A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.

a study on Breast Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around

Description

Summary

The purpose of this study is to learn about the safety and effects of the study medicine PF-07248144 when given along with fulvestrant for the possible treatment of HR-positive, HER2-negative advanced or metastatic breast cancer.

HR-positive breast cancer cells have proteins on their surface called receptors that bind to hormones like estrogen and progesterone (female sex hormones). These hormones can promote the growth of cancer cells.

HER2-negative describes cells that have a small amount or none of a protein called HER2 on their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2-negative may grow more slowly and are less likely to recur (come back) or spread to other parts of the body than cancer cells that have a large amount of HER2 on their surface.

Advanced cancer is a term that is often used to describe cancer that is unlikely to be cured.

Metastatic cancer is the type where the cancer cells spread from one part of the body to another.

This study is seeking for participants whose breast cancer has gotten worsen after receiving cyclin dependent kinase (CDK) 4/6 inhibitor-based therapy.

Half of participants in this study will receive their usual study treatment, everolimus with endocrine therapy (either exemestane or fulvestrant) for HR-positive/HER2-negative advanced or metastatic breast cancer (A/mBC). The study doctor will discuss which hormone therapy is right for the participant before treatment begins.

PF-07248144 is a tablet that will be taken by mouth at home every day in a 28-day cycle. Fulvestrant will be given as two injections (one injection in the buttock) at visits to the study clinic. Everolimus and exemestane are also tablets and will be taken by mouth at home every day in a 28-day cycle.

The study will compare the experiences of people receiving PF-07248144 in combination with fulvestrant to those of the people who do not. This will help see if PF-07248144 in combination with fulvestrant is safe and effective.

Official Title

An Interventional, Open-Label, Randomized, Multicenter, Phase 3 Study of PF-07248144 Plus Fulvestrant Compared to Investigator's Choice of Therapy in Adult Participants With Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Whose Disease Progressed After Prior CDK4/6 Inhibitor-based Therapy

Keywords

Breast Cancer, Locally advanced or metastatic breast cancer, Estrogen receptor positive [ER(+)], Progesterone receptor positive [PR(+)], Human epidermal growth factor receptor 2 negative [HER2(-)], ER(+)/HER2(-), PR(+)/HER2(-), HR(+)/HER2(-), Advanced Breast Cancer, Breast tumor, Everolimus, Exemestane, Fulvestrant, Metastatic breast cancer, Endocrine Therapy, Hormone Therapy, Hormone positive breast cancer, Recurrent breast cancer, HR+, HER2-negative, Relapse, Recurrent, Second line treatment, Third line treatment, Left Sided Breast Cancer, Right Sided Breast Cancer, Unilateral Breast Cancer, Cancer of the Breast, CDK4/6i, CDK4/6i-based Therapy, Bilateral Breast Cancer, Progression After CDK4/6i-based therapy, Breast Neoplasms, Recurrence, Unilateral Breast Neoplasms, PF-07248144 plus fulvestrant, everolimus plus ET

Eligibility

You can join if…

Open to people ages 18 years and up

  • Confirmed diagnosis of HR-positive HER2-negative breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
  • Prior CDK4/6 inhibitor therapy in combination with endocrine therapy in advance metastatic setting or in adjuvant setting with documented progression during or within 12 months after the last dose of CDK4/6i.
  • Participants are eligible if they previously received CDK4/6i or ET as a monotherapy, or in combination for rechallenge therapy in the advance or metastatic setting; have received prior therapy targeting estrogen receptor 1 (ESR1) or breast cancer gene (BRCA)1/2.
  • Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.

You CAN'T join if...

  • Documented detectable PIK3CA/AKT1/PTEN alterations in tissue
  • Received greater than two prior lines of systemic therapy in the advance or metastatic setting
  • Had received any prior chemotherapy, including antibody drug conjugates (ADCs), in advance or metastatic setting. Participants who have previously received chemotherapy in the (neo)adjuvant setting are not excluded from the study.
  • Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study.
  • Renal impairment, hepatic dysfunction, or hematologic abnormalities.

Locations

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center accepting new patients
    Torrance California 90502 United States
  • Harbor-UCLA Medical Center accepting new patients
    Torrance California 90509 United States
  • Oncura Health - Fountain Valley accepting new patients
    Fountain Valley California 92708 United States
  • Oncura Health - Valley Presbyterian accepting new patients
    Van Nuys California 91405 United States
  • Oncura Health - Good Samaritan accepting new patients
    Los Angeles California 90017 United States
  • Oncura Health - Corporate (Central IDS & Regulatory Only) accepting new patients
    Glendale California 91204 United States
  • Oncura Health - Anaheim accepting new patients
    Anaheim California 92805 United States
  • Torrance Memorial Physician Network - Cancer Care accepting new patients
    Torrance California 90505 United States
  • Torrance Memorial Physician Network-Cancer Care accepting new patients
    Torrance California 90505 United States
  • Clinical and Translational Research Unit (CTRU) accepting new patients
    Palo Alto California 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for the Katsis-1 study, click here.
ID
NCT07062965
Phase
Phase 3 Breast Cancer Research Study
Study Type
Interventional
Participants
Expecting 400 study participants
Last Updated
Contact us about this trial