Fezolinetant for the Improvement of Vasomotor Symptoms in Breast Cancer Patients Taking Endocrine Therapy, VENT Trial

Inclusion Criteria: * Female subject aged ≥ 18 years * Taking endocrine therapy (tamoxifen, anastrozole, exemestane, or letrozole) for adjuvant treatment of stage 1-3 breast cancer or for chemoprevention (breast ductal carcinoma in situ \[DCIS\] or high risk) * Planning to take the same endocrine therapy for at least 10 weeks after study drug initiation * Report 28 or more VMS episodes, at least some of which are severe or bothersome, during the 7-day screening period * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2 x upper limit of normal (ULN) within 28 days prior to randomization * Total bilirubin \< 2 x ULN within 28 days prior to randomization * Completion of chemotherapy, if given. Concurrent use of gonadotropin releasing hormone agonist (GnRHa) therapy, anti-HER2 therapy, bisphosphonate therapy, poly adenosine diphosphate-ribose polymerase (PARP) inhibitor therapy, and abemaciclib therapy is permitted * Patients receiving treatment with selective serotonin reuptake inhibitor (SSRIs), serotonin and norepinephrine reuptake inhibitor (SNRIs), gabapentinoids, clonidine, or oxybutynin must have been taking a stable dose for at least 30 days prior to enrollment if they plan to continue the drug during study participation, and willing to remain on the treatment for the duration of study participation. If they do not plan to take the medication during study participation, they should stop the medication at least 7 days before the start of the VMS scr…