Phase
Condition
Breast Cancer
Weight Loss
Diabetes Prevention
Treatment
Tirzepatide
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 estrogenreceptor (ER) >10% and/or progesterone receptor (PR) >10%; HER2 status is defined asimmunohistochemistry (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, orIII hormone receptor-positive breast cancer.
Definitive Treatment: Have had definitive treatment with curative intent for breastcancer, 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 morewith 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) performancestatus of 0 to 2.
Cardiac Function: Have a left ventricular ejection fraction (LVEF) of 50% orgreater, or greater than the institution's lower limit of normal (LLN), as assessedby echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed atscreening.
Organ Function: Demonstrate adequate organ function in screening labs.
Tumor Specimens: Have archived biopsy or surgical tumor specimens available as tumorblocks or unstained slides.
Exclusion
Exclusion Criteria:
Other Clinical Studies: Is currently enrolled, or will enroll in, a differentclinical study in which investigational therapeutic procedures are performed orinvestigational 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) performancestatus 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 emptyingabnormality (e.g., severe gastroparesis or gastric outlet obstruction) orchronically took drugs that directly affect gastrointestinal motility.
Study Design
Study Description
Connect with a study center
Trinitas Comprehensive Cancer Center
Elizabeth, New Jersey 07202
United StatesSite Not Available
RWJ Barnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey 08690
United StatesSite Not Available
RWJBarnabas Health - Cooperman Barnabas, Livingston
Livingston, New Jersey 07039
United StatesSite Not Available
RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey 07740
United StatesSite Not Available
Rutgers Cancer Institute
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey 07112
United StatesSite Not Available
RWJ Barnabas Health - Robert Wood Johnson University Hospital, Somerset
Somerville, New Jersey 08876
United StatesSite Not Available
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