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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether tirzepatide can help adults with early-stage breast cancer lose at least 5% of their body weight. It is for people with hormone receptor-positive, HER2-negative cancer who are receiving treatment after their main cancer treatment and meet weight requirements. The study also checks side effects and whether the cancer returns.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and willing and able to give written consent.
  • Have stage I, II, or III breast cancer confirmed by a biopsy. The cancer must use hormones to grow and test negative for HER2, a protein that helps cancer grow.
  • Have finished treatment meant to cure the cancer, including surgery and chemotherapy or radiation if needed.
  • Have a BMI of at least 30, or at least 27 with a weight-related health problem. BMI is a measure based on height and weight.
  • Have an ECOG activity score of 0–2, meaning you can do self-care and are out of bed at least half the day.
  • Have a heart scan showing a pumping strength of at least 50%, or above the testing center’s lower limit of normal.
  • Have screening blood tests showing that your organs work well enough.
  • Have stored tumor tissue from a biopsy or surgery available.

Who can't join

  • Be in, or plan to join, another study testing a treatment or procedure while taking part in this study.
  • Have stage IV breast cancer, meaning it has spread to distant parts of the body.
  • Have HER2-positive or triple-negative breast cancer.
  • Have another active cancer.
  • Have an ECOG activity score above 2, meaning daily activity or self-care is more limited.
  • Have a BMI below 27.
  • Have type 1 diabetes.
  • Have a serious problem with the stomach emptying, such as very slow emptying or a blockage, or have long-term use of drugs that directly change how food moves through the gut.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (7)

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