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| Name | Class |
|---|---|
| Princess Margaret Hospital, Canada | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Experimental | Patients will take metformin three times a day for two to three weeks prior surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 500 mg tablet, taken 3 times a day for 2-3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | two to three weeks |
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Inclusion Criteria:
Exclusion Criteria:
on metformin for any reason during the preceding 4 weeks
recent (within 4 weeks) antiestrogen or estrogen therapy
prior or concurrent systemic neoadjuvant BC therapy of any type (chemotherapy, hormone therapy, biologic therapy)
known diabetes or baseline fasting glucose > or = 7.0 mmol/L (specific treatment is required)
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
serum creatinine above upper limit of normal for the institution
history of lactic or other metabolic acidosis
consumption of > 3 alcoholic beverages per day (on average)
AST > 1.5 times upper limit of normal for the institution
known hypersensitivity or allergy to metformin
current or past congestive heart failure
coagulopathy (including use of anti-coagulants) precluding biopsy
pregnancy or lactation within 3 months.
Serious psychiatric illness
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| Name | Affiliation | Role |
|---|---|---|
| Pamela J Goodwin, MD | MOUNT SINAI HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada | ||
| Princess Margaret Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25849721 | Derived | Dowling RJ, Niraula S, Chang MC, Done SJ, Ennis M, McCready DR, Leong WL, Escallon JM, Reedijk M, Goodwin PJ, Stambolic V. Changes in insulin receptor signaling underlie neoadjuvant metformin administration in breast cancer: a prospective window of opportunity neoadjuvant study. Breast Cancer Res. 2015 Mar 3;17(1):32. doi: 10.1186/s13058-015-0540-0. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Toronto |
| Ontario |
| M5G 2M9 |
| Canada |
| D017437 |
| Skin and Connective Tissue Diseases |