Weight-Loss drug tirzepatide tested to boost breast cancer outcomes
NCT ID NCT06518837
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether tirzepatide, a drug used for weight loss, can help patients with early-stage hormone receptor-positive, HER2-negative breast cancer lose at least 5% of their body weight during adjuvant treatment. The trial will enroll 40 adults and also check safety, side effects, and long-term outcomes like cancer recurrence. The goal is to see if weight loss can improve overall health and treatment success.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tirzepatide
- What this could lead to
- If it works, this could point toward a way to improve treatment outcomes and reduce recurrence risk in early-stage breast cancer patients through weight loss.
- What could go wrong
- This is a small, early-phase feasibility study with only 40 participants. It may not show clear benefits, and tirzepatide can cause side effects like nausea or digestive issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Get notified about this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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RWJ Barnabas Health - Robert Wood Johnson University Hospital, Hamilton
NOT_YET_RECRUITINGHamilton, New Jersey, 08690, United States
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RWJ Barnabas Health - Robert Wood Johnson University Hospital, Somerset
RECRUITINGSomerville, New Jersey, 08876, United States
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RWJBarnabas Health - Cooperman Barnabas, Livingston
RECRUITINGLivingston, New Jersey, 07039, United States
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RWJBarnabas Health - Monmouth Medical Center
RECRUITINGLong Branch, New Jersey, 07740, United States
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RWJBarnabas Health - Newark Beth Israel Medical Center
RECRUITINGNewark, New Jersey, 07112, United States
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Rutgers Cancer Institute
RECRUITINGNew Brunswick, New Jersey, 08901, United States
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Trinitas Comprehensive Cancer Center
RECRUITINGElizabeth, New Jersey, 07202, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Daily pill giredestrant put to the test for sticking with breast cancer treatment
- Can an oral HER2 drug boost Chemo's punch in HER2-Low breast cancer?
- Can a blood test reveal when breast cancer treatment stops working?
- Can a platform trial match the right drug combo to each tumor?
- Can a Two-Drug combo shrink BRCA-Linked breast tumors?
- Can a new drug make hormone therapy work better for breast cancer?