Clinical and Biologic Effects of Metformin in Early Stage Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00897884
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : January 19, 2012
Princess Margaret Hospital, Canada
Information provided by:
Mount Sinai Hospital, Canada

May 8, 2009
May 12, 2009
January 19, 2012
October 2008
July 2011   (Final data collection date for primary 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. [ Time Frame: two to three weeks ]
Same as current
Complete list of historical versions of study NCT00897884 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Clinical and Biologic Effects of Metformin in Early Stage Breast Cancer
Clinical and Biologic Effects of Metformin in Early Stage Breast Cancer
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.
Not Provided
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
Drug: Metformin
500 mg tablet, taken 3 times a day for 2-3 weeks
Experimental: Metformin
Patients will take metformin three times a day for two to three weeks prior surgery.
Intervention: Drug: Metformin
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;17:32. doi: 10.1186/s13058-015-0540-0.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2011
July 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Dr. Pamela Goodwin, Mount Sinai Hospital
Mount Sinai Hospital, Canada
Princess Margaret Hospital, Canada
Principal Investigator: Pamela J Goodwin, MD MOUNT SINAI HOSPITAL
Mount Sinai Hospital, Canada
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP