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Clinical and Biologic Effects of Metformin in Early Stage Breast Cancer

18 Years
70 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Clinical and Biologic Effects of Metformin in Early Stage Breast Cancer

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

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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

two to three weeks

Safety Issue:


Principal Investigator

Pamela J Goodwin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai Hospital, New York


Canada: Health Canada

Study ID:




Start Date:

October 2008

Completion Date:

July 2011

Related Keywords:

  • Breast Cancer
  • breast cancer
  • metformin
  • breast surgery
  • Breast Neoplasms