Clinical and Biologic Effects of Metformin in Early Stage Breast Cancer

Breast Cancer Clinical Trial

Official title:

Clinical and Biologic Effects of Metformin in Early Stage Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897884
• Other study ID #: METFORMIN
• Status: Completed
• Phase: N/A
• First received: May 8, 2009
• Last updated: January 18, 2012
• Start date: October 2008
• Est. completion date: July 2011

Study information

• Verified date: January 2012
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Metformin
500 mg tablet, taken 3 times a day for 2-3 weeks

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No