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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03488693
Other study ID # CCTG MA.39
Secondary ID NCI-2017-02047
Status Recruiting
Phase Phase 3
First received
Last updated
Start date October 16, 2018
Est. completion date December 30, 2027

Study information

Verified date February 2024
Source Canadian Cancer Trials Group
Contact Wendy Parulekar
Phone 613-533-6430
Email wparulekar@ctg.queensu.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.


Description:

Women with node positive breast cancer normally will receive endocrine therapy and some may receive chemotherapy to help prevent the cancer from coming back. Many women will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiotherapy). No one really knows whether patients with low risk breast cancer need to receive regional radiotherapy. Some women may be getting regional radiotherapy who do not need it. These women may be exposed to the side effects of their treatment without benefit.


Recruitment information / eligibility

Status Recruiting
Enrollment 2140
Est. completion date December 30, 2027
Est. primary completion date September 1, 2027
Accepts healthy volunteers No
Gender Female
Age group 35 Years and older
Eligibility Inclusion Criteria: - Patients must be women with newly diagnosed histologically proven invasive carcinoma of the breast with no evidence of metastases, staged as per site standard of care. - Patients must have been treated by BCS or mastectomy with clear margins of excision. Post-mastectomy positive margins for invasive disease and/or DCIS is not allowed. Multifocal disease (i.e. the presence of two or more foci or breast cancer within the same breast quadrant) and multicentric disease (i.e. the presence of two or more foci of breast cancer in different quadrants of the same breast) are allowed. - Patients with T3N0 disease are eligible. - Patients with disease limited to nodal micrometastases are eligible - Patients with nodal macrometastases (>2mm) treated by axillary dissection must have 1-3 positive axillary nodes (macrometastases, > 2 mm). - Patients treated by mastectomy and SLNB alone must have only 1-2 positive axillary nodes (macrometastases, > 2 mm). - Patients must be ER = 1% and HER2 negative on local testing - Patients must have an Oncotype DX recurrence score =25 obtained from testing of breast tumour tissue from a core biopsy or from the surgical specimen. - Patient must consent to provision of, and investigator(s) must agree to submit to the CCTG Central Tumour Bank, a representative formalin fixed paraffin block of tumour tissue in order that the specific correlative marker assays described in the protocol may be conducted - Patient must consent to provision of samples of blood in order that the specific correlative marker assays described in the protocol may be conducted. - Patients must have had endocrine therapy initiated or planned for = 5 years. Premenopausal women will receive ovarian ablation plus aromatase inhibitor therapy or tamoxifen if adjuvant chemotherapy was not administered. For all patients, endocrine therapy can be given concurrently or following RT. - Patients may or may not have had adjuvant chemotherapy. - RT must commence within 16 weeks of definitive surgery if the patient is not treated with chemotherapy. If adjuvant chemotherapy is given, RT must begin within 12 weeks after the last dose. (Note: adjuvant chemotherapy may be ongoing at the time of randomization). Definitive surgery is defined as the last breast cancer-related surgery. - Patient's ECOG performance status must be 0, 1 or 2. - Patient's age must be = 35 years. - For the first 736 eligible English or French-speaking subjects who have agreed to optional questionnaire completion: Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life, health utilities and lost productivity questionnaires in either English or French (note: enrollment completed 2022Aug02) - Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements - Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. - In accordance with CCTG policy, protocol treatment is to begin within 6 weeks of patient randomization. - Women of childbearing potential must have agreed to use an effective contraceptive method. A woman is considered to be of "childbearing potential" if she has had menses at any time in the preceding 12 consecutive months. Exclusion Criteria: - Patients with nodal disease limited to isolated tumour cells (pN0i+ < 0.2 mm). - Patients with pT3N1 and pT4 disease (Note: patients with T3N0 are eligible). - Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy. (Patients with synchronous or previous ipsilateral LCIS are eligible.) - Synchronous or previous contralateral invasive breast cancer. (Patients with contralateral DCIS are eligible unless previously treated with radiation.) - History of non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers treated by local excision or other cancers curatively treated with no evidence of disease for = 5 years. - Patients who are pregnant. - Patients that have had prior ipsilateral chestwall/thoracic radiation. - Patients treated with chemo or endocrine therapy administered in the neoadjuvant setting for breast cancer. Endocrine therapy exposure 12 weeks or less prior to surgery is permitted. - Patients with serious non-malignant disease (e.g. cardiovascular, scleroderma etc.) which would preclude RT. - Patients with any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision).

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Radiation
Radiotherapy given
Other:
No Radiation
No radiotherapy given

Locations

Country Name City State
Canada BCCA-Abbotsford Cancer Centre Abbotsford British Columbia
Canada Royal Victoria Regional Health Centre Barrie Ontario
Canada Tom Baker Cancer Centre Calgary Alberta
Canada Cross Cancer Institute Edmonton Alberta
Canada CSSS Champlain-Charles Le Moyne Greenfield Park Quebec
Canada QEII Health Sciences Centre/Nova Scotia Health Authority Halifax Nova Scotia
Canada Juravinski Cancer Centre at Hamilton Health Sciences Hamilton Ontario
Canada BCCA-Cancer Centre for the Southern Interior Kelowna British Columbia
Canada Kingston Health Sciences Centre Kingston Ontario
Canada Grand River Regional Cancer Centre at Grand River Hospital Kitchener Ontario
Canada Hopital de la Cite-de-la-Sante Laval Quebec
Canada London Regional Cancer Program London Ontario
Canada Trillium Health Partners - Credit Valley Hospital Mississauga Ontario
Canada CHUM - Centre Hospitalier de l'Universite de Montreal Montreal Quebec
Canada CIUSSSEMTL-Hopital Maisonneuve-Rosemont Montreal Quebec
Canada Jewish General Hospital Montreal Quebec
Canada The Research Institute of the McGill University Health Centre (MUHC) Montreal Quebec
Canada Ottawa Hospital and Cancer Center-General Campus Ottawa Ontario
Canada BCCA-Cancer Centre for the North Prince George British Columbia
Canada CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) Quebec City Quebec
Canada Allan Blair Cancer Centre Regina Saskatchewan
Canada Niagara Health System-Saint Catharines General Saint Catharines Ontario
Canada Atlantic Health Sciences Corporation-Saint John Regional Hospital Saint John New Brunswick
Canada Saskatoon Cancer Centre Saskatoon Saskatchewan
Canada Algoma District Cancer Program Sault Area Hospital Sault Ste Marie Ontario
Canada Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke Quebec
Canada Doctor H. Bliss Murphy Cancer Centre St. John's Newfoundland and Labrador
Canada Health Sciences North Sudbury Ontario
Canada BCCA-Fraser Valley Cancer Centre Surrey British Columbia
Canada Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto Ontario
Canada University Health Network-Princess Margaret Hospital Toronto Ontario
Canada BCCA-Vancouver Cancer Centre Vancouver British Columbia
Canada BCCA-Vancouver Island Cancer Centre Victoria British Columbia
Canada CancerCare Manitoba Winnipeg Manitoba
United States Cleveland Clinic Akron General Akron Ohio
United States Lovelace Radiation Oncology Albuquerque New Mexico
United States New Mexico Oncology Hematology Consultants Albuquerque New Mexico
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States American Fork Hospital / Huntsman Intermountain Cancer Center American Fork Utah
United States Kaiser Permanente-Anaheim Anaheim California
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Anne Arundel Medical Center Annapolis Maryland
United States Langlade Hospital and Cancer Center Antigo Wisconsin
United States ThedaCare Regional Cancer Center Appleton Wisconsin
United States Hope Women's Cancer Centers-Asheville Asheville North Carolina
United States Mission Hospital Asheville North Carolina
United States Mount Sinai Queens Astoria New York
United States MultiCare Auburn Medical Center Auburn Washington
United States UCHealth University of Colorado Hospital Aurora Colorado
United States IU Health West Hospital Avon Indiana
United States UH Seidman Cancer Center at UH Avon Health Center Avon Ohio
United States Greater Baltimore Medical Center Baltimore Maryland
United States Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
United States MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore Maryland
United States MedStar Good Samaritan Hospital Baltimore Maryland
United States Saint Agnes Hospital Baltimore Maryland
United States University of Maryland/Greenebaum Cancer Center Baltimore Maryland
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States MaineHealth Coastal Cancer Treatment Center Bath Maine
United States McLaren Cancer Institute-Bay City Bay City Michigan
United States Houston Methodist San Jacinto Hospital Baytown Texas
United States UHHS-Chagrin Highlands Medical Center Beachwood Ohio
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Saint Charles Health System Bend Oregon
United States Alta Bates Summit Medical Center-Herrick Campus Berkeley California
United States Central Vermont Medical Center/National Life Cancer Treatment Berlin Vermont
United States Suburban Hospital Bethesda Maryland
United States Billings Clinic Cancer Center Billings Montana
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Saint Joseph's/Candler - Bluffton Campus Bluffton South Carolina
United States Boca Raton Regional Hospital Boca Raton Florida
United States Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States Rocky Mountain Cancer Centers-Boulder Boulder Colorado
United States Lafayette Family Cancer Center-EMMC Brewer Maine
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Montefiore Medical Center-Einstein Campus Bronx New York
United States Maimonides Medical Center Brooklyn New York
United States New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn New York
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Lahey Hospital and Medical Center Burlington Massachusetts
United States University of Vermont Medical Center Burlington Vermont
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Aultman Health Foundation Canton Ohio
United States Cleveland Clinic Mercy Hospital Canton Ohio
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Carlisle Regional Cancer Center Carlisle Pennsylvania
United States IU Health North Hospital Carmel Indiana
United States Sandra L Maxwell Cancer Center Cedar City Utah
United States Saint Luke's Hospital Cedar Rapids Iowa
United States Christiana Care Health System-Concord Health Center Chadds Ford Pennsylvania
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Geauga Hospital Chardon Ohio
United States Medical University of South Carolina Charleston South Carolina
United States Advocate Illinois Masonic Medical Center Chicago Illinois
United States Northwestern University Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States Swedish Covenant Hospital Chicago Illinois
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States University of Illinois Chicago Illinois
United States McLaren Cancer Institute-Clarkston Clarkston Michigan
United States Morton Plant Hospital Clearwater Florida
United States Case Western Reserve University Cleveland Ohio
United States MetroHealth Medical Center Cleveland Ohio
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho
United States Memorial Hospital North Colorado Springs Colorado
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Saint Francis Cancer Center Colorado Springs Colorado
United States UCHealth Memorial Hospital Central Colorado Springs Colorado
United States MU Health - University Hospital/Ellis Fischel Cancer Center Columbia Missouri
United States Grant Medical Center Columbus Ohio
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States Memorial Sloan Kettering Commack Commack New York
United States New Hampshire Oncology Hematology PA-Concord Concord New Hampshire
United States MD Anderson in The Woodlands Conroe Texas
United States Mary Imogene Bassett Hospital Cooperstown New York
United States UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables Florida
United States City of Hope Corona Corona California
United States Good Samaritan Hospital Corvallis Oregon
United States Greater Regional Medical Center Creston Iowa
United States Parkland Memorial Hospital Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Beaumont Hospital - Dearborn Dearborn Michigan
United States Decatur Memorial Hospital Decatur Illinois
United States UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida
United States Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois
United States Porter Adventist Hospital Denver Colorado
United States UCHealth - Cherry Creek Denver Colorado
United States Iowa Methodist Medical Center Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Wentworth-Douglass Hospital Dover New Hampshire
United States City of Hope Comprehensive Cancer Center Duarte California
United States Dublin Methodist Hospital Dublin Ohio
United States Kaiser Permanente Dublin Dublin California
United States Duke University Medical Center Durham North Carolina
United States University of Maryland Shore Medical Center at Easton Easton Maryland
United States HSHS Sacred Heart Hospital Eau Claire Wisconsin
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Saint Elizabeth Healthcare Edgewood Edgewood Kentucky
United States Crossroads Cancer Center Effingham Illinois
United States Mercy Cancer Center-Elyria Elyria Ohio
United States Englewood Hospital and Medical Center Englewood New Jersey
United States Saint Vincent Hospital Erie Pennsylvania
United States UPMC Hillman Cancer Center Erie Erie Pennsylvania
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States Exeter Hospital Exeter New Hampshire
United States Fairbanks Memorial Hospital Fairbanks Alaska
United States Farmington Health Center Farmington Utah
United States Beaumont Hospital - Farmington Hills Farmington Hills Michigan
United States UPMC Cancer Center at UPMC Horizon Farrell Pennsylvania
United States IU Health Central Indiana Cancer Centers-Fishers Fishers Indiana
United States Augusta Health Center for Cancer and Blood Disorders Fishersville Virginia
United States McLaren Cancer Institute-Flint Flint Michigan
United States Poudre Valley Hospital Fort Collins Colorado
United States Broward Health Medical Center Fort Lauderdale Florida
United States Saint Elizabeth Fort Thomas Fort Thomas Kentucky
United States Fresno Cancer Center Fresno California
United States University of Texas Medical Branch Galveston Texas
United States CaroMont Regional Medical Center Gastonia North Carolina
United States Northwestern Medicine Cancer Center Delnor Geneva Illinois
United States MultiCare Gig Harbor Medical Park Gig Harbor Washington
United States UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie Maryland
United States NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois
United States SCL Health Cancer Centers of Colorado - Lutheran Medical Center Golden Colorado
United States Aurora Cancer Care-Grafton Grafton Wisconsin
United States Altru Cancer Center Grand Forks North Dakota
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Trinity Health Grand Rapids Hospital Grand Rapids Michigan
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States North Colorado Medical Center Greeley Colorado
United States UCHealth Greeley Hospital Greeley Colorado
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States Bellin Memorial Hospital Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg Pennsylvania
United States Prisma Health Cancer Institute - Eastside Greenville South Carolina
United States Prisma Health Cancer Institute - Faris Greenville South Carolina
United States Saint Francis Cancer Center Greenville South Carolina
United States Self Regional Healthcare Greenwood South Carolina
United States Prisma Health Cancer Institute - Greer Greer South Carolina
United States Mount Carmel Grove City Hospital Grove City Ohio
United States Smilow Cancer Hospital Care Center - Guilford Guilford Connecticut
United States Smilow Cancer Hospital-Hamden Care Center Hamden Connecticut
United States The Cancer Institute of New Jersey Hamilton Hamilton New Jersey
United States UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg Pennsylvania
United States Memorial Sloan Kettering Westchester Harrison New York
United States Penn State Milton S Hershey Medical Center Hershey Pennsylvania
United States NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois
United States UCHealth Highlands Ranch Hospital Highlands Ranch Colorado
United States The Radiation Oncology Center-Hilton Head/Bluffton Hilton Head Island South Carolina
United States Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida
United States Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas
United States Houston Methodist Hospital Houston Texas
United States Houston Methodist West Hospital Houston Texas
United States M D Anderson Cancer Center Houston Texas
United States MD Anderson West Houston Houston Texas
United States Methodist Willowbrook Hospital Houston Texas
United States IRMC Cancer Center Indiana Pennsylvania
United States Community Cancer Center East Indianapolis Indiana
United States Community Cancer Center North Indianapolis Indiana
United States Community Cancer Center South Indianapolis Indiana
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States IU Health Methodist Hospital Indianapolis Indiana
United States City of Hope at Irvine Lennar Irvine California
United States Mayo Clinic in Florida Jacksonville Florida
United States Capital Region Southwest Campus Jefferson City Missouri
United States Jefferson Hospital Jefferson Hills Pennsylvania
United States UW Cancer Center Johnson Creek Johnson Creek Wisconsin
United States West Michigan Cancer Center Kalamazoo Michigan
United States University of Kansas Cancer Center Kansas City Kansas
United States University of Kansas Cancer Center - North Kansas City Missouri
United States Aurora Cancer Care-Kenosha South Kenosha Wisconsin
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States Northwestern Medicine Lake Forest Hospital Lake Forest Illinois
United States City of Hope Antelope Valley Lancaster California
United States Lancaster General Ann B Barshinger Cancer Institute Lancaster Pennsylvania
United States Lancaster General Hospital Lancaster Pennsylvania
United States Karmanos Cancer Institute at McLaren Greater Lansing Lansing Michigan
United States Doctor's Hospital of Laredo Laredo Texas
United States Memorial Medical Center - Las Cruces Las Cruces New Mexico
United States MD Anderson League City League City Texas
United States Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon New Hampshire
United States University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri
United States Saint Joseph Hospital East Lexington Kentucky
United States Saint Joseph Radiation Oncology Resource Center Lexington Kentucky
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Littleton Adventist Hospital Littleton Colorado
United States Logan Regional Hospital Logan Utah
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States Los Angeles General Medical Center Los Angeles California
United States USC / Norris Comprehensive Cancer Center Los Angeles California
United States The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky
United States McKee Medical Center Loveland Colorado
United States Lowell General Hospital Lowell Massachusetts
United States University of Wisconsin Carbone Cancer Center Madison Wisconsin
United States Solinsky Center for Cancer Care Manchester New Hampshire
United States Aurora Bay Area Medical Group-Marinette Marinette Wisconsin
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Loyola University Medical Center Maywood Illinois
United States UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg Pennsylvania
United States Riddle Memorial Hospital Media Pennsylvania
United States Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee
United States Froedtert Menomonee Falls Hospital Menomonee Falls Wisconsin
United States UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio
United States Miami Cancer Institute Miami Florida
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States UH Seidman Cancer Center at Southwest General Hospital Middleburg Heights Ohio
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Aurora Sinai Medical Center Milwaukee Wisconsin
United States Medical College of Wisconsin Milwaukee Wisconsin
United States NYU Winthrop Hospital Mineola New York
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Forbes Hospital Monroeville Pennsylvania
United States UPMC Cancer Center - Monroeville Monroeville Pennsylvania
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States West Virginia University Healthcare Morgantown West Virginia
United States McLaren Cancer Institute-Macomb Mount Clemens Michigan
United States ProHealth D N Greenwald Center Mukwonago Wisconsin
United States IU Health Ball Memorial Hospital Muncie Indiana
United States Intermountain Medical Center Murray Utah
United States Trinity Health Muskegon Hospital Muskegon Michigan
United States Providence Queen of The Valley Napa California
United States Houston Methodist Saint John Hospital Nassau Bay Texas
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Saint Peter's University Hospital New Brunswick New Jersey
United States Yale University New Haven Connecticut
United States UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York
United States Memorial Sloan Kettering Cancer Center New York New York
United States Mount Sinai Chelsea New York New York
United States Mount Sinai Hospital New York New York
United States Mount Sinai Union Square New York New York
United States Mount Sinai West New York New York
United States NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Helen F Graham Cancer Center Newark Delaware
United States Bryn Mawr Health Center Newtown Square Pennsylvania
United States Norwalk Hospital Norwalk Connecticut
United States Ascension Providence Hospitals - Novi Novi Michigan
United States Nyack Hospital Nyack New York
United States Drexel Town Square Health Center Oak Creek Wisconsin
United States Kaiser Permanente Oakland-Broadway Oakland California
United States ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States McKay-Dee Hospital Center Ogden Utah
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States Saint Joseph Hospital - Orange Orange California
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States University of Chicago Medicine-Orland Park Orland Park Illinois
United States Orlando Health Cancer Institute Orlando Florida
United States Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin
United States University of Kansas Cancer Center-Overland Park Overland Park Kansas
United States Owensboro Health Mitchell Memorial Cancer Center Owensboro Kentucky
United States Desert Regional Medical Center Palm Springs California
United States Paoli Memorial Hospital Paoli Pennsylvania
United States Advocate Lutheran General Hospital Park Ridge Illinois
United States University Hospitals Parma Medical Center Parma Ohio
United States Memorial Hospital West Pembroke Pines Florida
United States OSF Saint Francis Medical Center Peoria Illinois
United States McLaren Cancer Institute-Northern Michigan Petoskey Michigan
United States Jefferson Torresdale Hospital Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States UPMC-Magee Womens Hospital Pittsburgh Pennsylvania
United States UPMC-Passavant Hospital Pittsburgh Pennsylvania
United States UPMC-Saint Clair Hospital Cancer Center Pittsburgh Pennsylvania
United States UPMC-Saint Margaret Pittsburgh Pennsylvania
United States UPMC-Shadyside Hospital Pittsburgh Pennsylvania
United States West Penn Hospital Pittsburgh Pennsylvania
United States Miami Cancer Institute at Plantation Plantation Florida
United States McLaren-Port Huron Port Huron Michigan
United States Maine Medical Center-Bramhall Campus Portland Maine
United States Oregon Health and Science University Portland Oregon
United States Naval Medical Center - Portsmouth Portsmouth Virginia
United States Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Women and Infants Hospital Providence Rhode Island
United States Utah Valley Regional Medical Center Provo Utah
United States Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova California
United States University Hospitals Portage Medical Center Ravenna Ohio
United States Penn State Health Saint Joseph Medical Center Reading Pennsylvania
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States Riverton Hospital Riverton Utah
United States Rochester General Hospital Rochester New York
United States SwedishAmerican Regional Cancer Center/ACT Rockford Illinois
United States Rohnert Park Cancer Center Rohnert Park California
United States The Permanente Medical Group-Roseville Radiation Oncology Roseville California
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Mercy Cancer Center - Sacramento Sacramento California
United States Saint George Regional Medical Center Saint George Utah
United States Saint Helena Hospital Saint Helena California
United States Norris Cotton Cancer Center-North Saint Johnsbury Vermont
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Anthony's Hospital Cancer Care Center Saint Petersburg Florida
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States LDS Hospital Salt Lake City Utah
United States University of Utah Sugarhouse Health Center Salt Lake City Utah
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States UH Seidman Cancer Center at Firelands Regional Medical Center Sandusky Ohio
United States MaineHealth Cancer Care Center of York County Sanford Maine
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Saint John's Cancer Institute Santa Monica California
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Maine Medical Center- Scarborough Campus Scarborough Maine
United States Swedish Medical Center-First Hill Seattle Washington
United States Prisma Health Cancer Institute - Seneca Seneca South Carolina
United States Sidney Kimmel Cancer Center Washington Township Sewell New Jersey
United States HSHS Saint Nicholas Hospital Sheboygan Wisconsin
United States Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin
United States LSU Health Sciences Center at Shreveport Shreveport Louisiana
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Robert Wood Johnson University Hospital Somerset Somerville New Jersey
United States South Jordan Health Center South Jordan Utah
United States City of Hope South Pasadena South Pasadena California
United States Kaiser Permanente Cancer Treatment Center South San Francisco California
United States Ascension Providence Hospitals - Southfield Southfield Michigan
United States Baptist Memorial Hospital and Cancer Center-Desoto Southhaven Mississippi
United States Spartanburg Medical Center Spartanburg South Carolina
United States Baystate Medical Center Springfield Massachusetts
United States Memorial Medical Center Springfield Illinois
United States Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin
United States Stony Brook University Medical Center Stony Brook New York
United States Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay Wisconsin
United States Houston Methodist Sugar Land Hospital Sugar Land Texas
United States MD Anderson in Sugar Land Sugar Land Texas
United States Aurora Medical Center in Summit Summit Wisconsin
United States ProMedica Flower Hospital Sylvania Ohio
United States State University of New York Upstate Medical University Syracuse New York
United States MultiCare Tacoma General Hospital Tacoma Washington
United States Moffitt Cancer Center Tampa Florida
United States Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida
United States Houston Methodist The Woodlands Hospital The Woodlands Texas
United States Community Medical Center Toms River New Jersey
United States City of Hope South Bay Torrance California
United States UM Saint Joseph Medical Center Towson Maryland
United States Munson Medical Center Traverse City Michigan
United States William Beaumont Hospital - Troy Troy Michigan
United States Smilow Cancer Hospital Care Center-Trumbull Trumbull Connecticut
United States University of Arizona Cancer Center-North Campus Tucson Arizona
United States University of Arizona Cancer Center-Orange Grove Campus Tucson Arizona
United States Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin
United States Memorial Sloan Kettering Nassau Uniondale New York
United States City of Hope Upland Upland California
United States Carle Cancer Center Urbana Illinois
United States Sutter Solano Medical Center/Cancer Center Vallejo California
United States University Hospitals Sharon Health Center Wadsworth Ohio
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States Kent Hospital Warwick Rhode Island
United States MedStar Georgetown University Hospital Washington District of Columbia
United States MedStar Washington Hospital Center Washington District of Columbia
United States Sibley Memorial Hospital Washington District of Columbia
United States UPMC Washington Hospital Radiation Oncology Washington Pennsylvania
United States Smilow Cancer Hospital Care Center - Waterford Waterford Connecticut
United States Aspirus Regional Cancer Center Wausau Wisconsin
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Froedtert West Bend Hospital/Kraemer Cancer Center West Bend Wisconsin
United States Lexington Medical Center West Columbia South Carolina
United States Reading Hospital West Reading Pennsylvania
United States Saint Ann's Hospital Westerville Ohio
United States UH Seidman Cancer Center at Saint John Medical Center Westlake Ohio
United States UHHS-Westlake Medical Center Westlake Ohio
United States Cleveland Clinic-Weston Weston Florida
United States Diagnostic and Treatment Center Weston Wisconsin
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Wexford Health and Wellness Pavilion Wexford Pennsylvania
United States SCL Health Lutheran Medical Center Wheat Ridge Colorado
United States Ascension Via Christi Hospitals Wichita Wichita Kansas
United States Asplundh Cancer Pavilion Willow Grove Pennsylvania
United States Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin
United States Lankenau Medical Center Wynnewood Pennsylvania
United States University of Michigan Health - West Wyoming Michigan
United States UPMC Memorial York Pennsylvania

Sponsors (5)

Lead Sponsor Collaborator
Canadian Cancer Trials Group Alliance for Clinical Trials in Oncology, Eastern Cooperative Oncology Group, NRG Oncology, SWOG Cancer Research Network

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not Defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast, regional nodes, distant sites or death due to BC. 9.5 years
Secondary Compare the invasive disease-free survival between patients that received regional RT or not. Defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast, regional nodes, distant sites or death due to BC 9.5 years
Secondary Compare the breast cancer mortality between patients that received regional RT or not. Defined as death due to BC 9.5 years
Secondary Compare the overall survival (OS) between patients that received regional RT or not Defined as the time from randomization to the time of death from any cause 9.5 years
Secondary Compare the locoregional recurrence-free interval (LRRFI) between patients that received regional RT or not. Defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast or regional nodes, or death to due to BC 9.5 years
Secondary Compare the distant recurrence-free interval (DRFI) between patients that received regional RT or not. Defined as time from randomization to time of invasive recurrent disease in distant sites or death due to BC 9.5 years
Secondary Number and severity of adverse events using the current CTCAE version 4 9.5 years
Secondary Compare arm volume and mobility measurements between patients that received regional RT or not A Fisher's Exact Test will be used to compare lymphedema and arm abduction deficit between two arms. Defined as a difference in arm abduction of 10% or greater in the comparison of the ipsilateral to the contralateral arm. 9.5 years
Secondary Compare patient-reported outcomes (PROs) and the quality of life (QOL) between patients that received regional RT or not using the NSABP Questionnaire for patients treated by BCS or mastectomy. 9.5 years
Secondary Compare the quality of life (QOL) between patients that received regional RT or not Overall QOL (EORTC QLQ-C30) will be compared between the two treatment groups using a similar approach. 9.5 years
Secondary Compare the cost-effectiveness between patients that received regional RT or not Costs will be expressed in $US and $CAN base currencies based on the final year of the study. An average cost per study subject by treatment arm for an overall mean cost per study arm will be generated 9.5 years
Secondary Compare the quality of life (QOL) between patients that received regional RT or not breast symptoms (NSABP B32 Questionnaire) will be compared between the two treatment groups using a similar approach. 9.5 years
Secondary Compare the quality of life (QOL) between patients that received regional RT or not skin symptoms and fatigue (EORTC QLQ-BR23) will be compared between the two treatment groups using a similar approach. 9.5 years
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