Clinical Trial

A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer

Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This is a multicenter, open-label, Phase 2 bridging study to evaluate the efficacy and safety of elacestrant in Japanese post-menopausal women and men with estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer with estrogen receptor 1 gene mutation (ESR1-mut) whose disease has relapsed or progressed on at least 1 and no more than 2 prior lines of endocrine therapy for metastatic breast cancer, which must have included cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) therapy in combination with fulvestrant or an aromatase inhibitor.
Trial Details
NCT Number NCT07766018
Lead Sponsor Stemline Therapeutics, Inc.
Conditions ER+/HER2- Advanced or Metastatic Breast Cancer
Enrollment 70 participants
Start Date 2026-08
Primary Completion 2028-10 (estimated)
Study Completion 2028-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-14