Clinical Trial

FLASH-Breast: Evaluating the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy

Recruiting Phase 2
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Summary
This is a phase II, randomized, double-blinded, placebo-controlled trial designed to evaluate the efficacy of fezolinetant (45 mg a day) vs. placebo in reducing moderate to severe vasomotor symptoms (VMS) in breast cancer survivors on endocrine therapy (tamoxifen, aromatase inhibitors). The trial will proceed in a single stage, and the total of 92 participants will be randomized in 1:1 fashion to fezolinetant or placebo arm respectively.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2025-04-01; most recent amendment 2026-05-30.
Status change: Not Yet Recruiting → Recruiting 2025-10-30
Trial Details
NCT Number NCT06917313
Lead Sponsor Yale University
Collaborators: Astellas Pharma US, Inc.
Conditions Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Enrollment 92 participants
Start Date 2025-12-05
Primary Completion 2028-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-06-02