A Randomized Phase II Study to Evaluate the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy
Yale University
Summary
This is a phase II, randomized, double-blinded, placebo-controlled trial designed to evaluate the efficacy of fezolinetant (45 mg a day) vs. placebo in reducing moderate to severe vasomotor symptoms (VMS) in breast cancer survivors on endocrine therapy (tamoxifen, aromatase inhibitors). The trial will proceed in a single stage, and the total of 92 participants will be randomized in 1:1 fashion to fezolinetant or placebo arm respectively.
Description
This is a phase II, randomized, double-blinded, placebo-controlled trial designed to evaluate the efficacy of fezolinetant (45 mg a day) vs. placebo in reducing moderate to severe vasomotor symptoms (VMS) in breast cancer survivors on endocrine therapy (tamoxifen, aromatase inhibitors). The trial will proceed in a single stage, and the total of 92 participants will be randomized in 1:1 fashion to fezolinetant or placebo arm respectively. After the 7-14-day screening period when all the baseline, pre-treatment measures will be collected, we will record daily data on frequency and severity of VM…
Eligibility
- Age range
- 40–65 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: Women with diagnosed, histologically confirmed, clinical stage I-III, HR+ invasive breast cancer as defined by ASCO CAP guidelines for whom adjuvant endocrine therapy would be indicated. BMI of 18-40 kg/m2 Age 40-65 Currently on endocrine therapy (tamoxifen or aromatase inhibitors). Willing and able to provide written informed consent/assent for the trial. Postmenopausal as defined by spontaneous amenorrhea for at least 12 consecutive months, spontaneous amenorrhea for at least 6 months with biochemical criteria or menopause (FSH \> 40 IU/L), or bilateral oophorectomy…
Interventions
- DrugFezolinetant
45 mg tablets, administered orally once daily with or without food, to be taken throughout the entire study phase, i.e. 12 weeks
- DrugPlacebo
45 mg tablets, administered orally once daily with or without food, to be taken throughout the entire study phase, i.e. 12 weeks
Locations (2)
- Yale UniversityNew Haven, Connecticut
- The Ohio State University Comprehensive Cancer CenterColumbus, Ohio