Trial Title:
Fezolinetant for the Improvement of Vasomotor Symptoms in Breast Cancer Patients Taking Endocrine Therapy, VENT Trial
NCT ID:
NCT06617455
Condition:
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Breast Ductal Carcinoma In Situ
Localized Breast Carcinoma
Conditions: Official terms:
Carcinoma
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Supportive Care
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
All study drug will be blinded to the patients, the study investigators, and the study
coordinators to ensure masking of the treatments. The statistician and the study
investigators will remain blinded until the study database is locked. The only study
personnel that will not be blinded are the research pharmacy staff in order to facilitate
randomization codes and treatment delivery, and in case emergency unblinding is required.
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood samples
Arm group label:
Arm I (fezolinetant, placebo)
Arm group label:
Arm II (placebo, fezolinetant)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Drug
Intervention name:
Fezolinetant
Description:
Given PO
Arm group label:
Arm I (fezolinetant, placebo)
Arm group label:
Arm II (placebo, fezolinetant)
Intervention type:
Drug
Intervention name:
Placebo Administration
Description:
Given PO
Arm group label:
Arm I (fezolinetant, placebo)
Arm group label:
Arm II (placebo, fezolinetant)
Intervention type:
Other
Intervention name:
Quality-of-Life Assessment
Description:
Ancillary studies
Arm group label:
Arm I (fezolinetant, placebo)
Arm group label:
Arm II (placebo, fezolinetant)
Other name:
Quality of Life Assessment
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm I (fezolinetant, placebo)
Arm group label:
Arm II (placebo, fezolinetant)
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.
Criteria for eligibility:
Criteria:
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 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
Exclusion Criteria:
- Metastatic breast cancer
- Prior treatment with fezolinetant
- Known severe renal disease (estimated glomerular filtration rate [eGFR] less than 30
mL/min/1.73 m^2)
- Known cirrhosis
- Pregnant or breast feeding, or plan to become pregnant during the study period or
within 3 months of completing study medication
- Concomitant use of CYP1A2 inhibitors, including but not limited to fluvoxamine,
ciprofloxacin, cimetidine, citalopram, and ribociclib
- Concomitant use of systemic or transdermal estrogen products
- Known allergy or hypersensitivity to fezolinetant or any of the excipients in the
medication
- Unable to take oral medications
- Any medical condition that would interfere with the absorption of study medication.
Prior gastric bypass is permitted
- Concurrent medical disease that could confound or interfere with evaluation of VMS
- Patients with a prior or concurrent malignancy whose natural history or treatment,
in the opinion of the treating investigator, has the potential to interfere with the
safety or efficacy assessment of the investigational regimen
- Patients who are participating concurrently in another interventional study
(actually receiving a study medication) or participated in an interventional study
within 30 days prior to screening or received any investigational drug within 30
days or within 5 half-lives prior to screening, whichever is longer
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Michigan Rogel Cancer Center
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Contact:
Last name:
Cancer AnswerLine
Phone:
800-865-1125
Email:
CancerAnswerLine@med.umich.edu
Investigator:
Last name:
Norah L. Henry
Email:
Principal Investigator
Start date:
December 1, 2024
Completion date:
December 1, 2026
Lead sponsor:
Agency:
University of Michigan Rogel Cancer Center
Agency class:
Other
Collaborator:
Agency:
The Breast Cancer Research Foundation
Agency class:
Other
Source:
University of Michigan Rogel Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06617455
