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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 Nov 2, 2026, 3:13 PM EST

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

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

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 13, 2010 (Actual)
Primary completion
Sep 21, 2021 (Actual)
Completion
Aug 18, 2023 (Actual)
Last update posted
Sep 13, 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 13, 2023 · Synced Nov 2, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01101438 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →