Anatomic Stage I Breast Cancer AJCC v8Phase 2VEnTNCT06617455
Fezolinetant for the Improvement of Vasomotor Symptoms in Breast Cancer Patients Taking Endocrine Therapy, VENT Trial
A Phase 2 study testing Biospecimen Collection, Fezolinetant and Quality-of-Life Assessment in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- What is being tested?
- Biospecimen Collection, Fezolinetant and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2024to 21 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: Phase 2 Randomized, Cross-over Trial of Fezolinetant for Treatment of Vasomotor Symptoms in Patients Taking Endocrine Therapy (VEnT)
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.
Read the detailed description
15APR2026- Amendment processed to revise the statistical analysis plan, because the trial is being terminated early due to poor accrual. We are switching the analysis plan to be descriptive because of poor accrual. Additionally, we are removing the exploratory analyses.
- Conditions
- 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
- Being tested
- Biospecimen Collection, Fezolinetant, Placebo Administration, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood samples
FezolinetantDrug
Given PO
Placebo AdministrationDrug
Given PO
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (fezolinetant, placebo) | Experimental | 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. Receives: Procedure: Biospecimen Collection; Drug: Fezolinetant; Drug: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (placebo, fezolinetant) | Experimental | 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. Receives: Procedure: Biospecimen Collection; Drug: Fezolinetant; Drug: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of vasomotor symptoms (VMS)
Will perform an intent-to-treat analysis. The mean change in frequency of VMS with 4 weeks of fezolinetant versus placebo will be reported with the corresponding 95% confidence interval. Initial analysis will use a paired t-test of the mean change in frequency of VMS with 4 weeks of treatment with drug and placebo.
Measured: Baseline to day 71
Secondary outcomes (6)
Change of the severity of VMS
The mean change of the severity of VMS, as assessed with the hot flash log, with 4 weeks of fezolinetant versus placebo. Will perform an intent-to-treat analysis. Will be reported with corresponding 95% confidence intervals. Initial analysis will use a paired t-test of the mean change in severity of VMS from baseline to week 4 between drug and placebo.
Measured: Baseline to day 71
Change of the hot flash score
The mean change of the hot flash score, as assessed with the hot flash log and calculated by multiplying VMS frequency by severity, with 4 weeks of fezolinetant versus placebo. Will perform an intent-to-treat analysis. Will be reported with corresponding 95% confidence intervals. Initial analysis will use a paired t-test of the mean change in hot flash score from baseline to week 4 between drug and placebo.
Measured: Baseline to day 71
Change of the Menopause-Specific Quality of Life (MENQOL) hot flash subscore
The mean change of the MENQOL hot flash subscore with 4 weeks of fezolinetant versus placebo. Will perform an intent-to-treat analysis. Will be reported with corresponding 95% confidence intervals. Initial analysis will use a paired t-test of the mean change in MENQOL hot flash subscore from baseline to week 4 between drug and placebo.
Measured: Baseline to day 71
Patient Global Impression of Change (PGIC) for hot flashes and night sweats
The mean PGIC for hot flashes and for night sweats after 4 weeks of fezolinetant versus placebo. Will perform an intent-to-treat analysis. Will be reported with corresponding 95% confidence intervals. Initial analysis will use a paired t-test of PGIC score from baseline to week 4 between drug and placebo.
Measured: Baseline to day 71
Change of the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance
The mean change of the PROMIS Sleep Disturbance T score with 4 weeks of fezolinetant versus placebo. Will perform an intent-to-treat analysis. Will be reported with corresponding 95% confidence intervals. Initial analysis will use a paired t-test of the mean change in PROMIS Sleep Disturbance from baseline to week 4 between drug and placebo.
Measured: Baseline to day 71
Incidence of adverse events
Safety will be assessed throughout the trial and adverse events during the 10 weeks of study participation will be reported using descriptive statistics for fezolinetant and for placebo. Assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Measured: Baseline through 30 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start31 Oct 2024
- Primary completion22 Oct 2025
- Study completion21 Nov 2025
Why it stopped: Lack of Patient Interest
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Sponsor
- Investigators
- Norah L Henry, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617455
- Sponsor's protocol ID
- UMCC 2024.059
- Other IDs
- NCI-2024-06543, HUM00256706
- Acronym
- VEnT
- Status last verified
- May 2026
- First submitted
- 24 Sep 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: participant demographics and patient-reported outcomes data will be available to researchers upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized, Cross-over Trial of Fezolinetant for Treatment of Vasomotor Symptoms in Patients Taking Endocrine Therapy (VEnT)
- ClinicalTrials.gov ID
- NCT06617455
- Acronym / sponsor ID
- VEnT / UMCC 2024.059
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Patient Interest
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
15APR2026- Amendment processed to revise the statistical analysis plan, because the trial is being terminated early due to poor accrual. We are switching the analysis plan to be descriptive because of poor accrual. Additionally, we are removing the exploratory analyses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (fezolinetant, placebo) | Experimental | Procedure: Biospecimen Collection, Drug: Fezolinetant, Drug: Placebo Administration, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
| Arm II (placebo, fezolinetant) | Experimental | Procedure: Biospecimen Collection, Drug: Fezolinetant, Drug: Placebo Administration, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood samples | Procedure or surgery | Arm I (fezolinetant, placebo), Arm II (placebo, fezolinetant) |
| FezolinetantGiven PO | Drug | Arm I (fezolinetant, placebo), Arm II (placebo, fezolinetant) |
| Placebo AdministrationGiven PO | Drug | Arm I (fezolinetant, placebo), Arm II (placebo, fezolinetant) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (fezolinetant, placebo), Arm II (placebo, fezolinetant) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (fezolinetant, placebo), Arm II (placebo, fezolinetant) |
Primary outcome
Change in frequency of vasomotor symptoms (VMS)
Time frame: Baseline to day 71
Will perform an intent-to-treat analysis. The mean change in frequency of VMS with 4 weeks of fezolinetant versus placebo will be reported with the corresponding 95% confidence interval. Initial analysis will use a paired t-test of the mean change in frequency of VMS with 4 weeks of treatment with drug and placebo.
6 secondary outcomes
Change of the severity of VMS
Time frame: Baseline to day 71
Change of the hot flash score
Time frame: Baseline to day 71
Change of the Menopause-Specific Quality of Life (MENQOL) hot flash subscore
Time frame: Baseline to day 71
Patient Global Impression of Change (PGIC) for hot flashes and night sweats
Time frame: Baseline to day 71
Change of the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance
Time frame: Baseline to day 71
Incidence of adverse events
Time frame: Baseline through 30 days after the last dose of study treatment
Results and safety
The study was stopped early (reason given: Lack of Patient Interest). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. participant demographics and patient-reported outcomes data will be available to researchers upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norah L Henry principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection, Fezolinetant and Quality-of-Life Assessment in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of Patient Interest). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of vasomotor symptoms (VMS) (time frame: Baseline to day 71). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.