Tirzepatide for Weight Loss in Breast Cancer

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

Recruiting Phase 2 Interventional Study
Hormone Receptor-Positive Breast Cancer HER2-Negative Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Rutgers, The State University of New Jersey · Other
Who this trial is looking for

This trial is looking for people with early-stage hormone receptor-positive, HER2-negative breast cancer. Participants will take tirzepatide to see if it helps them lose weight while undergoing their cancer treatment.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have been diagnosed with hormone receptor-positive, HER2-negative breast cancer.
  • I have not received any treatment for breast cancer yet.
  • I have had treatment with curative intent, such as surgery or chemotherapy.
  • I have a body mass index (BMI) of 30 or higher, or 27 or higher with a weight-related health issue.
  • I have an ECOG performance status of 0 to 2.
  • I have a left ventricular ejection fraction of at least 50%.
  • I have my tumor specimens available for testing.

You may not be able to join if

  • I am currently in another clinical trial.
  • I have stage IV metastatic breast cancer.
  • I have HER2-positive or triple-negative breast cancer.
  • I have another active cancer.
  • I have an ECOG performance status greater than 2.
  • I have a BMI less than 27.
  • I have type 1 diabetes.
  • I have a known serious stomach emptying problem.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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…
Trial Locations
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Eligibility Criteria
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…
Contacts

Coral Omene, MD., PhD

732-235-3374

co273@cinj.rutgers.edu

CONTACT