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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-30

Study Completion Date

2027-09-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Hormone Receptor-Positive Breast Cancer HER2-Negative Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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LY3298176 (development code name) Mounjaro (brand name in certain regions) Zepbound (brand name in certain regions)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Coral Omene

Program Director, Breast Cancer Disparities Research; Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Coral Omene, MD., PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute

Locations

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