dose (MTD) of MGD013. Pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD), and the anti-tumor activity of MGD013 will also be assessed.

    at UCLA

  • A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

    open to eligible females ages 18 years and up

    This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several immunotherapy-based combination treatments in participants with inoperable locally advanced or metastatic HR-positive, HER2-negative breast cancer who have progressed during or following treatment with a cyclin-dependent kinase (CDK) 4/6 inhibitor in the first- or second-line setting, such as palbociclib, ribociclib, or abemaciclib. The study will be performed in two stages. During Stage 1, participants will be randomized to fulvestrant (control) or an atezolizumab-containing doublet or triplet combination. Those who experience disease progression, loss of clinical benefit, or unacceptable toxicity may be eligible to receive a new triplet combination treatment in Stage 2 until loss of clinical benefit or unacceptable toxicity. New treatment arms may be added and/or existing treatment arms may be closed during the course of the study on the basis of ongoing clinical efficacy and safety as well as the current treatments available.

    at UCLA UCSF

  • A Study of NKTR-262 in Combination With Bempegaldesleukin (NKTR-214) and With Bempegaldesleukin Plus Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumor Malignancies

    open to eligible people ages 18 years and up

    Patients will receive intra-tumoral (IT) NKTR-262 in 3-week treatment cycles. During the Phase 1 dose escalation portion of the trial, NKTR-262 will be combined with systemic administration of bempegaldesleukin. After determination of the recommended Phase 2 dose (RP2D) of NKTR-262, between 6 and 18 patients may be enrolled at the RP2D to further characterize the safety and tolerability profile of the combination of NKTR 262 plus bempegaldesleukin (doublet) or NKTR 262 plus bempegaldesleukin in combination with nivolumab (triplet) in Cohorts A and B, respectively. In the Phase 2 dose expansion portion, patients will be treated with doublet or triplet in the relapsed/refractory setting and earlier lines of therapy.

    at UCSD UCSF

  • A Study of PDR001 in Combination With LCL161, Everolimus or Panobinostat

    open to eligible people ages 18 years and up

    The purpose of this study is to combine the PDR001 checkpoint inhibitor with several agents with immunomodulatory activity to identify the doses and schedule for combination therapy and to preliminarily assess the safety, tolerability, pharmacological and clinical activity of these combinations.

    at UCLA

  • A Study of RO7198457 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors

    open to eligible people ages 18 years and up

    This is a Phase 1a/1b, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, immune response, and pharmacokinetics of RO7198457 as a single agent and in combination with atezolizumab (MPDL3280A, an engineered anti-programmed death-ligand 1 [anti-PD-L1] antibody).

    at UCSF

  • A Study of the Effectiveness and Safety of Experimental Pembrolizumab Plus Lenvatinib for Selected Solid Tumors

    open to eligible people ages 18 years and up

    The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), or biliary tract cancers (BTC). Participants will be enrolled into initial tumor-specific cohorts which will be expanded if adequate efficacy is determined.

    at UC Davis

  • A Study of the Experimental Combination of Radiation Therapy and Olaparib For Inflammatory Breast Cancer

    open to eligible people ages 18 years and up

    This phase II trial studies how well radiation therapy with or without olaparib works in treating patients with inflammatory breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy with or without olaparib may work better in treating patients with inflammatory breast cancer.

    at UC Davis

  • A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors

    open to eligible people ages 18 years and up

    This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb20717, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb20717 in subjects with selected advanced solid tumors.

    at UCLA UCSD UCSF

  • A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors

    open to eligible people ages 18 years and up

    This is a Phase 1, multiple dose, ascending-dose escalation study and expansion study designed to define a maximum tolerated dose and/or recommended dose of XmAb22841 monotherapy and in combination with pembrolizumab; to assess safety, tolerability, pharmacokinetics, immunogenicity, and anti-tumor activity of XmAb22841 monotherapy and in combination with pembrolizumab in subjects with select advanced solid tumors.

    at UCLA UCSD

  • A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)

    open to eligible people ages 18 years and up

    This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb23104, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb23104 in subjects with selected advanced solid tumors.

    at UCSD

  • A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer

    open to eligible people ages 18 years and up

    This is a multicenter, Phase 2a, open-label, 2-part study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) in combination with palbociclib plus fulvestrant. Eligible patients include those with locally advanced (unresectable) and/or metastatic human epidermal growth factor receptor 2 (HER2)-positive, hormone receptor (HR)-positive breast cancer.

    at UCLA

  • A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer

    open to eligible females ages 18 years and up

    This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole and expansion to estimate the objective response rate (OR) of the combination of gedatolisib plus palbociclib/letrozole or palbociclib/fulvestrant.

    at UCSF

  • A Study To Evaluate Escalating Doses of A Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC

    open to eligible people ages 18 years and up

    The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of a vaccine-based immunotherapy regimen for patients with advanced non-small cell lung cancer and metastatic triple-negative breast cancer.

    at UCLA UCSD

  • A Study to Evaluate Safety/Tolerability of Immunotherapy Combinations in Participants With Triple-Negative Breast Cancer or Gynecologic Malignancies

    open to eligible females ages 18 years and up

    This is a Phase 1/1b, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of etrumadenant (AB928) in combination with pegylated liposomal doxorubicin (PLD) with or without IPI-549 in participants with advanced metastatic triple-negative breast cancer (TNBC) or ovarian cancer, and etrumadenant in combination with nanoparticle albumin-bound-paclitaxel (NP) in participants with advanced metastatic TNBC.

    at UCLA

  • A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies

    open to eligible people ages 18 years and up

    ATLAS-101 is a Phase I/II clinical trial of AMXI-5001 in participants with advanced malignancies who have previously failed other therapies. The study has two phases. The purpose of Phase I (dose escalation) is to confirm the appropriate treatment dose. The purpose of Phase II (dose expansion) is to characterize the safety and efficacy of AMXI-5001.

    at UCLA

  • A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

    open to eligible people ages 18 years and up

    A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancer

    at UCLA UCSF

  • Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy

    open to eligible people ages 18-69

    This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) negative breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.

    at UC Davis UC Irvine UCSD UCSF

  • Assessing Breast Density's Value in Imaging - A Comparative Effectiveness Study

    open to eligible females ages 18-89

    This Breast Cancer Surveillance Consortium (BCSC) ADVANCE study is a large, observational pragmatic comparative effectiveness research study using high-quality, prospectively collected data from BCSC registries to generate evidence on how breast density should be integrated into decision making around breast cancer screening and preoperative diagnostic work-up. We will augment existing BCSC registry infrastructure with additional prospective data collection and collection of patient reported outcomes (PROs), CISNET modeling of long-term screening outcomes, and qualitative data from focus groups with women represented in two aims.

    at UC Davis UCSF

  • Avelumab With Binimetinib, Utomilumab, or Anti-OX40 Antibody PF-04518600 in Treating Triple Negative Breast Cancer

    open to eligible people ages 18 years and up

    This phase II trial studies how well avelumab in combination with binimetinib, utomilumab, or anti-OX40 antibody PF-04518600 works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent). Immunotherapy with checkpoint inhibitors like avelumab require activation of the patients immune system. This trial includes a two week induction or lead-in of medications that can stimulate the immune system. It is our hope that this induction will improve the response to immunotherapy with avelumab. Patients on this trial will receive two weeks of treatment with one of three treatments to stimulate the bodies immune system, including the monoclonal antibodies, utomilumab, and the anti-OX40 antibody PF-04518600 which may help the body's immune system attack the cancer, and could interfere with the ability of tumor cells to grow and spread. The third medication is called binimetinib , which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may help activate the immune system. It is not yet known whether giving avelumab in combination with binimetinib, utomilumab, or anti-OX40 antibody PF-04518600 will work better in treating patients with triple negative breast cancer

    at UCSF

  • Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)

    open to eligible people ages 18 years and up

    This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.

    at UC Irvine UCSD UCSF

  • Brain Health in Breast Cancer Survivors

    open to eligible females ages 35-65

    Endocrine therapy (ET) is widely used to treat hormone receptor positive breast cancer and prevent recurrence by downregulating estrogen function. However, ETs readily cross the blood brain barrier and interfere with the action of estrogen in the brain. Estrogen supports cognition and menopausal status is closely linked to cognitive health in women. This has raised concern that anti-estrogen ETs may affect cognition and brain health in breast cancer survivors. However, evidence across existing studies is inconsistent and these effects remain poorly understood. The incomplete understanding of the effects of ET are likely due to limitations of earlier studies - namely, the under-appreciation of the role of menopausal status and insensitivity of standard cognitive measures. This research project will address these earlier limitations by specifically comparing ET effects by menopausal status, and using highly sensitive, task-related functional magnetic resonance imaging (fMRI) measures to assess the effects of ET on brain function.

    at UCLA

  • Clinical Trial of ARV-471 in Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer

    open to eligible people ages 18 years and up

    This is a first in human, dose escalation study and will assess the safety and tolerability of ARV-471 in woman and men with ER+/HER2- locally advanced or metastatic breast cancer, who have received prior hormonal therapy and chemotherapy in the locally advanced/metastatic setting.

    at UCLA

  • COM701 in Subjects With Advanced Solid Tumors

    open to eligible people ages 18 years and up

    This is a Phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary clinical activity of COM701 as monotherapy and in combination with a programmed cell death protein 1 (PD-1) inhibitor.

    at UCLA

  • Comparison of radiation or surgery and radiation for Breast cancer patients with lymph node cancer in the armpit (axillary) area

    “Comparison of Axillary (Armpit) lymph node cancer after breast cancer, chemotherapy and surgery. Surgery or surgery and radiation treatment”

    open to eligible people ages 18 years and up

    This randomized phase III trial studies lymph node dissection and radiation therapy to see how well it works compared to radiation therapy alone in treating patients with breast cancer previously treated with chemotherapy and surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x rays or protons to kill tumor cells. It is not yet known if radiation therapy works better alone or with lymph node dissection in treating patients with breast cancer previously treated with chemotherapy and surgery.

    at UC Davis UCSD

  • Contrast-Enhanced MRI for the Characterization of Ductal Carcinoma in Situ (DCIS)

    open to eligible females ages 18 years and up

    RATIONALE: Diagnostic procedures, such as contrast-enhanced MRI, may help find and diagnose ductal carcinoma in situ.

    PURPOSE: This study is to develop and refine magnetic resonance (MR) imaging methods for pre-operative staging of ductal carcinoma in situ, a pre-invasive form of breast cancer, and atypical ductal hyperplasia, a risk factor for developing cancer.

    at UCSF

  • CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers

    open to eligible people ages 18 years and up

    This is a Phase 1/1b open-label, dose escalation and dose expansion study of CPI-006, a humanized monoclonal antibody (mAb) targeting the CD73 cell-surface ectonucleotidase in adult subjects with select advanced cancers. CPI-006 will be evaluated as a single agent, in combination with ciforadenant (an oral adenosine 2A receptor antagonist), in combination with pembrolizumab (an anti-PD1 antibody), and in combination with ciforadenant and pembrolizumab.

    at UCSF

  • Diarrhea Prophylaxis in Patients With HER2+ Breast Cancer Treated With Neratinib, With or Without Trastuzumab

    open to eligible people ages 18 years and up

    This is a study to evaluate the toxicity profile of neratinib in combination with trastuzumab in patients with early stage breast cancer with the use of anti-diarrheal prophylaxis. The anti-diarrheal medications being tested in this trial are loperamide and crofelemer. Crofelemer is an anti-diarrheal, enteric-coated drug product for oral administration. It is the only botanical drug currently approved by the FDA for oral administration and is approved for the treatment of diarrhea associated with HAART. Crofelemer has a novel mechanism of action, acting directly and simultaneously on 2 distinct intestinal luminal chloride channels. It is an inhibitor of both the cyclic adenosine monophosphate (cAMP)-stimulated cystic fibrosis transmembrane conductance regulator (CFTR) chloride ion (Cl-) channel found on the apical membranes, and the calcium-activated Cl- channels (CaCC) at the luminal membrane of enterocytes. The CFTR Cl-channel and CaCC regulate Cl and fluid secretion by intestinal epithelial cells. Crofelemer acts by blocking Cl- secretion and accompanying high volume water loss in diarrhea, normalizing the flow of Cl- and water in the GI tract.

    at UCSF

  • Dietary and Exercise Interventions in Reducing Side Effects in Patients With Stage I-IIIa Breast Cancer Receiving Aromatase Inhibitors

    open to eligible females

    This phase I/II trial studies how well dietary and exercise interventions work in reducing side effects in patients with stage I-IIIa breast cancer taking aromatase inhibitors. Anti-inflammatory Mediterranean dietary and bone strengthening exercise interventions may alleviate medication side effects such as joint and bone pain and protectively influence bone mineral density, improve heart functioning, and reduce risk of breast cancer recurrence in breast cancer patients taking aromatase inhibitors.

    at UCLA

  • Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer

    open to eligible females ages 45-74

    This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.

    at UCSF

  • Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer

    open to eligible people ages 18 years and up

    This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.

    at UC Davis UCSD

  • DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]

    open to eligible people ages 18 years and up

    This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: - cannot be removed by an operation - has spread to other parts of the body

    at UCLA

  • DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer

    open to eligible people ages 18 years and up

    This two-part study will include a dose escalation part to determine the recommended dose for expansion of DS8201a and pembrolizumab and a dose expansion part to evaluate efficacy, safety, and tolerability of the combination.

    at UCSF

  • DZD1516 in Combination With Trastuzumab and Capecitabine, or in Combination With T-DM1, in Patients With Metastatic HER2 Positive Breast Cancer

    open to eligible people ages 18 years and up

    DZD1516 is an oral, blood brain barrier penetrable, selective HER2 tyrosine kinase inhibitor. This study is designed to evaluate the safety and tolerability of DZD1516 in patients with metastatic HER2 positive breast cancer who have progressed following prior therapy. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and assess its anti-cancer activity as monotherapy and in combination with trastuzumab and/or capecitabine, or in combination with T-DM1

    at UCLA

  • Endocrine Response in Women With Invasive Lobular Breast Cancer

    open to eligible females

    RATIONALE: Currently, adjuvant endocrine therapy often follows a "one-size-fits- all" approach, with most premenopausal women receiving tamoxifen, and most postmenopausal receiving aromatase inhibitor therapy. In current clinical practice, patients with invasive lobular carcinoma are treated no differently than patients with invasive ductal carcinoma based on the void of information specific to patients with this tumor type. Identification of a biological signal of tamoxifen and/or AI-resistance and/or fulvestrant-sensitivity in ILC patients would have dramatic implications for the future management of this breast cancer subtype.

    PURPOSE: To study whether fulvestrant is more effective than anastrozole or tamoxifen in reducing Ki67 in ILC and whether that Ki67 reduction will correlate with alterations in expression of ER and ER-regulated genes. Differential Ki67 effect in this study will serve as a surrogate for outcome of ILC patients on endocrine therapy. Primary Objective: To determine the change from baseline to post-treatment Ki67 values in ER-positive, HER2-negative ILC tissue derived from postmenopausal women awaiting definitive surgery or further neoadjuvant treatment who are randomized to 21-24 days of neoadjuvant endocrine treatments with fulvestrant (two 250 mg IM injections given on day 1), anastrozole (1mg given orally daily), or tamoxifen (20mg given orally daily).

    at UCSF

  • Evaluation of IPI-549 Combined With Front-line Treatments in Pts. With Triple-Negative Breast Cancer or Renal Cell Carcinoma (MARIO-3)

    open to eligible people ages 18 years and up

    MARIO-3 is a Phase 2 multi-arm combination cohort study designed to evaluate IPI-549, Infinity Pharmaceutical's first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective inhibition of phosphoinositide-3-kinase (PI3K)-gamma, in combinations with Tecentriq and Abraxane (nab-paclitaxel) in front-line triple negative breast cancer (TNBC) and in combination with Tecentriq and Avastin (bevacizumab) in front-line renal cell cancer (RCC).

    at UCLA

  • Evaluation of Lasofoxifene Versus Fulvestrant in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

    open to eligible females ages 18 years and up

    This is an open label, randomized, multicenter study evaluating the activity of lasofoxifene relative to fulvestrant for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer with an acquired ESR1 mutation and who have disease progression on an aromatase inhibitor (AI) in combination with a cyclin dependent kinase (CDK) 4/6 inhibitor. The primary objective is to evaluate the progression free survival (PFS) of 5 mg lasofoxifene relative to fulvestrant for the treatment of pre- and postmenopausal women with locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation. The secondary objectives are to evaluate: 1. Clinical benefit rate (CBR) and Objective Response Rate (ORR) 2. Duration of response 3. Time to response 4. Overall Survival (OS) 5. Pharmacokinetics of lasofoxifene 6. Quality of life (QoL): Quality of Life (QoL): vaginal assessment scale (VAS) and vulvar assessment scale (VuAS) questionnaires 7. Safety of lasofoxifene 8. Response to various ESR1 mutation (Y537S, Y537C, D538G, E380Q, S463P, V534E, P535H, L536H, L536P, L536R, L536Q, or Y537N).

    at UCSF

  • Experimental Combination of Veliparib and Atezolizumab For Stage III-IV Triple Negative Breast Cancer

    “Experimental medicine (Veliparib), experimental immunotherapy (Atezolizumb) or combination for Stage III-IV Triple Negative Breast Cancer”

    open to eligible people ages 18 years and up

    This randomized phase II trial studies how well olaparib with or without atezolizumab work in treating patients with non-HER2-positive breast cancer that has spread from its original site of growth to nearby tissues or lymph nodes and is not amenable to surgical resection (locally advanced unresectable) or has spread to other places in the body (metastatic). Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. It is not known whether giving olaparib with or without atezolizumab will work better in patients with non-HER2-positive breast cancer.

    at UC Davis UCSD UCSF

  • Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues

    open to eligible people ages 18 years and up

    This phase I trial studies a new imaging technique called FAPi PET/CT to determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulate in normal and cancer tissues in patients with non-prostate cancer. The research team also want to know whether what they see on PET/CT images represents the tumor tissue being excised from the patient's body. The research team is also interested to investigate another new imaging technique called PSMA PET/CT. Participants will be invited to undergo a second PET/CT scan, with the PSMA tracer (68Ga-PSMA-11). This is not required but just an option for volunteer patients. Patients can decide to have only the FAPI PET/CT scan. The PET/CT scanner combines the PET and the CT scanners into a single device. This device combines the anatomic (body structure) information provided by the CT scan with the metabolic information obtained from the PET scan. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of, in the case of this research, 68Ga-PSMA-11 and 68Ga-FAPi. Because some cancers take up 68Ga-PSMA-11 and/or 68Ga-FAPi it can be seen with PET. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs where it occurs in patient's body. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors. The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers. PSMA stands for Prostate Specific Membrane Antigen. This name is incorrect as PSMA is also found in many other cancers. The function of PSMA is not well understood but imaging studies have shown that PSMA can be detected with PET in many non-prostate cancers. Imaging FAP with PET/CT may in the future provide additional information about various cancers.

    at UCLA

  • Experimental Radiotracer Imaging Study for Cancer Patients

    open to eligible people ages 18 years and up

    This clinical trial studies the side effects of 18F-alphavbeta6-binding-peptide and how well it works in imaging patients with primary or cancer that has spread to the breast, colorectal, lung, or pancreatic. Radiotracers, such as 18F-alphavbeta6-binding-peptide, may improve the ability to locate cancer in the body.

    at UC Davis

  • Experimental Study of a New Drug Combination - Copanlisib and Fulvestrant - in Postmenopausal Women With Advanced Breast Cancer

    open to eligible people ages 18 years and up

    This phase I/II trial studies the side effects and how well copanlisib works when given together with fulvestrant in treating patients with estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) breast cancer that has spread to other places in the body (advanced) and progressing after prior treatment. HER2 and ER are two types of proteins called receptors that can affect the growth of breast cancer cells. Additionally, investigators hope to learn from this study if tumor genetic information is important for predicting whether this type of breast cancer will respond to fulvestrant and copanlisib. Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving copanlisib and fulvestrant may work better in treating patients with ER+ and HER2- breast cancer compared to fulvestrant alone.

    at UC Davis

  • Experimental Treatment With "Carvedilol" to Avoid Heart Problems in Patients With HER-2-Positive Breast Cancer That Has Spread

    “This study will test whether carvedilol can reduce heart problems during your cancer treatment.”

    open to eligible people ages 18 years and up

    This phase III trial studies how well carvedilol works in preventing cardiac toxicity in patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has spread to other places in the body. A beta-blocker, such as carvedilol, is used to treat heart failure and high blood pressure, and it may prevent the heart from side effects of chemotherapy.

    at UC Davis

  • First-in-human Study of DS-1062a for Advanced Solid Tumors

    open to eligible people ages 18 years and up

    This study is one single group of participants with non-small cell lung cancer (NSCLC) who have not been cured by other treatments. It is the first time the drug has been used in humans, and will be in two parts. The primary purpose of the parts are: - Dose Escalation: To investigate the safety and tolerability and to determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of DS-1062a - Dose Expansion: To investigate the safety and tolerability of DS-1062a This study is expected to last approximately 4 years from the time the first participant is enrolled to the time the last subject is off the study. Study sites are located in both the United States and Japan. The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless: - they withdraw - their disease gets worse - they experience unacceptable side effects.

    at UCLA

  • FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors

    open to eligible people ages 18 years and up

    FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive immunity, and has the potential to overcome multiple mechanisms of immune checkpoint inhibitor (ICI) resistance. The preclinical data provide compelling evidence supporting the clinical investigation of FT500 as monotherapy and in combination with ICI in subjects with advanced solid tumors.

    at UCSD

  • HKI-272 for HER2-Positive Breast Cancer and Brain Metastases

    open to eligible people ages 18 years and up

    The purpose of this research study is to determine how well neratinib works in treating breast cancer that has spread to the brain. Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2). In this research study, the investigators are looking to see how well neratinib works to decrease the size of or stabilize breast cancer that has spread to the brain. The investigators are also looking at how previous treatments have affected your thinking (or cognition) and how much neratinib reaches the central nervous system.

    at UCSF

  • Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer

    open to eligible people ages 18 years and up

    This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells that remain after surgery and have fewer side effects.

    at UC Irvine

  • I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

    open to eligible people ages 18 years and up

    The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.

    at UCSD UCSF

  • Improving Cognition After Cancer

    open to eligible females ages 40 years and up

    This study will test whether a physical activity intervention can improve cognition in breast cancer survivors and help the development of physical activity guidelines for cognition in breast cancer survivors.

    at UCSD

  • Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery

    open to eligible females ages 45 years and up

    This phase IV trial studies the side effects of intraoperative radiation therapy and how well it works in treating patients with breast cancer undergoing breast-conserving surgery. Delivering radiation one time to the area where the tumor was removed while the patient is still in the operating room may kill any residual tumor cells and may be as effective as standard radiation therapy in patients with early stage breast cancer.

    at UC Irvine UCSF

  • Ipilimumab, Nivolumab, and Talimogene Laherparepvec Before Surgery in Treating Participants With Localized, Triple-Negative or Estrogen Receptor Positive, HER2 Negative Breast Cancer-deleted

    open to eligible females ages 18 years and up

    This phase I trial studies talimogene laherparepvec given together with ipilimumab and nivolumab before surgery in patients with triple-negative or estrogen receptor positive, HER2 negative localized breast cancer. Ipilimumab and Nivolumab are immune checkpoint inhibitors that enhance immune response towards cancer cells. Talimogene laherparepvec is a modifies human herpes virus 1 that is an oncolytic virus targeting cancer cells and makes tumor microenvironment more immunogenic to promote immune response against cancer. This study will assess the safety and efficacy of talimogene laherparepvec, ipilimumab, and nivolumab, and provide an insight for further improvement of immunotherapy in breast cancer.

    at UCLA

  • Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy

    open to eligible people ages 18 years and up

    Subjects who previously took part in the FT500-101 study and received allogeneic NK cell immunotherapy will take part in this long term follow-up study. Subjects will automatically enroll into study FT-003 once they have withdrawn or complete the parent interventional study. The purpose of this study is to provide long-term safety and survival data for subjects who have participated in the parent study. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.

    at UCSD

  • MGC018 With or Without MGA012 in Advanced Solid Tumors

    open to eligible people ages 18 years and up

    The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of MGC018 administered alone and in combination with MGA012 in patients with advanced solid tumors.

    at UCLA

  • Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer

    open to eligible people ages 18 years and up

    The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of DHP107 (Oral Paclitaxel, Korea brand name: Liporaxel®) compared to IV Paclitaxel in patients with Recurrent or Metastatic Breast Cancer.

    at UCSF

  • Pembrolizumab in Treating Patients With Triple-Negative Breast Cancer

    open to eligible people ages 18 years and up

    This randomized phase III trial studies how well pembrolizumab works in treating patients with triple-negative breast cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

    at UC Davis UC Irvine

  • Pembrolizumab With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease

    open to eligible people ages 18 years and up

    This is a phase II multicenter study including breast cancer patients with chest wall disease that is hormone resistant (estrogen receptor (ER) positive/progesterone receptor (PR) positive/human epidermal growth factor receptor 2 (HER2) negative breast cancer with progressive disease on 2 prior lines of hormonal therapy) or triple negative (ER negative/PR negative/HER2 negative, TNBC). Eighty-four patients will be enrolled at Translational Breast Cancer Research Consortium (TBCRC) sites and will be randomized 2:1 to receive treatment with pembrolizumab and carboplatin (n=56, Arm A) or carboplatin alone (n=28, Arm B) until documented disease progression. Patients randomized to Arm B may cross-over following progression to pembrolizumab with or without carboplatin at investigator's discretion (Arm Bx). Patients may have received any number of prior lines of chemotherapy. Patients in Arm A will be treated with pembrolizumab 200 mg IV and carboplatin area under curve (AUC) 5 IV every 3 weeks for at least 6 cycles followed by maintenance pembrolizumab 200 mg IV every 3 weeks if stable or responding disease. Patients in Arm B will be treated with carboplatin AUC 5 IV every 3 weeks until progression, whereupon they may cross-over to pembrolizumab 200 mg IV every 3 weeks with or without carboplatin at investigator's discretion (Arm Bx). An interim analysis for futility will be performed after 18 patients are enrolled into Arm B to allow early stopping of that trial arm for lack of efficacy. The primary endpoint is to compare disease control rates at 18 weeks of treatment. Secondary endpoints include progression free survival, toxicity, and overall response rate.

    at UCSF

  • PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors

    open to eligible people ages 18 years and up

    The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive and negative breast and gastric cancer (HER2 positive only and gastric were studied in Part 1A only). The study will expand to look at selected doses in patients with HER2 positive and negative breast cancer.

    at UCLA

  • Phase 2 Study of SAR439859 Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer (AMEERA-3)

    open to eligible people ages 18 years and up

    Primary Objective: To determine whether SAR439859 per os improves progression free survival (PFS) when compared with a endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer. Secondary Objectives: - To compare the overall survival in the 2 treatment arms - To assess the objective response rate in the 2 treatment arms. - To evaluate the disease control rate in the 2 treatment arms. - To evaluate the clinical benefit rate in the 2 treatment arms. - To evaluate the duration of response in the 2 treatment arms. - To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in the 2 treatment arms. - To evaluate the pharmacokinetics of SAR439859 as single agent. - To evaluate health related quality of life in the 2 treatment arms. - To compare the overall safety profile in the 2 treatment arms.

    at UCLA

  • Phase 2 Window Study of SAR439859 Versus Letrozole in ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer (AMEERA-4)

    open to eligible females ages 18 years and up

    Primary Objective: To determine whether SAR439859 given at 2 different doses improves the antiproliferative activity when compared to letrozole Secondary Objectives: - To assess the proportion of participants with a relative decrease from baseline in percentage of positive tumor cells tested by immunohistochemistry ≥50% (Ki67≥50%) in the three treatment arms - To assess estrogen receptor (ER) degradation in biopsies in participants in the three treatment arms - To assess safety in the three treatment arms

    at UCLA

  • Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies

    open to eligible people ages 18 years and up

    A Phase I-II, First-in-Human Study of SKB264 in Patients with Locally Advanced Unresectable/Metastatic Solid Tumors who are refractory to Available Standard Therapies. Patient must have historically documented, incurable, locally advanced or metastatic cancer that are refractory to standard therapies of one of the following types: i. Ovarian epithelial cancer (Phase I only) ii. Gastric adenocarcinoma (Phase I-II) iii. Pancreatic adenocarcinoma (Phase I-II) iv. Triple negative breast cancer (Phase I only) v. Bladder cancer (Phase I-II)

    at UCLA

  • Phase II Breast Ca Carboplatin + Paclitaxel With Pertuzumab + Trastuzumab or Bevacizumab

    open to eligible females ages 18 years and up

    The purpose of this phase II is to study the efficacy and toxicity of carboplatin and paclitaxel with pertuzumab and trastuzumab in HER2 positive and carboplatin and paclitaxel with bevacizumab in HER2 negative in the neoadjuvant setting for the treatment of breast cancer.

    at UC Irvine

  • Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer

    open to eligible people ages 18 years and up

    This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of HER2 negative, Locally Recurrent or Metastatic Breast Cancer.

    at UCSF

  • Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial

    open to eligible people ages 21 years and up

    A pragmatic randomized clinical trial of patients with locally advanced breast cancer randomized to either proton or photon therapy and followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life, and cancer control outcomes. Quality of life is the outcome measure for the estimated primary completion date of August, 2022, www.radcomp.org.

    at UCSD

  • Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer

    open to eligible people ages 18 years and up

    The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.

    at UCSF

  • Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer

    open to eligible people ages 18 years and up

    This trial studies SGN-LIV1A with pembrolizumab in patients with triple-negative breast cancer. It will find out what side effects happen when participants get these two drugs. A side effect is anything the drugs do besides treating cancer. Pembrolizumab is a drug that can be used to treat triple-negative breast cancer. The trial will also find out if the drugs work to treat this type of cancer. Participants in this study have metastatic breast cancer. This means the cancer has spread to other parts of the body.

    at UC Irvine

  • Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid Tumors and HER2-neg Breast Cancer

    open to eligible people ages 18 years and up

    The purpose of this study is to evaluate OBT076, which is a drug that combines an antibody with an anti-cancer drug. This class of drugs are called Antibody-Drug Conjugates (ADC). Antibodies are normally produced in the human body by the immune system to fight infections but can be designed to target cancer cells and deliver an anti-cancer drug. OBT076 is composed of an antibody that targets the CD205 protein on cancer cells and delivers an anti-cancer drug which can kill them. OBT076 is an "Investigational Drug", which means that it is still being studied and has not yet been approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) or any other regulatory authorities to be prescribed by doctors for the treatment of metastatic or recurrent solid tumors. The use of OBT076 in this study is investigational. This is a Phase I research study designed to look at several dose levels of the study drug to find the highest dose level that is safe and well-tolerated (does not cause unacceptable side effects), and to examine the effects of the study drug in a small group of research participants. The study will also look at the effectiveness of OBT076 as an anti-cancer therapy. Once the optimal dose is determined and safety is assessed, additional research participants will be treated at the optimal dose level to further evaluate safety and effectiveness.

    at UCLA

  • Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC

    open to eligible people ages 18 years and up

    This is a First-in-Human Phase IA/IB open label dose escalation study of intravenous (IV) administration of ONC-392, a humanized anti-CTLA4 IgG1 monoclonal antibody, as single agent and in combination with pembrolizumab in participants with advanced or metastatic solid tumors and non-small cell lung cancers.

    at UC Davis

  • SCOPE-Chinese Women Study

    open to eligible females ages 18 years and up

    This project examines the feasibility of a smartphone-based intervention to reduce obesity and breast cancer risk among Chinese women in China. The proposed intervention is to use the mobile application and an activity tracker device to promote a healthier lifestyle and physical activity. The intervention will be tailored to the participants' behaviors, personal needs, and preferences. The aim is to reduce abdominal obesity and improve healthy lifestyle behaviors in premenopausal women with children in order to reduce the growing cancer burden in China.

    at UCSF

  • SCOUT Reflector for Tagging Lymph Nodes for Targeted Removal in Patients With Breast Cancer

    open to eligible people ages 18 years and up

    This pilot clinical trial will evaluate whether the SCOUT reflector can be used to tag abnormal lymph nodes in patients with breast cancer prior to chemotherapy for targeted removal at the time of surgery. The SCOUT localization system with the SAVI reflector is non-radioactive and completely internal so can be placed into an abnormal lymph node prior to chemotherapy treatment, which theoretically will allow easier identification and therefore more reliable targeting of the abnormal lymph node for surgical removal.

    at UCLA

  • Standard or comprehensive radiation therapy to treat early-stage breast cancer previously treated with chemotherapy and surgery

    “Is comprehensive radiation therapy more effective than standard radiation therapy in treating patients with breast cancer?”

    open to eligible females ages 18 years and up

    This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer

    at UC Davis UC Irvine UCSD

  • Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutation With Advanced Breast Cancer Who Have Progressed on or After Prior Treatments

    open to eligible people ages 18 years and up

    Study assessing the efficacy and safety of alpelisib plus fulvestrant or letrozole, based on prior endocrine therapy, in patients with PIK3CA mutation with advanced breast cancer who have progressed on or after prior treatments

    at UC Irvine UCSF

  • Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC

    open to eligible people ages 18 years and up

    The GLORIA study is a Phase III, randomized, open-label study to prospectively evaluate the efficacy and safety of adagloxad simolenin (OBI 822)/OBI-821 in the adjuvant treatment of patients with high risk, early stage Globo-H Positive TNBC.

    at UCSD UCSF

  • Study of Cirmtuzumab and Paclitaxel for Metastatic or Locally Advanced, Unresectable Breast Cancer

    open to eligible people ages 18 years and up

    This is a pilot phase 1b study to investigate the safety and side effects of combining the ROR1-targeting monoclonal antibody, cirmtuzumab, with paclitaxel for patients with HER2 negative, metastatic breast cancer. Cirmtuzumab is a type of drug called a monoclonal antibody. This drug is designed to attach to a protein called receptor-tyrosine-kinase like orphan receptor 1 (ROR1) on the surface of breast cancer cells. Cirmtuzumab blocks the growth and survival of the breast cancer cells in laboratory tests. ROR1 is rarely expressed on healthy cells. Cirmtuzumab is considered experimental and is not approved by United States (U.S.) Food and Drug Administration (FDA).

    at UCSD

  • Study of IMMU-132 in HR+/HER2- MBC (TROPICS-02)

    open to eligible people ages 18 years and up

    This is an open-label, randomized, multicenter Phase 3 study to compare the efficacy and safety of Sacituzumab Govitecan versus TPC in subjects with metastatic or locally recurrent inoperable HR+/HER2- MBC, after failure of at least 2, and no more than 4, prior chemotherapy regimens for metastatic disease.

    at UC Irvine UCLA UCSD UCSF

  • Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction With First-Line Chemotherapy Plus Pembrolizumab in Triple Negative Breast Cancer (TNBC) (MK-7339-009/KEYLYNK-009)

    open to eligible people ages 18 years and up

    The purpose of this study is to compare the efficacy of olaparib (MK-7339) plus pembrolizumab (MK-3475) with chemotherapy plus pembrolizumab after induction with first-line chemotherapy plus pembrolizumab in triple negative breast cancer (TNBC). The primary hypotheses are: 1. Olaparib plus pembrolizumab prolongs progression-free survival (PFS) compared with chemotherapy plus pembrolizumab. 2. Olaparib plus pembrolizumab is non-inferior to chemotherapy plus pembrolizumab in terms of overall survival (OS). 3. Olaparib plus pembrolizumab prolongs OS compared with chemotherapy plus pembrolizumab.

    at UCSF

  • Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma

    open to eligible females ages 18 years and up

    This study is a randomized trial of hypofractionation (short-course) radiation therapy versus conventional radiation therapy in women who have undergone mastectomy and immediate breast reconstruction. The investigators will assess cosmetic and reconstruction outcomes, lymphedema, cancer status, side effects, and oncologic outcomes.

    at UCSF

  • Talimogene Laherparepvec With Chemotherapy or Endocrine Therapy in Treating Participants With Metastatic, Unresectable, or Recurrent HER2- Negative Breast Cancer

    open to eligible people ages 18 years and up

    This phase Ib trials studies the side effects and how well talimogene laherparepvec works when given together with chemotherapy or endocrine therapy in treating patients with breast cancer that does not express the human epidermal growth factor receptor 2 (HER2) protein and has spread to other places in the body (metastatic), cannot be removed by surgery (unresectable), or has come back (recurrent). Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may attack specific tumor cells and stop them from growing or kill them. Chemotherapy drugs, such as nab-paclitaxel, gemcitabine, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Estrogen can cause the growth of breast cancer cells. Drugs used as endocrine therapy, such as letrozole, anastrozole, exemestane, tamoxifen or fulvestrant, may lessen the amount of estrogen made by the body or may may stop the growth of tumor cells by blocking estrogen from connecting to the cancer cells. Giving talimogene laherparepvec with chemotherapy or endocrine therapy may work better in treating patients with HER2-negative breast cancer.

    at UCSF

  • Targeted therapy directed by genetic testing in treating patients with advanced solid tumors, lymphomas, or multiple myeloma

    “Will identifying genetic abnormalities in tumor cells help doctors plan better, more personalized treatment for cancer patients?”

    open to eligible people ages 18 years and up

    This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.

    at UC Davis UC Irvine UCSD

  • Testing the Addition of an Anti-cancer Drug, M6620, to the Usual Treatment (Radiation Therapy) for Chemotherapy-Resistant Triple-Negative and Estrogen and/or Progesterone Receptor Positive, HER2 Negative Breast Cancer

    open to eligible people ages 18 years and up

    This phase Ib trial studies the best dose of M6620 when given together with the usual treatment (radiation therapy) in treating patients with triple negative or estrogen receptor and/or progesterone receptor positive, HER-2 negative breast cancer. M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving M6620 and radiation therapy may kill tumor cells more effectively than radiation alone or shrink or stabilize breast cancer for longer than radiation therapy alone.

    at UC Davis

  • Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer

    open to eligible people ages 18 years and up

    This phase I/II trial studies the effects (good and bad) of adding copanlisib to the usual therapy of fulvestrant and abemaciclib in treating patients with hormone receptor positive and HER2 negative stage IV breast cancer. Some breast cancer cells have receptors for the hormones estrogen or progesterone. These cells are hormone receptor positive and they need estrogen or progesterone to grow. This can affect how the cancer is treated. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Abemaciclib and copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Adding copanlisib to the usual therapy of fulvestrant and abemaciclib may work better than giving fulvestrant and abemaciclib alone in treating patients with breast cancer.

    at UC Irvine

  • Testing the Addition of Radium Therapy (Radium-223 Dichloride) to the Usual Chemotherapy Treatment (Paclitaxel) for Advanced Breast Cancer That Has Spread to the Bones

    open to eligible people ages 18 years and up

    This phase II trial studies how well radium-223 dichloride and paclitaxel work in treating patients with advanced breast cancer that has spread to the bones. Radium-223 dichloride is a radioactive drug that behaves in a similar way to calcium and collects in cancer that has spread to the bones (bone metastases). The radioactive particles in radium-223 dichloride act on bone metastases, killing the tumor cells and reducing the pain that they can cause. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving radium-223 dichloride and paclitaxel may work better in treating patients with metastatic breast cancer compared to paclitaxel alone.

    at UC Davis

  • Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer

    open to eligible people ages 18 years and up

    This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body (metastatic). Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab is a form of "targeted therapy" because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Monoclonal antibodies, such as pertuzumab, may interfere with the ability of cancer cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab may kill more tumor cells.

    at UC Irvine

  • The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer

    open to eligible people ages 18 years and up

    This research study is studying a combination of drugs as a possible treatment for breast cancer. The drugs involved in this study are: - Group A: Trastuzumab (Herceptin) + Vinorelbine (Navelbine) - Group B: Trastuzumab + Vinorelbine + Avelumab - Group C: Trastuzumab + Vinorelbine + Avelumab + Utomilumab (PF-05082566)

    at UCSF

  • The Breast Cancer WEight Loss Study (BWEL Study)

    open to eligible females ages 18 years and up

    This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.

    at UC Davis UCSD UCSF

  • The PROMISE Study: Duavee in Women With DCIS

    open to eligible females ages 18-79

    The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the breast tissue of the study subjects. The study drug is approved by the US Food and Drug Administration in healthy postmenopausal women to treat certain symptoms of menopause such as hot flashes. Since it is not approved in women with DCIS, its use in this study is experimental. This study will also look at whether taking the study drug causes any significant or undesirable side effects in women with DCIS. The researchers hope that this study will help them determine if taking the study drug is safe in women taking DCIS and if it can possibly reduce the risk of developing breast cancer in women with DCIS.

    at UCSF

  • The WISDOM Study (thewisdomstudy.org)

    “What is the best mammogram screening schedule for women? Clinical experts disagree. Help us find out!”

    open to eligible females ages 40-74

    Most physicians still use a one-size-fits-all approach to breast screening in which all women, regardless of their personal history, family history or genetics (except BRCA carriers) are recommended to have annual mammograms starting at age 40. Mammograms benefit women by detecting cancers early when they are easier to treat, but they are not perfect. Recent news stories have discussed some of the potential harms: large numbers of positive results that cause stressful recalls for additional mammograms and biopsies. With the current screening approach, half of the women who undergo annual screening for ten years will have at least one false positive biopsy. Potentially more important are cancer diagnoses for growths that might never come to clinical attention if left alone (called "overdiagnosis"). This can lead to unnecessary treatment. Even more concerning is evidence that up to 20% of breast cancers detected today may fall into the category of "overdiagnosis." This study compares annual screening with a risk-based breast cancer screening schedule, based upon each woman's personal risk of breast cancer. The investigators have designed the study to be inclusive of all, so that even women who might be nervous about being randomly assigned to receive a particular type of care (a procedure that is typical in clinical studies) will still be able to participate by choosing the type of care they receive. For participants in the risk-based screening arm, each woman will receive a personal risk assessment that includes her family and medical history, breast density measurement and tests for genes (mutations and variations) linked to the development of breast cancer. Women who have the highest personal risk of developing breast cancer will receive more frequent screening, while women with a lower personal risk would receive less frequent screening. No woman will be screened less than is recommended by the USPSTF breast cancer screening guidelines. If this study is successful, women will gain a realistic understanding of their personal risk of breast cancer as well as strategies to reduce their risk, and fewer women will suffer from the anxiety of false positive mammograms and unnecessary biopsies. The investigators believe this study has the potential to transform breast cancer screening in America.

    at UC Davis UC Irvine UCLA UCSD UCSF

  • The XENERA™ 1 Study Tests Xentuzumab in Combination With Everolimus and Exemestane in Women With Hormone Receptor Positive and HER2-negative Breast Cancer That Has Spread

    open to eligible females ages 18 years and up

    The main objective of the trial is to assess the anti-tumor activity of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in patients with HR+/ HER2- advanced or metastatic breast cancer and non-visceral disease.

    at UCSF

  • This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer.

    open to eligible people ages 18 years and up

    For each dose finding cohorts (A, B, C and D): The primary objective of each dose finding cohort is to determine the maximum tolerated dose (MTD) / recommended phase II dose (RP2D) of xentuzumab in combination with abemaciclib with or without hormonal therapy (letrozole, anastrozole, fulvestrant). Dose limiting toxicities (DLT) will be assessed during the first treatment cycle to assess the MTD/RP2D. In case that no MTD is reached a RP2D dose will be determined taking into account safety data and other available information. This will be agreed with the Steering Committee. For each expansion cohorts (E, D1, D2 and F): The objectives of the expansion cohorts are to assess the anti-tumour activity of xentuzumab in combination with abemaciclib in patients with non-small cell lung cancer (cohort E). Cohort F will assess the anti-tumour activity of the triplet combination xentuzumab / abemaciclib and fulvestrant in a single-arm expansion group of patients with locally advanced / metastatic hormone receptor positive (HR+) HR2- breast cancer who have progressed following Prior therapy with an aromatase inhibitor and different CDK4/6 inhibitor (excluding abemaciclib). The primary objective of cohorts D1 and D2 is to assess the anti-tumour activity of the triplet combination xentuzumab, abemaciclib and fulvestrant in patients with locally advanced / metastatic HR+ breast cancer who have progressed on prior endocrine therapy. Cohort D1 will assess the anti-tumour activity for subjects with visceral metastasis and Cohort D2 for subjects with non-visceral metastasis.

    at UCLA

  • TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers

    open to eligible people ages 18 years and up

    This is a phase 1/1b open label, multicenter dose escalation and dose expansion study to investigate the safety, tolerability and anti-tumor activity of TPST-1120, a small molecule selective antagonist of PPARα (peroxisome proliferator activated receptor alpha) as monotherapy and in combination with a systemic anticancer agent, nivolumab, an anti-PD1 antibody, in subjects with advanced solid tumors.

    at UCSF

  • Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

    open to eligible people ages 18 years and up

    This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants' cancer: - Cannot be removed by an operation - Has spread to other parts of the body

    at UCLA UCSF

  • Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer

    open to eligible people ages 18 years and up

    This phase II trial investigates how well trastuzumab deruxtecan works alone or in combination with anastrozole in treating patients with HER2 low, hormone receptor positive breast cancer. Trastuzumab deruxtecan is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab attaches to HER2 expressed at low levels on cancer cells in a targeted way and delivers deruxtecan to kill them. Anastrozole works by decreasing estrogen production and suppressing the growth of tumors that need estrogen to grow. This study is evaluating how effective trastuzumab deruxtecan is at treating hormone receptor positive cancer cells that have low levels of HER2 expressed on them when given alone or in combination with anastrozole.

    at UCLA

  • Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer

    open to eligible people ages 18 years and up

    This is a study of trastuzumab deruxtecan, which was approved by the FDA (in December 2019) for the treatment of HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens. Participants will receive this study drug along with a cancer drug, an immune checkpoint inhibitor, anti-PD1, called nivolumab. The study will be done in two parts: - Part 1 is to identify the recommended dose to use for treatment. - Part 2 is to find out how well the combination works, and how safe and tolerable it is.

    at UCLA

  • Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer

    open to eligible females ages 18 years and up

    The purpose of phase 1 is to determine safety, tolerability and pharmacokinetics (PK) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer. The purpose of phase 2 is to estimate the efficacy of H3B-6545 in terms of best overall response rate, duration of response (DoR), clinical benefit rate (CBR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) in all participants with ER-positive, HER2-negative breast cancer and in those with and without ER alpha mutation [including a clonal estrogen receptor 1 gene (ESR1) Y537S mutation].

    at UCLA UCSF

  • 9-ING-41 in Patients With Advanced Cancers

    Sorry, not currently recruiting here

    GSK-3β is a potentially important therapeutic target in human malignancies. The Actuate 1801 Phase 1/2 study is designed to evaluate the safety and efficacy of 9-ING-41, a potent GSK-3β inhibitor, as a single agent and in combination with cytotoxic agents, in patients with refractory cancers.

    at UCSF

  • A Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

    Sorry, in progress, not accepting new patients

    The main purpose of this study is to learn if adding bevacizumab to standard treatment with chemotherapy (docetaxel, doxorubicin, and cyclophosphamide) for early stage HER2-negative breast cancer will prevent breast cancer from returning. A second purpose of this study is to learn if adding bevacizumab to treatment with chemotherapy will help women with HER2-negative breast cancer live longer. The researchers also want to learn about the side effects of the combination of drugs used in this study.

    at UCLA

  • A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors ( PIVOT-02 )

    Sorry, in progress, not accepting new patients

    In this four-part study, NKTR-214 will be administered in combination with nivolumab in Part 1, in combination with nivolumab with or without various chemotherapies in Part 2, and with nivolumab and ipilimumab in Parts 3 & 4. In Part 1, the Recommended Phase 2 Dose (RP2D) of NKTR-214 in combination with nivolumab will be determined. In Part 2, NKTR-214 with nivolumab at the RP2D will be evaluated as first-line therapy and/or as second or third line therapy in select patients with Melanoma, Renal Cell Carcinoma (RCC), Non-Small Cell Lung Cancer (NSCLC), Urothelial Carcinoma (UC), metastatic Breast Cancer (mBC) and Colorectal Cancer (CRC). In addition, in Part 2, the RP2D of NKTR-214 with nivolumab and various chemotherapies and regimens in select cohorts of NSCLC patients will be determined. In Part 3, several different regimens of the triplet combination of NKTR-214 plus nivolumab and ipilimumab will be evaluated in select patients with RCC, NSCLC, Melanoma, and UC. In Part 4, the safety and efficacy of the triplet combination will be evaluated further in select patients with RCC, NSCLC, Melanoma and UC.

    at UCLA

  • A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer

    Sorry, in progress, not accepting new patients

    This is an open-label, multicenter, Phase I/II study to assess the safety, tolerability, and pharmacokinetics of GDC-0032. The Phase I portion will be divided into two stages. During Stage 1, GDC-0032 will be administered every day orally and at escalating doses in participants with locally advanced or metastatic solid tumors. During Stage 2, GDC-0032 will be administered alone or as combination therapy within indication-specific cohorts. In Phase II of the study, the efficacy and safety of the combination GDC-0032 and fulvestrant will be evaluated in post-menopausal female participants with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative, hormone receptor-positive breast cancer.

    at UC Davis UC Irvine

  • A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549

    Sorry, in progress, not accepting new patients

    This dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IPI-549 monotherapy and IPI-549 in combination with nivolumab in subjects with advanced solid tumors.

    at UCLA UCSD

  • A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors

    Sorry, in progress, not accepting new patients

    This is a first-in-human, open-label, dose escalation study to evaluate the safety and tolerability of pegilodecakin in participants with advanced solid tumors, dosed daily subcutaneously as a monotherapy or in combination with chemotherapy or immunotherapy.

    at UCLA UCSF

  • A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer

    Sorry, in progress, not accepting new patients

    The study seeks to evaluate the efficacy and tolerability of veliparib/placebo in combination with carboplatin and paclitaxel in HER2-negative metastatic or locally advanced, unresectable, BRCA-associated breast cancer.

    at UCSD

  • A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer

    Sorry, in progress, not accepting new patients

    This study is looking at whether Metformin, an agent that is commonly used to treat diabetes, can decrease or affect the ability of breast cancer cells to grow and whether Metformin will work with other therapies to keep cancer from recurring. Health Canada has not approved the sale or use of Metformin to treat breast cancer, although they have approved its use in this clinical trial. Although Metformin is approved by the FDA for the treatment of diabetes, its use in breast cancer is considered investigational.

    at UC Davis UC Irvine UCLA UCSD UCSF

  • A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)

    Sorry, in progress, not accepting new patients

    The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations.

    at UCLA UCSF

  • A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer

    Sorry, in progress, not accepting new patients

    The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib + fulvestrant or fulvestrant alone. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9 months for each participant. For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.

    at UCSF

  • A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer

    Sorry, in progress, not accepting new patients

    The main purpose of this study is to evaluate the safety and efficacy of abemaciclib in combination with pembrolizumab in participants with advanced non-small cell lung cancer (NSCLC) or hormone receptor positive (HR+), human epidermal growth factor receptor negative (HER2-) breast cancer.

    at UCSF

  • A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer

    Sorry, in progress, not accepting new patients

    The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus physicians choice standard of care chemotherapy in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.

    at UCLA

  • A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)

    Sorry, in progress, not accepting new patients

    This multicenter, randomized, double-blind study will evaluate the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents.

    at UCSF

  • A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)

    Sorry, in progress, not accepting new patients

    Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug. It has not yet been approved for use. DS-8201a may slow down tumor growth. This might improve outcomes for these patients.

    at UCLA UCSF

  • A Study of Experimental Elacestrant vs. Standard of Care for ER+/HER2- Advanced Breast Cancer

    Sorry, in progress, not accepting new patients

    This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI) .

    at UC Davis UCLA

  • A Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer.

    Sorry, not currently recruiting here

    This study will evaluate the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.

    at UCLA

  • A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

    Sorry, not currently recruiting here

    This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2-) breast adenocarcinoma who are not suitable for endocrine therapy.

    at UC Davis UCSD UCSF

  • A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread

    Sorry, in progress, not accepting new patients

    This study evaluates the safety of abemaciclib in combination therapies (letrozole, anastrozole, tamoxifen, exemestane, exemestane plus everolimus, trastuzumab, LY3023414 plus fulvestrant, pertuzumab plus trastuzumab with loperamide, or ongoing endocrine therapy) for breast cancer that has spread to other parts of the body.

    at UCSD

  • A Study of LY3023414 in Participants With Advanced Cancer

    Sorry, in progress, not accepting new patients

    The purpose of this study is to find a recommended dose level and schedule of dosing LY3023414 that can safely be taken by participants with advanced or metastatic cancer. The study will also explore the changes to various markers in blood cells and potentially tumor cells. Finally, the study will help document any antitumor activity this drug may have. In Part A of this study, participants with advanced/metastatic cancer (including lymphoma) will receive increasing doses of LY3023414. In Part B, LY3023414 will be explored in different types of cancer, including breast and lung cancer, lymphoma and mesothelioma.

    at UCLA

  • A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer

    Sorry, not currently recruiting here

    The reason for this study is to see if the study drug LY3484356 alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer.

    at UC Irvine UCSF

  • A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer

    Sorry, in progress, not accepting new patients

    The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio.

    at UCLA

  • A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)

    Sorry, in progress, not accepting new patients

    The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.

    at UCLA UCSF

  • A Study of Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer

    Sorry, in progress, not accepting new patients

    This research study is evaluating a drug called Palbociclib in combination with endocrine therapy as a possible treatment for hormone receptor positive breast cancer. - Palbociclib is a drug that may stop cancer cells from growing. Palbociclib blocks activity of two closely related enzymes (proteins that help chemical reactions in the body occur), called Cyclin D Kinases 4 and 6 (CDK 4/6). These proteins are part of a pathway, or a sequence of steps which is known to regulate cell growth. Laboratory testing has suggested palbociclib may stop the growth of hormone receptor positive breast cancer. - Endocrine therapy prevents breast cancer cell growth by blocking estrogen stimulation. During this study endocrine therapy will either be tamoxifen or an aromatase inhibitor. It is standard of care for premenopausal women to take tamoxifen and for postmenopausal women to take either an aromatase inhibitor or tamoxifen after a diagnosis of hormone receptor positive breast cancer.

    at UCSF

  • A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer

    Sorry, in progress, not accepting new patients

    Approximately 70 patients with HR+ advanced breast cancer will be enrolled. All patients will receive either fulvestrant (500 mg IM every 2 weeks x 3 then every four weeks) or tamoxifen (20 mg PO daily by physician choice). Pre-menopausal women must be in chemical menopause. Arm 1 will receive palbociclib 100 mg qd, days 1-21 every 28 days. Arm 2 will receive palbociclib 125 mg qd, days 1-21 every 28 days. Restaging will be performed every 8 weeks. Therapy will be continued until PD or unacceptable toxicity. Patients will be randomly allocated in a 1:1 ratio to take either 100 mg or 125 mg of palbociclib. Randomized treatment assignments will be made by permuted blocks, generated by our collaborating statistician at Dana-Farber Cancer Institute.

    at UCSF

  • A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer

    Sorry, in progress, not accepting new patients

    This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).

    at UCSD

  • A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer

    Sorry, in progress, not accepting new patients

    This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane.

    at UC Davis

  • A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)

    Sorry, in progress, not accepting new patients

    This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.

    at UC Irvine

  • A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer

    Sorry, in progress, not accepting new patients

    This study is being done to see if tucatinib works better than placebo to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. All patients in the study will get capecitabine and trastuzumab, two drugs that are often used to treat this cancer. There are two parts to this study. The first part of the study is already complete. Patients were randomly assigned to get either tucatinib or placebo (a pill with no medicine). Since this part was "blinded," neither patients nor their doctors knew whether a patient got tucatinib or placebo. The second part of the study is called the Unblinded Phase. In this part of the study, participants and their doctors know which drugs are being given. Participants who used to get or are currently getting placebo may be able to start taking tucatinib instead. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills two times every day. They will swallow capecitabine pills two times a day during the first two weeks of each cycle. Patients will get trastuzumab injections from the study site staff on the first day of every cycle.

    at UCLA UCSF

  • A Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Advanced Malignancies

    Sorry, in progress, not accepting new patients

    This is a Phase 1, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and clinical activity of etrumadenant (AB928) in combination with zimberelimab (AB122) (an anti-PD-1 antibody) in participants with advanced malignancies.

    at UCLA

  • Abexinostat, Palbociclib, and Fulvestrant for the Treatment of Breast or Gynecologic Cancer

    Sorry, not yet accepting patients

    This phase I trial investigates the side effects and best dose of abexinostat and palbociclib when given together with fulvestrant in treating patients with breast or gynecologic cancer. Abexinostat may prevent tumor cells from growing and multiplying and may kill tumor cells. Palbociclib may prevent or slow the growth of tumor cells when used with other anti-hormonal therapy. Estrogen can cause the growth of breast and gynecologic tumor cells. Fulvestrant may help fight breast or gynecologic cancer by blocking the use of estrogen by the tumor cells. Giving abexinostat, palbociclib, and fulvestrant may work better in treating patients with breast or gynecologic cancer.

    at UCSF

  • Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer

    Sorry, in progress, not accepting new patients

    The purpose of this study is to find out what effect the postoperative combination of therapies: trastuzumab (herceptin) and paclitaxel (taxol) will have on breast cancer recurrence. A combination of trastuzuamb and chemotherapy has been used in women with node positive and high risk node negative disease. This tests utilizes a well tolerated regimen of weekly paclitaxel and trastuzumab in women with T1, node negative tumors that are HER2 positive. We would like to determine how effective this drug combination is when used in women with early stage breast cancer, as well as to better define the side effects of this treatment.

    at UCSF

  • ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D

    Sorry, in progress, not accepting new patients

    This is a randomised, open label multi-centre phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer. Patients will be enrolled according to one of two design schemas, with Design 2 having two chemotherapy options (Design 2 and 2B), and will be randomised to one of four treatment regimens within each design schema. The primary objective of this study is to compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomised to trastuzumab for one year versus lapatinib for one year versus trastuzumab (12 or 18 weeks, according to assigned design) followed by a six-week treatment-free interval followed by lapatinib (28 or 34 weeks, according to assigned design) versus trastuzumab in combination with lapatinib for one year (52 weeks). Secondary objectives include treatment comparisons with respect to overall survival, time to recurrence, time to distant recurrence, safety and tolerability, incidence of brain metastasis, and analyses conducted separately for cohorts of patients defined by presence or absence of cMyc oncogene amplification, expression level of PTEN and presence or absence of the p95HER2 receptor. On August 18, 2011, the ALTTO Independent Data Monitoring Committee (IDMC) met to review the first planned interim analysis. The IDMC reported that the comparison of lapatinib alone versus trastuzumab alone crossed the futility boundary, indicating that the lapatinib alone arm was unlikely to meet the pre-specified criteria to demonstrate non-inferiority to trastuzumab alone with respect to disease-free survival (DFS). The IDMC also stated that the other three arms (trastuzumab alone, sequential trastuzumab/lapatinib arm and the combination arm) should continue as planned with no changes.

    at UCSF

  • An Expanded Access Study to Provide at Home Subcutaneous Administration of Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Patients With HER2-Positive Breast Cancer During the COVID-19 Pandemic

    Sorry, not accepting new patients

    This single arm, multicenter study provides the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) administered at home by a home health nursing provider for patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer who are currently receiving pertuzumab (Perjeta) and trastuzumab (Herceptin) by intravenous administration (P+H IV). The main objective is to enable continuity of care during the COVID-19 pandemic. This study will enroll approximately 400 participants with HER2+ breast cancer who have completed concurrent chemotherapy with P+H IV and are currently receiving or will be receiving maintenance therapy with pertuzumab and trastuzumab. Participants will receive treatment every 3 weeks and continue treatment unless early cessation is necessary due to disease recurrence, disease progression, unacceptable toxicity or participant withdrawal. Only participants with HER2+ early breast cancer will receive PH FDC SC to complete 18 cycles of dual blockade, including the P+H IV they received prior to enrolling in this study. The Sponsor may decide to terminate the study when the COVID-19 pandemic is no longer a risk for this patient population.

    at UCSF

  • An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide

    Sorry, in progress, not accepting new patients

    An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated with Neratinib and Loperamide or other prophylactic measures.

    at UCLA UCSF

  • Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer

    Sorry, in progress, not accepting new patients

    The purpose of this study is to study patients presenting with stage IV breast cancer. Stage IV means that the breast cancer has spread to another part of the body outside the breast. This study is important because in different parts of the country some patients are being offered surgical treatment for the breast tumor and some are not. The doctors do not know if surgery for the breast tumor is helpful in patients with stage IV breast cancer. The doctors will collect information about the patient and their treatment to learn more about how patients and doctors make treatment decisions. The doctor will also collect blood samples and tissue samples for laboratory studies to learn more about tumors that have spread to other parts of the body.

    at UCSF

  • ASCENT-Study of Sacituzumab Govitecan in Refractory/Relapsed Triple-Negative Breast Cancer

    Sorry, in progress, not accepting new patients

    This is an international, multi-center, open-label, randomized, Phase III study in patients with metastatic TNBC refractory or relapsing after at least 2 prior chemotherapies (including a taxane) for their metastatic disease. Patients meeting eligibility will be randomized 1:1 to receive either sacituzumab govitecan or treatment of physician choice (TPC) Patients will be treated until progression, unacceptable toxicity, study withdrawal, or death, whichever comes first. Tumor progression leading to treatment withdrawal will be assessed by the investigator. Starting with the initial dose of sacituzumab govitecan or TPC, Imaging assessments will be obtained at least every 6 weeks for 36 weeks, then every 9 weeks thereafter until the occurrence of progression of disease requiring discontinuation of further treatment. All patients will be followed every 4 weeks for survival follow-up.

    at UCLA UCSF

  • Azacitidine and Entinostat in Treating Patients With Advanced Breast Cancer

    Sorry, in progress, not accepting new patients

    This phase II trial studies how well giving azacitidine and entinostat work in treating patients with advanced breast cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving azacitidine together with entinostat may kill more tumor cells.

    at UC Davis

  • Bicalutamide in Treating Patients With Metastatic Breast Cancer

    Sorry, in progress, not accepting new patients

    RATIONALE: Androgens can cause the growth of breast cancer cells. Antihormone therapy, such as bicalutamide, may stop the adrenal glands from making androgens.

    PURPOSE: This phase II trial is studying how well bicalutamide works in treating patients with metastatic breast cancer.

    at UCSF

  • Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer

    Sorry, in progress, not accepting new patients

    RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.

    PURPOSE: This phase II trial studies how well breast-conserving surgery and radiation therapy work in treating patients with multiple ipsilateral breast cancer

    at UCSD

  • BrUOG 291: Five Fraction Partial Breast Irradiation Using Non-invasive Image-guided Breast Brachytherapy (NIBB)

    Sorry, in progress, not accepting new patients

    To evaluate safety of 5 fraction accelerated partial brest irradiation in more convenient 5 fraction schedule.

    at UCSD

  • Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer

    Sorry, in progress, not accepting new patients

    This phase II randomized trial studies how well bupropion hydrochloride works in improving sexual desire in women with breast or gynecological cancer. Bupropion hydrochloride may work by boosting sexual desire, energy, or motivation without causing intolerable or undesirable side effects.

    at UCLA

  • Carboplatin and Paclitaxel With or Without Atezolizumab Before Surgery in Treating Patients With Newly Diagnosed, Stage II-III Triple-Negative Breast Cancer

    Sorry, in progress, not accepting new patients

    This phase II trial studies how well carboplatin and paclitaxel with or without atezolizumab before surgery works in treating patients with newly diagnosed, stage II-III triple negative breast cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carboplatin and paclitaxel with or without atezolizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

    at UC Davis

  • Carboplatin+Nab-paclitaxel, Plus Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting

    Sorry, in progress, not accepting new patients

    This phase II is studying the side effects and how well carboplatin and paclitaxel albumin-stabilized nanoparticle formulation when together with bevacizumab or trastuzumab before surgery works in treating patients with stage I-III breast cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab and trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) and monoclonal antibody therapy together before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

    at UC Irvine

  • Cisplatin With or Without Veliparib in Treating Patients With Recurrent or Metastatic Triple-Negative and/or BRCA Mutation-Associated Breast Cancer With or Without Brain Metastases

    Sorry, in progress, not accepting new patients

    This randomized phase II trial studies how well cisplatin works with or without veliparib in treating patients with triple-negative breast cancer and/or BRCA mutation-associated breast cancer that has come back (recurrent) or has or has not spread to the brain (brain metastases). Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as veliparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. It is not yet known if cisplatin is more effective with or without veliparib in treating patients with triple-negative and/or BRCA mutation-associated breast cancer.

    at UC Davis

  • Comparing Letrozole Given Alone to Letrozole Given With Avastin in Post-Menopausal Women Breast Cancer

    Sorry, in progress, not accepting new patients

    This purpose of this trial is to show that the combination of Avastin and hormone therapy should be more effective than hormone therapy alone for the treatment of breast cancer.

    at UCSF

  • Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer

    Sorry, in progress, not accepting new patients

    This phase I/II trial studies side effects and best dose of copanlisib when given together with letrozole and palbociclib and to see how well they work in treating hormone receptor positive HER2 negative stage I-IV breast cancer. Copanlisib and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs, such as letrozole, may lessen the amount of estrogen made by the body. Giving copanlisib, letrozole, and palbociclib may work better in treating patients with breast cancer.

    at UCLA

  • Docetaxel and Cyclophosphamide Compared to Anthracycline-Based Chemotherapy in Treating Women With HER2-Negative Breast Cancer

    Sorry, in progress, not accepting new patients

    RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of breast cancer cells, either by killing the cells or by stopping them from dividing. Giving the drugs in different combinations may kill more breast cancer cells. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.

    PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating women with non-metastatic breast cancer.

    at UCSD

  • Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer

    Sorry, in progress, not accepting new patients

    This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery and help prevent the tumor from returning. It is not yet known whether doxorubicin hydrochloride, cyclophosphamide, and paclitaxel are more effective with or without bevacizumab.

    at UC Davis UCSD UCSF

  • DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]

    Sorry, in progress, not accepting new patients

    This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.

    at UCLA UCSF

  • Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer

    Sorry, in progress, not accepting new patients

    RATIONALE: Early surgery may have fewer side effects and improve recovery. Palliative surgery or radiation therapy may help patients with advanced breast cancer live more comfortably. It is not yet known whether early surgery is more effective than palliative therapy for advanced breast cancer.

    PURPOSE: This randomized phase III trial is studying early surgery to see how well it works compared to standard palliative therapy in treating patients with stage IV breast cancer.

    at UC Irvine

  • Economic and Social Disparities and Breast Cancer

    Sorry, not currently recruiting here

    Precariousness is a multifactorial concept that can be broken down in the form of economic insecurity, and / or social insecurity and / or territorial insecurity. Precariousness has an impact on health that is difficult to assess precisely because it also impacts on other factors that may themselves influence health. Therefore, the understanding of the impact of precariousness on health involves studying individuals in their context. Our study is designed to assess the impact of precariousness on the history of breast cancer, on care pathways, on treatment and rehabilitation in a multidisciplinary contextual analysis. Indeed, the socio -economic and geographical inequalities affect the history of breast cancer, treatment and its delay and post- treatment rehabilitation. The main objective of this project is to compare the stage of disease at diagnosis (according to the TNM classification) in deprived and non deprived patients. The secondary objectives are to compare in the two groups - the socio-economic and geographical inequalities - the direct and indirect costs related to the management, the out-of pocket costs and to describe, based on individual inequalities identified, the pathway of care of the patient. These objectives will be pursued in the framework of an observational cohort study, prospective, multicenter (Ile de France) comparative exposed / unexposed category. Each precarious patient will be matched to a non- precarious patient in the same age group, regardless of the center. The study will include any patient resident in Ile de France seeking treatment for breast cancer, regardless of the stage.

    at UCSF

  • Efficacy and Safety of Dignicap System for Preventing Chemotherapy Induced Alopecia

    Sorry, in progress, not accepting new patients

    The efficacy and safety of the Dignicap System to prevent chemotherapy induced alopecia will be evaluated in women with early breast cancer undergoing adjuvant or neoadjuvant chemotherapy regimens. The scalp cold cap will be applied at each chemotherapy cycle. Hair loss will be evaluated by patient self assessment of 5 standardized photographs taken prior to each chemotherapy cycle. A concurrent control group not using a cold cap will also be evaluated.

    at UCSF

  • Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer

    Sorry, in progress, not accepting new patients

    The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.

    at UC Davis UCSF

  • Evaluating the Effectiveness and Outcomes of Silicone Breast Prosthetics

    Sorry, in progress, not accepting new patients

    This trial will evaluate the outcome of placement of silicone breast prosthetics.

    at UC Irvine

  • Evaluation of Mammographic Breast Density in Participants With Hormone Receptor-Negative Breast Cancer Enrolled on Study A011502

    Sorry, not currently recruiting here

    This phase III trial evaluates mammographic breast density in participants with hormone receptor-negative breast cancer enrolled on study A011502. High breast density has been shown to be a strong risk factor for developing breast cancer and decreasing breast density may decrease the risk for breast cancer. Participants treated with aspirin may show reduced breast density on a mammogram.

    at UC Davis

  • Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation

    Sorry, not accepting new patients

    Expanded access for patients with cancer with RET activation who are ineligible for an ongoing selpercatinib (also known as LOXO-292) clinical trial or have other considerations that prevent access to selpercatinib through an existing clinical trial.

    at UCLA UCSD UCSF

  • Expanded Access Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer

    Sorry, not accepting new patients

    The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

    at UCLA

  • FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors

    Sorry, in progress, not accepting new patients

    This is a Phase 1, single-dose, open-label, dose-escalation study. The study will be conducted in three parts (i.e. regimens) in an outpatient setting as follows: - Regimen A: FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies. - Regimen B: FATE-NK100 in combination with trastuzumab in subjects with human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer, HER2+ advanced gastric cancer or other advanced HER2+ solid tumors. - Regimen C: FATE-NK100 in combination with cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell cancer (HNSCC), or other epidermal growth factor receptor 1 positive (EGFR1+) advanced solid tumors.

    at UCSD

  • Following the Use of Gel Prosethetics in Breast Reconstruction

    Sorry, in progress, not accepting new patients

    Following placement of silicone breast prosthetics for reconstruction

    at UC Irvine

  • FPA150 in Patients With Advanced Solid Tumors

    Sorry, in progress, not accepting new patients

    This is a multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of FPA150, an anti-B7H4 antibody alone or in combination with pembrolizumab an anti-PD1 antibody in patients with advanced solid tumors. The Phase 1a, open-label, cohort will identify a recommended dose of FPA150 to use for Phase 1a Combination (FPA150 and Pembrolizumab) Safety Lead-in and for Phase 1b monotherapy cohorts.

    at UCLA

  • Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer

    Sorry, not currently recruiting here

    This is an open-label, multi-institution, phase Ib trial that evaluates the safety and tolerability and preliminary anti-tumor activity of fulvestrant, palbociclib and erdafitinib in patients with ER+/HER2-/FGFR-amplified metastatic breast cancer.

    at UCSF

  • Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery

    Sorry, in progress, not accepting new patients

    RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer.

    PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.

    at UC Davis UCLA UCSD

  • Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)

    Sorry, in progress, not accepting new patients

    This randomized phase III trial studies the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25. Estrogen can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hormone therapy together with more than one chemotherapy drug (combination chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the benefit of adding chemotherapy to hormone therapy for women with node-negative, estrogen-receptor positive breast cancer is small. New tests may provide information about which patients are more likely to benefit from chemotherapy.

    at UC Davis UC Irvine UCLA UCSD UCSF

  • Identification and Validation of Biomarkers for Breast Cancer Resistance Protein (BCRP)

    Sorry, not yet accepting patients

    This is a randomized, two-arm crossover study. Subjects will undergo a placebo and rosuvastatin phase and eltrombopag and rosuvastatin phase to identify biomarkers for Breast Cancer Resistance Protein (BCRP).

    at UCSF

  • Lapatinib and Bevacizumab for Metastatic Breast Cancer

    Sorry, in progress, not accepting new patients

    This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with ErbB2-overexpressing breast cancer.

    at UCSF

  • Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer

    Sorry, in progress, not accepting new patients

    RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating patients with hormone receptor-positive breast cancer.

    PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating postmenopausal women who have received hormone therapy for hormone receptor-positive breast cancer.

    at UC Irvine UCLA UCSD UCSF

  • Male Breast Cancer: Understanding the Biology for Improved Patient Care

    Sorry, in progress, not accepting new patients

    Rationale: Gathering medical information and tumor samples from patients with male breast cancer may help doctors learn more about the disease. Purpose retrospective part: to perform a large international retrospective analysis of clinical and biological data of male BC patients treated in the participating centers from 1990 to 2010. Purpose prospective part: to create a registry of men with breast cancer for a period of 30 months (starting early 2014).

    at UCSF

  • Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer

    Sorry, in progress, not accepting new patients

    The purpose of this study is to determine whether patients treated with margetuximab plus chemotherapy have longer progression free survival and overall survival than patients treated with trastuzumab plus chemotherapy.

    at UC Davis UCLA UCSF

  • Mindfulness Meditation or Survivorship Education in Improving Behavioral Symptoms in Younger Stage 0-III Breast Cancer Survivors (Pathways to Wellness)

    Sorry, in progress, not accepting new patients

    This randomized phase III trial studies how well mindfulness meditation or survivorship education work in improving behavioral symptoms in younger stage 0-III breast cancer survivors. Behavioral interventions, such as mindfulness meditation, use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. Survivorship education after treatment may reduce stress and improve the well-being and quality of life of patients with breast cancer. Mindfulness meditation or survivorship education may help improve the health behaviors of younger breast cancer survivors.

    at UCLA

  • MRI and Mammography Before Surgery in Patients With Stage I-II Breast Cancer

    Sorry, in progress, not accepting new patients

    The purpose of this study is to test whether patients undergoing a breast MRI (magnetic resonance imaging) before breast surgery will have better results after the surgery. Breast tumors are routinely evaluated using mammograms and ultrasound before surgery. This study would like to find out if using MRI in addition to mammography before surgery improves our ability to evaluate tumors and decide what kind of surgery is best for the patient.

    at UC Irvine

  • Neo-Adjuvant Abemaciclib With Fulvestrant in Patients With ER/PR +HER Negative Breast Cancer

    Sorry, not yet accepting patients

    This is a phase 2 single-arm, open-label determining efficacy of Neo-adjuvant Abemaciclib and Fulvestrant in subjects with Hormone receptor positive patients with localized non-metastatic breast cancer who develop local recurrence while on adjuvant endocrine therapy with molecular evidence of endocrine resistance.

    at UC Irvine

  • Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer

    Sorry, in progress, not accepting new patients

    This Phase 1/2 study will evaluate the safety and efficacy of combination treatment with niraparib and pembrolizumab (MK-3475) in patients with advanced or metastatic triple-negative breast cancer or recurrent ovarian cancer. (KEYNOTE-162)

    at UCSF

  • Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

    Sorry, in progress, not accepting new patients

    Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

    at UCLA

  • Olaparib In Metastatic Breast Cancer

    Sorry, not currently recruiting here

    This research study is for patients with metastatic breast cancer. - Metastatic means that the cancer has spread beyond the breast. In addition, through genetic testing of the blood or tumor, an altered gene has been found that suggests the tumor may not be able to repair its genetic material (DNA) when it becomes damaged. - This aspect of the cancer may cause it to be more sensitive - that is, more effectively killed by certain types of drugs such as the study agent being evaluated in this trial, Olaparib. - Olaparib is a type of drug known as a PARP inhibitor. Some types of breast cancer and ovarian cancer share some basic features that make them sensitive to similar treatments. Information from those other research studies suggests that this drug may help to treat metastatic breast cancer. - This study will evaluate whether olaparib is effective in breast cancer patients whose tumor has a mutation in one of the other genes that function with BRCA1 and BRCA2 to repair damaged DNA .This mutation may have been inherited from a parent, or may have developed only in the tumor. - This study will also evaluate whether olaparib is effective in breast cancer patients whose tumor has a mutation in BRCA1 or BRCA2 that was acquired by the tumor, but not inherited.

    at UCSF

  • Oxaloacetate for the Improvement of Cognitive Complaints in Stage 0-IIIA Breast Cancer Survivors

    Sorry, not yet accepting patients

    This phase II trial studies how well oxaloacetate works in reducing cognitive complaints in stage 0-IIIA breast cancer survivors. Oxaloacetate is a natural substance found in the body and is available as a nutritional supplement. Giving oxaloacetate may reduce inflammation in the brain that could be contributing to cognitive complaints seen after cancer treatments.

    at UCLA

  • Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery

    Sorry, in progress, not accepting new patients

    This randomized phase III trial studies paclitaxel and trastuzumab with or without lapatinib to see how well they work in treating patients with stage II or stage III breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel with trastuzumab and/or lapatinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which regimen is more effective in treating patients with breast cancer.

    at UC Davis UCSF

  • Paclitaxel, Nab-paclitaxel, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer

    Sorry, in progress, not accepting new patients

    This randomized phase III trial studies the side effects and how well different chemotherapy regimens with or without bevacizumab work in treating patients with stage IIIC or stage IV breast cancer. Drugs used in chemotherapy, such as paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel), and ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may block tumor growth by targeting certain cells and slowing the growth of blood vessels to the tumor. It is not yet known which treatment regimen is more effective in treating patients with breast cancer.

    at UCSD UCSF

  • Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

    Sorry, in progress, not accepting new patients

    The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy. The safety between the two treatment arms will also be compared. During study treatment, pre- and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex® or generic).

    at UCLA UCSD UCSF

  • Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer

    Sorry, in progress, not accepting new patients

    This phase II trial studies the side effects and how well palbociclib and letrozole or fulvestrant works in treating patients aged 70 years and older with estrogen receptor positive, HER2 negative breast cancer that has spread to other places in the body. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as letrozole or fulvestrant, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving palbociclib and letrozole or fulvestrant may work better in treating patients with breast cancer. The trial will explore factors other than chronologic age that can affect toxicity rates as identified using a cancer-specific geriatric assessment.

    at UC Davis

  • PALbociclib CoLlaborative Adjuvant Study

    Sorry, in progress, not accepting new patients

    This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC). The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned.

    at UCSD UCSF

  • Pembrolizumab and Tamoxifen With or Without Vorinostat for the Treatment of Estrogen Receptor Positive Breast Cancer

    Sorry, not yet accepting patients

    This phase II trial studies how well pembrolizumab and tamoxifen with or without vorinostat work for the treatment of estrogen receptor positive breast cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Estrogen can cause the growth of breast cancer cells. Hormone therapy with tamoxifen may may fight breast cancer by blocking the use of estrogen by the tumor cells. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial is being done to find a drug combination to better control estrogen receptor positive breast cancer and reduce the number of pills taken.

    at UCSF

  • Pembrolizumab Combined With Itacitinib (INCB039110) and/or Pembrolizumab Combined With INCB050465 in Advanced Solid Tumors

    Sorry, in progress, not accepting new patients

    This is an open-label, multicenter, Phase 1b platform study in subjects with advanced or metastatic solid tumors (Part 1a) and subjects with selected solid tumors (Part 1b and Part 2). Two treatment groups (Group A and Group B) will be evaluated Part 1a utilizes a 3+3 design to evaluate pembrolizumab and INCB combinations in advanced solid tumors. Group A will evaluate a JAK inhibitor with JAK1 selectivity itacitinib (INCB039110) in combination with pembrolizumab (MK-3475) and Group B will evaluate a PI3K-delta inhibitor (INCB050465) in combination with pembrolizumab to determine the maximum tolerated dose (MTD) or PAD and recommend a dose for the Part 1b safety expansion with each combination. Once the recommended dose has been identified in Part 1a, subjects with select solid tumor types will be enrolled into safety expansion cohorts based upon prior treatment history with a PD-1 pathway-targeted agent (Part 1b) for each combination. Part 2 utilizes a Simon 2-Stage design to evaluate INCB050465 in combination with pembrolizumab in patients with small cell lung cancer (SCLC) and a 1 stage design to evaluate the combination in patients with non-small cell lung cancer (NSCLC) and urothelial cancer (UC).

    at UCSF

  • PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors

    Sorry, not currently recruiting here

    A Phase 1 dose escalation study evaluating safety, tolerability and pharmacokinetics of PF-06952229 in adult patients with advanced solid tumors.

    at UCLA

  • Phase 1b Trial of Dinaciclib With Pembrolizumab for Advanced Breast Cancer

    Sorry, in progress, not accepting new patients

    The purpose of this trial is to determine the safety and tolerability (maximum tolerated dose (MTD)) of weekly dinaciclib in combination with pembrolizumab in patients with advanced breast cancer. Once this is defined, dose expansion will be performed at this MTD in patients with metastatic or locally advanced and unresectable triple negative breast cancer, to evaluate the efficacy of combined dinaciclib and pembrolizumab.

    at UCSF

  • Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors

    Sorry, in progress, not accepting new patients

    Part 1: to assess the safety and tolerability of pyrotinib and to define the maximum tolerated dose (MTD) of pyrotinib in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors (metastatic breast cancer, gastric cancer, or other solid tumors that have no targeted agent as standard of care). Part 2: to estimate the overall response rate (ORR) for patients with HER2-positive metastatic breast cancer (mBC) and HER2 mutant non-small cell lung cancer (NSCLC) treated at the RP2D (or MTD).

    at UC Davis UC Irvine

  • Phase III Study of Docetaxel + Ramucirumab or Placebo in Breast Cancer

    Sorry, in progress, not accepting new patients

    The objective of this study is to compare the progression-free survival (PFS) of the drug combination ramucirumab plus docetaxel to placebo plus docetaxel in previously untreated participants with human epidermal growth factor receptor 2 (HER2)-negative, unresectable, locally-recurrent or metastatic breast cancer.

    at UCLA

  • PRS-343 in Combination With Atezolizumab in HER2-Positive Solid Tumors

    Sorry, currently not accepting new patients, but might later

    A Phase 1b, open-label, dose escalation study of PRS-343 in combination with atezolizumab in patients with HER2-positive advanced or metastatic solid tumors.

    at UCLA

  • PRS-343 in HER2-Positive Solid Tumors

    Sorry, currently not accepting new patients, but might later

    A multi center, open-label, Phase 1 dose escalation study with expansion cohort is designed to determine the MTD, RP2D and dosing schedule of PRS-343 in patients with HER2+ advanced or metastatic solid tumors.

    at UCLA

  • Radiation Therapy (WBI Versus PBI) in Treating Women Who Have Undergone Surgery For Ductal Carcinoma In Situ or Stage I or Stage II Breast Cancer

    Sorry, in progress, not accepting new patients

    RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill any tumor cells that remain after surgery. It is not yet known whether whole breast radiation therapy is more effective than partial breast radiation therapy in treating breast cancer.

    PURPOSE: This randomized phase III trial is studying whole breast radiation therapy to see how well it works compared to partial breast radiation therapy in treating women who have undergone surgery for ductal carcinoma in situ or stage I or stage II breast cancer.

    at UC Davis UCLA UCSD

  • Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ

    Sorry, in progress, not accepting new patients

    RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. It is not yet known if radiation therapy is more effective than observation, with or without tamoxifen, in treating ductal carcinoma in situ.

    PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of observation, with or without tamoxifen, in treating women who have ductal carcinoma in situ.

    at UC Davis

  • Researching different medical imaging techniques for breast cancer

    “Comparing different medical imaging techniques for diagnosing breast cancer.”

    Sorry, in progress, not accepting new patients

    The investigators have studied the potential of breast computed tomography (bCT) for breast imaging under an NIH-funded Biomedical Research Partnership (BRP) grant (R01 EB002138-10), and 4 breast CT scanners have been developed that have imaged over 600 women to date (under more than one IRB-approved protocol). The BRP grant cannot be renewed, and with this (resubmitted) R01 grant application, the investigators seek to finalize the investigators' research in breast CT - The specific aims have been significantly modified as a result of the first critique, and the investigators now focus on a narrower set of remaining issues. This version of the protocol will add breast magnetic resonance imaging (MRI) to the experimental procedures.

    at UC Davis

  • Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction

    Sorry, in progress, not accepting new patients

    This phase I trial studies the side effects and best dose of romidepsin in treating patients with lymphoma, chronic lymphocytic leukemia, or solid tumors with liver dysfunction. Romidepsin may stop the growth of cancer cells by entering the cancer cells and by blocking the activity of proteins that are important for the cancer's growth and survival.

    at UC Davis

  • S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer

    Sorry, in progress, not accepting new patients

    RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating resected breast cancer.

    PURPOSE: This randomized phase III trial is comparing 2 different regimens of combination chemotherapy to see how well they work in treating patients who have undergone surgery for stage I, stage II, or stage III breast cancer.

    at UC Davis UCSF

  • S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer

    Sorry, in progress, not accepting new patients

    RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.

    PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.

    at UC Davis UC Irvine UCSD UCSF

  • Standard of Care Therapy With or Without Stereotactic Radiosurgery and/or Surgery in Treating Patients With Limited Metastatic Breast Cancer

    Sorry, not currently recruiting here

    This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be able to effectively remove the metastatic tumor cells. It is not yet known whether standard of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating limited metastatic breast cancer.

    at UC Davis UC Irvine UCSD

  • Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer

    Sorry, in progress, not accepting new patients

    This phase I trial studies the side effects and the best dose of stereotactic body radiation therapy in treating patients with breast cancer, non-small cell lung cancer, or prostate cancer that has spread to other parts of the body. Stereotactic body radiation therapy delivers fewer, tightly-focused, high doses of radiation therapy to all known sites of cancer in the body while minimizing radiation exposure of surrounding normal tissue.

    at UC Davis UCSD

  • Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

    Sorry, in progress, not accepting new patients

    To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.

    at UCSF

  • Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery

    Sorry, in progress, not accepting new patients

    Phase 2, open-label study of AVB-620 in women with primary, nonrecurrent and nonmetastatic breast cancer undergoing surgery.

    at UCSD

  • Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

    Sorry, in progress, not accepting new patients

    This is a multi-center, randomized, double-blinded, placebo controlled trial in pre-menopausal women with advanced breast cancer. The purpose of this study is to assess the efficacy of Ribociclib (LEE011), as measured by progression free survival (PFS), in premenopausal women with HR positive, HER2 negative advanced breast cancer

    at UCLA

  • Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.

    Sorry, in progress, not accepting new patients

    This is a multi-center, randomized double-blind, placebo controlled study of ribociclib in combination with fulvestrant for the treatment of postmenopausal women and men with hormone receptor positive, Her2 negative, advanced breast cancer who have received no or only one line of endocrine therapy for advanced breast cancer.

    at UCLA

  • Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2)

    Sorry, in progress, not accepting new patients

    This is a multi-center, randomized, double-blinded, placebo controlled trial.

    at UC Davis

  • Study of Imprime PGG and Pembrolizumab in Advanced Melanoma and Triple Negative Breast Cancer

    Sorry, in progress, not accepting new patients

    Objective: To determine the Overall Response Rate (ORR) to Imprime PGG + pembrolizumab in subjects with advanced melanoma or metastatic TNBC Safety: To characterize the safety of Imprime PGG + pembrolizumab given in combination Hypothesis: Restore (for melanoma) or enhance (for TNBC) sensitivity to checkpoint inhibitors (CPI) by appropriate and effective stimulation of the subject's innate and adaptive immune systems in those subjects who have failed 1st line therapy The study will incorporate Simon's optimal 2-stage design with sample size fixed at 12 subjects each in Stage 1 for advanced melanoma and for Triple Negative Breast Cancer (TNBC) subjects. The safety criterion of ≤ 4 (or ≤ 33%) subjects with Grade 3/4 adverse events in Cycle 1 within either tumor type must be met in order to proceed to Stage 2. The starting dose is 4 mg/kg for Imprime PGG. In the event there are a total of > 4 (or > 33%) of subjects with Grade 3/4 adverse events in Cycle 1, the dose of Imprime PGG will be reduced to 2 mg/kg, and Stage 1 will be repeated at a dose of 2 mg/kg with an additional cohort of n=12 subjects. For the dose that meets the safety criterion in Stage 1, at least 1 response in melanoma subjects and 2 responses in TNBC subjects amongst the 12 subjects within each tumor type must be observed in order to proceed to Stage 2. Stage 2 will enroll an additional 17 subjects with melanoma, and 30 subjects with TNBC. For the dose that meets the Stage 1 safety criterion, success will be declared if at least 4 amongst the total of up to 29 subjects with melanoma, and 13 amongst the total of up to 42 subjects with TNBC achieve an objective response.

    at UCLA

  • Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer

    Sorry, in progress, not accepting new patients

    The purpose of this trial is to inform the future clinical development of the two investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719 (PI3K-alpha inhibitor). This is a multi-center, open-label Phase Ib study. The Phase Ib dose escalation will estimate the MTD and/or RP2D for three regimens: two double combinations, LEE011 with letrozole and BYL719 with letrozole, followed by triple combinations of LEE011 + BYL719 with letrozole (Arms 3 and 4). The Phase Ib dose escalation part will be followed by Phase Ib dose expansions to further characterize the safety, tolerability, PK and preliminary clinical anti-tumor activity of the combinations. Optional crossover for patients who have progressed while on dose escalation or dose expansion with doublet treatment on Arms 1 or 2 to be treated with the triplet combination (Arm 3) after the determination of the RP2D for Arm 3; is no longer permitted after protocol amendment 6. Approximately 270 adult women with ER+/HER2- locally advanced or metastatic breast cancer will be enrolled.

    at UCSD UCSF

  • Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355)

    Sorry, in progress, not accepting new patients

    The study will consist of two parts. In Part 1, the safety of pembrolizumab (MK-3475) in combination with one of three different chemotherapies will be assessed in the treatment of locally recurrent inoperable or metastatic triple negative breast cancer (TNBC), which has not been previously treated with chemotherapy. In Part 2, the safety and efficacy of pembrolizumab plus chemotherapy will be assessed compared to the safety and efficacy of placebo plus chemotherapy in the treatment of locally recurrent inoperable or metastatic TNBC, which has not been previously treated with chemotherapy. The primary hypotheses are that: 1. the combination of pembrolizumab and chemotherapy prolongs Progression-Free Survival (PFS) compared to placebo and chemotherapy in: - all participants, - participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 tumors, and - participants with PD-L1 CPS ≥10 tumors, and 2. the combination of pembrolizumab and chemotherapy prolongs Overall Survival (OS) compared to placebo and chemotherapy in: - all participants, - participants with PD-L1 CPS ≥1 tumors, and - participants with PD-L1 CPS ≥10 tumors.

    at UCSF

  • Study of Radiation Exposure and Bilateral Breast Cancer

    Sorry, in progress, not accepting new patients

    This study is being done to find out what factors may be related to the risk of getting a second breast cancer among women who already have breast cancer in one breast. It will look at how genes, treatment for breast cancer; including radiation therapy, and the effects of different lifestyle activities, may affect the risk of breast cancer. It will use different processes to find genes that might increase the risk of breast cancer. The results of this study may help to develop better ways to detect, treat and prevent breast cancer. This study will compare women who have breast cancer in both breasts to women who have breast cancer in only one breast.

    at UC Irvine

  • Study of Talimogene Laherparepvec With Atezolizumab for Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases

    Sorry, in progress, not accepting new patients

    Approximately 36 DLT-evaluable subjects will be enrolled in this study. The locations of the study will be in the United States, Australia, Europe and Switzerland. The goal of this study is to evaluate the safety of intrahepatic injection (directly into the liver) of talimogene laherparepvec in combination with intravenously administered atezolizumab in subjects with triple negative breast cancer and colorectal cancer with liver metastases.

    at UCLA

  • Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC

    Sorry, in progress, not accepting new patients

    The purpose of this Phase IIIb study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer.

    at UC Irvine

  • Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers

    Sorry, in progress, not accepting new patients

    The purpose of this study was to assess the safety, tolerability, and efficacy when combining MK-3475 and INCB024360 in participants with certain cancers. This study was conducted in 2 phases, Phase 1 and Phase 2.

    at UCSD

  • Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

    Sorry, in progress, not accepting new patients

    RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer.

    PURPOSE: This randomized phase III trial studies ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer.

    at UCLA UCSD UCSF

  • Surgery to Remove the Sentinel Lymph Node and Axillary Lymph Nodes After Chemotherapy in Treating Women With Stage II, Stage IIIA, or Stage IIIB Breast Cancer

    Sorry, in progress, not accepting new patients

    RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

    PURPOSE: This phase II trial is studying surgery to remove the sentinel lymph node and axillary lymph nodes after chemotherapy in treating women with stage II, stage IIIA, or stage IIIB breast cancer.

    at UC Irvine

  • SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer

    Sorry, in progress, not accepting new patients

    The purpose of this study is to demonstrate that SYD985 [(vic-)trastuzumab duocarmazine] is superior to physician's choice in prolonging progression free survival.

    at UCSD

  • T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial)

    Sorry, in progress, not accepting new patients

    This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not approved this drug for use patients undergoing adjuvant treatment for HER2+ breast cancer. Trastuzumab emtansine (T-DM1) is a drug that may stop cancer cells from growing. This drug has been used in other research studies and information from those other research studies suggests that this drug may help to prevent the recurrence of breast cancer in this research study. The use of T-DM1 in this research study is experimental, which means it is not approved by any regulatory authority for the adjuvant treatment of HER2-positive breast cancer. However, it FDA-approved for metastatic HER2-positive breast cancer. T-DM1 has caused cancer cells to die in laboratory studies. In preclinical studies, this drug has prevented or slowed the growth of breast cancer. The breast cancer treatments (paclitaxel and Trastuzumab) used in this study are considered part of standard-of-care regimens in early breast cancer. A standard treatment means that this is a treatment that would be accepted by the majority of the medical community as a suitable treatment for your type of breast cancer. In this research study, the investigators are looking to see if the study drug T-DM1 will have less side effects than traditional HER2-positive breast cancer treatment of trastuzumab and paclitaxel. The investigators are also hoping to learn about the long term benefits and disease-free survival of participants who take the study drug T-DM1 in comparison to those participants to take the combination of trastuzumab and paclitaxel.

    at UCSF

  • Tamoxifen Citrate in Treating Patients With Metastatic or Recurrent Breast Cancer

    Sorry, in progress, not accepting new patients

    RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight cancer by blocking the use of estrogen by tumor cells.

    PURPOSE: This phase II trial is studying how well tamoxifen citrate works in patients with metastatic or recurrent breast cancer.

    at UC Davis

  • Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast Cancer

    Sorry, in progress, not accepting new patients

    This randomized phase III trial studies tamoxifen citrate or letrozole together with bevacizumab to see how well it works compared with tamoxifen citrate or letrozole alone in treating women with stage IIIB or stage IV breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Immunotherapy with monoclonal antibodies, such as bevacizumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving hormone therapy is more effective with or without bevacizumab in treating advanced breast cancer.

    at UC Davis UC Irvine UCSF

  • Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer

    Sorry, in progress, not accepting new patients

    This randomized phase II trial studies how well tamoxifen citrate works compared with z-endoxifen hydrochloride in treating patients with breast cancer that has spread to nearby tissue or lymph nodes or other parts of the body and has estrogen receptors but not human epidermal growth factor receptor 2 (HER2) receptors on the surface of its cells. Estrogen can cause the growth of tumor cells. Hormone therapy using tamoxifen citrate or z-endoxifen hydrochloride may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether tamoxifen citrate or z-endoxifen hydrochloride is more effective in treating patients with breast cancer.

    at UC Davis UCSD

  • Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer

    Sorry, in progress, not accepting new patients

    This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy work in treating patients with breast cancer that has spread from where it began in the breast to surrounding normal tissue (invasive). Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapy in treating patients with breast cancer.

    at UC Davis UC Irvine UCLA UCSD

  • Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC

    Sorry, in progress, not accepting new patients

    CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. The primary objective of the study is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee (IRC). Approximately 600 patients will be enrolled.

    at UCLA UCSF

  • The Active After Cancer Trial (AACT)

    Sorry, in progress, not accepting new patients

    This study is being done to determine whether a telephone-based counseling intervention can help survivors of breast and colorectal cancer increase their weekly physical activity. Observational evidence suggests that physical activity after breast and colorectal cancer diagnosis decreases recurrence rates. Unfortunately, many people become less active during cancer therapy, and a substantial proportion never return to pre-diagnosis levels of physical activity. This study looks to see if people who have recently finished chemotherapy for breast, colon or rectal cancer can be motivated to increase their exercise by talking to an exercise specialist over the phone. The study also looks at changes in mood, fatigue, fitness, fat distribution and weight.

    at UCSD UCSF

  • The Implementation and Sustainment of Digital MBC in Youth Mental Health Services

    Sorry, in progress, not accepting new patients

    This study will investigate the effects of an intervention called Leadership and Organizational Change for Implementation (LOCI), relative to implementation as usual (IAU), on clinician fidelity to, and youth service outcomes of, a well-established digital measurement-based care intervention called the Outcomes Questionnaire-Analyst in outpatient community mental health clinics.

    at UCSD

  • Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

    Sorry, in progress, not accepting new patients

    RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.

    PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.

    at UCSD UCSF

  • Veliparib With or Without Carboplatin in Treating Patients With Stage III-IV Breast Cancer

    Sorry, in progress, not accepting new patients

    This phase II trial studies how well veliparib with or without carboplatin works in treating patients with stage III-IV breast cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether veliparib is more effective with or without carboplatin in treating breast cancer.

    at UC Davis

  • Veliparib, Paclitaxel, and Carboplatin in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery and Liver or Kidney Dysfunction

    Sorry, in progress, not accepting new patients

    This phase I trial studies the side effects and the best dose of veliparib when given together with paclitaxel and carboplatin in treating patients with solid tumors that are metastatic or cannot be removed by surgery and liver or kidney dysfunction. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving veliparib together with paclitaxel and carboplatin may kill more tumor cells.

    at UC Davis

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