Comparing 5-Year Adjuvant Elacestrant Treatment With Standard Endocrine Therapy in High-Risk HRHER2- Early Breast Cancer

What this Trial Is About

Researchers are evaluating whether patients with hormone-receptor positive, HER2-negative early breast cancer HRHER2- eBC who have intermediate to high risk of recurrence may benefit from an initial 5-year treatment with elacestrant, with or without a CDK 46 inhibitor, followed by standard endocrine therapy ET for an additional 0 to 2.5 years. This is compared to the current standard of care ET lasting between 5 and 7.5 years, with or without CDK 46 inhibitors. The study is designed for patients identified by genomic tests like Oncotype DX and response to preoperative endocrine therapy, aiming to improve long-term survival by targeting resistance mechanisms such as ESR1 mutations. Participants are randomly assigned to one of two groups one receiving elacestrant orally for 5 years, possibly combined with ribociclib a CDK 46 inhibitor for 3 years if indicated, and the other receiving standard endocrine treatments for 5 to 10 years with optional CDK 46 inhibitors as decided by their doctor. The treatments are evaluated in a parallel study design. The trial builds on previous findings in metastatic breast cancer and early breast cancer studies exploring endocrine therapy responses and genomic risk assessments. Throughout the study, participants undergo regular clinical assessments, including tumor pathology reviews, laboratory tests, and electrocardiograms to monitor safety and treatment effects. Researchers measure outcomes such as 5-year invasive disease-free survival and other survival metrics. Participants must comply with contraception requirements and be followed for treatment adherence and safety until study completion, which is planned for up to 2033.

Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and/or Clinically High-risk ER+/HER2- eBC