Metformin Pre-Surgical Pilot Study
This trial is active, not recruiting.
|Collaborator||Breast Cancer Research Foundation|
|Start date||October 2009|
|End date||October 2011|
|Trial size||35 participants|
|Trial identifier||NCT00930579, AAAD6525|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Effects of metformin on AMPK/mTOR signaling pathway
time frame: 2 weeks
Reduction of fasting serum insulin levels
time frame: 2 weeks
Female participants at least 25 years old.
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
|Official title||Phase II Pre-Surgical Intervention Study for Evaluating the Effect of Metformin on Breast Cancer Proliferation|
|Principal investigator||Dawn L Hershman, MD|
|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.|
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