Conditions: Breast Cancer
Keywords: Breast Cancer Metformin
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 35
Healthy volunteers: no

Brief summary:
The purpose of this pilot study is to use a pre surgical intervention model to evaluate the biologic effects of metformin in women with newly diagnosed early invasive breast cancer. Metformin is a drug commonly used to treat patients with diabetes. This model will be used to evaluate the effects of metformin.

Detailed description:
Breast cancer is the most common cancer and the second leading cause of cancer death among women in the United States. Several epidemiologic studies have found an increased risk of breast cancer in women with type 2 diabetes. This association appears to be mediated by a state of hyperinsulinemia and insulin resistance. Population based studies have also found a decreased risk of cancer in diabetic patients taking metformin, an oral biguanide derivative. Proposed mechanisms include its effect on lowering serum insulin levels as well as modulation of cellular signaling pathways which inhibit tumor cellular proliferation.

Arms:
arm 1: Women with newly diagnosed early invasive breast cancer will receive Metformin

Interventions: intervention 1: Metformin
Intervention descriptions: intervention 1: 1500 mg per day, divided 500 mg in the morning and 1000 mg in the evening, for at least two weeks prior to surgery

Protocol document: