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Hormone Therapy

Fezolinetant for Hot Flashes in Breast Cancer

Phase 3
Recruiting
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant has a personal history of stage 0-3 hormone receptor positive (HR+), either human epidermal growth factor receptor (HER)-2+ or HER-2- breast cancer; appropriate documentation includes a written or electronic report.
Has an European Cooperative Oncology Group (ECOG) score 0 or 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 4, 8, 12 and 24
Awards & highlights
Pivotal Trial

Summary

"This trial is testing a new medication called fezolinetant to see if it can help reduce hot flashes in women who are on hormone therapy for breast cancer. Women who have moderate to severe hot

Who is the study for?
This trial is for women over 18 with breast cancer stages 0-3+, undergoing hormone therapy and experiencing at least 7 moderate to severe hot flashes daily. They must not be breastfeeding, expect to live at least another year, and agree to use contraception. Women cannot join if they are of childbearing potential or plan changes in their cancer treatment.
What is being tested?
The study tests Fezolinetant's effectiveness against hot flashes compared to a placebo in women receiving hormone therapy for breast cancer. Participants will randomly receive either Fezolinetant or a placebo, without knowing which one, and take it daily for a year while tracking their symptoms.
What are the potential side effects?
Potential side effects of Fezolinetant aren't specified here but may include reactions similar to other menopause treatments like headaches, nausea, or dizziness. Placebo has no active ingredients but can cause perceived side effects due to the 'placebo effect.'

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had breast cancer stages 0-3 that was hormone receptor positive.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I was born female.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks 4, 8, 12 and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 4, 8, 12 and 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean change from Baseline to Week 12 in the frequency of moderate to severe VMS
Mean change from Baseline to Week 12 in the severity of moderate to severe VMS
Mean change from Baseline to Week 4 in the frequency of moderate to severe VMS
+1 more
Secondary study objectives
Change from Baseline in the PGI-S SD Score
Change from Baseline in the Patient Global Impression of Severity (PGI-S) VMS Score
Mean Change from Baseline in the frequency of moderate to severe VMS to the average frequency of moderate to severe VMS over Weeks 5 to 11
+50 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: FezolinetantExperimental Treatment3 Interventions
Participants taking tamoxifen or an aromatase inhibitor will receive fezolinetant once daily for 52 weeks.
Group II: PlaceboPlacebo Group3 Interventions
Participants taking tamoxifen or an aromatase inhibitor will receive matching placebo once daily for 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fezolinetant
2020
Completed Phase 3
~1560
Tamoxifen
2005
Completed Phase 4
~30110
Aromatase inhibitor
2021
Completed Phase 4
~5510

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
199 Previous Clinical Trials
121,814 Total Patients Enrolled
6 Trials studying Hot Flashes
4,668 Patients Enrolled for Hot Flashes
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,877 Previous Clinical Trials
8,084,293 Total Patients Enrolled
7 Trials studying Hot Flashes
3,888 Patients Enrolled for Hot Flashes
~360 spots leftby Oct 2026
Unbiased ResultsWe believe in providing patients with all the options.
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