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Metformin Pre-Surgical Pilot Study

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ClinicalTrials.gov Identifier: NCT00930579
Recruitment Status : Unknown
Verified July 2013 by Dawn L. Hershman, Columbia University.
Recruitment status was:  Active, not recruiting
First Posted : June 30, 2009
Last Update Posted : July 31, 2013
Sponsor:
Collaborator:
Breast Cancer Research Foundation
Information provided by (Responsible Party):
Dawn L. Hershman, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Metformin Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Pre-Surgical Intervention Study for Evaluating the Effect of Metformin on Breast Cancer Proliferation
Study Start Date : October 2009
Primary Completion Date : October 2011
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Effects of metformin on AMPK/mTOR signaling pathway [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Reduction of fasting serum insulin levels [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dawn L. Hershman, Associate Professor of Medicine & Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT00930579     History of Changes
Other Study ID Numbers: AAAD6525
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: July 31, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs