Study Comparing Elacestrant to Standard Hormone Therapy in Women and Men with Early Breast Cancer at High Risk of Returning

Inclusion Criteria

• Diagnosed with early-stage breast cancer that is ER-positive (at least 10% of cells) and HER2-negative, based on lab tests.
• Considered at high risk of the cancer returning after initial diagnosis.
• Have been on hormone therapy (like AIs or tamoxifen) for at least 2 years but not more than 5 years, with or without additional treatments like CDK4/6 inhibitors.
• If previously treated with CDK4/6 inhibitors or PARP inhibitors, these treatments must be completed or stopped.

Exclusion Criteria

• Have inflammatory breast cancer.
• Have had any other invasive breast cancer in the past, on either side.
• Have had another type of cancer within the last 3 years, except for certain skin cancers or cervical cancer that was treated.
• Have stopped hormone therapy for more than 6 months continuously or stopped more than 6 months before joining the study.