Clinical and Biologic Effects of Metformin in Early Stage Breast Cancer

NCT ID: NCT00897884

Last Updated: 2012-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-07-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metformin

Patients will take metformin three times a day for two to three weeks prior surgery.

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

500 mg tablet, taken 3 times a day for 2-3 weeks

Interventions

Metformin

500 mg tablet, taken 3 times a day for 2-3 weeks

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Princess Margaret Hospital, Canada

OTHER

Sponsor Role: collaborator

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Mount Sinai Hospital

Principal Investigators

Pamela J Goodwin, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

References

Dowling RJ, Niraula S, Chang MC, Done SJ, Ennis M, McCready DR, Leong WL, Escallon JM, Reedijk M, Goodwin PJ, Stambolic V. Changes in insulin receptor signaling underlie neoadjuvant metformin administration in breast cancer: a prospective window of opportunity neoadjuvant study. Breast Cancer Res. 2015 Mar 3;17(1):32. doi: 10.1186/s13058-015-0540-0.

Reference Type: DERIVED

PMID: 25849721 (View on PubMed)

Other Identifiers

METFORMIN

Identifier Type: -

Identifier Source: org_study_id