A study testing whether a new weekly shot, tirzepatide, may help during breast cancer treatment.
Recruiting now. Registry record last updated January 21, 2026.
- Who can join
- Adults 18+, have hormone-receptor-positive breast cancer, BMI 27+.
- What you take
- tirzepatide, given as part of the study. Check ClinicalTrials.gov for this trial's study groups, including any placebo or comparison medicine.
- How long it lasts
- The full study runs about 2.9 years; your own time in it is usually shorter.
- What you get
- Many clinical trials pay for the study medication and the study visits. Some also pay for travel. Ask the study team what this one covers before you sign the consent form.
What this study is for
Primary condition: Hormone Receptor-Positive Breast Cancer. Also studied in: HER2-Negative Breast Cancer.
Full scientific study title: Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer.
Who can join
Adults 18+, have hormone-receptor-positive breast cancer, BMI 27+. A site coordinator confirms whether you qualify during a free screening visit. The exact medical requirements are below.
Full medical eligibility (for you and your doctor)verbatim from the registry
This is the exact wording from ClinicalTrials.gov, including clinical measures (lab values, imaging scores). Bring it to your doctor if any of it is unclear.
Key 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.
Key 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.
Where this trial is enrolling
This trial has 7 sites across 1 state. Contact a site coordinator directly to start screening.
New Jersey7 sites
- Trinitas Comprehensive Cancer CenterElizabeth, New Jersey
- RWJ Barnabas Health - Robert Wood Johnson University Hospital, HamiltonHamilton, New Jersey
- RWJBarnabas Health - Cooperman Barnabas, LivingstonLivingston, New Jersey
- RWJBarnabas Health - Monmouth Medical CenterLong Branch, New Jersey
- Rutgers Cancer InstituteNew Brunswick, New Jersey
- RWJBarnabas Health - Newark Beth Israel Medical CenterNewark, New Jersey
- RWJ Barnabas Health - Robert Wood Johnson University Hospital, SomersetSomerville, New Jersey
Timeline
Started enrolling: October 30, 2024. Expected completion: September 30, 2027. Last updated on ClinicalTrials.gov: January 21, 2026.
Official source
Every Monday we check this trial against ClinicalTrials.gov, the federal registry for clinical research. Last checked August 21, 2026. Confirm the current status there before you contact a site:
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