RecruitingPhase 2NCT06518837

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

FITWISE: Feasibility Study of Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer


Sponsor

Rutgers, The State University of New Jersey

Enrollment

40 participants

Start Date

Oct 30, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the weight-loss drug tirzepatide (a weekly injection that regulates blood sugar and appetite) in people with early-stage hormone receptor-positive, HER2-negative breast cancer. Researchers want to see whether losing weight through tirzepatide reduces the levels of cancer-related hormones and inflammatory markers that can drive breast cancer growth, potentially lowering recurrence risk. **You may be eligible if...** - You are 18 or older (any gender) - You have been diagnosed with hormone receptor-positive (ER or PR >10%), HER2-negative breast cancer - Your cancer was confirmed by biopsy - You are overweight or obese (your doctor will assess BMI eligibility) - You have completed primary cancer treatment **You may NOT be eligible if...** - You have metastatic (stage 4) breast cancer - You have a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2) - You are pregnant or breastfeeding - You have severe kidney or gastrointestinal disease that would make tirzepatide unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTirzepatide

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06518837


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