FLASH-Breast: Fezolinetant for Hot Flashes in Breast Cancer Patients

This study is testing if a drug called fezolinetant can help reduce moderate to severe hot flashes (vasomotor symptoms or VMS) in women with early-stage breast cancer (Stage 1-3) who are currently taking endocrine therapy like tamoxifen or aromatase inhibitors. You might be eligible if you are 18 or older, have HR+ breast cancer, and are on endocrine therapy. The study will compare fezolinetant to a placebo (an inactive pill) over 12 weeks. Researchers will consider the treatment successful if fezolinetant significantly reduces the frequency of moderate/severe hot flashes compared to the placebo group. The study plans to enroll 92 participants.

Study design
This is a Phase 2, randomized, double-blinded, placebo-controlled study involving 92 participants. Participants will be randomly assigned to receive either fezolinetant or a placebo.
What's involved
You would take either fezolinetant or a placebo pill once daily for 12 weeks. You will also record daily information about your hot flashes.
Compensation
Not stated in the trial record.
Follow-up
After the 12-week treatment period, your hot flashes will be formally assessed. You will then be told which treatment you received and can choose to switch if you wish.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06917313

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Yale University
~92 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:FezolinetantPlacebo

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of moderate/severe VMS at 12 weeks of treatment with fezolinetant vs. placebo
Measured over Baseline to 12 weeks
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
2 sites across 2 states
Connecticut1
Ohio1
  • Maryam Lustberg, MD · PRINCIPAL_INVESTIGATOR · Yale University

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  • Frequency of moderate/severe VMS at 12 weeks of treatment with fezolinetant vs. placeboBaseline to 12 weeks

    To evaluate the mean change reduction in frequency of moderate/severe VMS at 12 weeks of treatment with fezolinetant vs. placebo in breast cancer survivors on endocrine therapy (tamoxifen or aromatase inhibitors).