Metformin Pre-Surgical Pilot Study
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Breast Cancer |
Intervention | Drug: Metformin |
Phase | Phase 2 |
Sponsor | Columbia University |
Responsible Party | Columbia University |
ClinicalTrials.gov Identifier | NCT00930579 |
First Received | June 29, 2009 |
Last Updated | July 30, 2013 |
Last verified | July 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | June 29, 2009 |
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Last Updated Date | July 30, 2013 |
Start Date | October 2009 |
Estimated Primary Completion Date | March 2014 |
Current Primary Outcome Measures | Effects of metformin on AMPK/mTOR signaling pathway [Time Frame: 2 weeks] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures | Reduction of fasting serum insulin levels [Time Frame: 2 weeks] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
Brief Title | Metformin Pre-Surgical Pilot Study |
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Official Title | Phase II Pre-Surgical Intervention Study for Evaluating the Effect of Metformin on Breast Cancer Proliferation |
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 | 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 biguanide derivative which is commonly used to treat patients with diabetes. This model will be used to evaluate the effects of metformin on a specific molecular pathway called the AMPK/mTOR signaling pathway in the tumor. The effects of metformin on serum insulin levels and components of the insulin resistance syndrome will also be studied. |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Breast Cancer |
Intervention | Drug: Metformin 1500 mg per day, divided 500 mg in the morning and 1000 mg in the evening, for at least two weeks prior to surgery Other Names: Metformin |
Study Arm (s) | Experimental: Metformin |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Active, not recruiting |
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Estimated Enrollment | 35 |
Estimated Completion Date | March 2014 |
Estimated Primary Completion Date | October 2011 |
Eligibility 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 |
Gender | Female |
Ages | 25 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00930579 |
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Other Study ID Numbers | AAAD6525 |
Has Data Monitoring Committee | Yes |
Information Provided By | Columbia University |
Study Sponsor | Columbia University |
Collaborators | Breast Cancer Research Foundation |
Investigators | Principal Investigator: Dawn L Hershman, MD Columbia University |
Verification Date | July 2013 |
Locations[ + expand ][ + ]
Columbia University Medical Center | New York, New York, United States, 10032 |
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