Breast Cancer
Conditions
Keywords
breast cancer, metformin, breast surgery
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.
Interventions
DRUGMetformin
500 mg tablet, taken 3 times a day for 2-3 weeks
Sponsors
Princess Margaret Hospital, Canada
Mount Sinai Hospital, Canada
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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 |
Countries
Canada
Outcome results
None listed