NCT00897884

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

January 19, 2012

Status Verified

January 1, 2012

Enrollment Period

2.7 years

First QC Date

May 8, 2009

Last Update Submit

January 18, 2012

Conditions

Breast Cancer

Keywords

breast cancermetforminbreast surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Metformin

EXPERIMENTAL

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

Drug: Metformin

Interventions

MetforminDRUG

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

Metformin

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • invasive T1-4 (if T1, ≥ 1cm), NX operable breast cancer confirmed on core biopsy
  • \< 70 years of age
  • 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
  • patient and physician consent

You may not qualify if:

  • on metformin for any reason during the preceding 4 weeks
  • recent (within 4 weeks) antiestrogen or estrogen therapy
  • prior or concurrent systemic neoadjuvant BC therapy of any type (chemotherapy, hormone therapy, biologic therapy)
  • known diabetes or baseline fasting glucose \> or = 7.0 mmol/L (specific treatment is required)
  • 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
  • serum creatinine above upper limit of normal for the institution
  • history of lactic or other metabolic acidosis
  • consumption of \> 3 alcoholic beverages per day (on average)
  • AST \> 1.5 times upper limit of normal for the institution
  • known hypersensitivity or allergy to metformin
  • current or past congestive heart failure
  • coagulopathy (including use of anti-coagulants) precluding biopsy
  • pregnancy or lactation within 3 months.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

  • 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.

    PMID: 25849721DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Metformin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Pamela J Goodwin, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 8, 2009

First Posted

May 12, 2009

Study Start

October 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

January 19, 2012

Record last verified: 2012-01

Locations

CA(2)