A Phase II Randomized Study of Fezolinetant to Reduce Hot Flashes in Women With Early Stage Breast Cancer on Endocrine Therapy

What this Trial Is About

Researchers are investigating the effectiveness of fezolinetant, taken daily at 45 mg, compared to a placebo in reducing moderate to severe vasomotor symptoms (VMS) in women who have survived early-stage breast cancer and are undergoing endocrine therapy with tamoxifen or aromatase inhibitors. This phase II, randomized, double-blinded, placebo-controlled trial will include 92 participants, divided equally between the two treatment groups. The study aims to determine if fezolinetant can significantly decrease the frequency of VMS over a 12-week period. Participants will first complete a 7 to 14-day screening period where baseline data on VMS frequency and severity will be collected using a symptom diary. Following this, they will receive either fezolinetant or a placebo orally once daily for 12 weeks. After the treatment phase, the study will analyze changes in VMS frequency from baseline to week 12, comparing the two groups. Upon completion, participants will be informed about their treatment group and may choose to switch treatments if they wish. During the study, participants will provide daily reports on VMS to track symptom changes. Researchers will assess the primary outcome by measuring the frequency of moderate to severe VMS over the 12 weeks of treatment. Safety monitoring will be ongoing, but no interim efficacy or safety analyses are planned due to existing data on fezolinetant. The total duration of participation includes the screening and 12-week treatment periods, with assessments focused on symptom frequency and severity.

FLASH-Breast: Evaluating the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy