Metformin Pre-Surgical Pilot Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2013 by Columbia University.
Recruitment status was Active, not recruiting
Breast Cancer Research Foundation
Information provided by (Responsible Party):
Dawn L. Hershman, Columbia University
First received: June 29, 2009
Last updated: July 30, 2013
Last verified: July 2013
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Pre-Surgical Intervention Study for Evaluating the Effect of Metformin on Breast Cancer Proliferation
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:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||October 2011 (Final data collection date for primary outcome measure)
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
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.
|Ages Eligible for Study:
||25 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930579
|Columbia University Medical Center
|New York, New York, United States, 10032 |
Breast Cancer Research Foundation
||Dawn L Hershman, MD
No publications provided by Columbia University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Kalinsky K, Crew KD, Refice S, Xiao T, Wang A, Feldman SM, Taback B, Ahmad A, Cremers S, Hibshoosh H, Maurer M, Hershman DL. Presurgical trial of metformin in overweight and obese patients with newly diagnosed breast cancer. Cancer Invest. 2014 May;32(4):150-7. doi: 10.3109/07357907.2014.889706. Epub 2014 Mar 7.
||Dawn L. Hershman, Associate Professor of Medicine & Epidemiology, Columbia University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 29, 2009
||July 30, 2013
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 30, 2015
Physiological Effects of Drugs