Using tirzepatide to help with weight loss in early-stage breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of tirzepatide in achieving a minimum 5% body weight reduction in patients with hormone receptor-positive, HER2-negative breast cancer undergoing adjuvant treatment. The study focuses on assessing the safety and tolerability of tirzepatide, as well as its feasibility based on treatment completion rates. Secondary objectives include monitoring invasive disease-free survival and distant relapse-free survival over three years, along with changes in BMI, body fat distribution, metabolic markers, and circulating tumor DNA. Quality of life assessments and exploratory objectives related to metabolic pathways will also be conducted.

Why it matters

Who can join: the full rules

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.

Where it's running

• Trinitas Comprehensive Cancer Center
  Elizabeth, New Jersey, United States Recruiting
• RWJBarnabas Health - Cooperman Barnabas, Livingston
  Livingston, New Jersey, United States Recruiting
• RWJBarnabas Health - Monmouth Medical Center
  Long Branch, New Jersey, United States Recruiting
• Rutgers Cancer Institute
  New Brunswick, New Jersey, United States Recruiting
• RWJBarnabas Health - Newark Beth Israel Medical Center
  Newark, New Jersey, United States Recruiting
• RWJ Barnabas Health - Robert Wood Johnson University Hospital, Somerset
  Somerville, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Coral Omene, MD., PhD — Rutgers Cancer Institute
• Study coordinator: Coral Omene, MD., PhD
• Email: co273@cinj.rutgers.edu
• Phone: 732-235-3374

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.