Using tirzepatide to help with weight loss in early-stage breast cancer patients
FITWISE: Feasibility Study of Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer
This study is testing if the medication tirzepatide can help women with early-stage breast cancer lose at least 5% of their body weight while they receive treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Elizabeth, New Jersey and 6 other locations) |
| Trial ID | NCT06518837 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of tirzepatide in achieving a minimum 5% body weight reduction in patients with hormone receptor-positive, HER2-negative breast cancer undergoing adjuvant treatment. The study focuses on assessing the safety and tolerability of tirzepatide, as well as its feasibility based on treatment completion rates. Secondary objectives include monitoring invasive disease-free survival and distant relapse-free survival over three years, along with changes in BMI, body fat distribution, metabolic markers, and circulating tumor DNA. Quality of life assessments and exploratory objectives related to metabolic pathways will also be conducted.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with untreated early-stage hormone receptor-positive, HER2-negative breast cancer and a BMI of 27 kg/m² or more.
Not a fit: Patients with late-stage breast cancer or those with a BMI below the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve weight management and potentially enhance treatment outcomes for patients with early-stage breast cancer.
How similar studies have performed: While the use of tirzepatide for weight loss is a novel approach in this context, similar interventions targeting weight management in cancer patients have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Elizabeth, New Jersey and 6 other locations
- Trinitas Comprehensive Cancer Center — Elizabeth, New Jersey, United States (Recruiting)
- RWJ Barnabas Health - Robert Wood Johnson University Hospital, Hamilton — Hamilton, New Jersey, United States (Not_yet_recruiting)
- RWJBarnabas Health - Cooperman Barnabas, Livingston — Livingston, New Jersey, United States (Recruiting)
- RWJBarnabas Health - Monmouth Medical Center — Long Branch, New Jersey, United States (Recruiting)
- Rutgers Cancer Institute — New Brunswick, New Jersey, United States (Recruiting)
- RWJBarnabas Health - Newark Beth Israel Medical Center — Newark, New Jersey, United States (Recruiting)
- RWJ Barnabas Health - Robert Wood Johnson University Hospital, Somerset — Somerville, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Coral Omene, MD., PhD — Rutgers Cancer Institute
- Study coordinator: Coral Omene, MD., PhD
- Email: co273@cinj.rutgers.edu
- Phone: 732-235-3374
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.