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

NCT06518837 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 042403
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 7

Brief 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).

Conditions

Hormone Receptor-Positive Breast Cancer; HER2-Negative Breast Cancer

Keywords

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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)

  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).

  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)

  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.

  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.

  Obesity measurements will be evaluated through study completion for two years.

Study Arms (1)

Tirzepatide

EXPERIMENTAL

Tirzepatide will be administered subcutaneously in the stomach, upper arm, or thigh, rotating injection sites with each dose. Administer once weekly at any time of day, with or without meals. Start with an initial dosage of 2.5 mg. After 4 weeks, increase to 5 mg weekly. Further increases may be made in 2.5 mg increments after at least 4 weeks on the current dose, aiming for a target of 15 mg (i.e., 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg). Consider treatment tolerability when selecting the maintenance dose. If not tolerated, consider the next lower maintenance dose. Recommended maintenance doses are 5 mg, 10 mg, or 15 mg, with 5 mg as the lowest evaluable dose. The 2.5 mg dose is not a maintenance dose. The maximum allowed dosage is 15 mg once weekly.

Drug: Tirzepatide

Interventions

Tirzepatide DRUG

The intervention aims to assess the feasibility, safety, and efficacy of tirzepatide for weight loss in patients with early-stage hormone receptor-positive, HER2-negative breast cancer, potentially improving treatment outcomes and overall health.

Also known as: LY3298176 (development code name), Mounjaro (brand name in certain regions), Zepbound (brand name in certain regions)

Tirzepatide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ludwig Institute for Cancer Research: collaborator
• Rutgers, The State University of New Jersey: lead

Study Sites (7)

Trinitas Comprehensive Cancer Center

Elizabeth, New Jersey, 07202, United States

RECRUITING

RWJ Barnabas Health - Robert Wood Johnson University Hospital, Hamilton

Hamilton, New Jersey, 08690, United States

NOT YET RECRUITING

RWJBarnabas Health - Cooperman Barnabas, Livingston

Livingston, New Jersey, 07039, United States

RECRUITING

RWJBarnabas Health - Monmouth Medical Center

Long Branch, New Jersey, 07740, United States

RECRUITING

Rutgers Cancer Institute

New Brunswick, New Jersey, 08901, United States

RECRUITING

RWJBarnabas Health - Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

RECRUITING

RWJ Barnabas Health - Robert Wood Johnson University Hospital, Somerset

Somerville, New Jersey, 08876, United States

RECRUITING

MeSH Terms

Conditions

Weight Loss

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Coral Omene, MD., PhD

  Rutgers Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Coral Omene, MD., PhD

CONTACT

732-235-3374; co273@cinj.rutgers.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director, Breast Cancer Disparities Research; Associate Professor of Medicine

Model Details: Tirzepatide will be administered subcutaneously in the stomach, upper arm, or thigh. Administer once weekly at any time of day, with or without meals. Start with an initial dosage of 2.5 mg. After 4 weeks, increase to 5 mg weekly. Further increases may be made in 2.5 mg increments after at least 4 weeks on the current dose, aiming for a target of 15 mg (i.e., 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg). Consider treatment tolerability when selecting the maintenance dose. If not tolerated, consider the next lower maintenance dose. Recommended maintenance doses are 5 mg, 10 mg, or 15 mg, with 5 mg as the lowest evaluable dose. The 2.5 mg dose is not a maintenance dose. The maximum allowed dosage is 15 mg once weekly. 20 Black and 20 Non-Black breast cancer patients will be enrolled. More black patients will be enrolled to enrich this cohort with the population that has an established significant disparity in HR+ breast cancer and obesity related outcomes.

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 24, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)