NCT06492616

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,220 (estimated)
• Sponsor: Stemline Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Elacestrant	Administered as oral tablets
DRUG	Anastrozole	Administered as oral tablets
DRUG	Letrozole	Administered as oral tablets
DRUG	Exemestane	Administered as oral tablets
DRUG	Tamoxifen	Administered as oral tablets

Timeline

• Start date: 2024-09-27
• Primary completion: 2029-08-01
• Completion: 2032-10-01
• First posted: 2024-07-09
• Last updated: 2026-03-27

Locations

533 sites across 27 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Hong Kong, Hungary, Italy, Malaysia, Netherlands, Poland, Portugal, Romania, Singapore, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study