Fezolinetant for Breast Cancer
(VEnT Trial)
Trial Summary
Will I have to stop taking my current medications?
If you are taking certain medications like SSRIs, SNRIs, gabapentinoids, clonidine, or oxybutynin, you must have been on a stable dose for at least 30 days before joining the study and continue them during the study. If you plan to stop these medications, you should do so at least 7 days before the screening period. Over-the-counter supplements or herbal medications for VMS should also be stopped at least 7 days before the screening period.
Is fezolinetant safe for humans?
How is the drug fezolinetant unique for breast cancer treatment?
What is the purpose of this trial?
This phase II trial tests how well fezolinetant works in improving vasomotor symptoms (VMS) in breast cancer patients taking endocrine therapy (ET). Anti-hormone treatments are effective for lowering the risk of breast cancer but can cause bothersome VMS, such as hot flashes and night sweats. Fezolinetant inhibits the activity of the neurokinin type 3 receptor and has shown activity against VMS in postmenopausal women. Taking fezolinetant may work well at improving VMS in breast cancer patients taking ET.
Research Team
Norah L. Henry
Principal Investigator
University of Michigan Rogel Cancer Center
Eligibility Criteria
This trial is for breast cancer patients experiencing hot flashes and night sweats due to endocrine therapy. Participants should be currently receiving anti-hormone treatments for breast cancer.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive fezolinetant or placebo for 28 days, followed by a 14-day washout period, then crossover to the alternate treatment for another 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Fezolinetant
Fezolinetant is already approved in United States, European Union for the following indications:
- Moderate to severe vasomotor symptoms due to menopause
- Hot flushes (vasomotor symptoms) associated with menopause
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer Center
Lead Sponsor
The Breast Cancer Research Foundation
Collaborator