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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Metformin

• Registration Number: NCT00930579
• Lead Sponsor: Columbia University

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-06-29
• Study First Submitted QC: 2009-06-29
• Study First Posted: 2009-06-30
• Study Start: 2009-10-16
• Primary Completion: 2012-05-10
• Study Completion: 2017-01-09
• Results First Submitted: 2017-06-15
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-14
• Last Update Submitted: 2022-10-14
• Results First Posted: 2022-10-20
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	Women with newly diagnosed early invasive breast cancer will receive Metformin

Primary Outcome Measures

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

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States