Overview

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

Status:
NOT_YET_RECRUITING

Trial end date:
2028-01-01

Target enrollment:

Participant gender:

Summary

This is a phase II, randomized, 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 patients will be randomized in 1:1 fashion to fezolinetant or placebo arm respectively.

Phase:

PHASE2

Details

Lead Sponsor:

Yale University

Collaborator:

Astellas Pharma US, Inc.

Treatments:

fezolinetant