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.
FLASH-Breast: Evaluating the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Maryam Lustberg, MD · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
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What this trial measures
- 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).