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.
- 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 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 defined as estrogen receptor (ER) >10% and/or progesterone receptor (PR) >10%; HER2 status is defined as immunohistochemistry (IHC) 0 or 1+ or IHC 2+, fluorescence in situ hybridization (FISH) negative. - Stage: Have previously untreated early-stage, clinical or anatomic stage I, II, or III hormone receptor-positive breast cancer. - Definitive Treatment: Have had definitive treatment with curative intent for breast cancer, including surgery, chemotherapy, and radiotherapy as indicated. - Body Mass Index (BMI): Have a BMI of 30 kg/m² or more, or a BMI of 27 kg/m² or more with one weight-related complication (e.g., hypertension, type 2 diabetes, dyslipidemia, obstructive sleep apnea, or cardiovascular disease). - Performance Status: Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. - Cardiac Function: Have a left ventricular ejection fraction (LVEF) of 50% or greater, or greater than the institution's lower limit of normal (LLN), as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed at screening. - Organ Function: Demonstrate adequate organ function in screening labs. - Tumor Specimens: Have archived biopsy or surgical tumor specimens available as tumor blocks or unstained slides. Exclusion Criteria: - Other Clinical Studies: Is currently enrolled, or will enroll in, a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study. - Stage IV Breast Cancer: Have stage IV, metastatic breast cancer. - Cancer Type: Have HER2-positive or triple-negative breast cancer. - Active Malignancy: Have a concomitant active malignancy. - Performance Status: Have an Eastern Cooperative Oncology Group (ECOG) performance status greater than 2. - Body Mass Index: Have a BMI of less than 27 kg/m². - Type 1 Diabetes Mellitus: Have type 1 diabetes mellitus. - Gastric Emptying Abnormality: Have a known clinically important gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction) or chronically took drugs that directly affect gastrointestinal motility.
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.
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