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Tirzepatide Weight Loss for MRD+ Early Breast Cancer

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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.

Sponsor: Baylor Research Institute

You may qualify if…

  • ✓ 1. Female or male patients ≥18 years of age
  • ✓ 2. Have a diagnosis of node-positive, hormone receptor-positive (ER+ \> 10%), and HER2-negative breast cancer within the past 15 years per the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
  • ✓ 1. If patients have synchronous bilateral ER+ breast cancers, tissue from both primary cancers should be submitted for next-generation sequencing (NGS) to inform ctDNA testing
  • ✓ 2. Patients with multifocal/multicentric cancers are eligible and the largest focus of cancer should be submitted for NGS evaluation. If tested, all tumor foci must meet have ER \> 10%
  • ✓ 3. For patients who received neoadjuvant therapy and have discordant hormone receptor and/or HER2 results between the diagnostic biopsy (pre-treatment) and the surgical pathology (post-neoadjuvant treatment), the hormone receptor status and HER2 status of the post-treatment specimen will determine eligibility
  • ✓ 3. Overweight or obesity defined as body mass index (BMI) \> 27 kg/m2
  • ✓ 4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • ✓ 5. Have received at least 1 year of or having completed standard neo/adjuvant endocrine therapy. If adjuvant cyclin dependent kinase (CDK) 4/6 inhibitor therapy was prescribed, patients must have completed this therapy

You may not qualify if…

  • ✕ 1. Prior bariatric surgery and/or endoscopic procedures for weight loss (e.g., intragastric balloon, sleeve gastrostomy) following diagnosis of breast cancer
  • ✕ 2. Treatment with a GLP-1/Glucagon receptor agonist, GIP/GLP-1/Glucagon receptor agonist, GIP/GLP receptor agonist, or any combinations with GLP-1 receptor agonist therapies within the last 3 months
  • ✕ 3. History of severe hypersensitivity reaction to GLP-1/Glucagon receptor agonist, GIP/GLP-1/Glucagon receptor agonist, or any combinations with GLP-1 receptor agonist therapies
  • ✕ 4. Insulin-dependent diabetes
  • ✕ 5. Has clinical evidence of diabetic retinopathy
  • ✕ 6. Clinical evidence or suspicion of metastatic breast cancer
  • ✕ 7. Current or past invasive cancers, other than breast cancer, are not allowed except for:
  • ✕ 1. Adequately treated basal or squamous cell carcinoma of the skin

Where it's recruiting

Texas

Dallas

Source: ClinicalTrials.gov · NCT06517212 · last updated 2026-02-12

Tirzepatide Weight Loss for MRD+ Early Breast Cancer · TrialPath