RecruitingPhase 2NCT06917313

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

A Randomized Phase II Study to Evaluate the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy


Sponsor

Yale University

Enrollment

92 participants

Start Date

Dec 5, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 40 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called fezolinetant can reduce hot flashes and other vasomotor symptoms (sudden feelings of heat, sweating, flushing) in women with hormone receptor-positive (HR+) breast cancer who are taking hormonal therapy like tamoxifen or aromatase inhibitors. **You may be eligible if...** - You are a woman between 40 and 65 years old with a BMI between 18 and 40 - You have been diagnosed with stage I-III HR+ invasive breast cancer - You have been on endocrine therapy (tamoxifen or an aromatase inhibitor) for at least 3 months and plan to continue for at least 12 more weeks - You are experiencing 7 or more moderate-to-severe hot flashes per day and want relief - You are postmenopausal or chemically menopausal (on GnRH agonist therapy) **You may NOT be eligible if...** - You have stage IV (metastatic) breast cancer - You are premenopausal and not on ovarian suppression therapy - You are not on endocrine therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFezolinetant

45 mg tablets, administered orally once daily with or without food, to be taken throughout the entire study phase, i.e. 12 weeks

DRUGPlacebo

45 mg tablets, administered orally once daily with or without food, to be taken throughout the entire study phase, i.e. 12 weeks


Locations(2)

Yale University

New Haven, Connecticut, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT06917313


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