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

In this clinical trial, the Sponsor plans to investigate whether patients with HR+/HER2- eBC identified during routine clinical assessments and treatments as having intermediate to high-risk (based on Oncotype DX® or similar tests and on response assessment to 2-6 weeks of preoperative ET) achieve a survival benefit from an initial 5-years use of elacestrant (with or without a CDK 4/6 inhibitor) followed by SoC ET for further 0-2.5 years in comparison to at least 5 up to 7.5 years SoC ET therapy (+/- CDK4/6 inhibitor). Based on several studies in the metastatic setting, it is reasonable to assume that the adjuvant use of elacestrant with or without CDK 4/6 inhibitors will prevent or delay the activation of mechanisms conferring resistance to ET (e.g., ESR1 mutations).

NCT Number	NCT07242352
Lead Sponsor	Women's Cancer Study Group GmbH Collaborators: Berlin-Chemie Menarini
Conditions	Breast Cancer, HR+/HER2- Breast Cancer
Enrollment	1,520 participants
Start Date	2026-04-29
Primary Completion	2033-09-30 (estimated)
Study Completion	2033-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-07