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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

June 29, 2009
June 30, 2009
July 31, 2013
October 2009
October 2011   (Final data collection date for primary outcome measure)
Effects of metformin on AMPK/mTOR signaling pathway [ Time Frame: 2 weeks ]
Same as current
Complete list of historical versions of study NCT00930579 on ClinicalTrials.gov Archive Site
Reduction of fasting serum insulin levels [ Time Frame: 2 weeks ]
Same as current
Not Provided
Not Provided
 
Metformin Pre-Surgical Pilot Study
Phase II Pre-Surgical Intervention Study for Evaluating the Effect of Metformin on Breast Cancer Proliferation
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.
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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
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
Experimental: Metformin
Intervention: Drug: Metformin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
35
15
March 2014
October 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
25 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00930579
AAAD6525
Yes
Not Provided
Not Provided
Dawn L. Hershman, Columbia University
Columbia University
Breast Cancer Research Foundation
Principal Investigator: Dawn L Hershman, MD Columbia University
Columbia University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP