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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06917313
Phase
PHASE2
Status
Recruiting
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Conditions

  • Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Fezolinetant — DRUG
    45 mg tablets, administered orally once daily with or without food, to be taken throughout the entire study phase, i.e. 12 weeks
  • Placebo — DRUG
    45 mg tablets, administered orally once daily with or without food, to be taken throughout the entire study phase, i.e. 12 weeks

Study Details

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.

Key Dates

Start date
Dec 5, 2025
Status verified
May 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Fezolinetant
    Fezolinetant is an oral medication, and the first neurokinin 3 (NK3) receptor antagonist approved by the FDA in May 2023 for treatment of moderate to severe hot flashes due to menopause. It blocks the activities of the NK3 receptor which is involved in the brain's regulation of body temperature.
  • Placebo Comparator: Placebo
    Patients will be given placebo tablets to compare to active comparator.

Primary Outcome Measure

Frequency of moderate/severe VMS at 12 weeks of treatment with fezolinetant vs. placebo [ Time Frame: Baseline to 12 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06511
Carl Brown
[email protected]
203-785-4095
Maryam Lustberg, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State University Comprehensive Cancer CenterColumbusOhio43201
Cara Dauch
[email protected]
614-814-1393
Sagar Sardesai, MD (PRINCIPAL_INVESTIGATOR)

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