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| Sponsor: | Mount Sinai Hospital, Canada |
|---|---|
| Collaborator: |
Princess Margaret Hospital, Canada |
| Information provided by: | Mount Sinai Hospital, Canada |
| ClinicalTrials.gov Identifier: | NCT00897884 |
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Drug: Metformin |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Clinical and Biologic Effects of Metformin in Early Stage Breast Cancer |
| Enrollment: | 39 |
| Study Start Date: | October 2008 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Metformin
Patients will take metformin three times a day for two to three weeks prior surgery.
|
Drug: Metformin
500 mg tablet, taken 3 times a day for 2-3 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Serious psychiatric illness
Contacts and Locations| Canada, Ontario | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Mount Sinai Hospital | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Principal Investigator: | Pamela J Goodwin, MD | Mount Sinai Hospital, New York |
More Information
| Responsible Party: | Dr. Pamela Goodwin, Mount Sinai Hospital |
| ClinicalTrials.gov Identifier: | NCT00897884 History of Changes |
| Other Study ID Numbers: | METFORMIN |
| Study First Received: | May 8, 2009 |
| Last Updated: | January 18, 2012 |
| Health Authority: | Canada: Health Canada |
|
breast cancer metformin breast surgery |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |