Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT01101438
First received: April 9, 2010
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

This study is looking at whether Metformin, an agent that is commonly used to treat diabetes, can decrease or affect the ability of breast cancer cells to grow and whether Metformin will work with other therapies to keep cancer from recurring. Health Canada has not approved the sale or use of Metformin to treat breast cancer, although they have approved its use in this clinical trial. Although Metformin is approved by the FDA for the treatment of diabetes, its use in breast cancer is considered investigational.


Condition Intervention Phase
Breast Cancer
Drug: metformin hydrochloride
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • Invasive disease-free survival [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Distant relapse-free survival [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Breast cancer-free interval [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Long-term clinical and laboratory safety [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
  • Relevant medical endpoints (new diabetes, new cardiovascular hospitalizations) [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
  • Health-related quality of life, physical activity, and diet [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Change in body mass index [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Correlative science outcomes [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Enrollment: 3649
Study Start Date: July 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral metformin hydrochloride twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity.
Drug: metformin hydrochloride
Given orally
Placebo Comparator: Arm II
Patients receive oral placebo twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity.
Other: placebo
Given orally

Detailed Description:

OBJECTIVES:

Primary

  • To compare invasive disease-free survival of patients with early-stage breast cancer treated with metformin vs placebo in addition to standard adjuvant therapy.

Secondary

  • To compare overall survival of these patients.
  • To compare distant disease-free survival of these patients.
  • To compare breast cancer-free interval in these patients.
  • To compare invasive disease-free survival of patients who are hormone receptor-negative (both estrogen receptor and progesterone receptor).
  • To compare changes in body mass index in these patients.
  • To compare adverse events in these patients.
  • To compare other medical endpoints, including a new diagnosis of diabetes mellitus or cardiovascular hospitalization (including an emergency room visit or overnight stay) or death (stroke or myocardial infarction), in these patients.
  • To compare health-related quality of life measured using the EORTC QLQ-C30 (supplemented by a trial-specific checklist), the Block Alive Screener, and physical activity items from the Nurses Health Study Questionnaire II on a subset of these patients.
  • To compare embedded correlative science outcomes including plasma insulin and molecular markers of metformin action in these patients.
  • To compare metabolic parameters including metabolic components of the insulin resistance syndrome as defined by the ATP III criteria in a subset of these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to hormone-receptor status (estrogen receptor- and/or progesterone receptor- positive vs both receptors negative), body mass index (≤ 30 vs > 30 kg/m²), HER2 status (positive vs negative), and prior chemotherapy (any vs none). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral metformin hydrochloride twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive oral placebo twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity.

Blood and tumor samples are collected periodically for correlative studies.

Patients may complete quality-of-life, physical activity, and diet questionnaires at baseline and at 6, 12, 24, 36, 48, and 60 months. (Sub-set of patients).

After completion of study treatment, patients are followed annually.

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Eligibility Criteria:

  • Subjects must have histologically confirmed invasive breast cancer and be enrolled in the trial within 12 months after the first histologic diagnosis of invasive breast cancer. A core biopsy interpreted as invasive cancer meets this criterion; otherwise, the date of first histologic diagnosis will be the date of first surgical procedure that identifies invasive cancer (biopsy, lumpectomy or mastectomy). Neoadjuvant subjects should have no evidence of clinical T4 disease prior to chemotherapy and surgery. Bilateral breast carcinoma is allowed provided diagnoses are synchronous - that is, within 3 months of one another - and at least one of the two breast carcinomas meet the eligibility criteria and neither violates the eligibility criteria.
  • All subjects (both adjuvant and neo-adjuvant) must have sentinel lymph node biopsy and/or axillary lymph node dissection.

Sentinel lymph node biopsy alone is allowed in the following instances:

  1. sentinel lymph node biopsy is negative: pN0
  2. sentinel lymph node biopsy is positive for isolated tumour cells only: pN0 (i+)
  3. * clinically node negative, T1-2 tumours with sentinel lymph node biopsy positive in ≤ 2 lymph nodes without extra-capsular extension or matted nodes and undergoing breast conserving surgery and tangential whole breast irradiation (* excludes subjects treated with neo-adjuvant systemic therapy)

Definitive surgery and/or chemotherapy have been completed at least 4 weeks prior to randomization. Surgical margins must be clear of invasive carcinoma. If there is microscopic residual ductal in situ disease present at lumpectomy or total mastectomy margins, further excision is highly recommended. If further excision is not undertaken, the subject may still be entered on study, provided that in addition to breast or chest wall irradiation, a boost to the tumour bed is delivered. In situ lobular disease at the margin is acceptable.

Adjuvant subjects with the following pT pN combinations are eligible:

  • pT1c, pN0 AND negative estrogen and progesterone receptors AND HER2 negative OR
  • pT2N0 and at least one of the following tumour characteristics: histologic grade 3, lymphovascular invasion, negative estrogen and progesterone receptors, HER2 positive, Oncotype Dx recurrence score ≥ 25 (or if Oncotype Dx recurrence score is not available, Ki67 > 14%) OR
  • Subjects with pT3, pN0 OR
  • Subjects with pT1-3, pN1-3

The eligibility of neo-adjuvant subjects is assessed on the basis of cTNM. The same eligible TNM combinations apply.

  • HER2 status must be known. (Positive = 3+ over-expression by IHC in > 30% of invasive tumour cells OR HER2 gene amplification by FISH/CISH > 6 HER2 gene copies per nucleus, OR a FISH/CISH ratio: HER2 gene copies to chromosome 17 signals of ≥ 2.2. All other results will be considered negative).
  • Patients must have had a bilateral mammogram within 12 months prior to randomization, unless the initial surgery was a total mastectomy, in which case only a mammogram of the remaining breast is required. (Subjects with bilateral total mastectomies and no mammogram within 12 months prior to randomization must, instead, have a physical examination of the chest wall to ensure there is no residual or recurrent disease at the time of randomization. The date of this examination is used in place of the mammogram date on the eligibility checklist.)
  • Investigations, including chest X-ray or CT chest, bone scan (with radiographs of suspicious areas) and abdominal ultrasound or liver scan or CT abdomen have been performed between the first histologic diagnosis and the time of randomization.

    • Chest X-Ray, 2 view (or Chest CT) is mandatory
    • Bone scans (with x-rays of abnormal areas) are required only if there are signs or symptoms of metastatic disease
    • Abdominal imaging is required only if there are signs or symptoms of metastatic disease
  • Hematology investigations (WBC, Granulocytes, Platelets, Hemoglobin) have been completed within 28 days prior to randomization and results are available.
  • Biochemistry investigations have been completed within 28 days prior to randomization and values are within the parameters required by the protocol.

AST < 1.8 X ULN; ALT < 1.8 X ULN; Alkaline Phosphatase < 2 X ULN; Serum Creatinine < 115 μmol/L (1.3mg/dL) Serum Bilirubin < institution ULN (except for subjects with Gilbert's Disease who are eligible despite elevated serum bilirubin level)

  • ECOG Performance Status of 0,1 or 2 (at baseline evaluation visit within 28 days prior to randomization).
  • Age ≥ 18 and < 75 and life expectancy of at least 5 years (18 years of age was used as a cut-off due to the lack of data indicating that breast cancer is a health issue in the < 18 years age group and metformin safety in pediatric patients has not been confirmed. Age > 80 carries increased risk of lactic acidosis and study intervention is for 5 years).
  • Subjects must be accessible for treatment and follow-up. Investigators must assure themselves the subjects randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
  • In accordance with NCIC CTG policy, protocol treatment is to begin within 10 working days of patient randomization.
  • Subject consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements. It will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to the NCIC CTG Study Coordinator that such clearance has been obtained, before the trial can commence in that centre. Because of differing requirements, a standard consent form for the trial will not be provided but a sample form is given in Appendix XII. A copy of the initial full board REB approval and approved consent form must be sent to the central office. The patient must sign the consent form prior to randomization or registration. Please note that the consent form for this study must contain a statement which gives permission for the NCIC CTG and monitoring agencies to review patient records (see Section 16 for further details).

For the first 888 eligible English or French-speaking subjects only (sub-set enrollment completed 2011NOV04):

  • Subject is able (i.e. sufficiently fluent) and willing to complete the Quality of Life (EORTC QLQ C-30 and Trial Specific Checklist) in English or French. The baseline assessment must already have been completed at the time of enrollment. Inability (illiteracy in English or French, loss of sight or other equivalent reason) to complete questionnaires will not make the patient ineligible for the study; however, ability but unwillingness to complete the questionnaires will make the patient ineligible. (Once the target number of 888 subjects is achieved, this criterion will no longer need to be fulfilled.) [See Appendix VI]. Sub-set enrollment completed 2011NOV04.
  • English-speaking subjects who have completed the Quality of Life Questionnaire who are able (i.e. sufficiently fluent) and willing to complete Nurses Health Study II Physical Activity Questionnaire and Block Alive Screener in English. The baseline assessment must already have been completed at the time of enrollment. Inability (illiteracy in English, loss of sight or other equivalent reason) to complete questionnaires will not make the patient ineligible for the study; however, ability but unwillingness to complete the questionnaires will make the patient ineligible. (This component of the study will close at the same time as the Quality Of Life sub-study.) Closed to new patient enrollment as of 2011NOV04.

Ineligibility Criteria:

  • Subjects with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
  • Subjects with locally recurrent or metastatic breast carcinoma. (Subjects with prior invasive breast cancer at any time are not eligible. Subjects with prior DCIS only in either breast are eligible provided the DCIS has been curatively treated including surgery, radiotherapy and/or Tamoxifen).
  • Subjects whose axillary node status is unknown.
  • Known diabetes (type 1 or 2) or baseline fasting glucose > 7.0 mmol/L (126 mg/dL). (Sampled and assayed according to local institution's procedures.)
  • Known hypersensitivity or intolerance to metformin.
  • Any condition associated with increased risk of metformin-associated lactic acidosis (e.g. congestive heart failure defined as New York Heart Association {NYHA} Class III or IV functional status [see Appendix IX], history of acidosis of any type; habitual * Currently taking metformin, sulfonylureas, thiazolidinediones or insulin for any reason.
  • Current or planned pregnancy or lactation in women of child-bearing potential. Men should not father a child. (An effective method of birth control should be used while on study treatment which could include abstinence, IUD, condoms or other barrier methods of birth control because the safety of metformin in pregnancy or in male fertility has not been established).
  • Concurrent or planned participation in randomized trials of weight loss or exercise interventions or trials targeting insulin, IGF-1 or their receptors, or involving P13K inhibitors (at the time of randomization)*.
  • These interventions would interfere with the primary endpoint. (Also, in general, double randomizations in breast cancer trials for MA.32 patients are permitted only if the patient meets all the eligibility criteria for MA.32 and the sponsor of the previous trial has no objection to the patient also being enrolled in MA.32).
  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: NCT01101438

  Hide Study Locations
Locations
United States, Alaska
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States, 99701
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Pinnacle Oncology Associates
Scottsdale, Arizona, United States, 85258
Arizona Cancer Center at University Medical Center North
Tucson, Arizona, United States, 85719
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
United States, California
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States, 94531
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States, 94704
Enloe Medical Center
Chico, California, United States, 95926
Glendale Memorial Hospital and Health Center
Glendale, California, United States, 91204
Kaiser Permanente, Hayward
Hayward, California, United States, 94545
Moores University of California San Diego Cancer Center
La Jolla, California, United States, 92093
Long Beach Memorial Medical Center-Todd Cancer Institute
Long Beach, California, United States, 90806
University of California at Los Angeles (UCLA )
Los Angeles, California, United States, 90095
University of Southern California
Los Angeles, California, United States, 90033-0804
Fremont - Rideout Cancer Center
Marysville, California, United States, 95901
Bay Area Tumor Institution CCOP
Oakland, California, United States, 94609
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
University of California Medical Center At Irvine-Orange Campus
Orange, California, United States, 92868
Pomona Valley Hospital Medical Center
Pomona, California, United States, 91767
Kaiser Permanente-Redwood City
Redwood City, California, United States, 94063
Kaiser Permanente-Richmond
Richmond, California, United States, 94801
Kaiser Permanente-Roseville
Roseville, California, United States, 95661
Kaiser Permanente - Sacramento
Sacramento, California, United States, 95825
Kaiser Permanente-South Sacramento
Sacramento, California, United States, 95823
University of California Davis-Cancer Center
Sacramento, California, United States, 95817
Kaiser Permanente
San Diego, California, United States, 92108
Kaiser Permanente-Mission
San Diego, California, United States, 92108
Kaiser Permanente-San Francisco
San Francisco, California, United States, 94115
University of California San Francisco Medical Center-Mount Zion
San Francisco, California, United States, 94115
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States, 95119
Kaiser Permanente-San Rafael
San Rafael, California, United States, 94903
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States, 95403
Kaiser Permanente-South San Francisco
South San Francisco, California, United States, 94080
Stanford University
Stanford, California, United States, 94305
Kaiser Permanente-Stockton
Stockton, California, United States, 95210
Tahoe Forest Cancer Center
Truckee, California, United States, 96161
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, United States, 95688
Kaiser Permanente-Vallejo
Vallejo, California, United States, 94589
John Muir Medical Center
Walnut Creek, California, United States, 94598
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States, 94596
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Memorial Hospital Colorado Springs
Colorado Springs, Colorado, United States, 80909
Kaiser Permanente-Franklin
Denver, Colorado, United States, 80205
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
United States, Connecticut
University of Connecticut
Farmington, Connecticut, United States, 06030
Greenwich Hospital
Greenwich, Connecticut, United States, 06830
Hartford Hospital
Hartford, Connecticut, United States, 06102
Yale University
New Haven, Connecticut, United States, 06520-8032
Stamford Hospital
Stamford, Connecticut, United States, 06904
Connecticut Oncology and Hematology LLP
Torrington, Connecticut, United States, 06790
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
United States, Florida
Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
The Watson Clinic
Lakeland, Florida, United States, 33805
Mount Sinai Medical Center CCOP
Miami Beach, Florida, United States, 33140
Florida Hospital
Orlando, Florida, United States, 32803
Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Phoebe Putney Memorial Hospital
Albany, Georgia, United States, 31701
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
South Georgia Medical Center
Valdosta, Georgia, United States, 31602
United States, Hawaii
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, United States, 96819
University of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504
University of Chicago
Chicago, Illinois, United States, 60637-1470
Mount Sinai Hospital Medical Center
Chicago, Illinois, United States, 60608
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States, 60612-3785
Swedish Covenant Hospital
Chicago, Illinois, United States, 60625
Resurrection Healthcare
Chicago, Illinois, United States, 60631
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Elmhurst Memorial Hospital
Elmhurst, Illinois, United States, 60126
Evanston CCOP-NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Saint Francis Hospital
Evanston, Illinois, United States, 60202
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Trinity Medical Center
Moline, Illinois, United States, 61265
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Illinois Oncology Research Association CCOP
Peoria, Illinois, United States, 61615
Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Carle Foundation - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Elkhart Clinic
Elkhart, Indiana, United States, 46514-2098
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States, 46514
Indiana University Hospital/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Howard Regional Healthcare System
Kokomo, Indiana, United States, 46904
Saint Anthony Memorial Health Center
Michigan City, Indiana, United States, 46360
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States, 46563
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology-PC Westville
Westville, Indiana, United States, 46391
United States, Iowa
McFarland Clinic
Ames, Iowa, United States, 50010
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Heartland Oncology and Hematology LLP
Council Bluffs, Iowa, United States, 51503
Ottumwa Regional Health Center
Ottumwa, Iowa, United States, 52501
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States, 51101
United States, Kansas
Kansas City CCOP
Prairie Village, Kansas, United States, 66208
Wichita CCOP
Wichita, Kansas, United States, 67214
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
Owensboro Mercy Medical Center
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
York Hospital
York, Maine, United States, 03909
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287-8936
Mercy Medical Center
Baltimore, Maryland, United States, 21202
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201-1595
Suburban Hospital
Bethesda, Maryland, United States, 20814
Frederick Memorial Hospital
Frederick, Maryland, United States, 21701
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Lahey Clinic Medical Center
Burlington, Massachusetts, United States, 01805
Addison Gilbert Hospital
Gloucester, Massachusetts, United States, 01930
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
Saint Vincent Hospital - Fallon Clinic
Worcester, Massachusetts, United States, 01608
United States, Michigan
University of Michigan Health System-Cancer Center
Ann Arbor, Michigan, United States, 48109
Battle Creek Health System
Battle Creek, Michigan, United States, 49017
Wayne State University
Detroit, Michigan, United States, 48202
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Mercy Health Partners-Mercy Campus
Muskegon, Michigan, United States, 49444
Michiana Hematology Oncology PC-Niles
Niles, Michigan, United States, 49120
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Munson Medical Center
Traverse City, Michigan, United States, 49684
Metro Health Hospital
Wyoming, Michigan, United States, 49519
United States, Minnesota
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Duluth Clinic CCOP
Duluth, Minnesota, United States, 55805
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic
Rochester, Minnesota, United States, 55905
CentraCare Clinic
Saint Cloud, Minnesota, United States, 56303
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Saint Luke's Hospital
Chesterfield, Missouri, United States, 63017
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Saint Louis-Cape Girardeau CCOP
Saint Louis, Missouri, United States, 63141
Saint John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
Cox Medical Center
Springfield, Missouri, United States, 65807
Saint John's Hospital
Springfield, Missouri, United States, 65804
United States, Nebraska
Good Samaritan Hospital
Kearney, Nebraska, United States, 68847
Lincoln Medical Education Foundation Cancer Resource Center
Lincoln, Nebraska, United States, 68510
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
Missouri Valley Cancer Consortium CCOP
Omaha, Nebraska, United States, 68106
United States, New Hampshire
New Hampshire Oncology-Hematology PA
Concord, New Hampshire, United States, 03301
New Hampshire Oncology Hematology Associates
Hooksett, New Hampshire, United States, 03106
LRGHealthcare-Lakes Region General Hospital
Laconia, New Hampshire, United States, 03246
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
The Dana-Farber Cancer Institute at Londonderry
Londonderry, New Hampshire, United States, 03053
United States, New Jersey
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly, New Jersey, United States, 08060
Valley Hospital
Ridgewood, New Jersey, United States, 07450
United States, New Mexico
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, United States, 87110
University of New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467-2490
The North Division of Montefiore Medical Center
Bronx, New York, United States, 10466
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Coney Island Hospital
Brooklyn, New York, United States, 11235
Maimonides Medical Center
Brooklyn, New York, United States, 11219
State University of New York Downstate Medical Center
Brooklyn, New York, United States, 11203
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Hematology Oncology Associates of Central New York PC
East Syracuse, New York, United States, 13057
Monter Cancer Center
Lake Success, New York, United States, 11042
North Shore University Hospital
Manhasset, New York, United States, 11030
North Shore University Hospital CCOP
Manhasset, New York, United States, 11030
Mount Kisco Medical Group
Mount Kisco, New York, United States, 10549
Mount Kisco Medical Group at Northern Westchester Hospital
Mount Kisco, New York, United States, 10549-3417
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Beth Israel Medical Center
New York, New York, United States, 10003
Columbia University Medical Center
New York, New York, United States, 10032
Mount Sinai Medical Center
New York, New York, United States, 10029
New York University Langone Medical Center
New York, New York, United States, 10016
Saint Luke's Roosevelt Hospital Center - Saint Luke's Division
New York, New York, United States, 10025
Rochester General Hospital
Rochester, New York, United States, 14621
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Mission Hospitals Inc
Asheville, North Carolina, United States, 28801
Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
High Point Regional Hospital
High Point, North Carolina, United States, 27261
Kinston Medical Specialists PA
Kinston, North Carolina, United States, 28501
FirstHealth of the Carolinas-Moore Regional Hosiptal
Pinehurst, North Carolina, United States, 28374
Rex Cancer Center
Raleigh, North Carolina, United States, 27607
Forsyth Memorial Hospital
Winston-Salem, North Carolina, United States, 27103
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Mid Dakota Clinic
Bismarck, North Dakota, United States, 58501
Medcenter One Health Systems
Bismarck, North Dakota, United States, 58501
Sanford Clinic North-Fargo
Fargo, North Dakota, United States, 58102
Sanford Medical Center-Fargo
Fargo, North Dakota, United States, 58122
Altru Cancer Center
Grand Forks, North Dakota, United States, 58201
Trinity Cancer Care Center
Minot, North Dakota, United States, 58701
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44304
Akron General Medical Center
Akron, Ohio, United States, 44307
Aultman Health Foundation
Canton, Ohio, United States, 44710
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Kettering Medical Center
Kettering, Ohio, United States, 45429
United States, Oregon
Columbia River Oncology Program
Portland, Oregon, United States, 97225
Kaiser Permanente
Portland, Oregon, United States, 97227
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States, 97210
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
Phoenixville Hospital
Phoenixville, Pennsylvania, United States, 19460
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15232
Saint Joseph Medical Center
Reading, Pennsylvania, United States, 19605
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Chester County Hospital
West Chester, Pennsylvania, United States, 19380
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, Rhode Island
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States, 02860
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, South Carolina
AnMed Health Cancer Center
Anderson, South Carolina, United States, 29621
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
McLeod Regional Medical Center
Florence, South Carolina, United States, 29506
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Sanford Clinic
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
University of Tennessee - Knoxville
Knoxville, Tennessee, United States, 37920
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, United States, 37204
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
University Medical Center Brackenridge
Austin, Texas, United States, 78701
Doctor's Hospital of Laredo
Laredo, Texas, United States, 78045
University of Texas Health Science Center
San Antonio, Texas, United States, 78229-3900
United States, Utah
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
United States, Vermont
Mountainview Medical
Berlin, Vermont, United States, 05602
University of Vermont
Burlington, Vermont, United States, 05401
United States, Virginia
Martha Jefferson Hospital
Charlottesville, Virginia, United States, 22901
Lynchburg Hematology-Oncology Clinic
Lynchburg, Virginia, United States, 24501
United States, Washington
Saint John Medical Center
Longview, Washington, United States, 98632
Group Health Cooperative
Seattle, Washington, United States, 98112
Pacific Medical Center-First Hill
Seattle, Washington, United States, 98104
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
University of Washington Medical Center
Seattle, Washington, United States, 98195
Virginia Mason CCOP
Seattle, Washington, United States, 98101
Rockwood Clinic
Spokane, Washington, United States, 99220
Northwest CCOP
Tacoma, Washington, United States, 98405
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, United States, 99362
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
United States, West Virginia
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States, 25701
West Virginia University
Morgantown, West Virginia, United States, 26506
Wheeling Hospital
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, United States, 54701
Central Wisconsin Cancer Program
Fond Du Lac, Wisconsin, United States, 54935
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311-6519
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Gundersen Lutheran Health System/CCOP
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, United States, 53097
Columbia Saint Mary's Water Tower Medical Commons
Milwaukee, Wisconsin, United States, 53211
Wheaton Franciscan Healthcare - Saint Joseph
Milwaukee, Wisconsin, United States, 53210
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States, 54548
Aurora Medical Center in Summit
Summit, Wisconsin, United States, 53066
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BCCA - Abbotsford Centre
Abbotsford, British Columbia, Canada, V2S 0C2
BCCA - Cancer Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
BCCA - Vancouver Island Cancer Centre
Victoria, British Columbia, Canada, V8R 6V5
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
The Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6Z8
The Vitalite Health Network - Dr. Leon Richard
Moncton, New Brunswick, Canada, E1C 8X3
Atlantic Health Sciences Corporation
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada, AIB 3V6
Canada, Ontario
Cambridge Memorial Hospital
Cambridge, Ontario, Canada, N1R 3G2
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, Canada, K7L 5P9
Grand River Regional Cancer Centre
Kitchener, Ontario, Canada, N2G 1G3
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Credit Valley Hospital
Mississauga, Ontario, Canada, L5M 2N1
Stronach Regional Health Centre at Southlake
Newmarket, Ontario, Canada, L3Y 2P9
Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 2B9
Ottawa Health Research Institute - General Division
Ottawa, Ontario, Canada, K1H 8L6
Algoma District Cancer Program
Sault Ste. Marie, Ontario, Canada, P6B 0A8
Niagara Health System
St. Catharines, Ontario, Canada, L2R 7C6
Northeast Cancer Center Health Sciences
Sudbury, Ontario, Canada, P3E 5J1
Thunder Bay Regional Health Science Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Toronto East General Hospital
Toronto, Ontario, Canada, M4C 3E7
Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Trillium Health Centre - West Toronto
Toronto, Ontario, Canada, M9C 1A5
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Windsor Regional Cancer Centre
Windsor, Ontario, Canada, N8W 2X3
Canada, Prince Edward Island
PEI Cancer Treatment Centre,Queen Elizabeth Hospital
Charlottetown, Prince Edward Island, Canada, C1A 8T5
Canada, Quebec
Hopital Charles LeMoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Hopital de la Cite-de-la-Sante
Laval, Quebec, Canada, H7M 3L9
CHUM - Hotel Dieu du Montreal
Montreal, Quebec, Canada, H2W 1T8
McGill University - Dept. Oncology
Montreal, Quebec, Canada, H2W 1S6
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
CHA-Hopital Du St-Sacrement
Quebec City, Quebec, Canada, G1S 4L8
CHUQ-Pavillon Hotel-Dieu de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Switzerland
Switzerland-Chur (Ratisches Kantons- und Regionalspital)
Chur, Switzerland, 7000
Brustzentrum Thurgau, Spital Thurgau AG
Frauenfeld, Switzerland, 8501
Fondazione Oncologia Lago Maggiore, FOLM
Locarno, Switzerland, 6600
Switzerland-Luzern (Kantonsspital Luzern)
Luzern 16, Switzerland, 6000
Switzerland - Oncology Institute of Southern Switzerland (IOSI)
Mendrisio, Switzerland, 6850
Switzerland - Olten (Kantonsspital) affiliate-3101
Olten, Switzerland, 4600
Switzerland - ZeTup St.Gallen
St. Gallen, Switzerland, 9006
Switzerland - Brust-Zentrum, Zurich
Zurich, Switzerland, 8005
United Kingdom
University Hospital Birmingham NHS Foundation Trust
Edgbaston, Birmingham, United Kingdom, B15-2WB
Brighton and Sussex University Hospitals NHS Trust
Sussex, Brighton, United Kingdom, BN2 5BE
Edinburgh Cancer Centre, Western General Hospital
Edinburgh, Crewe Road South, United Kingdom, EH4 2XU
Medway NHS Foundation Trust
Kent, Gillingham, United Kingdom, ME75NY
Withybush General Hospital
Pembrokeshire, Haverfordwest, United Kingdom, SA61 2PZ
Kent Centre for Oncology
Kent, Maidstone, United Kingdom, ME16 9QQ
South Tees Hospitals NHS Foundation Trust
Middlesborough, Marton Road, United Kingdom, TS4 3BW
East and North Hertfordshire NHS Trust
Northwood; Middlesex, Rickmansworth Road, United Kingdom, HA6 2RN
Singleton Hospital
Swansea, Sketty Lane, United Kingdom, SA2 8QA
North Bristol NHS Trust
Bristol, Southmead, United Kingdom, BS10 5NB
St George's Healthcare NHS Trust
London, Tooting, United Kingdom, SW17 0QT
Ninewells Hospital
Dundee, University of Dundee, United Kingdom, DD1 9SY
Velindre Cancer Centre
Cardiff, Whitchurch, United Kingdom, CF14 2TL
The Christie NHS Foundation Trust
Manchester, Withington, United Kingdom, M20-4BX
Sandwell and West Birmingham Hospitals NHS Trust
Birmingham, United Kingdom, B187QH
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Principal Investigator: Pamela J. Goodwin, MD Mount Sinai Hospital, Toronto
  More Information

Additional Information:
No publications provided

Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01101438     History of Changes
Other Study ID Numbers: MA32, U10CA077202, CAN-NCIC-MA.32, CDR0000669788
Study First Received: April 9, 2010
Last Updated: February 18, 2014
Health Authority: Canada: Health Canada

Keywords provided by NCIC Clinical Trials Group:
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIC breast cancer
male breast cancer
estrogen receptor-negative breast cancer
HER2-negative breast cancer
progesterone receptor-negative breast cancer
estrogen receptor-positive breast cancer
HER2-positive breast cancer
progesterone receptor-positive breast cancer

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

ClinicalTrials.gov processed this record on November 24, 2014