- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00930579
Pre-Surgical Study: Effect of Metformin on Breast Cancer Proliferation
October 14, 2022 updated by: Dawn L. Hershman, Columbia University
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.
Study Overview
Detailed Description
Breast cancer is the most common cancer and the second leading cause of cancer death among women in the United States.
Several epidemiologic studies have found an increased risk of breast cancer in women with type 2 diabetes.
This association appears to be mediated by a state of hyperinsulinemia and insulin resistance.
Population based studies have also found a decreased risk of cancer in diabetic patients taking metformin, an oral biguanide derivative.
Proposed mechanisms include its effect on lowering serum insulin levels as well as modulation of cellular signaling pathways which inhibit tumor cellular proliferation.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10032
- Columbia University Irving Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Histologically-confirmed operable invasive breast cancer or ductal carcinoma in situ (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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Metformin
Women with newly diagnosed early invasive breast cancer will receive 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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor Proliferation in Tumor Specimens
Time Frame: Baseline, up to 4 weeks
|
This outcome measure examines the changes in tumor proliferation as measured by the amount of Ki-67 protein in the tumor.
|
Baseline, up to 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dawn L Hershman, MD, Columbia University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kalinsky K, Zheng T, Hibshoosh H, Du X, Mundi P, Yang J, Refice S, Feldman SM, Taback B, Connolly E, Crew KD, Maurer MA, Hershman DL. Proteomic modulation in breast tumors after metformin exposure: results from a "window of opportunity" trial. Clin Transl Oncol. 2017 Feb;19(2):180-188. doi: 10.1007/s12094-016-1521-1. Epub 2016 Jun 15.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 16, 2009
Primary Completion (Actual)
May 10, 2012
Study Completion (Actual)
January 9, 2017
Study Registration Dates
First Submitted
June 29, 2009
First Submitted That Met QC Criteria
June 29, 2009
First Posted (Estimate)
June 30, 2009
Study Record Updates
Last Update Posted (Actual)
October 20, 2022
Last Update Submitted That Met QC Criteria
October 14, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAD6525
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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