Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer (TAILOR RT)

June 30, 2026 updated by: Canadian Cancer Trials Group

TAILOR RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer

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.

Study Overview

Status

Active, not recruiting

Conditions

Breast Cancer

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

2138

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 5G2
    - Arthur J E Child Comprehensive Cancer Centre
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Cross Cancer Institute
- British Columbia
  - Abbotsford British Columbia, British Columbia, Canada, V2S 1K2
    - BCCA-Abbotsford Cancer Centre
  - Kelowna, British Columbia, Canada, V1Y 5L3
    - BCCA-Cancer Centre for the Southern Interior
  - Prince George, British Columbia, Canada, V2M 7E9
    - BCCA-Cancer Centre for the North
  - Surrey, British Columbia, Canada, V3V 1Z2
    - BCCA-Fraser Valley Cancer Centre
  - Vancouver, British Columbia, Canada, V5Z 4E6
    - BCCA-Vancouver Cancer Centre
  - Victoria, British Columbia, Canada, V8R 6V5
    - BCCA-Vancouver Island Cancer Centre
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 0V9
    - CancerCare Manitoba
- New Brunswick
  - Saint John, New Brunswick, Canada, E2L 4L2
    - Atlantic Health Sciences Corporation-Saint John Regional Hospital
- Newfoundland and Labrador
  - St. John's, Newfoundland and Labrador, Canada, A1B 3V6
    - Doctor H. Bliss Murphy Cancer Centre
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 2Y9
    - QEII Health Sciences Centre/Nova Scotia Health Authority
- Ontario
  - Barrie, Ontario, Canada, L4M 6M2
    - Royal Victoria Regional Health Centre
  - Greater Sudbury, Ontario, Canada, P3E 5J1
    - Health Sciences North
  - Hamilton, Ontario, Canada, L8V 5C2
    - Juravinski Cancer Centre at Hamilton Health Sciences
  - Kingston, Ontario, Canada, K7L 2V7
    - Kingston Health Sciences Centre
  - Kitchener, Ontario, Canada, N2G 1G3
    - Waterloo Regional Health Network
  - London, Ontario, Canada, N6A 4L6
    - London Regional Cancer Program
  - Mississauga, Ontario, Canada, L5M 2N1
    - Trillium Health Partners - Credit Valley Hospital
  - Ottawa, Ontario, Canada, K1H 8L6
    - Ottawa Hospital and Cancer Center-General Campus
  - Saint Catharines, Ontario, Canada, L2S 0A9
    - Niagara Health System-Saint Catharines General
  - Sault Ste. Marie, Ontario, Canada, P6B 0A8
    - Algoma District Cancer Program Sault Area Hospital
  - Toronto, Ontario, Canada, M5G 2M9
    - University Health Network-Princess Margaret Hospital
  - Toronto, Ontario, Canada, M4N 3M5
    - Odette Cancer Centre- Sunnybrook Health Sciences Centre
- Quebec
  - Greenfield Park, Quebec, Canada, J4V 2H1
    - CSSS Champlain-Charles Le Moyne
  - Laval, Quebec, Canada, H7M 3L9
    - Hopital de la Cite-de-la-Sante
  - Montreal, Quebec, Canada, H3T 1E2
    - Jewish General Hospital
  - Montreal, Quebec, Canada, H3H 2R9
    - The Research Institute of the McGill University Health Centre (MUHC)
  - Montreal, Quebec, Canada, H2X 3E4
    - CHUM - Centre Hospitalier de l'Universite de Montreal
  - Montreal, Quebec, Canada, H1T 2M4
    - CIUSSSEMTL-Hopital Maisonneuve-Rosemont
  - Québec, Quebec, Canada, G1R 2J6
    - CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
  - Sherbrooke, Quebec, Canada, J1H 5N4
    - Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4T 7T1
    - Allan Blair Cancer Centre
  - Saskatoon, Saskatchewan, Canada, S7N 4H4
    - Saskatoon Cancer Centre
United States
- Alaska
  - Fairbanks, Alaska, United States, 99701
    - Fairbanks Memorial Hospital
- Arizona
  - Gilbert, Arizona, United States, 85234
    - Banner MD Anderson Cancer Center
  - Phoenix, Arizona, United States, 85006
    - Banner-University Medical Center Phoenix
  - Tucson, Arizona, United States, 85704
    - University of Arizona Cancer Center-Orange Grove Campus
  - Tucson, Arizona, United States, 85719
    - University of Arizona Cancer Center-North Campus
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - University of Arkansas for Medical Sciences
- California
  - Anaheim, California, United States, 92806
    - Kaiser Permanente-Anaheim
  - Bellflower, California, United States, 90706
    - Kaiser Permanente-Bellflower
  - Berkeley, California, United States, 94704
    - Alta Bates Summit Medical Center-Herrick Campus
  - Corona, California, United States, 92882
    - City of Hope Corona
  - Duarte, California, United States, 91010
    - City of Hope Comprehensive Cancer Center
  - Dublin, California, United States, 94568
    - Kaiser Permanente Dublin
  - Encinitas, California, United States, 92024
    - UC San Diego Health System - Encinitas
  - Fresno, California, United States, 93720
    - Fresno Cancer Center
  - Irvine, California, United States, 92618
    - City of Hope at Irvine Lennar
  - La Jolla, California, United States, 92093
    - UC San Diego Moores Cancer Center
  - Lancaster, California, United States, 93534
    - City of Hope Antelope Valley
  - Los Angeles, California, United States, 90033
    - USC / Norris Comprehensive Cancer Center
  - Los Angeles, California, United States, 90027
    - Kaiser Permanente Los Angeles Medical Center
  - Los Angeles, California, United States, 90033
    - Los Angeles General Medical Center
  - Napa, California, United States, 94558
    - Providence Queen of The Valley
  - Oakland, California, United States, 94611
    - Kaiser Permanente Oakland-Broadway
  - Ontario, California, United States, 91761
    - Kaiser Permanente-Ontario
  - Orange, California, United States, 92868
    - UC Irvine Health/Chao Family Comprehensive Cancer Center
  - Orange, California, United States, 92868
    - Saint Joseph Hospital - Orange
  - Palm Springs, California, United States, 92262
    - Desert Regional Medical Center
  - Rancho Cordova, California, United States, 95670
    - Kaiser Permanente-Rancho Cordova Cancer Center
  - Rohnert Park, California, United States, 94928
    - Rohnert Park Cancer Center
  - Roseville, California, United States, 95678
    - The Permanente Medical Group-Roseville Radiation Oncology
  - Sacramento, California, United States, 95816
    - Mercy Cancer Center - Sacramento
  - Santa Clara, California, United States, 95051
    - Kaiser Permanente Medical Center - Santa Clara
  - Santa Monica, California, United States, 90404
    - Saint John's Cancer Institute
  - South Pasadena, California, United States, 91030
    - City of Hope South Pasadena
  - South San Francisco, California, United States, 94080
    - Kaiser Permanente Cancer Treatment Center
  - St. Helena, California, United States, 94574
    - Saint Helena Hospital
  - Torrance, California, United States, 90503
    - City of Hope South Bay
  - Upland, California, United States, 91786
    - City of Hope Upland
  - Vallejo, California, United States, 94589
    - Sutter Solano Medical Center/Cancer Center
  - Walnut Creek, California, United States, 94598
    - BASS Medical Group - Lennon
- Colorado
  - Aurora, Colorado, United States, 80045
    - UCHealth University of Colorado Hospital
  - Boulder, Colorado, United States, 80304
    - Rocky Mountain Cancer Centers-Boulder
  - Colorado Springs, Colorado, United States, 80907
    - Penrose-Saint Francis Healthcare
  - Colorado Springs, Colorado, United States, 80909
    - UCHealth Memorial Hospital Central
  - Colorado Springs, Colorado, United States, 80920
    - Memorial Hospital North
  - Colorado Springs, Colorado, United States, 80923
    - Saint Francis Cancer Center
  - Denver, Colorado, United States, 80206
    - UCHealth - Cherry Creek
  - Denver, Colorado, United States, 80210
    - AdventHealth Porter
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
  - Golden, Colorado, United States, 80401
    - Lutheran Hospital - Cancer Centers of Colorado
  - Greeley, Colorado, United States, 80631
    - UCHealth Greeley Hospital
  - Greeley, Colorado, United States, 80631
    - Banner North Colorado Medical Center
  - Highlands Ranch, Colorado, United States, 80129
    - UCHealth Highlands Ranch Hospital
  - Littleton, Colorado, United States, 80122
    - AdventHealth Littleton
  - Loveland, Colorado, United States, 80539
    - Banner North Colorado Medical Center - Loveland Campus
  - Westminster, Colorado, United States, 80023
    - Saint Anthony North Hospital
  - Wheat Ridge, Colorado, United States, 80401
    - Intermountain Health Lutheran Hospital
- Connecticut
  - Danbury, Connecticut, United States, 06810
    - Danbury Hospital
  - Guilford, Connecticut, United States, 06437
    - Smilow Cancer Hospital Care Center - Guilford
  - Hamden, Connecticut, United States, 06518
    - Smilow Cancer Hospital-Hamden Care Center
  - New Haven, Connecticut, United States, 06520
    - Yale University
  - Norwalk, Connecticut, United States, 06856
    - Norwalk Hospital
  - Trumbull, Connecticut, United States, 06611
    - Smilow Cancer Hospital Care Center-Trumbull
  - Waterford, Connecticut, United States, 06385
    - Smilow Cancer Hospital Care Center - Waterford
- Delaware
  - Newark, Delaware, United States, 19713
    - Helen F Graham Cancer Center
  - Newark, Delaware, United States, 19718
    - Christiana Care Health System-Christiana Hospital
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20010
    - MedStar Washington Hospital Center
  - Washington D.C., District of Columbia, United States, 20007
    - MedStar Georgetown University Hospital
  - Washington D.C., District of Columbia, United States, 20016
    - Sibley Memorial Hospital
- Florida
  - Boca Raton, Florida, United States, 33486
    - Boca Raton Regional Hospital
  - Clearwater, Florida, United States, 33756
    - Morton Plant Hospital
  - Coral Gables, Florida, United States, 33146
    - UM Sylvester Comprehensive Cancer Center at Coral Gables
  - Deerfield Beach, Florida, United States, 33442
    - UM Sylvester Comprehensive Cancer Center at Deerfield Beach
  - Fort Lauderdale, Florida, United States, 33316
    - Broward Health Medical Center
  - Gainesville, Florida, United States, 32610
    - UF Health Cancer Institute - Gainesville
  - Hollywood, Florida, United States, 33021
    - Memorial Regional Hospital/Joe DiMaggio Children's Hospital
  - Jacksonville, Florida, United States, 32224-9980
    - Mayo Clinic in Florida
  - Miami, Florida, United States, 33136
    - University of Miami Miller School of Medicine-Sylvester Cancer Center
  - Miami, Florida, United States, 33176
    - Miami Cancer Institute
  - Orlando, Florida, United States, 32806
    - Orlando Health Cancer Institute
  - Pembroke Pines, Florida, United States, 33028
    - Memorial Hospital West
  - Plantation, Florida, United States, 33324
    - UM Sylvester Comprehensive Cancer Center at Plantation
  - Plantation, Florida, United States, 33324
    - Miami Cancer Institute at Plantation
  - St. Petersburg, Florida, United States, 33705
    - Saint Anthony's Hospital Cancer Care Center
  - Tampa, Florida, United States, 33612
    - Moffitt Cancer Center
  - Tampa, Florida, United States, 33607
    - Saint Joseph's Hospital/Children's Hospital-Tampa
  - Weston, Florida, United States, 33331
    - Cleveland Clinic-Weston
- Georgia
  - Atlanta, Georgia, United States, 30308
    - Emory University Hospital Midtown
  - Atlanta, Georgia, United States, 30322
    - Emory University Hospital/Winship Cancer Institute
  - Atlanta, Georgia, United States, 30342
    - Emory Saint Joseph's Hospital
  - Atlanta, Georgia, United States, 30303
    - Grady Health System
  - Decatur, Georgia, United States, 30033
    - Emory Decatur Hospital
  - Savannah, Georgia, United States, 31405
    - Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Coeur d'Alene, Idaho, United States, 83814
    - Kootenai Health - Coeur d'Alene
  - Post Falls, Idaho, United States, 83854
    - Kootenai Clinic Cancer Services - Post Falls
- Illinois
  - Chicago, Illinois, United States, 60611
    - Northwestern University
  - Chicago, Illinois, United States, 60637
    - University of Chicago Comprehensive Cancer Center
  - Chicago, Illinois, United States, 60612
    - University of Illinois
  - Chicago, Illinois, United States, 60625
    - Swedish Covenant Hospital
  - Chicago, Illinois, United States, 60657
    - Advocate Illinois Masonic Medical Center
  - Chicago, Illinois, United States, 60612
    - Rush MD Anderson Cancer Center
  - DeKalb, Illinois, United States, 60115
    - Northwestern Medicine Cancer Center Kishwaukee
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital
  - Effingham, Illinois, United States, 62401
    - Crossroads Cancer Center
  - Evanston, Illinois, United States, 60201
    - NorthShore University HealthSystem-Evanston Hospital
  - Geneva, Illinois, United States, 60134
    - Northwestern Medicine Cancer Center Delnor
  - Glenview, Illinois, United States, 60026
    - NorthShore University HealthSystem-Glenbrook Hospital
  - Harvey, Illinois, United States, 60426
    - Ingalls Memorial Hospital
  - Highland Park, Illinois, United States, 60035
    - NorthShore University HealthSystem-Highland Park Hospital
  - Lake Forest, Illinois, United States, 60045
    - Northwestern Medicine Lake Forest Hospital
  - Maywood, Illinois, United States, 60153
    - Loyola University Medical Center
  - New Lenox, Illinois, United States, 60451
    - UC Comprehensive Cancer Center at Silver Cross
  - O'Fallon, Illinois, United States, 62269
    - HSHS Saint Elizabeth's Hospital
  - Orland Park, Illinois, United States, 60462
    - University of Chicago Medicine-Orland Park
  - Park Ridge, Illinois, United States, 60068
    - Advocate Lutheran General Hospital
  - Peoria, Illinois, United States, 61637
    - OSF Saint Francis Medical Center
  - Rockford, Illinois, United States, 61114
    - UW Health Carbone Cancer Center Rockford
  - Springfield, Illinois, United States, 62781
    - Springfield Memorial Hospital
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center
  - Warrenville, Illinois, United States, 60555
    - Northwestern Medicine Cancer Center Warrenville
- Indiana
  - Avon, Indiana, United States, 46123
    - IU Health West Hospital
  - Carmel, Indiana, United States, 46032
    - IU Health North Hospital
  - Crown Point, Indiana, United States, 46307
    - UChicago Medicine Northwest Indiana
  - Fishers, Indiana, United States, 46037
    - IU Health Central Indiana Cancer Centers-Fishers
  - Indianapolis, Indiana, United States, 46202
    - Indiana University/Melvin and Bren Simon Cancer Center
  - Indianapolis, Indiana, United States, 46219
    - Community Cancer Center East
  - Indianapolis, Indiana, United States, 46227
    - Community Cancer Center South
  - Indianapolis, Indiana, United States, 46256
    - Community Cancer Center North
  - Indianapolis, Indiana, United States, 46202
    - IU Health Methodist Hospital
  - Muncie, Indiana, United States, 47303
    - IU Health Ball Memorial Hospital
- Iowa
  - Cedar Rapids, Iowa, United States, 52402
    - Saint Luke's Hospital
  - Clive, Iowa, United States, 50325
    - Mercy Cancer Center-West Lakes
  - Creston, Iowa, United States, 50801
    - Greater Regional Medical Center
  - Des Moines, Iowa, United States, 50309
    - Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50314
    - Mercy Medical Center - Des Moines
- Kansas
  - Kansas City, Kansas, United States, 66160
    - University of Kansas Cancer Center
  - Olathe, Kansas, United States, 66061
    - The University of Kansas Cancer Center - Olathe
  - Overland Park, Kansas, United States, 66210
    - University of Kansas Cancer Center-Overland Park
  - Topeka, Kansas, United States, 66606
    - University of Kansas Health System Saint Francis Campus
  - Wichita, Kansas, United States, 67214
    - Ascension Via Christi Hospitals Wichita
- Kentucky
  - Edgewood, Kentucky, United States, 41017
    - Saint Elizabeth Healthcare Edgewood
  - Fort Thomas, Kentucky, United States, 41075
    - Saint Elizabeth Healthcare Fort Thomas
  - Lexington, Kentucky, United States, 40536
    - University of Kentucky/Markey Cancer Center
  - Lexington, Kentucky, United States, 40504
    - Saint Joseph Radiation Oncology Resource Center
  - Lexington, Kentucky, United States, 40509
    - Saint Joseph Hospital East
  - Louisville, Kentucky, United States, 40202
    - The James Graham Brown Cancer Center at University of Louisville
  - Louisville, Kentucky, United States, 40245
    - UofL Health Medical Center Northeast
  - Owensboro, Kentucky, United States, 42303
    - Owensboro Health Mitchell Memorial Cancer Center
- Louisiana
  - Shreveport, Louisiana, United States, 71103
    - LSU Health Sciences Center at Shreveport
- Maine
  - Bath, Maine, United States, 04530
    - MaineHealth Coastal Cancer Treatment Center
  - Brewer, Maine, United States, 04412
    - Lafayette Family Cancer Center-EMMC
  - Portland, Maine, United States, 04102
    - MaineHealth Maine Medical Center - Portland
  - Sanford, Maine, United States, 04073
    - MaineHealth Cancer Care Center of York County
  - Scarborough, Maine, United States, 04074
    - MaineHealth Maine Medical Center- Scarborough
- Maryland
  - Annapolis, Maryland, United States, 21401
    - Luminis Health Anne Arundel Medical Center
  - Baltimore, Maryland, United States, 21237
    - MedStar Franklin Square Medical Center/Weinberg Cancer Institute
  - Baltimore, Maryland, United States, 21287
    - Johns Hopkins University/Sidney Kimmel Cancer Center
  - Baltimore, Maryland, United States, 21204
    - Greater Baltimore Medical Center
  - Baltimore, Maryland, United States, 21201
    - University of Maryland/Greenebaum Cancer Center
  - Baltimore, Maryland, United States, 21229
    - Saint Agnes Hospital
  - Baltimore, Maryland, United States, 21239
    - MedStar Good Samaritan Hospital
  - Bel Air, Maryland, United States, 21014
    - UM Upper Chesapeake Medical Center
  - Bethesda, Maryland, United States, 20814
    - Suburban Hospital
  - Easton, Maryland, United States, 21601
    - University of Maryland Shore Medical Center at Easton
  - Glen Burnie, Maryland, United States, 21061
    - UM Baltimore Washington Medical Center/Tate Cancer Center
  - Largo, Maryland, United States, 20774
    - UM Capital Region Medical Center
  - Towson, Maryland, United States, 21204
    - UM Saint Joseph Medical Center
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, United States, 02111
    - Tufts Medical Center
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital Cancer Center
  - Burlington, Massachusetts, United States, 01805
    - Lahey Hospital and Medical Center
  - Lowell, Massachusetts, United States, 01854
    - Lowell General Hospital
  - Springfield, Massachusetts, United States, 01199
    - Baystate Medical Center
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - University of Michigan Rogel Cancer Center
  - Bay City, Michigan, United States, 48706
    - McLaren Cancer Institute-Bay City
  - Clarkston, Michigan, United States, 48346
    - McLaren Cancer Institute-Clarkston
  - Dearborn, Michigan, United States, 48124
    - Corewell Health Dearborn Hospital
  - Farmington Hills, Michigan, United States, 48336
    - Corewell Health Farmington Hills Hospital
  - Flint, Michigan, United States, 48532
    - McLaren Cancer Institute-Flint
  - Grand Rapids, Michigan, United States, 49503
    - Trinity Health Grand Rapids Hospital
  - Grand Rapids, Michigan, United States, 49503
    - Corewell Health Grand Rapids Hospitals - Butterworth Hospital
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
  - Lansing, Michigan, United States, 48910
    - Karmanos Cancer Institute at McLaren Greater Lansing
  - Mount Clemens, Michigan, United States, 48043
    - McLaren Cancer Institute-Macomb
  - Mount Pleasant, Michigan, United States, 48858
    - McLaren Cancer Institute-Central Michigan
  - Muskegon, Michigan, United States, 49444
    - Trinity Health Muskegon Hospital
  - Novi, Michigan, United States, 48374
    - Henry Ford Health Providence Novi Hospital
  - Petoskey, Michigan, United States, 49770
    - McLaren Cancer Institute-Northern Michigan
  - Port Huron, Michigan, United States, 48060
    - McLaren-Port Huron
  - Royal Oak, Michigan, United States, 48073
    - Corewell Health William Beaumont University Hospital
  - Southfield, Michigan, United States, 48075
    - Henry Ford Health Providence Southfield Hospital
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
  - Troy, Michigan, United States, 48085
    - Corewell Health Beaumont Troy Hospital
  - Wyoming, Michigan, United States, 49519
    - University of Michigan Health - West
- Minnesota
  - Bemidji, Minnesota, United States, 56601
    - Sanford Joe Lueken Cancer Center
  - Duluth, Minnesota, United States, 55805
    - Miller-Dwan Hospital
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, United States, 55407
    - Abbott-Northwestern Hospital
- Mississippi
  - Southhaven, Mississippi, United States, 38671
    - Baptist Memorial Hospital and Cancer Center-Desoto
- Missouri
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Columbia, Missouri, United States, 65212
    - MU Health - University Hospital/Ellis Fischel Cancer Center
  - Jefferson City, Missouri, United States, 65109
    - MU Health Care Goldschmidt Cancer Center
  - Kansas City, Missouri, United States, 64154
    - University of Kansas Cancer Center - North
  - Lee's Summit, Missouri, United States, 64064
    - University of Kansas Cancer Center - Lee's Summit
  - St Louis, Missouri, United States, 63131
    - Missouri Baptist Medical Center
- Montana
  - Billings, Montana, United States, 59101
    - Billings Clinic Cancer Center
  - Butte, Montana, United States, 59701
    - Saint James Community Hospital and Cancer Treatment Center
  - Great Falls, Montana, United States, 59405
    - Benefis Sletten Cancer Institute
  - Havre, Montana, United States, 59501
    - Hi-Line Sletten Cancer Center
  - Missoula, Montana, United States, 59804
    - Community Medical Center
- Nebraska
  - Omaha, Nebraska, United States, 68198
    - University of Nebraska Medical Center
  - Omaha, Nebraska, United States, 68124
    - Alegent Health Bergan Mercy Medical Center
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - Radiation Oncology Centers of Nevada Central
  - Las Vegas, Nevada, United States, 89119
    - Radiation Oncology Centers of Nevada Southeast
- New Hampshire
  - Concord, New Hampshire, United States, 03301
    - New Hampshire Oncology Hematology PA-Concord
  - Dover, New Hampshire, United States, 03820
    - Wentworth-Douglass Hospital
  - Exeter, New Hampshire, United States, 03833
    - Exeter Hospital
  - Lebanon, New Hampshire, United States, 03756
    - Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
  - Manchester, New Hampshire, United States, 03103
    - Solinsky Center for Cancer Care
- New Jersey
  - Basking Ridge, New Jersey, United States, 07920
    - Memorial Sloan Kettering Basking Ridge
  - Englewood, New Jersey, United States, 07631
    - Englewood Hospital and Medical Center
  - Freehold, New Jersey, United States, 07728
    - CentraState Medical Center
  - Hamilton, New Jersey, United States, 08690
    - The Cancer Institute of New Jersey Hamilton
  - Middletown, New Jersey, United States, 07748
    - Memorial Sloan Kettering Monmouth
  - Montvale, New Jersey, United States, 07645
    - Memorial Sloan Kettering Bergen
  - New Brunswick, New Jersey, United States, 08903
    - Rutgers Cancer Institute of New Jersey
  - New Brunswick, New Jersey, United States, 08901
    - Saint Peter's University Hospital
  - Sewell, New Jersey, United States, 08080
    - Sidney Kimmel Cancer Center Washington Township
  - Somerville, New Jersey, United States, 08876
    - Robert Wood Johnson University Hospital Somerset
  - Toms River, New Jersey, United States, 08755
    - Community Medical Center
- New Mexico
  - Albuquerque, New Mexico, United States, 87109
    - Lovelace Radiation Oncology
  - Albuquerque, New Mexico, United States, 87109
    - New Mexico Oncology Hematology Consultants
  - Albuquerque, New Mexico, United States, 87106
    - University of New Mexico Cancer Center
  - Las Cruces, New Mexico, United States, 88011
    - Memorial Medical Center-Las Cruces
- New York
  - Astoria, New York, United States, 11102
    - Mount Sinai Queens
  - Brooklyn, New York, United States, 11219
    - Maimonides Medical Center
  - Brooklyn, New York, United States, 11215
    - New York-Presbyterian/Brooklyn Methodist Hospital
  - Brooklyn, New York, United States, 11220
    - NYU Langone Hospital - Brooklyn
  - Canandaigua, New York, United States, 14424
    - Sands Cancer Center
  - Commack, New York, United States, 11725
    - Memorial Sloan Kettering Commack
  - Cooperstown, New York, United States, 13326
    - Mary Imogene Bassett Hospital
  - Dansville, New York, United States, 14437
    - Noyes Memorial Hospital/Myers Cancer Center
  - Harrison, New York, United States, 10604
    - Memorial Sloan Kettering Westchester
  - Mineola, New York, United States, 11501
    - NYU Langone Hospital - Long Island
  - New York, New York, United States, 10065
    - Memorial Sloan Kettering Cancer Center
  - New York, New York, United States, 10019
    - Mount Sinai West
  - New York, New York, United States, 10029
    - Mount Sinai Hospital
  - New York, New York, United States, 10032
    - NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
  - New York, New York, United States, 10011
    - Mount Sinai Chelsea
  - New York, New York, United States, 10016
    - Laura and Isaac Perlmutter Cancer Center at NYU Langone
  - New York, New York, United States, 10003
    - Mount Sinai Union Square
  - Nyack, New York, United States, 10960
    - Nyack Hospital
  - Oceanside, New York, United States, 11572
    - Mount Sinai South Nassau
  - Rochester, New York, United States, 14642
    - University of Rochester
  - Rochester, New York, United States, 14620
    - Highland Hospital
  - Rochester, New York, United States, 14621
    - Rochester General Hospital
  - Rochester, New York, United States, 14606
    - Wilmot Cancer Institute Radiation Oncology at Greece
  - Rochester, New York, United States, 14623
    - Pluta Cancer Center
  - Stony Brook, New York, United States, 11794
    - Stony Brook University Medical Center
  - Syracuse, New York, United States, 13210
    - State University of New York Upstate Medical University
  - The Bronx, New York, United States, 10461
    - Montefiore Medical Center-Einstein Campus
  - The Bronx, New York, United States, 10467
    - Montefiore Medical Center - Moses Campus
  - Uniondale, New York, United States, 11553
    - Memorial Sloan Kettering Nassau
  - Webster, New York, United States, 14580
    - Wilmot Cancer Institute at Webster
- North Carolina
  - Asheville, North Carolina, United States, 28801
    - Mission Hospital
  - Asheville, North Carolina, United States, 28816
    - Hope Women's Cancer Centers-Asheville
  - Cary, North Carolina, United States, 27518
    - Duke Cancer Center Cary
  - Chapel Hill, North Carolina, United States, 27599
    - UNC Lineberger Comprehensive Cancer Center
  - Durham, North Carolina, United States, 27710
    - Duke University Medical Center
  - Gastonia, North Carolina, United States, 28054
    - CaroMont Regional Medical Center
  - Hendersonville, North Carolina, United States, 28791
    - Margaret R Pardee Memorial Hospital
  - Raleigh, North Carolina, United States, 27607
    - Duke Women's Cancer Care Raleigh
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Sanford Bismarck Medical Center
  - Grand Forks, North Dakota, United States, 58201
    - Altru Cancer Center
- Ohio
  - Akron, Ohio, United States, 44307
    - Cleveland Clinic Akron General
  - Avon, Ohio, United States, 44011
    - UH Seidman Cancer Center at UH Avon Health Center
  - Beachwood, Ohio, United States, 44122
    - UHHS-Chagrin Highlands Medical Center
  - Canton, Ohio, United States, 44708
    - Cleveland Clinic Mercy Hospital
  - Canton, Ohio, United States, 44710
    - Aultman Health Foundation
  - Chardon, Ohio, United States, 44024
    - Geauga Hospital
  - Cleveland, Ohio, United States, 44106
    - Case Western Reserve University
  - Cleveland, Ohio, United States, 44109
    - MetroHealth Medical Center
  - Columbus, Ohio, United States, 43214
    - Riverside Methodist Hospital
  - Columbus, Ohio, United States, 43210
    - Ohio State University Comprehensive Cancer Center
  - Columbus, Ohio, United States, 43219
    - The Mark H Zangmeister Center
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center
  - Delaware, Ohio, United States, 43015
    - Delaware Health Center-Grady Cancer Center
  - Dublin, Ohio, United States, 43016
    - Dublin Methodist Hospital
  - Elyria, Ohio, United States, 44035
    - Mercy Cancer Center-Elyria
  - Grove City, Ohio, United States, 43123
    - Mount Carmel Grove City Hospital
  - Mansfield, Ohio, United States, 44903
    - OhioHealth Mansfield Hospital
  - Mentor, Ohio, United States, 44060
    - UH Seidman Cancer Center at Lake Health Mentor Campus
  - Middleburg Heights, Ohio, United States, 44130
    - UH Seidman Cancer Center at Southwest General Hospital
  - Parma, Ohio, United States, 44129
    - University Hospitals Parma Medical Center
  - Perrysburg, Ohio, United States, 43551
    - Mercy Health - Perrysburg Hospital
  - Ravenna, Ohio, United States, 44266
    - University Hospitals Portage Medical Center
  - Sandusky, Ohio, United States, 44870
    - UH Seidman Cancer Center at Firelands Regional Medical Center
  - Sylvania, Ohio, United States, 43560
    - ProMedica Flower Hospital
  - Wadsworth, Ohio, United States, 44281
    - University Hospitals Sharon Health Center
  - Westerville, Ohio, United States, 43081
    - Saint Ann's Hospital
  - Westlake, Ohio, United States, 44145
    - UH Seidman Cancer Center at Saint John Medical Center
  - Westlake, Ohio, United States, 44145
    - UHHS-Westlake Medical Center
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
- Oregon
  - Bend, Oregon, United States, 97701
    - Saint Charles Health System
  - Corvallis, Oregon, United States, 97330
    - Good Samaritan Hospital
  - Portland, Oregon, United States, 97239
    - Oregon Health and Science University
- Pennsylvania
  - Bryn Mawr, Pennsylvania, United States, 19010
    - Bryn Mawr Hospital
  - Carlisle, Pennsylvania, United States, 17015
    - Carlisle Regional Cancer Center
  - Chadds Ford, Pennsylvania, United States, 19317
    - Christiana Care Health System-Concord Health Center
  - Chambersburg, Pennsylvania, United States, 17201
    - Chambersburg Hospital
  - Ephrata, Pennsylvania, United States, 17522
    - Ephrata Cancer Center
  - Erie, Pennsylvania, United States, 16505
    - UPMC Hillman Cancer Center Erie
  - Erie, Pennsylvania, United States, 16544
    - Saint Vincent Hospital
  - Farrell, Pennsylvania, United States, 16121
    - UPMC Cancer Center at UPMC Horizon
  - Gettysburg, Pennsylvania, United States, 17325
    - Adams Cancer Center
  - Greensburg, Pennsylvania, United States, 15601
    - UPMC Cancer Centers - Arnold Palmer Pavilion
  - Harrisburg, Pennsylvania, United States, 17109
    - UPMC Pinnacle Cancer Center/Community Osteopathic Campus
  - Hershey, Pennsylvania, United States, 17033-0850
    - Penn State Milton S Hershey Medical Center
  - Indiana, Pennsylvania, United States, 15701
    - IRMC Cancer Center
  - Jefferson Hills, Pennsylvania, United States, 15025
    - Jefferson Hospital
  - Johnstown, Pennsylvania, United States, 15901
    - UPMC-Johnstown/John P. Murtha Regional Cancer Center
  - Lancaster, Pennsylvania, United States, 17601
    - Lancaster General Ann B Barshinger Cancer Institute
  - Lancaster, Pennsylvania, United States, 17602
    - Lancaster General Hospital
  - Mechanicsburg, Pennsylvania, United States, 17050
    - UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
  - Media, Pennsylvania, United States, 19063
    - Riddle Memorial Hospital
  - Monroeville, Pennsylvania, United States, 15146
    - Forbes Hospital
  - Monroeville, Pennsylvania, United States, 15146
    - UPMC Cancer Center - Monroeville
  - Newtown Square, Pennsylvania, United States, 19073
    - Bryn Mawr Health Center
  - Paoli, Pennsylvania, United States, 19301
    - Paoli Memorial Hospital
  - Philadelphia, Pennsylvania, United States, 19107
    - Thomas Jefferson University Hospital
  - Philadelphia, Pennsylvania, United States, 19114
    - Jefferson Torresdale Hospital
  - Pittsburgh, Pennsylvania, United States, 15212
    - Allegheny General Hospital
  - Pittsburgh, Pennsylvania, United States, 15224
    - West Penn Hospital
  - Pittsburgh, Pennsylvania, United States, 15213
    - UPMC-Magee Womens Hospital
  - Pittsburgh, Pennsylvania, United States, 15232
    - UPMC-Shadyside Hospital
  - Pittsburgh, Pennsylvania, United States, 15215
    - UPMC-Saint Margaret
  - Pittsburgh, Pennsylvania, United States, 15237
    - UPMC-Passavant Hospital
  - Pittsburgh, Pennsylvania, United States, 15243
    - UPMC-Saint Clair Hospital Cancer Center
  - Reading, Pennsylvania, United States, 19605
    - Penn State Health Saint Joseph Medical Center
  - Washington, Pennsylvania, United States, 15301
    - UPMC Washington Hospital Radiation Oncology
  - West Reading, Pennsylvania, United States, 19611
    - Reading Hospital
  - Wexford, Pennsylvania, United States, 15090
    - Wexford Health and Wellness Pavilion
  - Willow Grove, Pennsylvania, United States, 19090
    - Asplundh Cancer Pavilion
  - Wynnewood, Pennsylvania, United States, 19096
    - Lankenau Medical Center
  - York, Pennsylvania, United States, 17403
    - WellSpan Health-York Cancer Center
  - York, Pennsylvania, United States, 17408
    - UPMC Memorial
- Rhode Island
  - Providence, Rhode Island, United States, 02905
    - Women and Infants Hospital
  - Warwick, Rhode Island, United States, 02886
    - Kent Hospital
- South Carolina
  - Bluffton, South Carolina, United States, 29910
    - Saint Joseph's/Candler - Bluffton Campus
  - Boiling Springs, South Carolina, United States, 29316
    - Prisma Health Cancer Institute - Spartanburg
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Cancer Institute - Faris
  - Greenville, South Carolina, United States, 29607
    - Saint Francis Cancer Center
  - Greenville, South Carolina, United States, 29615
    - Prisma Health Cancer Institute - Eastside
  - Greenwood, South Carolina, United States, 29646
    - Self Regional Healthcare
  - Greer, South Carolina, United States, 29650
    - Prisma Health Cancer Institute - Greer
  - Greer, South Carolina, United States, 29651
    - Gibbs Cancer Center-Pelham
  - Hilton Head Island, South Carolina, United States, 29926
    - The Radiation Oncology Center-Hilton Head/Bluffton
  - Okatie, South Carolina, United States, 29909
    - Beaufort Memorial/New River Cancer Center
  - Seneca, South Carolina, United States, 29672
    - Prisma Health Cancer Institute - Seneca
  - Spartanburg, South Carolina, United States, 29303
    - Spartanburg Medical Center
  - West Columbia, South Carolina, United States, 29169
    - Lexington Medical Center
- South Dakota
  - Sioux Falls, South Dakota, United States, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
- Tennessee
  - Memphis, Tennessee, United States, 38120
    - Baptist Memorial Hospital and Cancer Center-Memphis
- Texas
  - Baytown, Texas, United States, 77521
    - Houston Methodist San Jacinto Hospital
  - Conroe, Texas, United States, 77384
    - MD Anderson in The Woodlands
  - Cypress, Texas, United States, 77429
    - Houston Methodist Cypress Hospital
  - Dallas, Texas, United States, 75235
    - Parkland Memorial Hospital
  - Dallas, Texas, United States, 75390
    - UT Southwestern/Simmons Cancer Center-Dallas
  - Galveston, Texas, United States, 77555-0565
    - University of Texas Medical Branch
  - Houston, Texas, United States, 77030
    - M D Anderson Cancer Center
  - Houston, Texas, United States, 77030
    - Houston Methodist Hospital
  - Houston, Texas, United States, 77030
    - Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
  - Houston, Texas, United States, 77070
    - Methodist Willowbrook Hospital
  - Houston, Texas, United States, 77030
    - Ben Taub General Hospital
  - Houston, Texas, United States, 77094
    - Houston Methodist West Hospital
  - Houston, Texas, United States, 77079
    - MD Anderson West Houston
  - Laredo, Texas, United States, 78041
    - Doctor's Hospital of Laredo
  - League City, Texas, United States, 77573
    - MD Anderson League City
  - Nassau Bay, Texas, United States, 77058
    - Houston Methodist Saint John Hospital
  - San Antonio, Texas, United States, 78229
    - University of Texas Health Science Center at San Antonio
  - Sugar Land, Texas, United States, 77478
    - MD Anderson in Sugar Land
  - Sugar Land, Texas, United States, 77479
    - Houston Methodist Sugar Land Hospital
  - The Woodlands, Texas, United States, 77385
    - Houston Methodist The Woodlands Hospital
- Utah
  - American Fork, Utah, United States, 84003
    - American Fork Hospital / Huntsman Intermountain Cancer Center
  - Cedar City, Utah, United States, 84720
    - Sandra L Maxwell Cancer Center
  - Farmington, Utah, United States, 84025
    - Farmington Health Center
  - Logan, Utah, United States, 84321
    - Logan Regional Hospital
  - Murray, Utah, United States, 84107
    - Intermountain Medical Center
  - Ogden, Utah, United States, 84403
    - McKay-Dee Hospital Center
  - Provo, Utah, United States, 84604
    - Utah Valley Regional Medical Center
  - Riverton, Utah, United States, 84065
    - Riverton Hospital
  - Salt Lake City, Utah, United States, 84112
    - Huntsman Cancer Institute/University of Utah
  - Salt Lake City, Utah, United States, 84143
    - LDS Hospital
  - Salt Lake City, Utah, United States, 84106
    - University of Utah Sugarhouse Health Center
  - South Jordan, Utah, United States, 84009
    - South Jordan Health Center
  - St. George, Utah, United States, 84770
    - Saint George Regional Medical Center
- Vermont
  - Berlin Corners, Vermont, United States, 05602
    - Central Vermont Medical Center/National Life Cancer Treatment
  - Burlington, Vermont, United States, 05401
    - University of Vermont Medical Center
  - Saint Johnsbury, Vermont, United States, 05819
    - Dartmouth Cancer Center - North
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - University of Virginia Cancer Center
  - Fishersville, Virginia, United States, 22939
    - Augusta Health Center for Cancer and Blood Disorders
  - Midlothian, Virginia, United States, 23114
    - Bon Secours Saint Francis Medical Center
  - Portsmouth, Virginia, United States, 23708-2197
    - Naval Medical Center - Portsmouth
  - Richmond, Virginia, United States, 23230
    - Bon Secours Cancer Institute at Reynolds Crossing
  - Richmond, Virginia, United States, 23235
    - CJW Medical Center - Johnston-Willis Campus
- Washington
  - Auburn, Washington, United States, 98001
    - MultiCare Auburn Medical Center
  - Gig Harbor, Washington, United States, 98335
    - MultiCare Gig Harbor Medical Park
  - Seattle, Washington, United States, 98122
    - Swedish Medical Center-First Hill
  - Tacoma, Washington, United States, 98405
    - MultiCare Tacoma General Hospital
- West Virginia
  - Morgantown, West Virginia, United States, 26506
    - West Virginia University Healthcare
- Wisconsin
  - Antigo, Wisconsin, United States, 54409
    - Langlade Hospital and Cancer Center
  - Appleton, Wisconsin, United States, 54911
    - ThedaCare Regional Cancer Center
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Medical Center-EC Cancer Center
  - Eau Claire, Wisconsin, United States, 54701
    - HSHS Sacred Heart Hospital
  - Grafton, Wisconsin, United States, 53024
    - Aurora Cancer Care-Grafton
  - Green Bay, Wisconsin, United States, 54311
    - Aurora BayCare Medical Center
  - Green Bay, Wisconsin, United States, 54301
    - Saint Vincent Hospital Cancer Center Green Bay
  - Green Bay, Wisconsin, United States, 54303
    - Saint Vincent Hospital Cancer Center at Saint Mary's
  - Green Bay, Wisconsin, United States, 54301
    - Bellin Memorial Hospital
  - Johnson Creek, Wisconsin, United States, 53038
    - University of Wisconsin Carbone Cancer Center - Johnson Creek
  - Kenosha, Wisconsin, United States, 53142
    - Aurora Cancer Care-Kenosha South
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Medical Center
  - Madison, Wisconsin, United States, 53792
    - University of Wisconsin Carbone Cancer Center - University Hospital
  - Madison, Wisconsin, United States, 53718
    - University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
  - Marinette, Wisconsin, United States, 54143
    - Aurora Bay Area Medical Group-Marinette
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Medical Center-Marshfield
  - Menomonee Falls, Wisconsin, United States, 53051
    - Froedtert Menomonee Falls Hospital
  - Milwaukee, Wisconsin, United States, 53226
    - Medical College of Wisconsin
  - Milwaukee, Wisconsin, United States, 53215
    - Aurora Saint Luke's Medical Center
  - Milwaukee, Wisconsin, United States, 53233
    - Aurora Sinai Medical Center
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Medical Center - Minocqua
  - Mukwonago, Wisconsin, United States, 53149
    - ProHealth D N Greenwald Center
  - New Richmond, Wisconsin, United States, 54017
    - Cancer Center of Western Wisconsin
  - Oak Creek, Wisconsin, United States, 53154
    - Drexel Town Square Health Center
  - Oconomowoc, Wisconsin, United States, 53066
    - ProHealth Oconomowoc Memorial Hospital
  - Oshkosh, Wisconsin, United States, 54904
    - Vince Lombardi Cancer Clinic - Oshkosh
  - Rhinelander, Wisconsin, United States, 54501
    - Aspirus Cancer Care - James Beck Cancer Center
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Medical Center-Rice Lake
  - Sheboygan, Wisconsin, United States, 53081
    - Vince Lombardi Cancer Clinic-Sheboygan
  - Sheboygan, Wisconsin, United States, 53081
    - HSHS Saint Nicholas Hospital
  - Stevens Point, Wisconsin, United States, 54482
    - Marshfield Medical Center-River Region at Stevens Point
  - Stevens Point, Wisconsin, United States, 54481
    - Aspirus Cancer Care - Stevens Point
  - Sturgeon Bay, Wisconsin, United States, 54235-1495
    - Saint Vincent Hospital Cancer Center at Sturgeon Bay
  - Summit, Wisconsin, United States, 53066
    - Aurora Medical Center in Summit
  - Two Rivers, Wisconsin, United States, 54241
    - Vince Lombardi Cancer Clinic-Two Rivers
  - Wausau, Wisconsin, United States, 54401
    - Aspirus Regional Cancer Center
  - West Allis, Wisconsin, United States, 53227
    - Aurora West Allis Medical Center
  - West Bend, Wisconsin, United States, 53095
    - Froedtert West Bend Hospital/Kraemer Cancer Center
  - Weston, Wisconsin, United States, 54476
    - Marshfield Medical Center - Weston
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Aspirus Cancer Care - Wisconsin Rapids

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: No Regional Radiotherapy A. Whole Breast Irradiation (WBI) following BCS or; B. No Radiotherapy (RT) following mastectomy	Radiation: Radiation Radiotherapy given Other: No Radiation No radiotherapy given
Active Comparator: Regional Radiotherapy A. WBI plus RT to the regional nodes (supraclavicular, non-dissected axillary, and internal mammary) following BCS or; B. RT to the chestwall and regional nodes (supraclavicular, non-dissected axillary, and internal mammary) following mastectomy	Radiation: Radiation Radiotherapy given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not Time Frame: 9.5 years	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the invasive disease-free survival between patients that received regional RT or not. Time Frame: 9.5 years	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
Compare the breast cancer mortality between patients that received regional RT or not. Time Frame: 9.5 years	Defined as death due to BC	9.5 years
Compare the overall survival (OS) between patients that received regional RT or not Time Frame: 9.5 years	Defined as the time from randomization to the time of death from any cause	9.5 years
Compare the locoregional recurrence-free interval (LRRFI) between patients that received regional RT or not. Time Frame: 9.5 years	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
Compare the distant recurrence-free interval (DRFI) between patients that received regional RT or not. Time Frame: 9.5 years	Defined as time from randomization to time of invasive recurrent disease in distant sites or death due to BC	9.5 years
Number and severity of adverse events using the current CTCAE version 4 Time Frame: 9.5 years		9.5 years
Compare arm volume and mobility measurements between patients that received regional RT or not Time Frame: 9.5 years	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
Compare patient-reported outcomes (PROs) and the quality of life (QOL) between patients that received regional RT or not Time Frame: 9.5 years	using the NSABP Questionnaire for patients treated by BCS or mastectomy.	9.5 years
Compare the quality of life (QOL) between patients that received regional RT or not Time Frame: 9.5 years	Overall QOL (EORTC QLQ-C30) will be compared between the two treatment groups using a similar approach.	9.5 years
Compare the cost-effectiveness between patients that received regional RT or not Time Frame: 9.5 years	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
Compare the quality of life (QOL) between patients that received regional RT or not Time Frame: 9.5 years	breast symptoms (NSABP B32 Questionnaire) will be compared between the two treatment groups using a similar approach.	9.5 years
Compare the quality of life (QOL) between patients that received regional RT or not Time Frame: 9.5 years	skin symptoms and fatigue (EORTC QLQ-BR23) will be compared between the two treatment groups using a similar approach.	9.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Cancer Trials Group

Collaborators

Alliance for Clinical Trials in Oncology

NRG Oncology

Eastern Cooperative Oncology Group

SWOG Cancer Research Network

Investigators

Study Chair: Timothy Whelan, Juravinski Cancer Centre at Hamilton Health Sciences, Ontario Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2018

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

March 28, 2018

First Submitted That Met QC Criteria

April 4, 2018

First Posted (Actual)

April 5, 2018

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

CCTG MA.39
NCI-2017-02047 (Other Identifier: NCI CTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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CYP17 Lyase and Androgen Receptor Inhibitor Treatment With Seviteronel Trial (INO-VT-464-006; NCT02580448) (CLARITY-01)

Breast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the Breast

United States
Case Comprehensive Cancer Center
National Institute on Minority Health and Health Disparities (NIMHD)

Completed

Attitudes, Beliefs, and Preferences of Older Stage I-III Breast Cancer Survivors Towards Physical Activity

Cancer Survivor | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer

United States
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)

Completed

Combination Chemotherapy and Peripheral Blood Stem Cell Transplant Followed By Aldesleukin and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer

Inflammatory Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage IIIB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast Cancer

United States

Clinical Trials on Radiation

Cancer Institute and Hospital, Chinese Academy...

Terminated

Clinical Trial of Postmastectomy Radiotherapy in Breast Cancer With One to Three Positive Nodes

Breast Cancer

China
Massachusetts General Hospital

Completed

High-Dose Proton/Photon RT + Surgery of Sarcomas of the Thoracic, Lumbar Spine/Sacrum

Mesenchymal Tumor

United States
Memorial Sloan Kettering Cancer Center
The Leukemia and Lymphoma Society

Recruiting

A Study of Reduced Dose Radiation Therapy for People With B-Cell Lymphomas

Follicular Lymphoma | Marginal Zone Lymphoma

United States
Fudan University

Active, not recruiting

Orelabrutinib Followed by Response-adapted Ultra-low Dose 4Gy Radiation as First-line Treatment of MALT Lymphoma

Lymphoma, B-Cell, Marginal Zone

China
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Active, not recruiting

Ultra Low Dose Orbital Radiation Therapy in Treating Patients With Stage I-IV Indolent B-cell Lymphoma or Mantle Cell Lymphoma

Ann Arbor Stage I Grade 1 Follicular Lymphoma | Ann Arbor Stage I Grade 2 Follicular Lymphoma | Ann Arbor Stage II Grade 1 Follicular Lymphoma | Ann Arbor Stage II Grade 2 Follicular Lymphoma | Ann Arbor Stage IV B-Cell Non-Hodgkin Lymphoma | Ann Arbor Stage I B-Cell Non-Hodgkin Lymphoma | Ann... and other conditions

United States
Ohio State University Comprehensive Cancer Center

Completed

Stereotactic Radiation Therapy in Treating Patients With Brain Metastases

Unspecified Adult Solid Tumor, Protocol Specific | Metastatic Cancer

United States
Maastricht Radiation Oncology
The Netherlands Cancer Institute; Diakonessenhuis, Utrecht

Completed

Radiotherapy After Primary Chemotherapy for Breastcancer (RAPCHEM)

Breast Cancer

Netherlands
University of Chicago

Active, not recruiting

Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma

Lymphoma | Hodgkin Lymphoma | Non-hodgkin Lymphoma

United States
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Completed

Radiation Therapy Alone for the Treatment of Stage 1 and 2 Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma

Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Extranodal Marginal Zone Lymphoma

United States
University of Texas Southwestern Medical Center

Completed

Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-III Non-Small Cell Lung Cancer

Non-small Cell Lung Cancer

United States

Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer (TAILOR RT)

TAILOR RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer

Study Overview

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product manufactured in and exported from the U.S.

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