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
Yale University
92 participants
Dec 5, 2025
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
Plain Language Summary
Simplified for easier understanding
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Interventions
45 mg tablets, administered orally once daily with or without food, to be taken throughout the entire study phase, i.e. 12 weeks
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06917313