Astellas Pharma has dosed the first patient in its Phase III study of Fezolinetant.
The HIGHLIGHT 1 clinical trial will test the safety and efficacy of the therapeutic in mitigating hot flushes in patients with breast cancer who are receiving endocrine therapy.
Approximately 540 patients with stage 0 to 3 hormone receptor-positive breast cancer will be involved, and the study will last approximately 55 weeks.
Fezolinetant is a non-hormonal drug compound, and — if approved — will be used to treat those with breast cancer experiencing moderate to severe vasomotor symptoms (VMS).
Hot flushes and night sweats are commonly associated with endocrine therapies, which are often used to treat breast cancer.
Astellas Pharma’s Vice President and Head of Biopharma development, Marci English, commented: “VMS can adversely affect a patient’s quality of life, while also impacting treatment compliance with endocrine therapies.”
“We are excited to get the HIGHLIGHT 1 study underway, as there are currently no approved treatments for moderate to severe VMS; we hope we can fill this unmet need.”