Trial intelligence / Profile preview

Phase 3 randomized placebo-controlled study of fezolinetant for hot flashes in women with hormone receptor-positive breast cancer receiving adjuvant endocrine therapy

2024-510719-31-00Phase 3Authorised

Sponsor
Astellas Pharma
Start
Jan 2025
Modality
Small Molecules
Countries
11
01

Overview

Phase 3, randomised, double-blind trial in vasomotor symptoms comparing Fezolinetant with Placebo (2 arms). Primary endpoints: Change in frequency of moderate to severe vasomotor symptoms from baseline to week 4, Change in frequency of moderate to severe vasomotor symptoms from baseline to week 12 and 2 more. Planned start Jan 2025; status: authorised.

02

Drugs

fezolinetant
03

Conditions

vasomotor symptoms

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