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

Status
Active
Cancer Type
Breast Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06492616
Protocol IDs
STML-ELA-0422 (primary)
NCI-2025-00399
Study Sponsor
Stemline Therapeutics, Inc.

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.

Eligibility

  1. 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
  2. Participants considered at high risk of recurrence at initial staging
  3. 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)
  4. Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor must have already completed or discontinued these treatments. Key

Treatment Sites in Georgia

Northside Hospital Cancer Institute


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.