Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Michelle Melisko
Headshot of Michelle Melisko
Michelle Melisko

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, Recurrence, Tamoxifen, Letrozole, Anastrozole, Exemestane, Elacestrant

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

  • Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94158 United States
  • Dignity Health dba Health Research Institute accepting new patients
    Sacramento California 95816 United States
  • Sutter Institute for Medical Research accepting new patients
    Sacramento California 95816 United States

Lead Scientist at UCSF

  • Michelle Melisko
    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.

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