A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence

a study on Breast Cancer HER2

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine UCLA UCSD UCSF
Dates
study started
study ends around
Principal Investigator
by Michelle Melisko (ucsf)Rebecca Shatsky (ucsd)Marla Lipsyc-Sharf (ucla)Ritesh Parajuli (uci)
Headshot of Michelle Melisko
Michelle Melisko
Headshot of Rebecca Shatsky
Rebecca Shatsky

Description

Summary

The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.

Official Title

Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study

Keywords

Breast Cancer, ELEGANT, Breast Cancer Stage II, Breast Cancer Stage III, Breast Cancer Female, Breast Cancer, Male, High-Risk Breast Cancer, High Risk Breast Carcinoma, ER-positive Breast Cancer, ER-positive HER-2 Negative Breast Cancer, ER Positive/HER2 Low Breast Cancer, Breast Cancer, ER+, HER2-, Adjuvant, Adjuvant Therapy, Breast Neoplasms, Male Breast Neoplasms, elacestrant, Anastrozole, Letrozole, exemestane, Tamoxifen

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry [IHC]), HER2-negative [IHC = 0 or 1, or (IHC = 2 and in situ hybridization [ISH]-negative)] on tumor biopsy or final surgical pathology specimen early stage resected invasive breast cancer without evidence of recurrence or distant metastases, per local laboratory, according to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
  • Participants considered at high risk of recurrence at initial staging
  • Participants who have received at least 24 months but not more than 60 months of endocrine therapy (AIs or tamoxifen) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i)
  • Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor must have already completed or discontinued these treatments.

You CAN'T join if...

  • Participants with inflammatory breast cancer
  • History of any prior (ipsilateral and/or contralateral) invasive breast cancer
  • Participant with history of malignancy within 3 years of the date of randomization, except for adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix
  • Participants who have had more than a 6-month continuous interruption of prior SoC adjuvant endocrine therapy or who discontinued adjuvant endocrine therapy more than 6 months prior to randomization

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • UCSF Cancer Center Berkeley accepting new patients
    Berkeley California 94702 United States
  • UCSF Wash Cancer CNTR accepting new patients
    Fremont California 94538 United States
  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92037 United States
  • UCLA Department of Medicine - Hematology/Oncology accepting new patients
    Los Angeles California 90095 United States
  • UC Irvine Health, Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868-3201 United States
  • UCSF Zuckerberg SF General accepting new patients
    San Francisco California 94143 United States
  • University of California, San Francisco (UCSF) accepting new patients
    San Francisco California 94158 United States
  • UCSF Cancer Center San Mateo accepting new patients
    San Mateo California 94402 United States
  • Hoag Memorial Hospital Presbyterian accepting new patients
    Newport Beach California 92663 United States
  • USC/Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States

Lead Scientists at University of California Health

  • Michelle Melisko (ucsf)
    Dr. Michelle E. Melisko is a cancer specialist with expertise in breast cancer treatment and research. She is interested in testing new chemotherapy combinations, biological therapies and immunotherapies for breast cancer, with a particular focus on treatment of cancer that has spread to the brain.
  • Rebecca Shatsky (ucsd)
    Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 33 research publications
  • Marla Lipsyc-Sharf (ucla)
  • Ritesh Parajuli (uci)
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 21 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Stemline Therapeutics, Inc.
ID
NCT06492616
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 4220 study participants
Last Updated
Contact us about this trial