Clinical and Biologic Effects of Metformin in Early Stage Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT00897884
First received: May 8, 2009
Last updated: January 18, 2012
Last verified: January 2012
  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.


Condition Intervention
Breast Cancer
Drug: Metformin

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical and Biologic Effects of Metformin in Early Stage Breast Cancer

Resource links provided by NLM:


Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: October 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin
Patients will take metformin three times a day for two to three weeks prior surgery.
Drug: Metformin
500 mg tablet, taken 3 times a day for 2-3 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897884

Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Pamela J Goodwin, MD Mount Sinai Hospital, New York
  More Information

No publications provided

Responsible Party: Dr. Pamela Goodwin, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT00897884     History of Changes
Other Study ID Numbers: METFORMIN
Study First Received: May 8, 2009
Last Updated: January 18, 2012
Health Authority: Canada: Health Canada

Keywords provided by Mount Sinai Hospital, Canada:
breast cancer
metformin
breast surgery

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014