OncoMatch/Clinical Trials/NCT06517212
Tirzepatide Weight Loss for MRD+ Early Breast Cancer
Is NCT06517212 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tirzepatide for breast cancer.
Treatment: Tirzepatide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy — neo/adjuvant
Have received at least 1 year of or having completed standard neo/adjuvant endocrine therapy
Cannot have received: bariatric surgery and/or endoscopic procedures for weight loss (intragastric balloon, sleeve gastrostomy)
Prior bariatric surgery and/or endoscopic procedures for weight loss (e.g., intragastric balloon, sleeve gastrostomy) following diagnosis of breast cancer
Cannot have received: GLP-1/Glucagon receptor agonist, GIP/GLP-1/Glucagon receptor agonist, GIP/GLP receptor agonist, or any combinations with GLP-1 receptor agonist therapies
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
Cannot have received: investigational agent
Has received an investigational agent within 4 weeks prior to study treatment; investigational monoclonal antibodies should have a 4-week (28 day) or 5 half-life washout period
Cannot have received: any other investigational or anti-cancer treatments
Exception: with the exception of standard adjuvant endocrine therapy, zoledronic acid, or denosumab
Any other investigational or anti-cancer treatments while participating in this study with the exception of standard adjuvant endocrine therapy, zoledronic acid, or denosumab
Lab requirements
Blood counts
ANC >1500/µL; Platelet count ≥100,000/µL; Hemoglobin ≥9 g/dL or ≥5.6 mmol/L
Kidney function
Serum creatinine ≤1.5 x ULN or calculated creatinine clearance of ≥30 mL/min
Liver function
AST and ALT ≤3 x ULN; Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ULN for patients with total bilirubin levels >1.5 × ULN
Have adequate hematologic function, defined by: ANC >1500/µL; Platelet count ≥100,000/µL; Hemoglobin ≥9 g/dL or ≥5.6 mmol/L. Have adequate liver function, defined by: AST and ALT ≤3 x ULN; Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ULN for patients with total bilirubin levels >1.5 × ULN. Have adequate renal function, defined by: Serum creatinine ≤1.5 x ULN or calculated creatinine clearance of ≥30 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Baylor University Medical Center, Baylor Charles A Sammons Cancer Center · Dallas, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify