drugset / Trial / NCT06518837
Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer
Phase 2
Recruiting
40 enrolled
Rutgers, The State University of New Jersey
Ludwig Institute for Cancer Research · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tirzepatide | Peptide | 5 mg | Subcutaneous |
| Subject | Tirzepatide | Peptide | 10 mg | Subcutaneous |
| Subject | Tirzepatide | Peptide | 15 mg | Subcutaneous |