RECRUITING

Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer

Conditions

Hormone Receptor-Positive Breast Cancer HER2-Negative Breast Cancer Weight Loss Body Weight Reduction Feasibility of Weight Loss Intervention invasive Disease-Free Survival (IDFS)Body Mass Index (BMI)Body Fat Distribution Metabolic Markers Circulating Tumor DNA (ctDNA)Tirzepatide GIP and GLP-1 dual agonist Black patients distant relapse-free survival (DRFS)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

FITWISE: Feasibility Study of Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer

Quick Facts

Study Start:2024-10-30

Study Completion:2027-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06518837

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Coral Omene, MD., PhD

CONTACT

732-235-3374

co273@cinj.rutgers.edu

Principal Investigator

Coral Omene, MD., PhD

PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

Coral Omene, MD., PhD, PRINCIPAL_INVESTIGATOR, Rutgers Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-30

Study Completion Date2027-09-30

Study Record Updates

Study Start Date2024-10-30

Study Completion Date2027-09-30

Terms related to this study

Keywords Provided by Researchers

Weight Loss
Body Weight Reduction
Feasibility of Weight Loss Intervention
invasive Disease-Free Survival (IDFS)
Body Mass Index (BMI)
Body Fat Distribution
Metabolic Markers
Circulating Tumor DNA (ctDNA)
Tirzepatide
GIP and GLP-1 dual agonist
Black patients
distant relapse-free survival (DRFS)

Additional Relevant MeSH Terms

Hormone Receptor-Positive Breast Cancer
HER2-Negative Breast Cancer