Life sciences · Phase 2 Trial
ClinicalTrials.gov · November 3, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT06917313). This is a study registration, not published results. Lead sponsor: Yale University. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 92 participants (ESTIMATED). Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3). Interventions: DRUG: Fezolinetant; DRUG: Placebo. Primary outcome measures: Frequency of moderate/severe VMS at 12 weeks of treatment with fezolinetant vs. placebo , Baseline to 12 weeks. Brief summary: 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.