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

Last updated: November 27, 2024
Sponsor: Rutgers, The State University of New Jersey
Overall Status: Active - Recruiting

Phase

2

Condition

Breast Cancer

Weight Loss

Diabetes Prevention

Treatment

Tirzepatide

Clinical Study ID

NCT06518837
042403
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 estrogenreceptor (ER) >10% and/or progesterone receptor (PR) >10%; HER2 status is defined asimmunohistochemistry (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, orIII hormone receptor-positive breast cancer.

  • Definitive Treatment: Have had definitive treatment with curative intent for breastcancer, 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 morewith 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) performancestatus of 0 to 2.

  • Cardiac Function: Have a left ventricular ejection fraction (LVEF) of 50% orgreater, or greater than the institution's lower limit of normal (LLN), as assessedby echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed atscreening.

  • Organ Function: Demonstrate adequate organ function in screening labs.

  • Tumor Specimens: Have archived biopsy or surgical tumor specimens available as tumorblocks or unstained slides.

Exclusion

Exclusion Criteria:

  • Other Clinical Studies: Is currently enrolled, or will enroll in, a differentclinical study in which investigational therapeutic procedures are performed orinvestigational 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) performancestatus 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 emptyingabnormality (e.g., severe gastroparesis or gastric outlet obstruction) orchronically took drugs that directly affect gastrointestinal motility.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Tirzepatide
Phase: 2
Study Start date:
October 30, 2024
Estimated Completion Date:
September 30, 2027

Study Description

The primary objective of this clinical trial is to determine the proportion of patients who achieve a 5% or greater reduction in body weight by the end of the study treatment with tirzepatide, during adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. Secondary objectives include assessing the safety and tolerability of tirzepatide for weight loss during this treatment. The feasibility of using tirzepatide for weight loss intervention will be evaluated through discontinuation rates and completion of the treatment course. Additionally, the trial will determine the 3-year invasive disease-free survival (IDFS) and 3-year distant relapse-free survival (DRFS) with the use of tirzepatide. The study will also assess changes in Body Mass Index (BMI), body fat distribution (measured via Waist/Hip Ratio (WHR) and waist circumference), and obesity-related metabolic markers (including Blood Pressure, fasting insulin, fasting blood glucose, HgbA1c, cholesterol, LDL, HDL, triglycerides, IGF1, estrogen, and testosterone). Finally, the trial will monitor for circulating tumor DNA (ctDNA) and assess changes when using tirzepatide for weight loss in the adjuvant treatment of HR+/Her2- breast cancer. Quality of Life assessments will be obtained and exploratory objectives investigating adipokines (adiponectin, leptin) and their receptors, metabolomic pathways and immune cell metabolism will be conducted.

Connect with a study center

  • Trinitas Comprehensive Cancer Center

    Elizabeth, New Jersey 07202
    United States

    Site Not Available

  • RWJ Barnabas Health - Robert Wood Johnson University Hospital, Hamilton

    Hamilton, New Jersey 08690
    United States

    Site Not Available

  • RWJBarnabas Health - Cooperman Barnabas, Livingston

    Livingston, New Jersey 07039
    United States

    Site Not Available

  • RWJBarnabas Health - Monmouth Medical Center

    Long Branch, New Jersey 07740
    United States

    Site Not Available

  • Rutgers Cancer Institute

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • RWJBarnabas Health - Newark Beth Israel Medical Center

    Newark, New Jersey 07112
    United States

    Site Not Available

  • RWJ Barnabas Health - Robert Wood Johnson University Hospital, Somerset

    Somerville, New Jersey 08876
    United States

    Site Not Available

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