Actively Recruiting
Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer
Led by Rutgers, The State University of New Jersey · Updated on 2026-01-21
40
Participants Needed
7
Research Sites
152 weeks
Total Duration
On this page
Sponsors
R
Rutgers, The State University of New Jersey
Lead Sponsor
L
Ludwig Institute for Cancer Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 include evaluating 3-year invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), changes in BMI and body fat distribution, metabolic markers, and circulating tumor DNA (ctDNA).
CONDITIONS
Official Title
Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent for the trial
- Male or female patients aged 18 years or older
- Diagnosed with hormone receptor-positive, HER2-negative breast cancer by biopsy
- Have untreated early-stage (stage I, II, or III) hormone receptor-positive breast cancer
- Have received definitive treatment with curative intent including surgery, chemotherapy, and radiotherapy as indicated
- Have a body mass index (BMI) of 30 kg/m8 or more, or BMI of 27 kg/m8 or more with a weight-related complication such as hypertension, type 2 diabetes, dyslipidemia, obstructive sleep apnea, or cardiovascular disease
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Have a left ventricular ejection fraction (LVEF) of 50% or greater or above the institution's lower limit of normal as assessed by echocardiogram or MUGA scan
- Demonstrate adequate organ function based on screening laboratory tests
- Have archived biopsy or surgical tumor specimens available as tumor blocks or unstained slides
You will not qualify if you...
- Currently enrolled in or planning to enroll in another clinical study with investigational therapies
- Have stage IV or metastatic breast cancer
- Have HER2-positive or triple-negative breast cancer
- Have a concomitant active malignancy
- Have an Eastern Cooperative Oncology Group (ECOG) performance status greater than 2
- Have a body mass index (BMI) less than 27 kg/m8
- Have type 1 diabetes mellitus
- Have a known clinically important gastric emptying abnormality such as severe gastroparesis or gastric outlet obstruction, or chronically use drugs affecting gastrointestinal motility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Trinitas Comprehensive Cancer Center
Elizabeth, New Jersey, United States, 07202
Actively Recruiting
2
RWJ Barnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey, United States, 08690
Not Yet Recruiting
3
RWJBarnabas Health - Cooperman Barnabas, Livingston
Livingston, New Jersey, United States, 07039
Actively Recruiting
4
RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, United States, 07740
Actively Recruiting
5
Rutgers Cancer Institute
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
6
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Actively Recruiting
7
RWJ Barnabas Health - Robert Wood Johnson University Hospital, Somerset
Somerville, New Jersey, United States, 08876
Actively Recruiting
Research Team
C
Coral Omene, MD., PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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