What is the Purpose of this Study?
The purpose of this study is to compare elacestrant with standard endocrine therapy in people with node-positive, estrogen receptor-positive (ER+), HER2-negative early breast cancer who are considered to have a high risk of recurrence. Participants will be randomly assigned to 1 of 2 groups. One group will switch to elacestrant, and the other group will continue standard endocrine therapy. The study is designed to determine whether elacestrant can reduce the risk of the cancer coming back compared with standard endocrine therapy. Researchers will also evaluate safety, side effects, patient-reported quality of life, blood levels of elacestrant, and blood-based markers that may help explain how the treatment works. Elacestrant is an oral endocrine therapy called a selective estrogen receptor degrader, or SERD. It blocks and reduces estrogen receptors on breast cancer cells. Elacestrant is approved by the U.S. Food and Drug Administration (FDA) for certain patients with advanced or metastatic ER+, HER2-negative breast cancer after prior endocrine therapy. Its use in this early breast cancer study is investigational.
Eligibility
- * 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.
Where can I participate?
- CS Cancer Tarzana : Nikki Kem-Bernard
- CS Cancer at Beverly Hills : Nikki Kem-Bernard
- CS Cancer at Cedars-Sinai Medical Center : Nikki Kem-Bernard
More about this Clinical Trial
What is the full name of this clinical trial?
STML-ELA-0422: 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