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

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

Trial Details

NCT ID
NCT06518837
Phase
PHASE2
Sponsor
Rutgers, The State University of New Jersey
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • Tirzepatide
Locations (sample)
  • Elizabeth, New Jersey, United States|40.66399,-74.2107
  • Hamilton, New Jersey, United States|40.20706,-74.08125
  • Livingston, New Jersey, United States|40.79593,-74.31487
  • Long Branch, New Jersey, United States|40.30428,-73.99236
  • New Brunswick, New Jersey, United States|40.48622,-74.45182

Key Eligibility Criteria

  • Consent: Be willing and able to provide written informed consent for the trial.
  • Age: Male or Female patients aged 18 years or older.
  • Breast Cancer Diagnosis: Have hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer previously diagnosed by biopsy. HR status is def…
  • Stage: Have previously untreated early-stage, clinical or anatomic stage I, II, or III hormone receptor-positive breast cancer.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find HER2 Negative Breast Cancer Trials on Trialify →