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

RecruitingPhase 2

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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).

What is being tested

Sponsor: Rutgers, The State University of New Jersey · Participants: 40 · Started: Oct 30, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06518837

Locations in the U.S.

New JerseyTrinitas Comprehensive Cancer Center, Elizabeth
RWJ Barnabas Health - Robert Wood Johnson University Hospital, Hamilton, Hamilton (Not yet recruiting)
RWJBarnabas Health - Cooperman Barnabas, Livingston, Livingston
RWJBarnabas Health - Monmouth Medical Center, Long Branch
Rutgers Cancer Institute, New Brunswick
RWJBarnabas Health - Newark Beth Israel Medical Center, Newark
RWJ Barnabas Health - Robert Wood Johnson University Hospital, Somerset, Somerville

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.