Status:
RECRUITING
Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
Ludwig Institute for Cancer Research
Conditions:
Hormone Receptor-Positive Breast Cancer
HER2-Negative Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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-nega...
Detailed Description
The primary objective of this clinical trial is to determine the proportion of patients who achieve a 5% or greater reduction in body weight by the end of the study treatment with tirzepatide, during ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06518837
Start Date
October 30 2024
End Date
September 30 2027
Last Update
December 2 2024
Active Locations (7)
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1
Trinitas Comprehensive Cancer Center
Elizabeth, New Jersey, United States, 07202
2
RWJ Barnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey, United States, 08690
3
RWJBarnabas Health - Cooperman Barnabas, Livingston
Livingston, New Jersey, United States, 07039
4
RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, United States, 07740