ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01101438

Public ClinicalTrials.gov record NCT01101438. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 6, 2026, 8:10 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer

Study identification

NCT ID
NCT01101438
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Canadian Cancer Trials Group
Network
Enrollment
3,649 participants

Conditions and interventions

Conditions

Interventions

  • metformin hydrochloride Drug
  • placebo Other

Drug · Other

Eligibility (public fields only)

Age range
18 Years to 74 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 12, 2010
Primary completion
Sep 20, 2021
Completion
Aug 17, 2023
Last update posted
Sep 12, 2023

2010 – 2023

United States locations

U.S. sites
280
U.S. states
43
U.S. cities
216
Facility City State ZIP Site status
Providence Alaska Medical Center Anchorage Alaska 99508
Fairbanks Memorial Hospital Fairbanks Alaska 99701
Pinnacle Oncology Associates Scottsdale Arizona 85258
Mayo Clinic in Arizona Scottsdale Arizona 85259
Arizona Cancer Center at University Medical Center North Tucson Arizona 85719
University of Arizona Health Sciences Center Tucson Arizona 85724
Kaiser Permanente-Deer Valley Medical Center Antioch California 94531
Alta Bates Summit Medical Center-Herrick Campus Berkeley California 94704
Enloe Medical Center Chico California 95926
Glendale Memorial Hospital and Health Center Glendale California 91204
Kaiser Permanente, Hayward Hayward California 94545
Moores University of California San Diego Cancer Center La Jolla California 92093
Long Beach Memorial Medical Center-Todd Cancer Institute Long Beach California 90806
University of Southern California Los Angeles California 90033-0804
University of California at Los Angeles (UCLA ) Los Angeles California 90095
Fremont - Rideout Cancer Center Marysville California 95901
Bay Area Tumor Institution CCOP Oakland California 94609
Kaiser Permanente-Oakland Oakland California 94611
University of California Medical Center At Irvine-Orange Campus Orange California 92868
Pomona Valley Hospital Medical Center Pomona California 91767
Kaiser Permanente-Redwood City Redwood City California 94063
Kaiser Permanente-Richmond Richmond California 94801
Kaiser Permanente-Roseville Roseville California 95661
University of California Davis-Cancer Center Sacramento California 95817
Kaiser Permanente-South Sacramento Sacramento California 95823
Kaiser Permanente - Sacramento Sacramento California 95825
Kaiser Permanente-Mission San Diego California 92108
Kaiser Permanente San Diego California 92108
Kaiser Permanente-San Francisco San Francisco California 94115
University of California San Francisco Medical Center-Mount Zion San Francisco California 94115
Kaiser Permanente-Santa Teresa-San Jose San Jose California 95119
Kaiser Permanente-San Rafael San Rafael California 94903
Kaiser Permanente Medical Center - Santa Clara Santa Clara California 95051
Kaiser Permanente-Santa Rosa Santa Rosa California 95403
Kaiser Permanente-South San Francisco South San Francisco California 94080
Stanford University Stanford California 94305
Kaiser Permanente-Stockton Stockton California 95210
Tahoe Forest Cancer Center Truckee California 96161
Kaiser Permanente Medical Center-Vacaville Vacaville California 95688
Kaiser Permanente-Vallejo Vallejo California 94589
Kaiser Permanente-Walnut Creek Walnut Creek California 94596
John Muir Medical Center Walnut Creek California 94598
University of Colorado Cancer Center - Anschutz Cancer Pavilion Aurora Colorado 80045
Memorial Hospital Colorado Springs Colorado Springs Colorado 80909
Kaiser Permanente-Franklin Denver Colorado 80205
Poudre Valley Hospital Fort Collins Colorado 80524
Front Range Cancer Specialists Fort Collins Colorado 80528
University of Connecticut Farmington Connecticut 06030
Greenwich Hospital Greenwich Connecticut 06830
Hartford Hospital Hartford Connecticut 06102
Yale University New Haven Connecticut 06520-8032
Stamford Hospital Stamford Connecticut 06904
Connecticut Oncology and Hematology LLP Torrington Connecticut 06790
Georgetown University Hospital Washington D.C. District of Columbia 20007
Washington Hospital Center Washington D.C. District of Columbia 20010
Sibley Memorial Hospital Washington D.C. District of Columbia 20016
Boca Raton Regional Hospital Boca Raton Florida 33486
Mayo Clinic in Florida Jacksonville Florida 32224-9980
The Watson Clinic Lakeland Florida 33805
Mount Sinai Medical Center CCOP Miami Beach Florida 33140
Florida Hospital Orlando Florida 32803
Moffitt Cancer Center and Research Institute Tampa Florida 33612
Phoebe Putney Memorial Hospital Albany Georgia 31701
Northeast Georgia Medical Center Gainesville Georgia 30501
South Georgia Medical Center Valdosta Georgia 31602
University of Hawaii Honolulu Hawaii 96813
Kaiser Permanente Moanalua Medical Center Honolulu Hawaii 96819
Rush - Copley Medical Center Aurora Illinois 60504
Mount Sinai Hospital Medical Center Chicago Illinois 60608
John H Stroger Jr Hospital of Cook County Chicago Illinois 60612-3785
Swedish Covenant Hospital Chicago Illinois 60625
Resurrection Healthcare Chicago Illinois 60631
University of Chicago Chicago Illinois 60637-1470
Decatur Memorial Hospital Decatur Illinois 62526
Elmhurst Memorial Hospital Elmhurst Illinois 60126
Evanston CCOP-NorthShore University HealthSystem Evanston Illinois 60201
Saint Francis Hospital Evanston Illinois 60202
Ingalls Memorial Hospital Harvey Illinois 60426
Loyola University Medical Center Maywood Illinois 60153
Trinity Medical Center Moline Illinois 61265
Illinois CancerCare-Peoria Peoria Illinois 61615
Illinois Oncology Research Association CCOP Peoria Illinois 61615
Memorial Medical Center Springfield Illinois 62781-0001
Carle Foundation - Carle Cancer Center Urbana Illinois 61801
Elkhart Clinic Elkhart Indiana 46514-2098
Michiana Hematology Oncology PC-Elkhart Elkhart Indiana 46514
Indiana University Hospital/Melvin and Bren Simon Cancer Center Indianapolis Indiana 46202
Howard Regional Healthcare System Kokomo Indiana 46904
Saint Anthony Memorial Health Center Michigan City Indiana 46360
Michiana Hematology Oncology PC-Mishawaka Mishawaka Indiana 46545-1470
Michiana Hematology Oncology PC-Plymouth Plymouth Indiana 46563
Michiana Hematology Oncology PC-South Bend South Bend Indiana 46601
Michiana Hematology Oncology-PC Westville Westville Indiana 46391
McFarland Clinic Ames Iowa 50010
Oncology Associates at Mercy Medical Center Cedar Rapids Iowa 52403
Heartland Oncology and Hematology LLP Council Bluffs Iowa 51503
Ottumwa Regional Health Center Ottumwa Iowa 52501
Siouxland Hematology Oncology Associates Sioux City Iowa 51101
Kansas City CCOP Prairie Village Kansas 66208
Wichita CCOP Wichita Kansas 67214
Central Baptist Hospital Lexington Kentucky 40503
Owensboro Mercy Medical Center Owensboro Kentucky 42303
Mary Bird Perkins Cancer Center Baton Rouge Louisiana 70809
Eastern Maine Medical Center Bangor Maine 04401
York Hospital York Village Maine 03909
University of Maryland Greenebaum Cancer Center Baltimore Maryland 21201-1595
Mercy Medical Center Baltimore Maryland 21202
Johns Hopkins University Baltimore Maryland 21287-8936
Suburban Hospital Bethesda Maryland 20814
Frederick Memorial Hospital Frederick Maryland 21701
Dana-Farber Cancer Institute Boston Massachusetts 02115
Beth Israel Deaconess Medical Center Boston Massachusetts 02215
Lahey Clinic Medical Center Burlington Massachusetts 01805
Addison Gilbert Hospital Gloucester Massachusetts 01930
Lowell General Hospital Lowell Massachusetts 01854
Saint Vincent Hospital - Fallon Clinic Worcester Massachusetts 01608
University of Michigan Health System-Cancer Center Ann Arbor Michigan 48109
Battle Creek Health System Battle Creek Michigan 49017
Wayne State University Detroit Michigan 48202
Grand Rapids Clinical Oncology Program Grand Rapids Michigan 49503
Saint Mary's Health Care Grand Rapids Michigan 49503
Spectrum Health at Butterworth Campus Grand Rapids Michigan 49503
West Michigan Cancer Center Kalamazoo Michigan 49007
Mercy Health Partners-Mercy Campus Muskegon Michigan 49444
Michiana Hematology Oncology PC-Niles Niles Michigan 49120
William Beaumont Hospital Royal Oak Michigan 48073
Marie Yeager Cancer Center Saint Joseph Michigan 49085
Munson Medical Center Traverse City Michigan 49684
Metro Health Hospital Wyoming Michigan 49519
Mercy Hospital Coon Rapids Minnesota 55433
Duluth Clinic CCOP Duluth Minnesota 55805
Fairview-Southdale Hospital Edina Minnesota 55435
Unity Hospital Fridley Minnesota 55432
Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota 55109
Saint John's Hospital - Healtheast Maplewood Minnesota 55109
Abbott-Northwestern Hospital Minneapolis Minnesota 55407
North Memorial Medical Health Center Robbinsdale Minnesota 55422
Mayo Clinic Rochester Minnesota 55905
CentraCare Clinic Saint Cloud Minnesota 56303
Metro-Minnesota CCOP Saint Louis Park Minnesota 55416
Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota 55416
Regions Hospital Saint Paul Minnesota 55101
United Hospital Saint Paul Minnesota 55102
Rice Memorial Hospital Willmar Minnesota 56201
Minnesota Oncology and Hematology PA-Woodbury Woodbury Minnesota 55125
University of Mississippi Medical Center Jackson Mississippi 39216
Singing River Hospital Pascagoula Mississippi 39581
Saint Luke's Hospital Chesterfield Missouri 63017
Saint John's Hospital Springfield Missouri 65804
Cox Medical Center Springfield Missouri 65807
Washington University School of Medicine St Louis Missouri 63110
Missouri Baptist Medical Center St Louis Missouri 63131
Saint John's Mercy Medical Center St Louis Missouri 63141
Saint Louis-Cape Girardeau CCOP St Louis Missouri 63141
Good Samaritan Hospital Kearney Nebraska 68847
Lincoln Medical Education Foundation Cancer Resource Center Lincoln Nebraska 68510
Missouri Valley Cancer Consortium CCOP Omaha Nebraska 68106
Methodist Estabrook Cancer Center Omaha Nebraska 68114
New Hampshire Oncology-Hematology PA Concord New Hampshire 03301
New Hampshire Oncology Hematology Associates Hooksett New Hampshire 03106
LRGHealthcare-Lakes Region General Hospital Laconia New Hampshire 03246
Dartmouth Hitchcock Medical Center Lebanon New Hampshire 03756
The Dana-Farber Cancer Institute at Londonderry Londonderry New Hampshire 03053
Saint Barnabas Medical Center Livingston New Jersey 07039
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County Mount Holly New Jersey 08060
Valley Hospital Ridgewood New Jersey 07450
University of New Mexico Albuquerque New Mexico 87106
Presbyterian Kaseman Hospital Albuquerque New Mexico 87110
State University of New York Downstate Medical Center Brooklyn New York 11203
Maimonides Medical Center Brooklyn New York 11219
Coney Island Hospital Brooklyn New York 11235
Roswell Park Cancer Institute Buffalo New York 14263
Hematology Oncology Associates of Central New York PC East Syracuse New York 13057
Monter Cancer Center Lake Success New York 11042
North Shore University Hospital CCOP Manhasset New York 11030
North Shore University Hospital Manhasset New York 11030
Mount Kisco Medical Group at Northern Westchester Hospital Mount Kisco New York 10549-3417
Mount Kisco Medical Group Mount Kisco New York 10549
Long Island Jewish Medical Center New Hyde Park New York 11040
Beth Israel Medical Center New York New York 10003
New York University Langone Medical Center New York New York 10016
Saint Luke's Roosevelt Hospital Center - Saint Luke's Division New York New York 10025
Mount Sinai Medical Center New York New York 10029
Columbia University Medical Center New York New York 10032
Rochester General Hospital Rochester New York 14621
Stony Brook University Medical Center Stony Brook New York 11794
State University of New York Upstate Medical University Syracuse New York 13210
Albert Einstein College of Medicine The Bronx New York 10461
The North Division of Montefiore Medical Center The Bronx New York 10466
Montefiore Medical Center The Bronx New York 10467-2490
Mission Hospitals Inc Asheville North Carolina 28801
Presbyterian Hospital Charlotte North Carolina 28204
Wayne Memorial Hospital Goldsboro North Carolina 27534
Margaret R Pardee Memorial Hospital Hendersonville North Carolina 28791
High Point Regional Hospital High Point North Carolina 27261
Kinston Medical Specialists PA Kinston North Carolina 28501
FirstHealth of the Carolinas-Moore Regional Hosiptal Pinehurst North Carolina 28374
Rex Cancer Center Raleigh North Carolina 27607
Forsyth Memorial Hospital Winston-Salem North Carolina 27103
Wake Forest University Health Sciences Winston-Salem North Carolina 27157
Medcenter One Health Systems Bismarck North Dakota 58501
Mid Dakota Clinic Bismarck North Dakota 58501
Sanford Clinic North-Fargo Fargo North Dakota 58102
Sanford Medical Center-Fargo Fargo North Dakota 58122
Altru Cancer Center Grand Forks North Dakota 58201
Trinity Cancer Care Center Minot North Dakota 58701
Akron City Hospital Akron Ohio 44304
Akron General Medical Center Akron Ohio 44307
Aultman Health Foundation Canton Ohio 44710
Case Western Reserve University Cleveland Ohio 44106
MetroHealth Medical Center Cleveland Ohio 44109
Cleveland Clinic Foundation Cleveland Ohio 44195
Ohio State University Medical Center Columbus Ohio 43210
Kettering Medical Center Kettering Ohio 45429
Legacy Good Samaritan Hospital and Medical Center Portland Oregon 97210
Columbia River Oncology Program Portland Oregon 97225
Kaiser Permanente Portland Oregon 97227
Oregon Health and Science University Portland Oregon 97239
Bryn Mawr Hospital Bryn Mawr Pennsylvania 19010
Geisinger Medical Center Danville Pennsylvania 17822-2001
Penn State Milton S Hershey Medical Center Hershey Pennsylvania 17033-0850
Lancaster General Hospital Lancaster Pennsylvania 17604
Paoli Memorial Hospital Paoli Pennsylvania 19301
Pennsylvania Hospital Philadelphia Pennsylvania 19107
Fox Chase Cancer Center Philadelphia Pennsylvania 19111-2497
Albert Einstein Medical Center Philadelphia Pennsylvania 19141
Phoenixville Hospital Phoenixville Pennsylvania 19460
University of Pittsburgh Pittsburgh Pennsylvania 15232
Saint Joseph Medical Center Reading Pennsylvania 19605
Mount Nittany Medical Center State College Pennsylvania 16803
Chester County Hospital West Chester Pennsylvania 19380
Lankenau Hospital Wynnewood Pennsylvania 19096
Memorial Hospital of Rhode Island Pawtucket Rhode Island 02860
Rhode Island Hospital Providence Rhode Island 02903
Women and Infants Hospital Providence Rhode Island 02905
AnMed Health Cancer Center Anderson South Carolina 29621
Medical University of South Carolina Charleston South Carolina 29425
McLeod Regional Medical Center Florence South Carolina 29506
Spartanburg Regional Medical Center Spartanburg South Carolina 29303
Rapid City Regional Hospital Rapid City South Dakota 57701
Sanford Clinic Sioux Falls South Dakota 57104
Avera Cancer Institute Sioux Falls South Dakota 57105
University of Tennessee - Knoxville Knoxville Tennessee 37920
Vanderbilt Breast Center at One Hundred Oaks Nashville Tennessee 37204
Vanderbilt University Nashville Tennessee 37232
University Medical Center Brackenridge Austin Texas 78701
Doctor's Hospital of Laredo Laredo Texas 78045
University of Texas Health Science Center San Antonio Texas 78229-3900
Huntsman Cancer Institute/University of Utah Salt Lake City Utah 84112
Mountainview Medical Berlin Corners Vermont 05602
University of Vermont Burlington Vermont 05401
Martha Jefferson Hospital Charlottesville Virginia 22901
Lynchburg Hematology-Oncology Clinic Lynchburg Virginia 24501
Saint John Medical Center Longview Washington 98632
Virginia Mason CCOP Seattle Washington 98101
Pacific Medical Center-First Hill Seattle Washington 98104
Group Health Cooperative Seattle Washington 98112
Swedish Medical Center-First Hill Seattle Washington 98122-4307
University of Washington Medical Center Seattle Washington 98195
Rockwood Clinic Spokane Washington 99220
Northwest CCOP Tacoma Washington 98405
Providence Saint Mary Regional Cancer Center Walla Walla Washington 99362
Wenatchee Valley Medical Center Wenatchee Washington 98801
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington 98902
Edwards Comprehensive Cancer Center Huntington West Virginia 25701
West Virginia University Morgantown West Virginia 26506
Wheeling Hospital Wheeling West Virginia 26003
Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire Wisconsin 54701
Central Wisconsin Cancer Program Fond du Lac Wisconsin 54935
Saint Vincent Hospital Green Bay Wisconsin 54301
Aurora BayCare Medical Center Green Bay Wisconsin 54311-6519
Gundersen Lutheran Health System/CCOP La Crosse Wisconsin 54601
University of Wisconsin Hospital and Clinics Madison Wisconsin 53792
Marshfield Clinic Marshfield Wisconsin 54449
Columbia Saint Mary's Hospital - Ozaukee Mequon Wisconsin 53097
Wheaton Franciscan Healthcare - Saint Joseph Milwaukee Wisconsin 53210
Columbia Saint Mary's Water Tower Medical Commons Milwaukee Wisconsin 53211
Marshfield Clinic-Minocqua Center Minocqua Wisconsin 54548
Aurora Medical Center in Summit Summit Wisconsin 53066
Marshfield Clinic - Weston Center Weston Wisconsin 54476

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 64 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01101438, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 12, 2023 · Synced May 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01101438 live on ClinicalTrials.gov.

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