Clinical and Biologic Effects of Metformin in Early Stage Breast Cancer
Overview[ - collapse ][ - ]
Purpose | The study will be testing metformin in patients with breast cancer who are about to undergo surgery. Patients will take metformin 3 times daily for about 2-3 weeks prior to their surgery date. It is hypothesized that metformin will reduce cell proliferation rates in tumour tissue. |
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Condition | Breast Cancer |
Intervention | Drug: Metformin |
Phase | N/A |
Sponsor | Mount Sinai Hospital, Canada |
Responsible Party | Mount Sinai Hospital, Canada |
ClinicalTrials.gov Identifier | NCT00897884 |
First Received | May 8, 2009 |
Last Updated | January 18, 2012 |
Last verified | January 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | May 8, 2009 |
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Last Updated Date | January 18, 2012 |
Start Date | October 2008 |
Estimated Primary Completion Date | July 2011 |
Current Primary Outcome Measures | To determine if taking metformin prior to surgery can reduce cell proliferation rates in tumour tissue. To be determined by tumour specimen analysis using pre- and post-operative biopsy sample. [Time Frame: two to three weeks] [Designated as safety issue: No] |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Clinical and Biologic Effects of Metformin in Early Stage Breast Cancer |
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Official Title | Clinical and Biologic Effects of Metformin in Early Stage Breast Cancer |
Brief Summary | The study will be testing metformin in patients with breast cancer who are about to undergo surgery. Patients will take metformin 3 times daily for about 2-3 weeks prior to their surgery date. It is hypothesized that metformin will reduce cell proliferation rates in tumour tissue. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Breast Cancer |
Intervention | Drug: Metformin 500 mg tablet, taken 3 times a day for 2-3 weeks |
Study Arm (s) | Experimental: Metformin Patients will take metformin three times a day for two to three weeks prior surgery. |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 39 |
Estimated Completion Date | July 2011 |
Estimated Primary Completion Date | July 2011 |
Eligibility Criteria | Inclusion Criteria: 1. invasive T1-4 (if T1, ≥ 1cm), NX operable breast cancer confirmed on core biopsy 2. < 70 years of age 3. breast surgery scheduled at least 2 weeks after study entry at one of the participating institutions (metformin will be started no more than 3 weeks prior to scheduled surgery) for the current breast cancer 4. patient and physician consent Exclusion Criteria: 1. on metformin for any reason during the preceding 4 weeks 2. recent (within 4 weeks) antiestrogen or estrogen therapy 3. prior or concurrent systemic neoadjuvant BC therapy of any type (chemotherapy, hormone therapy, biologic therapy) 4. known diabetes or baseline fasting glucose > or = 7.0 mmol/L (specific treatment is required) 5. current or recent (within 4 weeks) use of drugs that may influence insulin or insulin sensitivity including oral corticosteroids, insulin sensitizers, exogenous insulin or oral hypoglycemic agents 6. serum creatinine above upper limit of normal for the institution 7. history of lactic or other metabolic acidosis 8. consumption of > 3 alcoholic beverages per day (on average) 9. AST > 1.5 times upper limit of normal for the institution 10. known hypersensitivity or allergy to metformin 11. current or past congestive heart failure 12. coagulopathy (including use of anti-coagulants) precluding biopsy 13. pregnancy or lactation within 3 months. 14. Serious psychiatric illness - Note: Women with childbearing potential will be required to use an effective form of birth control (condom or other barrier method, tubal ligation or vasectomy - oral contraceptives are contra-indicated in breast cancer) and to have a negative pregnancy test prior to starting metformin. |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Canada |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00897884 |
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Other Study ID Numbers | METFORMIN |
Has Data Monitoring Committee | No |
Information Provided By | Mount Sinai Hospital, Canada |
Study Sponsor | Mount Sinai Hospital, Canada |
Collaborators | Princess Margaret Hospital, Canada |
Investigators | Principal Investigator: Pamela J Goodwin, MD Mount Sinai Hospital, New York |
Verification Date | January 2012 |
Locations[ + expand ][ + ]
Princess Margaret Hospital | Toronto, Ontario, Canada, M5G 2M9 |
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Mount Sinai Hospital | Toronto, Ontario, Canada, M5G 1X5 |