Phase II Pre-Surgical Intervention Study for Evaluating the Effect of Metformin on Breast Cancer Proliferation
Overview
- Phase
- Phase 2
- Intervention
- Metformin
- Conditions
- Breast Cancer
- Sponsor
- Columbia University
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Tumor Proliferation in Tumor Specimens
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Dawn L. Hershman
Associate Professor of Medicine & Epidemiology
Columbia University
Eligibility Criteria
Inclusion Criteria
- •Histologically-confirmed operable invasive breast cancer or ductal carcinoma in situ (DCIS) who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment
- •Body mass index \> 25
- •Age ≥ 21 years
- •No prior chemotherapy, radiation therapy, or surgery within 6 months of study entry
- •Signed informed consent
Exclusion Criteria
- •History of diabetes mellitus requiring medical therapy
- •Treatment with other investigational drugs within 6 months of study entry
- •Significant renal impairment with a creatinine \> 1.4 mg/dl
- •Other serious intercurrent medical illness
Arms & Interventions
Metformin
Women with newly diagnosed early invasive breast cancer will receive Metformin
Intervention: Metformin
Outcomes
Primary Outcomes
Tumor Proliferation in Tumor Specimens
Time Frame: Baseline, up to 4 weeks
This outcome measure examines the changes in tumor proliferation as measured by the amount of Ki-67 protein in the tumor.