Clinical Trial

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

Study acronym: ELEGANT
Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 changes
notable Trial sites expanded: 541 -> 555 locations 2026-07-09
notable Trial sites expanded: 536 -> 541 locations 2026-05-28
notable Trial sites expanded: 533 -> 536 locations 2026-04-25
Trial Details
NCT Number NCT06492616
Lead Sponsor Stemline Therapeutics, Inc.
Conditions Breast Cancer
Enrollment 4,220 participants
Start Date 2024-09-27
Primary Completion 2029-08 (estimated)
Study Completion 2032-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-08