A study testing whether a new weekly shot from Rutgers, The State University of New Jersey, tirzepatide, may help during breast cancer treatment.

Who can join

Adults 18+, have hormone-receptor-positive breast cancer, BMI 27+.

What you take

tirzepatide, given as part of the study at no cost to you. Some participants may receive a placebo (an inactive version) instead, decided at random.

How long it lasts

The full study runs about 2.9 years; your own time in it is usually shorter.

What you get

The study medication and study-related care at no cost. Compensation varies by study site; many cover travel and provide the study medication at no cost. The trial coordinator will explain what that site offers before you join.

What this study is for

Full study title: Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer.

Primary condition: Hormone Receptor-Positive Breast Cancer. Also studied in: HER2-Negative Breast Cancer.

Who can join, in detail

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 study is enrolling

This trial has 7 US sites across 1 states. Contact the site coordinator directly to start the screening process.

Timeline

Started enrolling: 2024-10-30. Expected completion: 2027-09-30. Last updated on ClinicalTrials.gov: 2026-01-21.

Official source

We sync this data quarterly from ClinicalTrials.gov, the federal registry for clinical research. Before contacting a site, verify the trial is still recruiting on the official page:

View on ClinicalTrials.gov →

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