Phase III clinical study of fezolinetant is initiated for VMS in women with breast cancer receiving adjuvant endocrine therapy

Breast cancer is the most common cancer in women globally, with approximately 2.3 million new cases in 2022. Hot flashes and night sweats, also known as VMS, are recognized as the most prominent side effect of adjuvant endocrine therapies used in the treatment of breast cancer. Approximately 77% of breast cancers can be treated with adjuvant endocrine therapies, most commonly tamoxifen and aromatase inhibitors, and up to 97% of breast cancer patients experience hot flashes or night sweats.

About HIGHLIGHT 1: HIGHLIGHT 1 (NCT06440967) is a randomized, placebo-controlled, double-blind, Phase III clinical study to assess the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS in women with stage 0 to 3 hormone receptor-positive breast cancer who are receiving adjuvant endocrine therapy. Approximately 540 participants are planned to be randomized 1:1 to fezolinetant or placebo at up to 100 sites globally. The four coprimary endpoints are change in the frequency and severity of moderate to severe VMS from baseline to weeks 4 and 12. Patients will be treated for 52 weeks with a final evaluation at 55 weeks.