Overview

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