Status:
COMPLETED
Pre-Surgical Study: Effect of Metformin on Breast Cancer Proliferation
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Breast Cancer Research Foundation
Conditions:
Breast Cancer
Eligibility:
FEMALE
21+ years
Phase:
PHASE2
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 dru...
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 wo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 16 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2017
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00930579
Start Date
October 16 2009
End Date
January 9 2017
Last Update
October 20 2022
Active Locations (1)
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1
Columbia University Irving Medical Center
New York, New York, United States, 10032