OncoMatch/Clinical Trials/NCT06517212
Tirzepatide Weight Loss for MRD+ Early Breast Cancer
Is NCT06517212 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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 →Frequently asked questions
Is NCT06517212 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior bariatric surgery and/or endoscopic procedures for weight loss, GLP-1/Glucagon receptor agonist, GIP/GLP-1/Glucagon receptor agonist, GIP/GLP receptor agonist, or any combinations with GLP-1 receptor agonist therapies, investigational agent disqualifies patients from enrollment.
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 qualifyRelated pages