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Tirzepatide for Weight Loss in Early-Stage Breast Cancer

This study is looking at how well tirzepatide helps people with early-stage hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer lose weight. You might be able to join if you are 18 or older and have this type of breast cancer. The main goal is to see if tirzepatide can help participants reduce their body weight by 5% or more over two years. The study is also checking how safe tirzepatide is and if it's easy for people to stick with the treatment. The study is currently unclear on its recruitment status and plans to enroll 40 participants.

Study design
This is an interventional study planning to enroll 40 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures weight loss through study completion, a total of two years. Secondary objectives include evaluating survival rates at 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06518837

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Rutgers, The State University of New Jersey
~40 participants
Updated 2026-01-21 on ClinicalTrials.gov
What's tested:Tirzepatide

At a glance

Recruiting sites
6 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Weight Loss Reduction with Tirzepatide during Adjuvant Treatment for HR+/Her2- Breast Cancer (Measured by Body Weight Reduction)
Measured over Through study completion, total of two years.

Conditions

Hormone Receptor-Positive Breast Cancer
HER2-Negative Breast Cancer

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Where it's being run

7 sites across 1 states
New Jersey7

Study leadership

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

Who to contact

Coral Omene, MD., PhD
[email protected]
732-235-3374
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Weight Loss Reduction with Tirzepatide during Adjuvant Treatment for HR+/Her2- Breast Cancer (Measured by Body Weight Reduction)Through study completion, total of two years.

    To determine the effectiveness of tirzepatide in facilitating a 5% or more weight loss in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer.