Clinical and Biologic Effects of Metformin in Early Stage Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Metformin

• Registration Number: NCT00897884
• Lead Sponsor: Mount Sinai Hospital, Canada

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-05-08
• Study First Submitted QC: 2009-05-08
• Study First Posted: 2009-05-12
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 39

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	Patients will take metformin three times a day for two to three weeks prior surgery.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada