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

Description

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).

Conditions

Hormone Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Hormone Receptor-Positive Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Elizabeth

Trinitas Comprehensive Cancer Center, Elizabeth, New Jersey, United States, 07202

Hamilton

RWJ Barnabas Health - Robert Wood Johnson University Hospital, Hamilton, Hamilton, New Jersey, United States, 08690

Livingston

RWJBarnabas Health - Cooperman Barnabas, Livingston, Livingston, New Jersey, United States, 07039

Long Branch

RWJBarnabas Health - Monmouth Medical Center, Long Branch, New Jersey, United States, 07740

New Brunswick

Rutgers Cancer Institute, New Brunswick, New Jersey, United States, 08901

Newark

RWJBarnabas Health - Newark Beth Israel Medical Center, Newark, New Jersey, United States, 07112

Somerville

RWJ Barnabas Health - Robert Wood Johnson University Hospital, Somerset, Somerville, New Jersey, United States, 08876

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Rutgers, The State University of New Jersey,

Coral Omene, MD., PhD, PRINCIPAL_INVESTIGATOR, Rutgers Cancer Institute

Study Record Dates

2027-09-30