This phase II trial tests how well tirzepatide works for weight loss in patients with early stage, hormone receptor positive, HER2 negative breast cancer. Obesity at time of breast cancer diagnosis and following treatment in survivorship years is associated with poorer overall and breast cancer survival. Tirzepatide is a medication that is used for the treatment of type 2 diabetes. It works by increasing insulin levels in the body, which decreases blood sugar and can lead to weight loss. Tirzepatide may be effective in inducing weight loss in patients with early stage, hormone receptor positive, HER2 negative breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06518837.
Locations matching your search criteria
United States
New Jersey
Elizabeth
Trinitas Hospital and Comprehensive Cancer Center - Williamson Street CampusStatus: Active
Contact: Trishala Meghal
Phone: 800-994-8000
Livingston
Saint Barnabas Medical CenterStatus: Active
Contact: George Raptis
Phone: 972-322-5200
Long Branch
Monmouth Medical CenterStatus: Active
Contact: Patrick Lee
Phone: 732-222-1711
New Brunswick
Rutgers Cancer Institute of New JerseyStatus: Active
Contact: Coral Oghenerukevwe Omene
Phone: 732-235-3374
Newark
Newark Beth Israel Medical CenterStatus: Active
Contact: Sari Jacoby
Phone: 973-926-7230
Somerville
Robert Wood Johnson University Hospital SomersetStatus: Active
Contact: Kathleen C. Toomey
Phone: 908-972-8702
PRIMARY OBJECTIVE:
I. To determine how many patients achieve a 5% or more body weight reduction at the end of study treatment with tirzepatide during the adjuvant treatment for hormone receptor positive breast cancer (hormone receptor [HR]+/Her2-).
SECONDARY OBJECTIVES:
I. To assess the safety and tolerability of tirzepatide for weight loss during the adjuvant treatment for HR+/Her2- breast cancer.
II. To determine the feasibility of using tirzepatide for weight loss intervention during the adjuvant treatment for hormone receptor positive breast cancer (HR+/Her2-), as assessed by discontinuation rates and completion of treatment course.
III. To determine the 3-year invasive disease-free survival (IDFS) with use of tirzepatide for weight loss in the adjuvant treatment of HR+/Her2- breast cancer.
IV. To determine the 3-year distant relapse-free survival (DRFS) with use of tirzepatide for weight loss in the adjuvant treatment of HR+/Her2- breast cancer.
V. To assess changes in body mass index (BMI), body fat distribution (via waist/hip ratio [WHR]) and waist circumference when using tirzepatide for weight loss in the adjuvant treatment of HR+/Her2- breast cancer.
VI. To assess changes in obesity related metabolic markers (blood pressure, fasting insulin, fasting blood glucose, hemoglobin A1c [HgbA1c], cholesterol, low density lipoprotein [LDL], high density lipoprotein [HDL], triglycerides, insulin-like growth factor [IGF1], estrogen, testosterone) when using tirzepatide for weight loss in the adjuvant treatment of HR+/Her2- breast cancer.
VII. To monitor for circulating tumor-derived deoxyribonucleic acid (DNA) (ctDNA) and assess changes when using tirzepatide for weight loss in the adjuvant treatment of HR+/Her2- breast cancer.
EXPLORATORY OBJECTIVES:
I. To assess gene and protein expression of adiposity-related adipokines and adipokine receptor expression in breast tumors from patients eligible for treatment and blood during the 2-year study duration of treatment with tirzepatide for weight loss.
II. To study metabolomic pathways and immune cell metabolism from adipose tissues and blood during the 2-year study duration of treatment with tirzepatide for weight loss.
OUTLINE:
Patients receive tirzepatide subcutaneously (SC) once weekly (QW) for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo abdominal adipose fat biopsy and blood sample collection on study.
After completion of study treatment, patients are followed up at 6 months, and 1, 2, and 3 years.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationRutgers Cancer Institute of New Jersey
Principal InvestigatorCoral Oghenerukevwe Omene
