Print this page

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

Primary Objective:
To determine how many patients achieve a 5% or more body weight reduction at the end of study treatment with tirzepatide during the adjuvant treatment for hormone receptor positive breast cancer (HR+/Her2-).

Secondary Objectives:
1.To assess the safety and tolerability of tirzepatide for weight loss during the adjuvant treatment for ER+/Her2- breast cancer.

2.To determine the feasibility of using tirzepatide for weight loss intervention during the adjuvant treatment for hormone receptor positive breast cancer (HR+/Her2-), as assessed by discontinuation rates and completion of treatment course.

3. To determine the 3-year invasive disease-free survival (IDFS) with use of tirzepatide for weight loss in the adjuvant treatment of HR+/Her2- breast cancer.

4. To determine the 3-year distant relapse-free survival (DRFS) with use of tirzepatide for weight loss in the adjuvant treatment of HR+/Her2- breast cancer.

5. To assess changes in Body Mass Index (BMI), body fat distribution (via Waist/Hip Ratio (WHR) and waist circumference when using tirzepatide for weight loss in the adjuvant treatment of HR+/Her2- breast cancer.

6. To assess changes in obesity related metabolic markers (Blood Pressure, fasting insulin, fasting blood glucose, HgbA1c, cholesterol, LDL, HDL, triglycerides, IGF1, estrogen, testosterone) when using tirzepatide for weight loss in the adjuvant treatment of HR+/Her2- breast cancer.

7. To monitor for ctDNA and assess changes when using tirzepatide for weight loss in the adjuvant treatment of HR+/Her2- breast cancer.

Exploratory Objectives:
1. To assess gene and protein expression of adiposity-related adipokines and adipokine receptor expression in breast tumors from patients eligible for treatment and blood during the 2-year study duration of treatment with tirzepatide for weight loss.

2. To study metabolomic pathways and immune cell metabolism from adipose tissues and blood during the 2-year study duration of treatment with tirzepatide for weight loss.

Protocol Number: 042403
Phase: Phase II
Applicable Disease Sites: Breast
Drugs Involved: Tirzepatide
Principal Investigator: Coral Omene
Scope: Local
Therapies Involved: Chemotherapy single agent systemic
Participating Institutions:
  • RWJBarnabas Health
    • Cooperman Barnabas, Livingston
    • Monmouth Medical Center
    • Newark Beth Israel Medical Center
    • Robert Wood Johnson University Hospital, Somerset
    • Trinitas Hospital and Comprehensive Cancer Center
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.