Céline Bouchard1, Kentaro Miyazaki2, Chun-Hang Tang3, Karla Martins3, Xuegong Wang4, Sonja Medley-Wilson4, Paula Briggs5
1Clinique RSF Inc., Quebec, Canada, 2Astellas Pharma Inc, Tokyo, Japan, 3Astellas Pharma Europe Ltd, Addlestone, United Kingdom, 4Astellas Pharma Inc, Northbrook, United States, 5Liverpool Women's Hospital, Liverpool Women's NHS Foundation Trust, Liverpool, United Kingdom
Biography:
Alana S. Philips, PhD, is a senior medical affairs specialist with extensive experience across women’s health, specifically contraception and menopause. She is currently Medical Affairs Lead for Menopause at Astellas Australia, having commenced this role in November 2025, where she is responsible for medical strategy, scientific exchange, and evidence generation and dissemination. Alana holds a PhD in Medicine from the University of New South Wales and has over 15 years of experience in medical affairs roles across multinational pharmaceutical organisations, including Astellas, Organon, MSD, Novo Nordisk, and Novartis. She has authored peer reviewed publications in molecular biology and clinical research.
Aims:
This global, double-blind, placebo-controlled phase 3 Trial in Progress study (HIGHLIGHT 1 [NCT06440967]) assesses efficacy and safety of fezolinetant 45 mg once daily for treatment of moderate to severe vasomotor symptoms (VMS) in women receiving adjuvant endocrine therapy with tamoxifen or aromatase inhibitors for hormone receptor-positive breast cancer from stage 0 (cancer cells not spread to nearby tissue) to stage 3+ (cancer has spread from breast to nearby lymph nodes or chest wall).
Methods:
Participants are women ≥18 years with ≥7 moderate to severe VMS episodes/day, randomized 1:1 to fezolinetant 45 mg or placebo, who record VMS daily via electronic diaries. Study duration is ~2 years: 28-days screening, 52-weeks treatment, 3-weeks follow-up, 1-year extension. Co-primary endpoints: mean change from baseline to week 4 and 12 in frequency and severity of moderate to severe VMS. Key secondary endpoints: mean change from baseline to week 12 in MENQOL VMS domain score and PROMIS Total Score Sleep Disturbance–Short Form 8b. Treatment-emergent adverse events assess fezolinetant safety and tolerability.
Results:
575 participants enrolled: analysis underway.
Conclusions:
To confirm if fezolinetant helps reduce treatment-induced VMS in women with stage 0-3 hormone receptor-positive breast cancer who are receiving hormone therapy.