Clinical and Biologic Effects of Metformin in Early Stage Breast Cancer

Overview[ - collapse ][ - ]

Purpose 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.
ConditionBreast Cancer
InterventionDrug: Metformin
PhaseN/A
SponsorMount Sinai Hospital, Canada
Responsible PartyMount Sinai Hospital, Canada
ClinicalTrials.gov IdentifierNCT00897884
First ReceivedMay 8, 2009
Last UpdatedJanuary 18, 2012
Last verifiedJanuary 2012

Tracking Information[ + expand ][ + ]

First Received DateMay 8, 2009
Last Updated DateJanuary 18, 2012
Start DateOctober 2008
Estimated Primary Completion DateJuly 2011
Current Primary Outcome MeasuresTo 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. [Time Frame: two to three weeks] [Designated as safety issue: No]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleClinical and Biologic Effects of Metformin in Early Stage Breast Cancer
Official TitleClinical and Biologic Effects of Metformin in Early Stage Breast Cancer
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 DescriptionNot Provided
Study TypeInterventional
Study PhaseN/A
Study DesignEndpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionBreast Cancer
InterventionDrug: Metformin
500 mg tablet, taken 3 times a day for 2-3 weeks
Study Arm (s)Experimental: Metformin
Patients will take metformin three times a day for two to three weeks prior surgery.

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment39
Estimated Completion DateJuly 2011
Estimated Primary Completion DateJuly 2011
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.
GenderFemale
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesCanada

Administrative Information[ + expand ][ + ]

NCT Number NCT00897884
Other Study ID NumbersMETFORMIN
Has Data Monitoring CommitteeNo
Information Provided ByMount Sinai Hospital, Canada
Study SponsorMount Sinai Hospital, Canada
CollaboratorsPrincess Margaret Hospital, Canada
Investigators Principal Investigator: Pamela J Goodwin, MD Mount Sinai Hospital, New York
Verification DateJanuary 2012

Locations[ + expand ][ + ]

Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5