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Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer
Sponsor: Rutgers, The State University of New Jersey
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).
Official title: FITWISE: Feasibility Study of Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-10-30
Completion Date
2027-09-30
Last Updated
2026-01-21
Healthy Volunteers
No
Interventions
Tirzepatide
The intervention aims to assess the feasibility, safety, and efficacy of tirzepatide for weight loss in patients with early-stage hormone receptor-positive, HER2-negative breast cancer, potentially improving treatment outcomes and overall health.
Locations (7)
Trinitas Comprehensive Cancer Center
Elizabeth, New Jersey, United States
RWJ Barnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey, United States
RWJBarnabas Health - Cooperman Barnabas, Livingston
Livingston, New Jersey, United States
RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, United States
Rutgers Cancer Institute
New Brunswick, New Jersey, United States
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, United States
RWJ Barnabas Health - Robert Wood Johnson University Hospital, Somerset
Somerville, New Jersey, United States