Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer
NCT Number: NCT06518837
Acronym: FITWISE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hormone Receptor-Positive Breast Cancer|HER2-Negative Breast Cancer
Interventions: DRUG: Tirzepatide
Sponsor: Rutgers, The State University of New Jersey
Collaborators: Ludwig Institute for Cancer Research
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2027-09-30
Locations: Trinitas Comprehensive Cancer Center, Elizabeth, New Jersey, 07202, United States|RWJ Barnabas Health - Robert Wood Johnson University Hospital, Hamilton, Hamilton, New Jersey, 08690, United States|RWJBarnabas Health - Cooperman Barnabas, Livingston, Livingston, New Jersey, 07039, United States|RWJBarnabas Health - Monmouth Medical Center, Long Branch, New Jersey, 07740, United States|Rutgers Cancer Institute, New Brunswick, New Jersey, 08901, United States|RWJBarnabas Health - Newark Beth Israel Medical Center, Newark, New Jersey, 07112, United States|RWJ Barnabas Health - Robert Wood Johnson University Hospital, Somerset, Somerville, New Jersey, 08876, United States

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-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).

Primary Outcome Measures: Weight Loss Reduction with Tirzepatide during Adjuvant Treatment for HR+/Her2- Breast Cancer (Measured by Body Weight Reduction), To determine the effectiveness of tirzepatide in facilitating a 5% or more weight loss in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer., Through study completion, total of two years.
Secondary Outcome Measures: Safety and Tolerability of Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer (Measured by Incidence of Adverse Events Using CTCAE v5.0), This outcome assesses the safety and tolerability of tirzepatide for weight loss in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to monitor and document the incidence of adverse events (AEs) associated with tirzepatide use, utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. This assessment will help determine the risk profile of tirzepatide and ensure that the benefits of weight loss outweigh potential adverse effects in this patient population., Adverse events will be monitored through study completion for two years.|Feasibility of Tirzepatide for Weight Loss Intervention during Adjuvant Treatment for HR+/Her2- Breast Cancer (Assessed by Discontinuation Rates and Completion of Treatment Course)., This outcome measures the feasibility of using tirzepatide for weight loss intervention in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to assess the intervention's practicality by evaluating discontinuation rates and the completion of the treatment course. High completion rates and low discontinuation rates will indicate that tirzepatide is a feasible weight loss intervention in this patient population., Feasibility will be evaluated through study completion for two years.|Clinical Efficacy of Tirzepatide during Adjuvant Treatment for HR+/Her2- Breast Cancer (Measured by 3-Year Invasive Disease-Free Survival and 3-Year Distant Relapse-Free Survival), This outcome measures the clinical efficacy of tirzepatide in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to determine the 3-year invasive disease-free survival (IDFS) and the 3-year distant relapse-free survival (DRFS) rates. These metrics will help evaluate whether weight loss using tirzepatide contributes to preventing cancer recurrence and metastasis in this patient population., Patients will be monitored for recurrence through study completion and an additional year, for total three years.|Assessment of Obesity Measurements Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer, as measured by Waist/Hip Ratio (WHR), and waist circumference., This outcome measures the impact of tirzepatide on obesity-related metrics in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to evaluate changes in Body Mass Index (BMI), body fat distribution as measured by Waist/Hip Ratio (WHR), and waist circumference. These assessments will help determine the effectiveness of tirzepatide in improving body fat distribution and reducing obesity in this patient population. Weight and height will be combined to report BMI in kg/m\^2 and waist circumference reported in inches., Obesity measurements will be evaluated through study completion for two years.|Assessment of Obesity Measurements Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer, Weight and height will be combined to report BMI in kg/m^2., This outcome measures the impact of tirzepatide on obesity-related metrics in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to evaluate changes in Body Mass Index (BMI), body fat distribution These assessments will help determine the effectiveness of tirzepatide in improving body fat distribution and reducing obesity in this patient population. Weight and height will be combined to report BMI in kg/m\^2., Obesity measurements will be evaluated through study completion for two years.|Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer Assessment of Blood Pressure Changes unit of Measure: Millimeters of mercury (mm Hg)., This outcome measures the impact of tirzepatide on obesity-related metabolic markers in participants undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to evaluate changes in various metabolic markers, blood pressure (mm Hg),assessment of blood pressure changes unit of measure: millimeters of mercury (mm Hg)These assessments will help determine the effectiveness of tirzepatide in improving metabolic health and reducing obesity-related risks in this participant population., Metabolic markers will be evaluated through study completion for two years.|Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer Assessment of fasting insulin changes, unit of Measure: Milli-international units per liter (mIU/L), This outcome measures the impact of tirzepatide on obesity-related metabolic markers in participants undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to evaluate changes in various metabolic markers, Assessment of Fasting Insulin changes, unit of measure: milli-international units per liter (mIU/L)This assessment will help determine the effectiveness of tirzepatide in improving metabolic health and reducing obesity-related risks in this participant population., Metabolic markers will be evaluated through study completion for two years.|Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer, Assessment of Fasting Blood Glucose Changes, Unit of Measure: Millimoles per liter (mmol/L), This outcome measures the impact of tirzepatide on obesity-related metabolic markers in participants undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to evaluate changes in various metabolic markers, assessment of fasting blood glucose changes unit of measure: millimoles per liter (mmol/L). This assessment will help determine the effectiveness of tirzepatide in improving metabolic health and reducing obesity-related risks in this participant population., Metabolic markers will be evaluated through study completion for two years.|Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer Assessment of HgbA1c Changes, Unit of Measure: Millimoles per mole (mmol/mol), This outcome measures the impact of tirzepatide on obesity-related metabolic markers in participants undergoing adjuvant treatment for hormone receptor-positive, HER2-assessment of HgbA1c Changes unit of measure: millimoles per mole (mmol/mol). This assessment will help determine the effectiveness of tirzepatide in improving metabolic health and reducing obesity-related risks in this participant population., Metabolic markers will be evaluated through study completion for two years.|Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer Assessment of Cholesterol (Total, LDL, HDL) Changes Unit of Measure: Milligrams per deciliter (mg/dl), This outcome measures the impact of tirzepatide on obesity-related metabolic markers in participants undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to evaluate changes in various metabolic markers, assessment of cholesterol (Total, LDL, HDL) changes unit of measure: milligrams per deciliter (mg/dl)This assessment will help determine the effectiveness of tirzepatide in improving metabolic health and reducing obesity-related risks in this participant population., Metabolic markers will be evaluated through study completion for two years.|Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer, Assessment of Triglyceride Changes Unit of Measure: Millimoles per liter (mmol/L), This outcome measures the impact of tirzepatide on obesity-related metabolic markers in participants undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to evaluate changes in various metabolic markers, assessment of triglyceride changes unit of measure: millimoles per liter (mmol/L)This assessment will help determine the effectiveness of tirzepatide in improving metabolic health and reducing obesity-related risks in this participant population., Metabolic markers will be evaluated through study completion for two years.|Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer, Assessment of IGF1 Changes, Unit of Measure: Nanograms per milliliter (ng/ml), This outcome measures the impact of tirzepatide on obesity-related metabolic markers in participants undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to evaluate changes in various metabolic markers, assessment of IGF1 changes unit of measure: nanograms per milliliter (ng/ml)This assessment will help determine the effectiveness of tirzepatide in improving metabolic health and reducing obesity-related risks in this participant population., Metabolic markers will be evaluated through study completion for two years.|Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer, Assessment of Estrogen Changes, Unit of Measure: Picograms per milliliter (pg/ml), This outcome measures the impact of tirzepatide on obesity-related metabolic markers in participants undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to evaluate changes in various metabolic markers, assessment of estrogen changes unit of measure: Picograms per milliliter (pg/ml)This assessment will help determine the effectiveness of tirzepatide in improving metabolic health and reducing obesity-related risks in this participant population., Metabolic markers will be evaluated through study completion for two years.|Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer Assessment of Testosterone Changes, Unit of Measure: Nanograms per deciliter (ng/dL), This outcome measures the impact of tirzepatide on obesity-related metabolic markers in participants undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to evaluate changes in various metabolic markers, assessment of testosterone changes unit of measure: nanograms per deciliter (ng/dL)This assessment will help determine the effectiveness of tirzepatide in improving metabolic health and reducing obesity-related risks in this participant population., Metabolic markers will be evaluated through study completion for two years.|Monitoring Circulating Tumor DNA (ctDNA) Levels Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer (Detection and Changes in ctDNA Levels during Treatment)., This outcome measures the effect of tirzepatide on circulating tumor DNA (ctDNA) levels, which potentially serve as an early indicator of cancer recurrence in participants undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to detect ctDNA and monitor changes in its levels throughout the treatment duration. Assessing ctDNA levels can provide insights into the molecular response to obesity treatment using tirzepatide., ctDNA levels will be monitored through study completion for two years.