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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorYale University

About this trial

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 criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Fezolinetant
  • Placebo

Treatment groups

92 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Yale University

Lead sponsor

Astellas Pharma US, Inc.

Collaborator