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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry [IHC]), HER2-negative [IHC = 0, 1+, 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 may not be able to 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 are off current adjuvant endocrine therapy more than 6 months prior to randomization Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where this trial is running

• Southern Cancer Center, PC, Daphne, Alabama, United States
• Ironwood Cancer and Research Centers, Chandler, Arizona, United States
• Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
• Mayo Clinic, Scottsdale, Arizona, United States
• Arizona Clinical Research Center, Inc., Tucson, Arizona, United States
• University of Arizona Cancer Center, Tucson, Arizona, United States
• Highlands Oncology Group, PA, Springdale, Arkansas, United States
• Comprehensive Blood & Cancer Center, Bakersfield, California, United States
• UCSF Cancer Center Berkeley, Berkeley, California, United States
• Cedars-Sinai Cancer Beverly Hills, Beverly Hills, California, United States
• City of Hope National Medical Center, Duarte, California, United States
• UCSF Wash Cancer CNTR, Fremont, California, United States

+ 543 more sites.

Who to contact

Stemline Trials · 1-877-332-7961 · clinicaltrials@menarinistemline.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06492616.