Metformin Pre-Surgical Pilot Study - Full Text View

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.

Condition	Intervention	Phase
Breast Cancer	Drug: Metformin	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Pre-Surgical Intervention Study for Evaluating the Effect of Metformin on Breast Cancer Proliferation

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Diabetes Medicines

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

Effects of metformin on AMPK/mTOR signaling pathway [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Reduction of fasting serum insulin levels [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	35
Study Start Date:	October 2009
Estimated Study Completion Date:	March 2014
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Metformin	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 Name: 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.

Eligibility

Ages Eligible for Study:	25 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930579

Locations

United States, New York
Columbia University Medical Center
New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Breast Cancer Research Foundation

Investigators

Principal Investigator:

Dawn L Hershman, MD

Columbia University

More Information

No publications provided

Responsible Party:	Dawn L. Hershman, Associate Professor of Medicine & Epidemiology, Columbia University
ClinicalTrials.gov Identifier:	NCT00930579 History of Changes
Other Study ID Numbers:	AAAD6525
Study First Received:	June 29, 2009
Last Updated:	February 19, 2013
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013