Metformin Pre-Surgical Pilot Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Breast Cancer Research Foundation
Information provided by (Responsible Party):
Dawn L. Hershman, Columbia University
ClinicalTrials.gov Identifier:
NCT00930579
First received: June 29, 2009
Last updated: July 30, 2013
Last verified: July 2013
  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: 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:


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: July 30, 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 April 17, 2014