Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer
FITWISE: Feasibility Study of Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer
Rutgers, The State University of New Jersey
40 participants
Oct 30, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria10
- 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 Criteria8
- 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.
Interventions
The intervention aims to assess the feasibility, safety, and efficacy of tirzepatide for weight loss in patients with early-stage hormone receptor-positive, HER2-negative breast cancer, potentially improving treatment outcomes and overall health.
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT06518837