Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients With Metastatic Breast Cancer
3 other identifiers
interventional
390
5 countries
377
Brief Summary
RATIONALE: The primary tumor might be a source of re-seeding of distant sites and therefore elimination of this source of metastasizing cells by early local therapy may be of benefit. PURPOSE: This randomized phase III trial is studying early surgery to see how well it works compared to standard palliative therapy in treating patients with stage IV breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started May 2011
Longer than P75 for not_applicable breast-cancer
377 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
November 16, 2010
CompletedFirst Posted
Study publicly available on registry
November 17, 2010
CompletedStudy Start
First participant enrolled
May 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2022
CompletedResults Posted
Study results publicly available
February 2, 2023
CompletedJune 29, 2023
June 1, 2023
8.6 years
November 16, 2010
January 5, 2022
June 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3-year Overall Survival Rate
Overall survival (OS) was defined as time from randomization to death from any cause. All patients will be followed for survival through 5 years. Cases with incomplete follow-up or without record of vital status will be censored at the date of last contact. 3-year OS rate was estimated using Kaplan-Meier method.
Assessed at baseline, then every 3 months within 2 years and every 6 months between 2-5 years, up to 5 years
Secondary Outcomes (2)
3-year Cumulative Incidence of Locoregional Recurrence/Progression
Assessed at baseline, then every 3 months within 2 years and every 6 months between 2-5 years, up to 5 years
Health-related Quality of Life (HRQL)
Assessed at 18 months after randomization
Study Arms (2)
Arm I
ACTIVE COMPARATORPatients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both.
Arm II
EXPERIMENTALPatients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of intact primary (not recurrent) invasive carcinoma of the breast
- Stage IV disease
- Confirmation of the primary tumor should be by needle biopsy (preferred)
- Incisional surgical biopsy allowed as long as there is residual palpable or tumor image in the breast
- Patients must be judged to be candidates for complete resection with free margins followed by radiation therapy (if radiation therapy is indicated)
- For women not undergoing axillary dissection, sentinel node biopsy should document an axillary nodal burden of 1-2 involved lymph nodes (i.e., ACOSOG Z-11 criteria may be applied)
- Prior non-invasive (Ductal Carcinoma In Situ) cancer allowed provided there has been no recurrence
- Prior ipsilateral invasive cancer allowed if more than 5 years previous
- Patients should have at least one organ system involved with distant metastatic disease
- If patient has only one metastatic lesion/focus, this must be proven by biopsy and the pathology report confirming the diagnosis of primary breast cancer, as well as the metastatic site, must be available
- Must have available radiologic reports documenting disease status within the past 6 weeks prior to initiating systemic therapy
- CNS metastases allowed provided projected survival \> 6 months
- Patients must have completed at least 16 weeks of optimal systemic therapy (appropriate to the tumor biological profile and the patient's age and menopausal status)
- If systemic therapy is discontinued for toxicity, but there is no distant progression and at least 12 weeks of therapy have been delivered, then the patient remains eligible
- Radiation therapy (if indicated) must begin within 12 weeks of final therapeutic surgical procedure (including re-excision for free margins and completion of axillary dissection)
- +14 more criteria
You may not qualify if:
- Synchronous contralateral breast cancer
- Pregnant or nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (377)
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36604, United States
Providence Cancer Center
Anchorage, Alaska, 99508, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499, United States
East Bay Radiation Oncology Center
Castro Valley, California, 94546, United States
Enloe Cancer Center at Enloe Medical Center
Chico, California, 95926, United States
North Bay Cancer Center
Fairfield, California, 94533, United States
California Cancer Care, Incorporated - Greenbrae
Greenbrae, California, 94904, United States
Todd Cancer Institute at Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
Contra Costa Regional Medical Center
Martinez, California, 94553-3156, United States
Community Hospital of the Monterey Peninsula Comprehensive Cancer Center
Monterey, California, 93940, United States
El Camino Hospital Cancer Center
Mountain View, California, 94040, United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609, United States
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, 92868, United States
Doctors Medical Center - San Pablo Campus
San Pablo, California, 94806, United States
Stanford Cancer Center
Stanford, California, 94305-5824, United States
Boulder Community Hospital
Boulder, Colorado, 80301-9019, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, 80933, United States
Presbyterian - St. Luke's Medical Center
Denver, Colorado, 80218, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105, United States
Norwalk Hospital
Norwalk, Connecticut, 06856, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, 06360, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, 19958, United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19713, United States
Herbert D. Kerman Regional Oncology Center - Daytona Beach
Daytona Beach, Florida, 32114, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, 32803-1273, United States
M.D. Anderson Cancer Center at Orlando
Orlando, Florida, 32806, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, 33612-9497, United States
Georgia Cancer Center for Excellence at Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
Emory Crawford Long Hospital
Atlanta, Georgia, 30308, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
Northside Hospital Cancer Center
Atlanta, Georgia, 30342-1611, United States
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342-1701, United States
John B. Amos Cancer Center
Columbus, Georgia, 31904, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, 30033, United States
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta, Georgia, 30060, United States
Southern Regional Medical Center
Riverdale, Georgia, 30274-2600, United States
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, 31405, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813, United States
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Straub Clinic and Hospital, Incorporated
Honolulu, Hawaii, 96813, United States
Hawaii Medical Center - East
Honolulu, Hawaii, 96817, United States
Kuakini Medical Center
Honolulu, Hawaii, 96817, United States
Kapiolani Medical Center at Pali Momi
‘Aiea, Hawaii, 96701, United States
Leeward Radiation Oncology
‘Ewa Beach, Hawaii, 96706, 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
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho, 83619, United States
Mountain States Tumor Institute - Meridian
Meridian, Idaho, 83642, United States
Saint Luke's Mountain States Tumor Institute
Nampa, Idaho, 83686, United States
Mountain States Tumor Institute at St. Luke's
Twin Falls, Idaho, 83301, 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
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013, United States
Hematology and Oncology Associates
Chicago, Illinois, 60611, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, 60612-3785, United States
University of Illinois Cancer Center
Chicago, Illinois, 60612-7243, United States
Resurrection Medical Center
Chicago, Illinois, 60631, United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526, United States
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126, United States
Eureka Community Hospital
Eureka, Illinois, 61530, United States
Galesburg Clinic, PC
Galesburg, Illinois, 61401, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Kellogg Cancer Care Center
Highland Park, Illinois, 60035, United States
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, 60521, United States
Provena St. Mary's Regional Cancer Center - Kankakee
Kankakee, Illinois, 60901, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville, Illinois, 60048, United States
McDonough District Hospital
Macomb, Illinois, 61455, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, 60153, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline, Illinois, 61265, United States
Cancer Care and Hematology Specialists of Chicagoland - Niles
Niles, Illinois, 60714, 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
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
West Suburban Center for Cancer Care
River Forest, Illinois, 60305, United States
Swedish-American Regional Cancer Center
Rockford, Illinois, 61104-2315, United States
Hematology Oncology Associates - Skokie
Skokie, Illinois, 60076, United States
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, 62781-0001, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, 46107, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Center for Cancer Care at Goshen General Hospital
Goshen, Indiana, 46526, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202-5289, United States
William N. Wishard Memorial Hospital
Indianapolis, Indiana, 46202, 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
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, 46545-1470, United States
Saint Joseph Regional Medical Center
Mishawaka, Indiana, 46545-1470, United States
Reid Hospital & Health Care Services
Richmond, Indiana, 47374, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
McFarland Clinic, PC
Ames, Iowa, 50010, United States
Medical Oncology and Hematology Associates - West Des Moines
Clive, Iowa, 50325, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, 50316, 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, 51102, 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 - Fort Scott
Fort Scott, Kansas, 66701, 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
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, 67901, United States
Cancer Center of Kansas, PA - McPherson
McPherson, Kansas, 67460, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, 67357, United States
CCOP - Kansas City
Prairie Village, Kansas, 66208, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, 67401, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, 67152, 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
St. Elizabeth Medical Center
Edgewood, Kentucky, 41017, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, 40536-0093, United States
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, 71315-3198, United States
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
Greater Baltimore Medical Center Cancer Center
Baltimore, Maryland, 21204, United States
St. Agnes Hospital Cancer Center
Baltimore, Maryland, 21229, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410, United States
Shore Regional Cancer Center at Memorial Hospital - Easton
Easton, Maryland, 21601, United States
Union Hospital of Cecil County
Elkton, Maryland, 21921, 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
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
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
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
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
Sparrow Regional Cancer Center
Lansing, Michigan, 48912-1811, United States
St. Mary Mercy Hospital
Livonia, Michigan, 48154, United States
MidMichigan Medical Center - Midland
Midland, Michigan, 48670, 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, 49444, 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
Spectrum Health Reed City Hospital
Reed City, Michigan, 49677, 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
Lakeside Cancer Specialists, PLLC
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
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
Immanuel St. Joseph's
Mankato, Minnesota, 56002, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, 55109, United States
Minnesota Oncology - Maplewood
Maplewood, Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, 55415, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, 55422-2900, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology - Woodbury
Woodbury, Minnesota, 55125, United States
University of Mississippi Cancer Clinic
Jackson, Mississippi, 39216, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, 39581, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, 64111, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Mercy Clinic Cancer and Hematology - Rolla
Rolla, Missouri, 65401, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Saint Joseph Oncology, Incorporated
Saint Joseph, Missouri, 64507, 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
St. Anthony's Cancer Center
St Louis, Missouri, 63128, 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
Billings Clinic - Downtown
Billings, Montana, 59107-7000, 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
Cancer Resource Center - Lincoln
Lincoln, Nebraska, 68510, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106, United States
Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Lakeside Hospital
Omaha, Nebraska, 68130, United States
Creighton University Medical Center
Omaha, Nebraska, 68131-2197, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0002, United States
Norris Cotton Cancer Center at Catholic Medical Center
Manchester, New Hampshire, 03102, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington, New Jersey, 08822, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, 08053, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Radiation Oncology Center at Kennedy Health System - Sewell
Sewell, New Jersey, 08080, United States
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River, New Jersey, 08755, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, 08043, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees Township, New Jersey, 08043, United States
Lovelace Medical Center - Downtown
Albuquerque, New Mexico, 87102, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131-5636, United States
University of New Mexico Cancer Center - South
Las Cruces, New Mexico, 88011, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001, United States
Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
Cooperstown, New York, 13326, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Beth Israel Medical Center - Petrie Division
New York, New York, 10003-3803, United States
St. Luke's - Roosevelt Hospital Center - St.Luke's Division
New York, New York, 10025, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Dyson Center for Cancer Care at Vassar Brothers Medical Center
Poughkeepsie, New York, 12601-3990, United States
Highland Hospital of Rochester
Rochester, New York, 14620, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642, United States
Nalitt Cancer Institute at Staten Island University Hospital
Staten Island, New York, 10305, United States
Dickstein Cancer Treatment Center at White Plains Hospital Center
White Plains, New York, 10601, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, 28232-2861, United States
Batte Cancer Center at Northeast Medical Center
Concord, North Carolina, 28025, United States
Iredell Memorial Hospital
Statesville, North Carolina, 28677, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096, 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
Trinity CancerCare Center
Minot, North Dakota, 58701, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, 44307, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, 44309-2090, United States
Wood County Oncology Center
Bowling Green, Ohio, 43402, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065, 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
Good Samaritan Hospital
Dayton, Ohio, 45406, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Cancer Care Center
Dayton, Ohio, 45415, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Community Cancer Center
Elyria, Ohio, 44035, United States
Hematology Oncology Center
Elyria, Ohio, 44035, United States
Blanchard Valley Medical Associates
Findlay, Ohio, 45840, United States
Middletown Regional Hospital
Franklin, Ohio, 45005-1066, 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
Knox Community Hospital
Mount Vernon, Ohio, 43050, 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
Southern Ohio Medical Center Cancer Center
Portsmouth, Ohio, 45662, 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
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, 45373-1300, United States
Fulton County Health Center
Wauseon, Ohio, 43567, United States
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, 43081, United States
Genesis - Good Samaritan Hospital
Zanesville, Ohio, 43701, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, 73104, United States
St. Luke's Cancer Network at St. Luke's Hospital
Bethlehem, Pennsylvania, 18015, United States
Easton Regional Cancer Center at Easton Hospital
Easton, Pennsylvania, 18042, United States
Cherry Tree Cancer Center
Hanover, Pennsylvania, 17331, United States
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17604, United States
St. Mary Regional Cancer Center
Langhorne, Pennsylvania, 19047, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
Charles A. & Betty Bott Cancer Center at Holy Redeemer Hospital
Meadowbrook, Pennsylvania, 19046, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232, United States
Mount Nittany Medical Center
State College, Pennsylvania, 16803, United States
Susquehanna Cancer Center at Divine Providence Hospital
Williamsport, Pennsylvania, 17701, United States
York Cancer Center at Apple Hill Medical Center
York, Pennsylvania, 17405, United States
Roper St. Francis Cancer Center at Roper Hospital
Charleston, South Carolina, 29401, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425, 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
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, 57117-5039, United States
West Tennessee Cancer Center at Jackson-Madison County General Hospital
Jackson, Tennessee, 38301, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0361, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009, United States
Methodist Hospital
Houston, Texas, 77030, United States
Baylor Medical Center at Irving
Irving, Texas, 75061, United States
Doctor's Hospital of Laredo
Laredo, Texas, 78045, United States
CCOP - Scott and White Hospital
Temple, Texas, 76508, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112, United States
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, 22401, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298-0037, United States
St. Joseph Cancer Center
Bellingham, Washington, 98225, United States
Harrison Medical Center
Bremerton, Washington, 98310, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, 98122-4307, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, 98195, United States
St. Mary Regional Cancer Center at St. Mary Medical Center
Walla Walla, Washington, 99362, United States
St. Mary's Regional Cancer Center at St. Mary's Medical Center
Huntington, West Virginia, 25702, United States
Langlade Memorial Hospital
Antigo, Wisconsin, 54409, United States
Fox Valley Hematology and Oncology - East Grant Street
Appleton, Wisconsin, 54911-3496, United States
Fox Valley Surgical Associates at Appleton Medical Center
Appleton, Wisconsin, 54911, United States
Theda Care Cancer Institute
Appleton, Wisconsin, 54911, United States
Marshfield Clinic - Chippewa Center
Chippewa Falls, Wisconsin, 54729, 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
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
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, 53038, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164, United States
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc, Wisconsin, 54221-1450, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Vince Lombardi Cancer Clinic - Marinette
Marinette, Wisconsin, 54143, United States
Saint Joseph's Hospital
Marshfield, Wisconsin, 54449, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226, United States
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, 54548, United States
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, 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
St. Nicholas Hospital
Sheboygan, Wisconsin, 53081, United States
Vince Lombardi Cancer Clinic - Sheboygan
Sheboygan, Wisconsin, 53081, United States
Marshfield Clinic at Saint Michael's Hospital
Stevens Point, Wisconsin, 54481, 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
Aurora Medical Center
Summit, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic - Two Rivers
Two Rivers, Wisconsin, 54241, United States
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, 53188, United States
Marshfield Clinic - Wausau Center
Wausau, Wisconsin, 54401, United States
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, 54401, United States
Oncology Alliance, SC - Milwaukee - West
Wauwatosa, Wisconsin, 53226, United States
Diagnostic and Treatment Center
Weston, Wisconsin, 54476, 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
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, T6G 1Z2, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, N6A 4L6, Canada
McGill Cancer Centre at McGill University
Montreal, Quebec, H2W 1S6, Canada
Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
King Faisal Specialist Hospital and Research Center
Riyadh, 11211, Saudi Arabia
Pretoria Academic Hospital
Pretoria, 0002, South Africa
Related Publications (1)
Khan SA, Zhao F, Goldstein LJ, Cella D, Basik M, Golshan M, Julian TB, Pockaj BA, Lee CA, Razaq W, Sparano JA, Babiera GV, Dy IA, Jain S, Silverman P, Fisher CS, Tevaarwerk AJ, Wagner LI, Sledge GW. Early Local Therapy for the Primary Site in De Novo Stage IV Breast Cancer: Results of a Randomized Clinical Trial (EA2108). J Clin Oncol. 2022 Mar 20;40(9):978-987. doi: 10.1200/JCO.21.02006. Epub 2022 Jan 7. Erratum In: J Clin Oncol. 2022 Apr 20;40(12):1392. doi: 10.1200/JCO.22.00666.
PMID: 34995128DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG-ACRIN Cancer Research Group
Study Officials
- PRINCIPAL INVESTIGATOR
Seema A. Khan, MD
Robert H. Lurie Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2010
First Posted
November 17, 2010
Study Start
May 16, 2011
Primary Completion
December 10, 2019
Study Completion
December 21, 2022
Last Updated
June 29, 2023
Results First Posted
February 2, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive