The Anti-tumor Effect of Metformin And Atorvastatin in Breast Cancer

Comparative Clinical Study Evaluating the Anti-tumor Effect of Metformin Versus Atorvastatin as an Adjuvant Therapy With Chemotherapy in Patients With Non-metastatic Breast Cancer

This study aims at evaluating and comparing the anti-tumor effects of metformin and statins (hydroxyl-methyl-glutaryl-CoA reductase inhibitors) in patients with non-metastatic breast cancer (stage I, II, & III).

Worldwide, BC is the most frequently diagnosed life-threatening cancer in women. In EGYPT, breast cancer is the foremost oncologic problem, contributing to 20% of all cancers and 43% of female cancers. Metformin and atorvastatin have anti-tumor effects. To date, there are limited data to investigate and compare the anti-tumor effect between metformin and statins in patients with breast cancer.

Inclusion Criteria:

• Patients with radiologically and histologically (biopsy) confirmed diagnosis of breast cancer and with stage I, II, and stage III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer).
• Patients with no contraindication for chemotherapy, metformin, or statins
• Females aged ≥ 18 years old
• Performance status < 2 according to the Eastern Cooperative Oncology Group (ECOG) score

Exclusion Criteria:

• Patients with metastatic breast cancer (stage IV)
• Pregnant or lactating women.
• Patients with hepatic or renal impairment.
• Patients with myopathy.
• Patients with any condition predispose to acidosis (COPD, heart failure, ….)
• Patients who had dementia, mental retarded, and any psychiatric condition that would prohibit the understanding or signing of informed consent.