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

NCT06518837 · Recruiting

Last updated 2026-05-28

This clinical trial is testing whether the medication tirzepatide helps people with early-stage hormone receptor-positive/HER2-negative breast cancer lose weight during their treatment.

Status Recruiting Currently enrolling participants.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design open-label (no blinding) treatment study

Participants 40 people Planned (estimated).

Who can join Ages 18+ · all sexes

Timeline Started 2024-10 · est. completion 2027-09

Where 7 sites · United States

What this study is testing ClinicalTrials.gov NCT06518837 ↗

Description as written by the study sponsor.

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).

Treatments tested

Tirzepatide also known as LY3298176 (development code name), Mounjaro (brand name in certain regions), Zepbound (brand name in certain regions) Drug

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.

Main thing measured	Weight Loss Reduction with Tirzepatide during Adjuvant Treatment for HR+/Her2- Breast Cancer (Measured by Body Weight Reduction)
Sponsor	Rutgers, The State University of New Jersey
Conditions studied	Hormone Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer
GLP-1 drugs	tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06518837 ↗