A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women with Breast Cancer
Research type
Research Study
Full title
A Randomized, Placebo-controlled, Double-blind, Phase 3 Clinical Study to Investigate the Efficacy and Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms (Hot Flashes) in Women with Stage 0 to 3 Hormone Receptor-positive Breast Cancer Who Are Receiving Adjuvant Endocrine Therapy
IRAS ID
1010129
Contact name
Taisa Paluch-Kassenberg
Contact email
Sponsor organisation
Astellas Pharma Global Development Inc.
Eudract number
2024-510719-31
Clinicaltrials.gov Identifier
Research summary
The goal of this study is to see if a study drug called fezolinetant is effective and safe as a treatment for women with moderate to severe hot flashes due to use of tamoxifen or aromatase inhibitors for stage 0 to 3 HR+ breast cancer. Fezolinetant has been approved in the United States and European Union for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. However, fezolinetant has not yet been approved by any regulatory agency for use in patients experiencing VMS while receiving adjuvant endocrine therapy. Adjuvant therapy is a therapy that is given in addition to the primary or initial therapy to maximise its effectiveness. The information collected in this study is necessary to find out whether fezolinetant is effective and safe.
Participation in the study will take approximately 59 weeks. This includes a 4-week screening period, a 52-week treatment period, and a 3-week follow-up period. A total of approximately 540 people will take part in this study coming from approximately 100 different study sites in 12 different countries.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
24/EE/0157
Date of REC Opinion
27 Nov 2024
REC opinion
Further Information Favourable Opinion