S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer
Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer
4 other identifiers
interventional
695
2 countries
426
Brief Summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using drugs such as anastrozole and fulvestrant may fight breast cancer by blocking the use of estrogen. It is not yet known whether anastrozole is more effective with or without fulvestrant in treating breast cancer. PURPOSE: This randomized phase III trial is studying giving anastrozole together with fulvestrant to see how well it works compared to anastrozole alone as first-line therapy in treating postmenopausal women with metastatic breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Apr 2004
Longer than P75 for phase_3 breast-cancer
426 active sites
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
First Submitted
Initial submission to the registry
January 9, 2004
CompletedFirst Posted
Study publicly available on registry
January 13, 2004
CompletedStudy Start
First participant enrolled
April 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedResults Posted
Study results publicly available
April 4, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedJanuary 13, 2021
January 1, 2021
8.7 years
January 9, 2004
October 26, 2016
January 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Tumor Progression
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. From date of randomization to time of first documentation of progression, symptomatic deterioration or death due to any cause. Patients last known to be alive and progression free are considered at last date of contact.
Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.
Secondary Outcomes (3)
Clinical Benefit (CR, PR, Confirmed or Unconfirmed, or Stable Disease >= 24 Weeks).
Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.
Overall Survival
Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Study Arms (2)
Arm I
ACTIVE COMPARATORPatients receive oral anastrozole once daily on days 1-28.
Arm II
EXPERIMENTALPatients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- SWOG Cancer Research Networklead
- National Cancer Institute (NCI)collaborator
- NCIC Clinical Trials Groupcollaborator
Study Sites (426)
Regional Medical Center
Anniston, Alabama, 36202, United States
Providence Cancer Center at Providence Hospital
Mobile, Alabama, 36608, United States
Alaska Regional Hospital Cancer Center
Anchorage, Alaska, 99508, United States
Providence Cancer Center
Anchorage, Alaska, 99508, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724-5024, United States
Highlands Oncology Group - Springdale
Bentonville, Arkansas, 72712, United States
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, Arkansas, 72903, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000, United States
Glendale Memorial Hospital Comprehensive Cancer Center
Glendale, California, 91204, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, 92354, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90089-9181, United States
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
Marysville, California, 95901, United States
University of California Davis Cancer Center
Sacramento, California, 95817, United States
San Francisco General Hospital Medical Center
San Francisco, California, 94110, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95405, United States
Tahoe Forest Cancer Center
Truckee, California, 96161, United States
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, 80045, United States
Memorial Hospital Cancer Center - Colorado Springs
Colorado Springs, Colorado, 80909, United States
Denver Health Medical Center
Denver, Colorado, 80204, United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220, United States
Shaw Regional Cancer Center
Edwards, Colorado, 81632, United States
Valley View Hospital Cancer Center
Glenwood Springs, Colorado, 81601, United States
Middlesex Hospital Cancer Center
Middletown, Connecticut, 06457, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5001, United States
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
Boca Raton, Florida, 33486, United States
North Broward Medical Center
Deerfield Beach, Florida, 33064-3596, United States
Sacred Heart Cancer Center at Sacred Heart Hospital
Pensacola, Florida, 32504, United States
West Florida Cancer Institute at West Florida Hospital - Pensacola
Pensacola, Florida, 32514, United States
Northeast Georgia Cancer Care, LLC - Medical Oncology
Athens, Georgia, 30607, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Northside Hospital Cancer Center
Atlanta, Georgia, 30342-1611, United States
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342-1701, United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342, United States
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, 30912, United States
WellStar Cobb Hospital
Austell, Georgia, 30106, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, 30033, United States
Gwinnett Medical Center
Lawrenceville, Georgia, 30045, United States
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta, Georgia, 30060, United States
Southern Regional Medical Center
Riverdale, Georgia, 30274-2600, United States
Harbin Clinic Cancer Center - Medical Oncology
Rome, Georgia, 30165, United States
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, 31405, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, 83712, United States
Portneuf Cancer Center at Portneuf Medical Center
Pocatello, Idaho, 83201, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, 62002, United States
St. Joseph Medical Center
Bloomington, Illinois, 61701, United States
Graham Hospital
Canton, Illinois, 61520, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
University of Illinois Cancer Center
Chicago, Illinois, 60612-7243, United States
Resurrection Medical Center
Chicago, Illinois, 60631, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526, United States
Sherman Hospital
Elgin, Illinois, 60120, United States
Eureka Community Hospital
Eureka, Illinois, 61530, United States
Galesburg Clinic, PC
Galesburg, Illinois, 61401, United States
Galesburg Cottage Hospital
Galesburg, Illinois, 61401, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Hopedale Medical Complex
Hopedale, Illinois, 61747, United States
Provena St. Mary's Regional Cancer Center - Kankakee
Kankakee, Illinois, 60901, United States
La Grange Memorial Hospital
La Grange, Illinois, 60525, United States
McDonough District Hospital
Macomb, Illinois, 61455, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, 60153, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864, United States
Edward Hospital Cancer Center
Naperville, Illinois, 60540, United States
Hematology Oncology Consultants - Naperville
Naperville, Illinois, 60540, United States
BroMenn Regional Medical Center
Normal, Illinois, 61761, United States
Community Cancer Center
Normal, Illinois, 61761, United States
Community Hospital of Ottawa
Ottawa, Illinois, 61350, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, 61350, United States
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068-1174, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, 61554, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61615, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF St. Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois Valley Community Hospital
Peru, Illinois, 61354, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
St. Margaret's Hospital
Spring Valley, Illinois, 61362, United States
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, 62781-0001, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, 46260, United States
Howard Community Hospital
Kokomo, Indiana, 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, 46350, United States
Clarian Arnett Cancer Care
Lafayette, Indiana, 47904, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Saint Joseph Regional Medical Center
South Bend, Indiana, 46617, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
McFarland Clinic, PC
Ames, Iowa, 50010, United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, 52722, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, 52403, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
Heartland Oncology and Hematology
Council Bluffs, Iowa, 51503, United States
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, 52803, United States
Genesis Medical Center - West Campus
Davenport, Iowa, 52804, United States
McCreery Cancer Center at Ottumwa Regional
Ottumwa, Iowa, 52501, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Southwest Medical Center
Liberal, Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, 67114, United States
Menorah Medical Center
Overland Park, Kansas, 66209, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, 67042, United States
Shawnee Mission Medical Center
Shawnee Mission, Kansas, 66204, United States
Cotton-O'Neil Cancer Center
Topeka, Kansas, 66606, United States
St. Francis Comprehensive Cancer Center
Topeka, Kansas, 66606, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, 67214, United States
CCOP - Wichita
Wichita, Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, 67156, United States
Pennington Cancer Center at Baton Rouge General
Baton Rouge, Louisiana, 70806, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, 70809, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112, United States
Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, 70112, United States
Central Maine Comprehensive Cancer Center at Central Maine Medical Center
Lewiston, Maine, 04240, United States
York Hospital's Oncology Treatment Center
York Village, Maine, 03909, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, 21215, United States
Caritas St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135-2997, United States
Caritas Holy Family Hospital
Methuen, Massachusetts, 01844, United States
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, 49221, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, 48106-0995, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0942, United States
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, 49017, United States
Mecosta County Medical Center
Big Rapids, Michigan, 49307, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, 48123-2500, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202, United States
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, 49431, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, 49503, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, 49503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, 48236, United States
Dickinson County Healthcare System
Iron Mountain, Michigan, 49801, United States
Foote Memorial Hospital
Jackson, Michigan, 49201, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, 48144, United States
Sparrow Regional Cancer Center
Lansing, Michigan, 48912-1811, United States
St. Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Upper Michigan Cancer Center at Marquette General Hospital
Marquette, Michigan, 49855, United States
Community Cancer Center of Monroe
Monroe, Michigan, 48162, United States
Mercy Memorial Hospital - Monroe
Monroe, Michigan, 48162, United States
Mercy General Health Partners
Muskegon, Michigan, 49443, United States
Northern Michigan Hospital
Petoskey, Michigan, 49770, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, 48341-2985, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, 48060, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, 48073, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, 48601, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, 49085, United States
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, 48075, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
St. John Macomb Hospital
Warren, Michigan, 48093, United States
Metro Health Hospital
Wyoming, Michigan, 49519, United States
MeritCare Bemidji
Bemidji, Minnesota, 56601, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, 55805-1983, United States
CCOP - Duluth
Duluth, Minnesota, 55805, United States
Miller - Dwan Medical Center
Duluth, Minnesota, 55805, United States
St. Luke's Hospital Cancer Care Center
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, 55432, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, 55422-2900, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, 55416, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, 55379, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, 55125, United States
Keesler Air Force Base Medical Center
Keesler Air Force Base, Mississippi, 39534, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, 39581, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Cape Girardeau, Missouri, 63701, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Independence Regional Health Center
Independence, Missouri, 64050, United States
Freeman Cancer Institute at Freeman Health System
Joplin, Missouri, 64804, United States
Truman Medical Center - Hospital Hill
Kansas City, Missouri, 64108, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, 64111, United States
St. Joseph Medical Center
Kansas City, Missouri, 64114, United States
North Kansas City Hospital
Kansas City, Missouri, 64116, United States
Parvin Radiation Oncology
Kansas City, Missouri, 64116, United States
CCOP - Kansas City
Kansas City, Missouri, 64131, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, 64086, United States
Liberty Hospital
Liberty, Missouri, 64068, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65802, United States
St. John's Regional Health Center
Springfield, Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807, United States
Midwest Hematology Oncology Group, Incorporated
St Louis, Missouri, 63109, United States
Saint Louis University Cancer Center
St Louis, Missouri, 63110, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, 63141, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, 63141, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101, United States
St. Vincent Healthcare Cancer Care Services
Billings, Montana, 59101, United States
Billings Clinic - Downtown
Billings, Montana, 59107-7000, United States
St. James Healthcare Cancer Care
Butte, Montana, 59701, United States
Big Sky Oncology
Great Falls, Montana, 59405-5309, United States
Great Falls Clinic - Main Facility
Great Falls, Montana, 59405, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, 59405, United States
Unknown Facility
Great Falls, Montana, 59405, United States
Northern Montana Hospital
Havre, Montana, 59501, United States
Glacier Oncology, PLLC
Kalispell, Montana, 59901, United States
Kalispell Medical Oncology at KRMC
Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Community Medical Center
Missoula, Montana, 59801, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, 59804, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, 59807-7877, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, 59807, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, 68848-1990, United States
Cancer Resource Center - Lincoln
Lincoln, Nebraska, 68510, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska, 68114, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord, New Hampshire, 03301, United States
Center for Cancer Care at Exeter Hospital
Exeter, New Hampshire, 03833, United States
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett, New Hampshire, 03106, United States
Lakes Region General Hospital
Laconia, New Hampshire, 03246, United States
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, 03103, United States
Monmouth Medical Center
Long Branch, New Jersey, 07740-6395, United States
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, 07962, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903, United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503, United States
Overlook Hospital
Summit, New Jersey, 07902, United States
Capital Health Regional Cancer Center
Trenton, New Jersey, 08618, United States
St. Francis Regional Cancer Center
Trenton, New Jersey, 08629, United States
Lovelace Medical Center - Downtown
Albuquerque, New Mexico, 87102, United States
Hematology Oncology Associates, PC
Albuquerque, New Mexico, 87106, United States
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
Albuquerque, New Mexico, 87110, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131-5636, United States
New Mexico Cancer Care Associates
Santa Fe, New Mexico, 87505, United States
St. Vincent Cancer Center at St. Vincent Regional Medical Center
Santa Fe, New Mexico, 87505, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001, United States
Finger Lakes Hematology and Oncology
Clifton Springs, New York, 14432, United States
Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
Cooperstown, New York, 13326, United States
Adirondack Cancer Care - Glens Falls
Glens Falls, New York, 12801, United States
Union State Bank Cancer Center at Nyack Hospital
Nyack, New York, 10960-1998, United States
Dyson Center for Cancer Care at Vassar Brothers Medical Center
Poughkeepsie, New York, 12601-3990, United States
Cancer Center of Poughkeepsie
Poughkeepsie, New York, 12601, United States
Hudson Valley Oncology Associates
Poughkeepsie, New York, 12601, United States
Highland Hospital of Rochester
Rochester, New York, 14620, United States
Interlakes Oncology/Hematology PC
Rochester, New York, 14623, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642, United States
Hope A Women's Cancer Center
Asheville, North Carolina, 28801, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, 28801, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534, United States
Kinston Medical Specialists
Kinston, North Carolina, 28501, United States
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, 28374, United States
Rutherford Hospital
Rutherfordton, North Carolina, 28139, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, 28401, United States
Bismarck Cancer Center
Bismarck, North Dakota, 58501, United States
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, 58501, United States
Mid Dakota Clinic, PC
Bismarck, North Dakota, 58501, United States
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, 58502, United States
CCOP - MeritCare Hospital
Fargo, North Dakota, 58122, United States
MeritCare Broadway
Fargo, North Dakota, 58122, United States
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, 58201, United States
Trinity CancerCare Center
Minot, North Dakota, 58701, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, 44307, United States
Cleveland Clinic Beachwood Family Health and Surgery Center
Beachwood, Ohio, 44122, United States
Mary Rutan Hospital
Bellefontaine, Ohio, 43311, United States
Wood County Oncology Center
Bowling Green, Ohio, 43402, United States
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, 44710-1799, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, 43214-3998, United States
CCOP - Columbus
Columbus, Ohio, 43215, United States
Grant Medical Center Cancer Care
Columbus, Ohio, 43215, United States
Mount Carmel Health - West Hospital
Columbus, Ohio, 43222, United States
Doctors Hospital at Ohio Health
Columbus, Ohio, 43228, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Hematology Oncology Center
Elyria, Ohio, 44035, United States
Cleveland Clinic Cancer Center
Independence, Ohio, 44131, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Lima Memorial Hospital
Lima, Ohio, 45804, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Northwest Ohio Oncology Center
Maumee, Ohio, 43537-1839, United States
St. Luke's Hospital
Maumee, Ohio, 43537, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, 44124, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, 43055, United States
St. Charles Mercy Hospital
Oregon, Ohio, 43616, United States
Toledo Clinic - Oregon
Oregon, Ohio, 43616, United States
North Coast Cancer Care, Incorporated
Sandusky, Ohio, 44870, United States
Mercy Medical Center
Springfield, Ohio, 45504, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, 45505, United States
Flower Hospital Cancer Center
Sylvania, Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883, United States
Toledo Hospital
Toledo, Ohio, 43606, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, 43614, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43617, United States
St. Anne Mercy Hospital
Toledo, Ohio, 43623, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, 43623, United States
Fulton County Health Center
Wauseon, Ohio, 43567, United States
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, 43081, United States
Tod Children's Hospital
Youngstown, Ohio, 44501, United States
Genesis - Good Samaritan Hospital
Zanesville, Ohio, 43701, United States
St. Charles Medical Center - Bend
Bend, Oregon, 97701, United States
Bay Area Hospital
Coos Bay, Oregon, 97420, United States
Three Rivers Community Hospital
Grants Pass, Oregon, 97527, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030, United States
Dubs Cancer Center at Rogue Valley Medical Center
Medford, Oregon, 97504, United States
Providence Cancer Center at PMCC
Medford, Oregon, 97504, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, 97222, United States
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Portland, Oregon, 97210, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213-2967, United States
Adventist Medical Center
Portland, Oregon, 97216, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Legacy Emanuel Hospital and Health Center and Children's Hospital
Portland, Oregon, 97227, United States
Kaiser Permanente Health Care - Portland
Portland, Oregon, 97232, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, 97062, United States
St. Luke's Cancer Network at St. Luke's Hospital
Bethlehem, Pennsylvania, 18015, United States
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026, United States
Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center
DuBois, Pennsylvania, 15801, United States
Easton Regional Cancer Center at Easton Hospital
Easton, Pennsylvania, 18042, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17604, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232, United States
Guthrie Cancer Center at Guthrie Clinic Sayre
Sayre, Pennsylvania, 18840, United States
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, 18501, United States
Hematology and Oncology Associates of Northeastern Pennsylvania
Scranton, Pennsylvania, 18510, United States
Mount Nittany Medical Center
State College, Pennsylvania, 16803, United States
AnMed Cancer Center
Anderson, South Carolina, 29621, United States
McLeod Regional Medical Center
Florence, South Carolina, 29501, United States
Mabry Center for Cancer Care at Regional Medical Center
Orangeburg, South Carolina, 29118, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Medical X-Ray Center, PC
Sioux Falls, South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, 57117-5039, United States
University of Tennessee Cancer Institute - Memphis
Memphis, Tennessee, 38104, United States
American Fork Hospital
American Fork, Utah, 84003, United States
Sandra L. Maxwell Cancer Center
Cedar City, Utah, 84720, United States
Logan Regional Hospital
Logan, Utah, 84321, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, 84157, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84604, United States
LDS Hospital
Salt Lake City, Utah, 84103, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112, United States
Dixie Regional Medical Center - East Campus
St. George, Utah, 84770, United States
Martha Jefferson Hospital Cancer Care Center
Charlottesville, Virginia, 22901, United States
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, 22401, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298-0037, United States
Auburn Regional Center for Cancer Care
Auburn, Washington, 98002, United States
St. Joseph Cancer Center
Bellingham, Washington, 98225, United States
Olympic Hematology and Oncology
Bremerton, Washington, 98310, United States
Providence Centralia Hospital
Centralia, Washington, 98531-9027, United States
St. Francis Hospital
Federal Way, Washington, 98003, United States
Columbia Basin Hematology
Kennewick, Washington, 99336, United States
Providence St. Peter Hospital Regional Cancer Center
Olympia, Washington, 98506-5166, United States
Good Samaritan Cancer Center
Puyallup, Washington, 98372, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98104, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Minor and James Medical, PLLC
Seattle, Washington, 98104, United States
Group Health Central Hospital
Seattle, Washington, 98112, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, 98122-4307, United States
Polyclinic First Hill
Seattle, Washington, 98122, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, 98195-6043, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202, United States
Rockwood Clinic Cancer Treatment Center
Spokane, Washington, 99204-2967, United States
Franciscan Cancer Center at St. Joseph Medical Center
Tacoma, Washington, 98405-3004, United States
Allenmore Hospital
Tacoma, Washington, 98405, United States
CCOP - Northwest
Tacoma, Washington, 98405, United States
MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma, Washington, 98405, United States
Madigan Army Medical Center - Tacoma
Tacoma, Washington, 98431, United States
St. Clare Hospital
Tacoma, Washington, 98499, United States
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, 98668, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, 98902, United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington, West Virginia, 25701, United States
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
Parkersburg, West Virginia, 26102, United States
Center for Cancer Treatment & Prevention at Sacred Heart Hospital
Eau Claire, Wisconsin, 54701, United States
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, 54701, United States
Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn
Elkhorn, Wisconsin, 53121, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54301-3526, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, 54303, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, 54303, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508, United States
Mercy Regional Cancer Center
Janesville, Wisconsin, 53547, United States
Franciscan Skemp Healthcare - La Crosse Campus
La Crosse, Wisconsin, 54601, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, 54601, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, 54449, United States
Saint Joseph's Hospital
Marshfield, Wisconsin, 54449, United States
Medical Consultants, Limited
Milwaukee, Wisconsin, 53215, United States
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, 54548, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin, 53405, United States
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin, 54501, United States
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, 54868, United States
Vince Lombardi Cancer Clinic - Sheboygan
Sheboygan, Wisconsin, 53081, United States
Saint Michael's Hospital Cancer Center
Stevens Point, Wisconsin, 54481, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
Marshfield Clinic - Wausau Center
Wausau, Wisconsin, 54401, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, 54476, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
Riverview UW Cancer Center at Riverview Hospital
Wisconsin Rapids, Wisconsin, 54494, United States
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, T2N 4N2, Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Northeastern Ontario Regional Cancer Centre
Greater Sudbury, Ontario, P3E 5J1, Canada
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, N6A 4L6, Canada
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9, Canada
Cancer Care Program at Thunder Bay Regional Health Sciences
Thunder Bay, Ontario, P7B 6V4, Canada
St. Michael's Hospital - Toronto
Toronto, Ontario, M5B 1W8, Canada
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, S4T 7T1, Canada
Related Publications (4)
Bergqvist M, Nordmark A, Williams A, Paoletti C, Barlow W, Cobain EF, Mehta RS, Gralow JR, Hortobagyi GN, Albain KS, Pusztai L, Sharma P, Godwin AK, Thompson AM, Hayes DF, Rae JM. Thymidine kinase activity levels in serum can identify HR+ metastatic breast cancer patients with a low risk of early progression (SWOG S0226). Biomarkers. 2023 May;28(3):313-322. doi: 10.1080/1354750X.2023.2168063. Epub 2023 Jan 29.
PMID: 36647745DERIVEDMehta RS, Barlow WE, Albain KS, Vandenberg TA, Dakhil SR, Tirumali NR, Lew DL, Hayes DF, Gralow JR, Linden HH, Livingston RB, Hortobagyi GN. Overall Survival with Fulvestrant plus Anastrozole in Metastatic Breast Cancer. N Engl J Med. 2019 Mar 28;380(13):1226-1234. doi: 10.1056/NEJMoa1811714.
PMID: 30917258DERIVEDUnger JM, LeBlanc M, Blanke CD. The Effect of Positive SWOG Treatment Trials on Survival of Patients With Cancer in the US Population. JAMA Oncol. 2017 Oct 1;3(10):1345-1351. doi: 10.1001/jamaoncol.2017.0762.
PMID: 28586789DERIVEDMehta RS, Barlow WE, Albain KS, Vandenberg TA, Dakhil SR, Tirumali NR, Lew DL, Hayes DF, Gralow JR, Livingston RB, Hortobagyi GN. Combination anastrozole and fulvestrant in metastatic breast cancer. N Engl J Med. 2012 Aug 2;367(5):435-44. doi: 10.1056/NEJMoa1201622.
PMID: 22853014DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Breast Committee Statistician
- Organization
- SWOG
Study Officials
- STUDY CHAIR
Rita S. Mehta, MD
Chao Family Comprehensive Cancer Center
- STUDY CHAIR
Theodore A. Vandenberg, MD
London Health Sciences Centre
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2004
First Posted
January 13, 2004
Study Start
April 1, 2004
Primary Completion
December 1, 2012
Study Completion
October 1, 2018
Last Updated
January 13, 2021
Results First Posted
April 4, 2017
Record last verified: 2021-01