Status:
COMPLETED
Clinical and Biologic Effects of Metformin in Early Stage Breast Cancer
Lead Sponsor:
Mount Sinai Hospital, Canada
Collaborating Sponsors:
Princess Margaret Hospital, Canada
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
NA
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 h...
Eligibility Criteria
Inclusion
- invasive T1-4 (if T1, ≥ 1cm), NX operable breast cancer confirmed on core biopsy
- \< 70 years of age
- 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
- patient and physician consent
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00897884
Start Date
October 1 2008
End Date
July 1 2011
Last Update
January 19 2012
Active Locations (2)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
2
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9