drugset / Trial / NCT06518837

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

NCT06518837

NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2024-10-30
Primary completion
2027-09-30
Completion
2027-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Tirzepatide Peptide 5 mg Subcutaneous
Subject Tirzepatide Peptide 10 mg Subcutaneous
Subject Tirzepatide Peptide 15 mg Subcutaneous