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New treatment option for Hormone Receptor-Positive Breast Cancer
Official title Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer
ClinicalTrials.gov ID: NCT06518837
What this study is testing
What is Tirzepatide?
Tirzepatide is an investigational medicine, being studied as a potential treatment for hormone receptor-positive breast cancer.
Also referred to as LY3298176 (development code name), Mounjaro (brand name in certain regions).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
You likely can't join if
- Other Clinical Studies: Is currently enrolled, or will enroll in, a different clinical study in which investigational therapeutic procedures are...
- 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.
See the full eligibility 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)...
- 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...
- 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)...
- 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Elizabeth, New Jersey, United States
- Hamilton, New Jersey, United States
- Livingston, New Jersey, United States
- Long Branch, New Jersey, United States
- New Brunswick, New Jersey, United States
- Newark, New Jersey, United States
- Somerville, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Elizabeth, New Jersey, United States; Hamilton, New Jersey, United States; Livingston, New Jersey, United States; Long Branch, New Jersey, United States; New Brunswick, New Jersey, United States; Newark, New Jersey, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.