Clinical Trial

Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer

Study acronym: FITWISE
Recruiting Phase 2
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Summary
This clinical trial aims to evaluate the effectiveness of tirzepatide in achieving a 5% or more body weight reduction in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The study will also assess the safety and tolerability of tirzepatide, its feasibility based on discontinuation rates, and completion of treatment. Secondary objectives include evaluating 3-year invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), changes in BMI and body fat distribution, metabolic markers, and circulating tumor DNA (ctDNA).
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-07-18; most recent amendment 2026-01-17.
Status change: Not Yet Recruiting → Recruiting 2024-11-27
Trial Details
NCT Number NCT06518837
Lead Sponsor Rutgers, The State University of New Jersey
Collaborators: Ludwig Institute for Cancer Research
Conditions Hormone Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer
Enrollment 40 participants
Start Date 2024-10-30
Primary Completion 2027-09-30 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-21