Phase 2 Randomized, Cross-over Trial of Fezolinetant for Treatment of Vasomotor Symptoms in Patients Taking Endocrine Therapy (VEnT)

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 screening period

• Patients taking over-the-counter supplements or herbal medications for treatment of VMS must stop the medication at least 7 days before the start of the VMS screening period

• Able to self-complete questionnaires in English

• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

• For women of childbearing potential, participants must agree to use an effective contraceptive method during protocol therapy and for 3 months following completion of protocol therapy with details provided as a part of the consent process and must have a negative pregnancy test at screening. In addition to routine contraceptive methods, effective contraception also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, and bilateral tubal ligation/occlusion

Locations
United States
Michigan
University of Michigan Rogel Cancer Center
RECRUITING
Ann Arbor
Contact Information
Primary
Cancer AnswerLine
CancerAnswerLine@med.umich.edu
1-800-865-1125
Time Frame
Start Date: 2024-10-31
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 36
Treatments
Experimental: Arm I (fezolinetant, placebo)
Patients receive fezolinetant PO QD for 28 days in the absence of unacceptable toxicity. Patients then go through a washout period and take no study medication for the next 14 days. Following the washout, patients receive placebo PO QD for 28 days in the absence of unacceptable toxicity. Patients undergo collection of blood samples throughout the study.
Experimental: Arm II (placebo, fezolinetant)
Patients receive placebo PO QD for 28 days in the absence of unacceptable toxicity. Patients then go through a washout period and take no study medication for the next 14 days. Following the washout, patients receive fezolinetant PO QD for 28 days in the absence of unacceptable toxicity. Patients undergo collection of blood samples throughout the study.
Related Therapeutic Areas
Sponsors
Leads: University of Michigan Rogel Cancer Center
Collaborators: The Breast Cancer Research Foundation

This content was sourced from clinicaltrials.gov

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