Pre-Surgical Study: Effect of Metformin on Breast Cancer Proliferation

Study Overview
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Brief Summary
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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
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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 women with type 2 diabetes. This association appears to be mediated by a state of hyperinsulinemia and insulin resistance. Population based studies have also found a decreased risk of cancer in diabetic patients taking metformin, an oral biguanide derivative. Proposed mechanisms include its effect on lowering serum insulin levels as well as modulation of cellular signaling pathways which inhibit tumor cellular proliferation.

Official Title
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Phase II Pre-Surgical Intervention Study for Evaluating the Effect of Metformin on Breast Cancer Proliferation

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin<br>Women with newly diagnosed early invasive breast cancer will receive Metformin | Drug: Metformin<br>* 1500 mg per day, divided 500 mg in the morning and 1000 mg in the evening, for at least two weeks prior to surgery<br>* Other names: Metformin hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Proliferation in Tumor Specimens | This outcome measure examines the changes in tumor proliferation as measured by the amount of Ki-67 protein in the tumor. | Baseline, up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Metformin