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

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.

Trial Details

NCT ID
NCT06917313
Phase
PHASE2
Sponsor
Yale University
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Fezolinetant
  • Placebo
Locations (sample)
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Columbus, Ohio, United States|39.96118,-82.99879

Key Eligibility Criteria

  • Women with diagnosed, histologically confirmed, clinical stage I-III, HR+ invasive breast cancer as defined by ASCO CAP guidelines for whom adjuvan…
  • Age 18 years and older.
  • Currently on endocrine therapy (tamoxifen or aromatase inhibitors) as part of standard of care treatment for HR+ breast cancer. Endocrine therapy m…
  • Willing and able to provide written informed consent/assent for the trial.

For full eligibility, visit ClinicalTrials.gov.

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