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Presurgical Trial of Metformin in Overweight and Obese Patients with Newly Diagnosed Breast Cancer

Introduction: We conducted a presurgical trial to assess the tissue-related effects of metformin in overweight/obese breast cancer (BC) patients. Methods: Metformin 1,500 mg daily was administered to 35 nondiabetics with stage 0–III BC, body mass index (BMI) ≥ 25 kg/m2. The primary endpoint was tumor proliferation change (i.e., ki-67). Tumor proliferation change was compared to untreated historical controls, matched by age, BMI, and stage. Results: There was no reduction in ln(ki-67) after metformin (p = .98) or compared to controls (p = .47). There was a significant reduction in BMI, cholesterol, and leptin. Conclusion: Despite no proliferation changes, we observed reductions in other relevant biomarkers.