Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment metformin
Phase phase 2
Sponsor Columbia University
Collaborator Breast Cancer Research Foundation
Start date October 2009
End date October 2011
Trial size 35 participants
Trial identifier NCT00930579, AAAD6525

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
metformin 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

Primary Outcomes

Measure
Effects of metformin on AMPK/mTOR signaling pathway
time frame: 2 weeks

Secondary Outcomes

Measure
Reduction of fasting serum insulin levels
time frame: 2 weeks

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Columbia University.