RecruitingPhase 2NCT06517212

Tirzepatide Weight Loss for MRD+ Early Breast Cancer

Adjuvant Tirzepatide Plus Standard of Care Endocrine Therapy in Patients With Obesity or Overweight Who Have Hormone Receptor-positive, HER2-negative, Node-positive Early Breast Cancer, With Molecular Residual Disease (MRD), as Determined by Circulating Tumor DNA (ctDNA)

Sponsor

Baylor Research Institute

Enrollment

48 participants

Start Date

Nov 26, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Breast Neoplasms Breast Cancers

Summary

This trial aims to asses if tirzepatide-induced weight loss will lead to metabolic and hormonal changes in hormone receptor-positive (HR+), human epidermal growth factor receptor-negative (HER2-), node-positive (N+) high risk early breast cancer patients with obesity or overweight, inhibiting the growth and survival of micrometastatic disease and leading to clearance of tumor-informed circulating tumor DNA (ctDNA) and freedom from the development of metastatic disease.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether the weight-loss drug tirzepatide (a weekly injection that regulates blood sugar and appetite, used for type 2 diabetes and obesity) can help people with hormone receptor-positive, HER2-negative breast cancer who show signs of residual cancer in their blood after treatment. The target is to achieve weight loss and reduce cancer recurrence risk. **You may be eligible if...** - You are 18 or older (any gender) - You have hormone receptor-positive (ER+ >10%), HER2-negative breast cancer diagnosed within the past 15 years - Your breast cancer had spread to lymph nodes - You show signs of residual cancer activity (MRD positive — detected by a blood test) - You are overweight or obese (BMI ≥ 25) **You may NOT be eligible if...** - You have metastatic (stage 4) breast cancer - You have a personal or family history of certain thyroid tumors (medullary thyroid cancer or MEN2) - You are pregnant or breastfeeding - You have serious kidney or gastrointestinal problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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