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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

Tracking Information
First Submitted Date  ICMJE June 29, 2009
First Posted Date  ICMJE June 30, 2009
Last Update Posted Date July 31, 2013
Study Start Date  ICMJE October 2009
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2009)
Effects of metformin on AMPK/mTOR signaling pathway [ Time Frame: 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2009)
Reduction of fasting serum insulin levels [ Time Frame: 2 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metformin Pre-Surgical Pilot Study
Official Title  ICMJE Phase II Pre-Surgical Intervention Study for Evaluating the Effect of Metformin on Breast Cancer Proliferation
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 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Metformin
Intervention: Drug: Metformin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 21, 2010)
35
Original Estimated Enrollment  ICMJE
 (submitted: June 29, 2009)
15
Estimated Study Completion Date  ICMJE March 2014
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00930579
Other Study ID Numbers  ICMJE AAAD6525
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dawn L. Hershman, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE Breast Cancer Research Foundation
Investigators  ICMJE
Principal Investigator: Dawn L Hershman, MD Columbia University
PRS Account Columbia University
Verification Date July 2013

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