Metformin Pre-Surgical Pilot Study

• Status: Unknown status
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborator: Breast Cancer Research Foundation
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Histologically-confirmed operable invasive breast cancer or 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