Recruiting

Phase 2

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

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT06518837

Conditions

Hormone Receptor-Positive Breast Cancer

HER2-Negative Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tirzepatide

Study Details

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

Study ID

NCT06518837

Start date

Oct 30, 2024

Status verified date

Jan, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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.

Exclusion Criteria:

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tirzepatide

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.

Interventions

Tirzepatide

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.

Primary outcome measure

Weight Loss Reduction with Tirzepatide during Adjuvant Treatment for HR+/Her2- Breast Cancer (Measured by Body Weight Reduction) [ Time Frame: Through study completion, total of two years. ]

Central Contacts and Locations

Central contacts

Coral Omene, MD., PhD

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

Locations

Trinitas Comprehensive Cancer Center

Recruiting

Elizabeth, New Jersey, United States, 07202

Contacts

Coral Omene, MD.,PhD

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

RWJBarnabas Health - Cooperman Barnabas, Livingston

Recruiting

Livingston, New Jersey, United States, 07039

Contacts

Coral Omene, MD.,PhD

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

RWJBarnabas Health - Monmouth Medical Center

Recruiting

Long Branch, New Jersey, United States, 07740

Contacts

Coral Omene, MD., PhD

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

Rutgers Cancer Institute

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Coral Omene,, MD.PhD

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

RWJBarnabas Health - Newark Beth Israel Medical Center

Recruiting

Newark, New Jersey, United States, 07112

Contacts

Coral Omene, MD., PhD

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

RWJ Barnabas Health - Robert Wood Johnson University Hospital, Somerset

Recruiting

Somerville, New Jersey, United States, 08876

Contacts

Coral Omene, MD., PhD

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

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

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)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-01-21.