Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery
A Phase III Trial of Accelerated Whole Breast Irradiation With Hypofractionation Plus Concurrent Boost Versus Standard Whole Breast Irradiation Plus Sequential Boost for Early-Stage Breast Cancer
3 other identifiers
interventional
2,354
8 countries
415
Brief Summary
RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer. PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
415 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
May 5, 2011
CompletedFirst Posted
Study publicly available on registry
May 6, 2011
CompletedStudy Start
First participant enrolled
May 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2022
CompletedResults Posted
Study results publicly available
April 6, 2023
CompletedMarch 5, 2026
September 1, 2025
10.7 years
May 5, 2011
January 12, 2023
February 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With In-breast Recurrence (Local Failure)
In-breast recurrence (IBR) is defined as any of the following: invasive local recurrence-ipsilateral breast (within treatment field); invasive local recurrence-ipsilateral breast (outside treatment field); non-invasive local recurrence-ipsilateral breast (within treatment field); or non-invasive local recurrence-ipsilateral breast (outside treatment field). Time to IBR is defined as time from randomization to the date of first IBR, last known follow-up (censored), or death without IBR (competing risk). IBR rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. 5-year rates are provided.
From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. Five-year rates are reported here.
Secondary Outcomes (9)
Percentage of Participants Alive
From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. Five-year rates are provided here.
Percentage of Participants Alive Without Disease
From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. Five-year rates are provided here.
Percentage of Participants Alive Without Distant Disease
From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. Five-year rates are provided here.
Number of Participants by Highest Grade Adverse Event Reported as Definitely, Probably, or Possibly Related to Protocol Treatment
From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years.
Change in Breast Cancer Treatment Outcome Scale (BCTOS) Cosmesis Subscale Score From Baseline to 3 Years
Baseline and 3 years
- +4 more secondary outcomes
Other Outcomes (2)
Percentage of Participants With In-breast Recurrence (Local Failure) by Race
From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. Five-year rates are reported here.
Percentage of Participants With In-breast Recurrence (Local Failure) by Ethnicity
From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. Five-year rates are reported here.
Study Arms (2)
Whole breast irradiation + sequential boost
ACTIVE COMPARATORStandard fractionation whole breast irradiation (WBI) with sequential boost.
Hypofractionated whole breast irradiation + concurrent boost
EXPERIMENTALHypofractionated whole breast (H-WBI) irradiation with a concurrent boost
Interventions
6 fractions of 2.0 Gy per fraction for a total dose of 12 Gy or 7 fractions of 2.0 Gy for a total dose of 14 Gy to the lumpectomy cavity. May be given by either electron beam or photon beams using either 3D-CRT or IMRT. Begins without a treatment break after completion of the treatment to the entire breast.
Target-based radiation using three-dimensional conformal radiation therapy (3D-CRT) or intensity-modulated radiation therapy (IMRT) to deliver 15 fractions of 2.67 Gy for a total dose of 40.0 Gy. Must begin within 9 weeks of last surgery or chemotherapy delivery.
Target-based radiation using three-dimensional conformal radiation therapy (3D-CRT) or intensity-modulated radiation therapy (IMRT) to deliver 25 fractions of 2.0 Gy for a total dose of 50.0 Gy or 16 fractions of 2.67 Gy for a total dose of 42.7 Gy. Must begin within 9 weeks of last surgery or chemotherapy delivery.
15 fractions of 3.2 Gy for a total dose of 48 Gy to the lumpectomy cavity. Given concurrently with treatment to the entire breast. May be given by either electron beam or photon beams using either 3D-CRT or IMRT.
Eligibility Criteria
You may qualify if:
- Pathologically proven diagnosis of breast cancer resected by lumpectomy and whole breast irradiation with boost without regional nodal irradiation planned
- The patient must be female
- The patient must meet at least one of the three following criteria:
- A. Pathological stage I, II Breast Cancer AND at least one of the following:
- Age \< 50 years or
- Positive axillary nodes or
- Lymphovascular space invasion or
- or more close resection margins (\> 0 mm to ≤ 2 mm) or
- close resection margin and extensive intraductal component (EIC) \[Per College of American Pathologist (CAP) Recommendation\] or
- Focally positive resection margins or
- Non-hormone sensitive breast cancer (estrogen receptor (ER)- and progesterone receptor(PR)-negative) or
- Grade III histology or
- Oncotype recurrence score \> 25 or
- B. Pathological stage 0 breast cancer with nuclear grade 3 ductal carcinoma in situ (DCIS) and patient age \<50 years or
- C. Post-neoadjuvant pathological 0, I, II breast cancer resected by lumpectomy after neoadjuvant systemic therapy
- +37 more criteria
You may not qualify if:
- American Joint Committee on Cancer (AJCC) pathologic T4, N2 or N3, M1 pathologic stages III or IV breast cancer
- Treatment plan that includes regional node irradiation
- Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to study entry
- Prior invasive or in-situ carcinoma of the breast \[-prior lobular carcinoma in situ (LCIS) is eligible\]
- Two or more breast cancers not resectable through a single lumpectomy incision
- Bilateral breast cancer
- DCIS only (without an invasive component) and age ≥ 50 years
- DCIS nuclear grade 1 or 2 only (without an invasive component) and age \< 50 years
- Invasive breast cancer and low risk for 5-year in breast recurrence after lumpectomy with negative margins that does not meet one of the eligibility factors in 3.1.3.
- Unable to delineate on CT scan the extent of the target lumpectomy cavity for boost (Placement of surgical clips to assist in treatment planning of the boost is strongly recommended, see Section 6.4.2 for details)
- Suspicious unresected microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign
- Non-epithelial breast malignancies such as sarcoma or lymphoma
- Paget's disease of the nipple
- Male breast cancer
- Prior radiotherapy to the breast or prior radiation to the region of the ipsilateral breast that would result in overlap of radiation therapy fields
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)collaborator
- NRG Oncologycollaborator
- Radiation Therapy Oncology Grouplead
Study Sites (415)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
The Kirklin Clinic at Acton Road
Birmingham, Alabama, 35243, United States
21st Century Oncology-Scottsdale
Scottsdale, Arizona, 85251, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Arizona Oncology Associates-West Orange Grove
Tucson, Arizona, 85704, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, 71913, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682, United States
Mercy San Juan Medical Center
Carmichael, California, 95608, United States
Enloe Medical Center
Chico, California, 95926, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Epic Care-Dublin
Dublin, California, 94568, United States
21st Century Oncology - El Segundo
El Segundo, California, 90245, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Los Angeles County-USC Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
Kaiser Permanente Oakland-Broadway
Oakland, California, 94611, United States
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, 95670, United States
Rohnert Park Cancer Center
Rohnert Park, California, 94928, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661, United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
South Sacramento Cancer Center
Sacramento, California, 95823, United States
Santa Clara Valley Medical Center
San Jose, California, 95128, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
City of Hope South Pasadena
South Pasadena, California, 91030, United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080, United States
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, 95687, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Shaw Cancer Center
Edwards, Colorado, 81632, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
John Fitzgerald Kennedy Medical Center
Atlantis, Florida, 33462, United States
Florida Hospital Memorial Medical Center
Daytona Beach, Florida, 32117, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
21st Century Oncology - Fort Walton Beach
Fort Walton Beach, Florida, 32547, United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
Integrated Community Oncology Network-Southside Cancer Center
Jacksonville, Florida, 32207, United States
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, 32209, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
Baptist Medical Center South
Jacksonville, Florida, 32258, United States
Integrated Community Oncology Network-Florida Cancer Center Beaches
Jacksonville Beach, Florida, 32250, United States
Jackson Memorial Hospital-Holtz Children's Hospital
Miami, Florida, 33136, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
21st Century Oncology-Orange Park
Orange Park, Florida, 32073, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
Cancer Center of Putnam
Palatka, Florida, 32177, United States
Integrated Community Oncology Network-Flager Cancer Center
Saint Augustine, Florida, 32086, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
The Villages Regional Hospital
The Villages, Florida, 32159, United States
Grady Health System
Atlanta, Georgia, 30303, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Northside Hospital-Forsyth
Cumming, Georgia, 30041, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Rush - Copley Medical Center
Aurora, Illinois, 60504, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Freeport Memorial Hospital/Leonard C Ferguson Cancer Center
Freeport, Illinois, 61032, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451, United States
Carle Cancer Institute Normal
Normal, Illinois, 61761, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, 61615, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Swedish American Hospital
Rockford, Illinois, 61104, United States
SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois, 61114, United States
Saint John's Hospital
Springfield, Illinois, 62702, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
Saint Vincent Anderson Regional Hospital/Cancer Center
Anderson, Indiana, 46016, United States
IU Health West Hospital
Avon, Indiana, 46123, United States
Goshen Center for Cancer Care
Goshen, Indiana, 46526, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
IU Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
Community Cancer Center East
Indianapolis, Indiana, 46219, United States
Community Cancer Center North
Indianapolis, Indiana, 46256, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, 46545, United States
IU Health Ball Memorial Hospital
Muncie, Indiana, 47303, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
Finley Hospital
Dubuque, Iowa, 52001, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210, United States
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, 66208, United States
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka, Kansas, 66606, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214, United States
Wichita NCI Community Oncology Research Program
Wichita, Kansas, 67214, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky, 42303, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Saint Agnes Hospital
Baltimore, Maryland, 21229, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600, United States
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, 21044, United States
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061, United States
TidalHealth Peninsula Regional
Salisbury, Maryland, 21801, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Mass General/North Shore Cancer Center
Danvers, Massachusetts, 01923, United States
Lowell General Hospital
Lowell, Massachusetts, 01854, United States
Newton-Wellesley Hospital
Newton, Massachusetts, 02462, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
GenesisCare USA - Clarkston
Clarkston, Michigan, 48346, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Ascension Saint John Hospital
Detroit, Michigan, 48236, United States
GenesisCare USA - Farmington Hills
Farmington Hills, Michigan, 48334, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
Beaumont Hospital - Farmington Hills
Farmington Hills, Michigan, 48336, United States
McLaren Cancer Institute-Flint
Flint, Michigan, 48532, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
KCC Radiation Oncology at Monroe Cancer Center
Monroe, Michigan, 48162, United States
McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan, 49770, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073, United States
Ascension Providence Hospitals - Southfield
Southfield, Michigan, 48075, United States
William Beaumont Hospital - Troy
Troy, Michigan, 48085, United States
GenesisCare USA - Troy
Troy, Michigan, 48098, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805, United States
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, 56001, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Singing River Hospital
Pascagoula, Mississippi, 39581, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Saint Luke's Hospital
Chesterfield, Missouri, 63017, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
The University of Kansas Cancer Center-South
Kansas City, Missouri, 64131, United States
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154, United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064, United States
Liberty Radiation Oncology Center
Liberty, Missouri, 64068, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, 89106, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Saint Mary's Regional Medical Center
Reno, Nevada, 89503, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Ocean Medical Center
Brick, New Jersey, 08724, United States
Monmouth Medical Center
Long Branch, New Jersey, 07740, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Virtua Memorial
Mount Holly, New Jersey, 08060, United States
Jersey Shore Medical Center
Neptune City, New Jersey, 07753, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901, United States
Capital Health Medical Center-Hopewell
Pennington, New Jersey, 08534, United States
Riverview Medical Center/Booker Cancer Center
Red Bank, New Jersey, 07701, United States
Sparta Cancer Treatment Center
Sparta, New Jersey, 07871, United States
Overlook Hospital
Summit, New Jersey, 07902, United States
Community Medical Center
Toms River, New Jersey, 08755, United States
Virtua Voorhees
Voorhees Township, New Jersey, 08043, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
Memorial Medical Center - Las Cruces
Las Cruces, New Mexico, 88011, United States
New York Oncology Hematology PC - Albany
Albany, New York, 12206, United States
Saint Peter's Health Partners
Albany, New York, 12208, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Sands Cancer Center
Canandiaqua, New York, 14424, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Mary Imogene Bassett Hospital
Cooperstown, New York, 13326, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057, United States
Cayuga Medical Center
Ithaca, New York, 14850, United States
Northwell Health NCORP
Lake Success, New York, 11042, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Hudson Valley Oncology Associates
Poughkeepsie, New York, 12601, United States
Wilmot Cancer Institute Radiation Oncology at Greece
Rochester, New York, 14606, United States
Highland Hospital
Rochester, New York, 14620, United States
Rochester General Hospital
Rochester, New York, 14621, United States
University of Rochester
Rochester, New York, 14642, United States
Memorial Sloan Kettering Sleepy Hollow
Sleepy Hollow, New York, 10591, United States
Staten Island University Hospital
Staten Island, New York, 10305, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Dickstein Cancer Treatment Center
White Plains, New York, 10601, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
East Carolina University
Greenville, North Carolina, 27834, United States
The Coleman Radiation Center-Carteret General Hospital
Morehead City, North Carolina, 28557, United States
CarolinaEast Medical Center
New Bern, North Carolina, 28561, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374, United States
Iredell Memorial Hospital
Statesville, North Carolina, 28677, United States
NHRMC Radiation Oncology - Supply
Supply, North Carolina, 28462, United States
New Hanover Regional Medical Center/Zimmer Cancer Center
Wilmington, North Carolina, 28401, United States
NHRMC Radiation Oncology - 16th Street
Wilmington, North Carolina, 28401, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Altru Cancer Center
Grand Forks, North Dakota, 58201, United States
Summa Health System - Akron Campus
Akron, Ohio, 44304, United States
Cleveland Clinic Akron General
Akron, Ohio, 44307, United States
Summa Health System - Barberton Campus
Barberton, Ohio, 44203, United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122, United States
Geauga Hospital
Chardon, Ohio, 44024, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Cleveland Clinic Cancer Center Independence
Independence, Ohio, 44131, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
Summa Health Medina Medical Center
Medina, Ohio, 44256, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060, United States
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights, Ohio, 44130, United States
University Hospitals Parma Medical Center
Parma, Ohio, 44129, United States
University Hospitals Portage Medical Center
Ravenna, Ohio, 44266, United States
North Coast Cancer Care
Sandusky, Ohio, 44870, United States
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio, 44136, United States
UHHS-Westlake Medical Center
Westlake, Ohio, 44145, United States
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio, 44691, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, 74136, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015, United States
Willamette Valley Cancer Center
Eugene, Oregon, 97401, United States
Three Rivers Community Hospital
Grants Pass, Oregon, 97527, United States
Providence Medford Medical Center
Medford, Oregon, 97504, United States
Rogue Valley Medical Center
Medford, Oregon, 97504, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Jefferson Abington Hospital
Abington, Pennsylvania, 19001, United States
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, 15009, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026, United States
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, 18512, United States
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301, United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505, United States
Fox Chase Cancer Center Buckingham
Furlong, Pennsylvania, 18925, United States
Adams Cancer Center
Gettysburg, Pennsylvania, 17325, United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601, United States
Cherry Tree Cancer Center
Hanover, Pennsylvania, 17331, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, 15901, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17602, United States
Saint Mary Medical and Regional Cancer Center
Langhorne, Pennsylvania, 19047, United States
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, 15132, United States
Holy Redeemer Hospital and Medical Center
Meadowbrook, Pennsylvania, 19046, United States
Riddle Memorial Hospital
Media, Pennsylvania, 19063, United States
Intercommunity Cancer Center
Monroeville, Pennsylvania, 15146, United States
UPMC-Coraopolis/Heritage Valley Radiation Oncology
Moon Township, Pennsylvania, 15108, United States
Allegheny Valley Hospital
Natrona Heights, Pennsylvania, 15065, United States
UPMC Jameson
New Castle, Pennsylvania, 16105, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, 15215, United States
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232, United States
UPMC Jefferson Regional Radiation Oncology
Pittsburgh, Pennsylvania, 15236, United States
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, 15237, United States
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, 15243, United States
Penn State Health Saint Joseph Medical Center
Reading, Pennsylvania, 19605, United States
Grand View Hospital
Sellersville, Pennsylvania, 18960, United States
Mount Nittany Medical Center
State College, Pennsylvania, 16803, United States
Crozer-Chester Medical Center
Upland, Pennsylvania, 19013, United States
UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania, 15301, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
WellSpan Health-York Hospital
York, Pennsylvania, 17403, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, 29601, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
The Radiation Oncology Center-Hilton Head/Bluffton
Hilton Head Island, South Carolina, 29926, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Lexington Medical Center
West Columbia, South Carolina, 29169, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Texas Oncology-Arlington South
Arlington, Texas, 76014, United States
Texas Oncology-Austin Midtown
Austin, Texas, 78705, United States
Texas Oncology - South Austin Cancer Center
Austin, Texas, 78745, United States
Texas Oncology Bedford
Bedford, Texas, 76022, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
Texas Oncology - Denison Cancer Center
Denison, Texas, 75020, United States
Texas Oncology-Denton South
Denton, Texas, 76201, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Texas Oncology - Fort Worth Cancer Center
Fort Worth, Texas, 76104, United States
Memorial Hermann Memorial City Medical Center
Houston, Texas, 77024, United States
Baylor Medical Center at Irving
Irving, Texas, 75061, United States
Texas Oncology - Lewisville
Lewisville, Texas, 75067, United States
West Texas Cancer Center
Odessa, Texas, 79761, United States
Texas Oncology-Plano West
Plano, Texas, 75093, United States
Texas Oncology-Seton Williamson
Round Rock, Texas, 78665, United States
Texas Oncology - Round Rock Cancer Center
Round Rock, Texas, 78681, United States
Cancer Care Centers of South Texas- Northeast
San Antonio, Texas, 78217, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, 77479, United States
Texas Oncology-Wichita Falls Texoma Cancer Center
Wichita Falls, Texas, 76310, United States
Logan Regional Hospital
Logan, Utah, 84321, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
Dixie Medical Center Regional Cancer Center
St. George, Utah, 84770, United States
Norris Cotton Cancer Center-North
Saint Johnsbury, Vermont, 05819, United States
Inova Alexandria Hospital
Alexandria, Virginia, 22304, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Augusta Health Center for Cancer and Blood Disorders
Fishersville, Virginia, 22939, United States
Sentara Cancer Institute at Sentara CarePlex Hospital
Hampton, Virginia, 23666, United States
Sentara Rockingham Memorial Hospital Hahn Cancer Center
Harrisonburg, Virginia, 22801, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Naval Medical Center - Portsmouth
Portsmouth, Virginia, 23708-2197, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Sentara Virginia Beach General Hospital
Virginia Beach, Virginia, 23454, United States
Harrison Medical Center
Bremerton, Washington, 98310, United States
Saint Francis Hospital
Federal Way, Washington, 98003, United States
Tri-Cities Cancer Center
Kennewick, Washington, 99336, United States
Skagit Valley Hospital
Mount Vernon, Washington, 98274, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Olympic Medical Cancer Care Center
Sequim, Washington, 98384, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202, United States
Cancer Care Northwest-North Spokane
Spokane, Washington, 99218, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 98801, United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia, 25701, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, 26003, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409, United States
ThedaCare Regional Medical Center - Appleton
Appleton, Wisconsin, 54911, United States
Beloit Memorial Hospital
Beloit, Wisconsin, 53511, United States
Mayo Clinic Health System Eau Claire Hospital-Luther Campus
Eau Claire, Wisconsin, 54703, United States
Saint Agnes Hospital/Agnesian Cancer Center
Fond du Lac, Wisconsin, 54935, United States
Bellin Memorial Hospital
Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, 53038, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051, United States
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon, Wisconsin, 53097, United States
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee, Wisconsin, 53211, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Ascension All Saints Hospital
Racine, Wisconsin, 53405, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495, United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Atlantic Health Sciences Corporation-Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Grand River Regional Cancer Centre at Grand River Hospital
Kitchener, Ontario, N2G 1G3, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
Stronach Regional Health Centre at Southlake
Newmarket, Ontario, L3Y 2P9, Canada
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, K1H 8L6, Canada
Ottawa Hospital-Civic Campus
Ottawa, Ontario, K1Y 4E9, Canada
Irving Greenberg Family Cancer Centre
Ottawa, Ontario, K2H 8P4, Canada
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3, Canada
Hopital de la Cite-de-la-Sante
Laval, Quebec, H7M 3L9, Canada
CIUSSSEMTL-Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
CHUM - Hopital Notre-Dame
Montreal, Quebec, H2L 4M1, Canada
McGill University Department of Oncology
Montreal, Quebec, H2W 1S6, Canada
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4, Canada
The Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec, H3H 2R9, Canada
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Québec, Quebec, G1R 2J6, Canada
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, J1H 5N4, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Pamela Youde Nethersole Eastern Hospital
Chai Wan, Hong Kong
Rabin Medical Center
Petah Tikva, 49100, Israel
Chaim Sheba Medical Center
Tel Litwinsky, 52621, Israel
Shizuoka Cancer Center
Shizuoka, Suntou, 411-8777, Japan
National University Hospital Singapore
Singapore, 119074, Singapore
National Cancer Centre Singapore
Singapore, 169610, Singapore
National Cancer Center-Korea
Goyang-si, Gyeonggi-do, 410-769, South Korea
Yonsei University Health System-Severance Hospital
Seoul, 120-752, South Korea
Kantonsspital Aarau
Aarau, 5001, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to a lower than anticipated incidence of in-breast recurrence (IBR), the protocol was amended to allow for timely reporting of the trial results with at least 46 IBR events, while maintaining statistical integrity and reflecting current knowledge of the observed IBR incidence in the control arm.
Results Point of Contact
- Title
- Wendy Seiferheld
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Frank A. Vicini, MD, FACR
St. Joseph Mercy Oakland
- STUDY CHAIR
Gary M. Freedman, MD
University of Pennsylvania
- STUDY CHAIR
Julia R. White, MD
Ohio State University
- STUDY CHAIR
Douglas W. Arthur, MD
Virginia Commonwealth University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- 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
May 5, 2011
First Posted
May 6, 2011
Study Start
May 24, 2011
Primary Completion
January 25, 2022
Last Updated
March 5, 2026
Results First Posted
April 6, 2023
Record last verified: 2025-09