drugset / Trial / NCT06492616

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

NCT06492616

Phase 3 Recruiting 4220 enrolled Stemline Therapeutics, Inc.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-09-27
Primary completion
2029-08
Completion
2032-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Anastrozole Other / unclassified 1 mg Oral
Subject Elacestrant Other / unclassified 345 mg Oral
Subject Exemestane Small molecule 25 mg Oral
Subject Letrozole Other / unclassified 2.5 mg Oral
Subject Tamoxifen Small molecule 20 mg Oral

Indications