AzTrials
AzTrials

Breast CancerPhase 3TAILOR RTNCT03488693

Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer

A Phase 3 study testing Radiation and No Radiation in people with Breast Cancer, run by Canadian Cancer Trials Group at 485 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 35 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Radiation and No Radiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,138 participants
Where
485 sitesin 2 countries
Study dates
16 Oct 2018to 30 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

485 sites in 2 countries.

334 sites in 2 countries

United States300 sites

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Lovelace Radiation Oncology

    Albuquerque, New Mexico, 87109

  • New Mexico Oncology Hematology Consultants

    Albuquerque, New Mexico, 87109

  • American Fork Hospital / Huntsman Intermountain Cancer Center

    American Fork, Utah, 84003

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

  • Luminis Health Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Langlade Hospital and Cancer Center

    Antigo, Wisconsin, 54409

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • Mission Hospital

    Asheville, North Carolina, 28801

  • Hope Women's Cancer Centers-Asheville

    Asheville, North Carolina, 28816

  • Mount Sinai Queens

    Astoria, New York, 11102

  • Grady Health System

    Atlanta, Georgia, 30303

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

  • IU Health West Hospital

    Avon, Indiana, 46123

  • UH Seidman Cancer Center at UH Avon Health Center

    Avon, Ohio, 44011

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute

    Baltimore, Maryland, 21237

  • MedStar Good Samaritan Hospital

    Baltimore, Maryland, 21239

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • MaineHealth Coastal Cancer Treatment Center

    Bath, Maine, 04530

  • McLaren Cancer Institute-Bay City

    Bay City, Michigan, 48706

  • Houston Methodist San Jacinto Hospital

    Baytown, Texas, 77521

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Saint Charles Health System

    Bend, Oregon, 97701

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

  • Suburban Hospital

    Bethesda, Maryland, 20814

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Saint Joseph's/Candler - Bluffton Campus

    Bluffton, South Carolina, 29910

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Lafayette Family Cancer Center-EMMC

    Brewer, Maine, 04412

  • New York-Presbyterian/Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • NYU Langone Hospital - Brooklyn

    Brooklyn, New York, 11220

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Sands Cancer Center

    Canandaigua, New York, 14424

  • Cleveland Clinic Mercy Hospital

    Canton, Ohio, 44708

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Carlisle Regional Cancer Center

    Carlisle, Pennsylvania, 17015

  • IU Health North Hospital

    Carmel, Indiana, 46032

  • Duke Cancer Center Cary

    Cary, North Carolina, 27518

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Saint Luke's Hospital

    Cedar Rapids, Iowa, 52402

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

  • Chambersburg Hospital

    Chambersburg, Pennsylvania, 17201

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Geauga Hospital

    Chardon, Ohio, 44024

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • Swedish Covenant Hospital

    Chicago, Illinois, 60625

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • McLaren Cancer Institute-Clarkston

    Clarkston, Michigan, 48346

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

  • Saint Francis Cancer Center

    Colorado Springs, Colorado, 80923

  • MU Health - University Hospital/Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

  • MD Anderson in The Woodlands

    Conroe, Texas, 77384

  • Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

  • City of Hope Corona

    Corona, California, 92882

  • Good Samaritan Hospital

    Corvallis, Oregon, 97330

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • UChicago Medicine Northwest Indiana

    Crown Point, Indiana, 46307

  • Houston Methodist Cypress Hospital

    Cypress, Texas, 77429

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Danbury Hospital

    Danbury, Connecticut, 06810

  • Noyes Memorial Hospital/Myers Cancer Center

    Dansville, New York, 14437

  • Corewell Health Dearborn Hospital

    Dearborn, Michigan, 48124

  • Emory Decatur Hospital

    Decatur, Georgia, 30033

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • UCHealth - Cherry Creek

    Denver, Colorado, 80206

  • AdventHealth Porter

    Denver, Colorado, 80210

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Wentworth-Douglass Hospital

    Dover, New Hampshire, 03820

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Kaiser Permanente Dublin

    Dublin, California, 94568

  • Dublin Methodist Hospital

    Dublin, Ohio, 43016

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • University of Maryland Shore Medical Center at Easton

    Easton, Maryland, 21601

  • HSHS Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Saint Elizabeth Healthcare Edgewood

    Edgewood, Kentucky, 41017

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Mercy Cancer Center-Elyria

    Elyria, Ohio, 44035

  • UC San Diego Health System - Encinitas

    Encinitas, California, 92024

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

  • Saint Vincent Hospital

    Erie, Pennsylvania, 16544

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Exeter Hospital

    Exeter, New Hampshire, 03833

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • Farmington Health Center

    Farmington, Utah, 84025

  • Corewell Health Farmington Hills Hospital

    Farmington Hills, Michigan, 48336

  • UPMC Cancer Center at UPMC Horizon

    Farrell, Pennsylvania, 16121

  • IU Health Central Indiana Cancer Centers-Fishers

    Fishers, Indiana, 46037

  • Augusta Health Center for Cancer and Blood Disorders

    Fishersville, Virginia, 22939

  • McLaren Cancer Institute-Flint

    Flint, Michigan, 48532

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

  • Saint Elizabeth Healthcare Fort Thomas

    Fort Thomas, Kentucky, 41075

  • CentraState Medical Center

    Freehold, New Jersey, 07728

  • Fresno Cancer Center

    Fresno, California, 93720

  • UF Health Cancer Institute - Gainesville

    Gainesville, Florida, 32610

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • CaroMont Regional Medical Center

    Gastonia, North Carolina, 28054

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • MultiCare Gig Harbor Medical Park

    Gig Harbor, Washington, 98335

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • UM Baltimore Washington Medical Center/Tate Cancer Center

    Glen Burnie, Maryland, 21061

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026

  • Lutheran Hospital - Cancer Centers of Colorado

    Golden, Colorado, 80401

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Altru Cancer Center

    Grand Forks, North Dakota, 58201

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Banner North Colorado Medical Center

    Greeley, Colorado, 80631

  • UCHealth Greeley Hospital

    Greeley, Colorado, 80631

  • Bellin Memorial Hospital

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • UPMC Cancer Centers - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Self Regional Healthcare

    Greenwood, South Carolina, 29646

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Mount Carmel Grove City Hospital

    Grove City, Ohio, 43123

  • Smilow Cancer Hospital Care Center - Guilford

    Guilford, Connecticut, 06437

  • Smilow Cancer Hospital-Hamden Care Center

    Hamden, Connecticut, 06518

  • The Cancer Institute of New Jersey Hamilton

    Hamilton, New Jersey, 08690

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania, 17109

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Hi-Line Sletten Cancer Center

    Havre, Montana, 59501

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois, 60035

  • UCHealth Highlands Ranch Hospital

    Highlands Ranch, Colorado, 80129

  • The Radiation Oncology Center-Hilton Head/Bluffton

    Hilton Head Island, South Carolina, 29926

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77030

  • Ben Taub General Hospital

    Houston, Texas, 77030

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Methodist Willowbrook Hospital

    Houston, Texas, 77070

  • MD Anderson West Houston

    Houston, Texas, 77079

  • Houston Methodist West Hospital

    Houston, Texas, 77094

  • IRMC Cancer Center

    Indiana, Pennsylvania, 15701

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • IU Health Methodist Hospital

    Indianapolis, Indiana, 46202

  • Community Cancer Center East

    Indianapolis, Indiana, 46219

  • Community Cancer Center South

    Indianapolis, Indiana, 46227

  • Community Cancer Center North

    Indianapolis, Indiana, 46256

  • City of Hope at Irvine Lennar

    Irvine, California, 92618

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • MU Health Care Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • Jefferson Hospital

    Jefferson Hills, Pennsylvania, 15025

  • University of Wisconsin Carbone Cancer Center - Johnson Creek

    Johnson Creek, Wisconsin, 53038

  • UPMC-Johnstown/John P. Murtha Regional Cancer Center

    Johnstown, Pennsylvania, 15901

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

  • City of Hope Antelope Valley

    Lancaster, California, 93534

  • Lancaster General Ann B Barshinger Cancer Institute

    Lancaster, Pennsylvania, 17601

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602

  • Karmanos Cancer Institute at McLaren Greater Lansing

    Lansing, Michigan, 48910

  • Doctor's Hospital of Laredo

    Laredo, Texas, 78041

  • UM Capital Region Medical Center

    Largo, Maryland, 20774

  • Memorial Medical Center-Las Cruces

    Las Cruces, New Mexico, 88011

  • Radiation Oncology Centers of Nevada Central

    Las Vegas, Nevada, 89106

  • Radiation Oncology Centers of Nevada Southeast

    Las Vegas, Nevada, 89119

  • MD Anderson League City

    League City, Texas, 77573

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

  • Saint Joseph Radiation Oncology Resource Center

    Lexington, Kentucky, 40504

  • Saint Joseph Hospital East

    Lexington, Kentucky, 40509

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • AdventHealth Littleton

    Littleton, Colorado, 80122

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Los Angeles General Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • UofL Health Medical Center Northeast

    Louisville, Kentucky, 40245

  • Banner North Colorado Medical Center - Loveland Campus

    Loveland, Colorado, 80539

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    Madison, Wisconsin, 53718

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

  • Solinsky Center for Cancer Care

    Manchester, New Hampshire, 03103

  • OhioHealth Mansfield Hospital

    Mansfield, Ohio, 44903

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

    Mechanicsburg, Pennsylvania, 17050

  • Riddle Memorial Hospital

    Media, Pennsylvania, 19063

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • Miami Cancer Institute

    Miami, Florida, 33176

  • UH Seidman Cancer Center at Southwest General Hospital

    Middleburg Heights, Ohio, 44130

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Bon Secours Saint Francis Medical Center

    Midlothian, Virginia, 23114

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

  • Community Medical Center

    Missoula, Montana, 59804

  • Forbes Hospital

    Monroeville, Pennsylvania, 15146

  • UPMC Cancer Center - Monroeville

    Monroeville, Pennsylvania, 15146

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

  • McLaren Cancer Institute-Macomb

    Mount Clemens, Michigan, 48043

  • McLaren Cancer Institute-Central Michigan

    Mount Pleasant, Michigan, 48858

  • ProHealth D N Greenwald Center

    Mukwonago, Wisconsin, 53149

  • IU Health Ball Memorial Hospital

    Muncie, Indiana, 47303

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Trinity Health Muskegon Hospital

    Muskegon, Michigan, 49444

  • Providence Queen of The Valley

    Napa, California, 94558

  • Houston Methodist Saint John Hospital

    Nassau Bay, Texas, 77058

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Yale University

    New Haven, Connecticut, 06520

  • UC Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • Mount Sinai Union Square

    New York, New York, 10003

  • Mount Sinai Chelsea

    New York, New York, 10011

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Mount Sinai West

    New York, New York, 10019

  • Mount Sinai Hospital

    New York, New York, 10029

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Bryn Mawr Health Center

    Newtown Square, Pennsylvania, 19073

  • Norwalk Hospital

    Norwalk, Connecticut, 06856

  • Henry Ford Health Providence Novi Hospital

    Novi, Michigan, 48374

  • Nyack Hospital

    Nyack, New York, 10960

  • HSHS Saint Elizabeth's Hospital

    O'Fallon, Illinois, 62269

  • Drexel Town Square Health Center

    Oak Creek, Wisconsin, 53154

  • Kaiser Permanente Oakland-Broadway

    Oakland, California, 94611

  • Mount Sinai South Nassau

    Oceanside, New York, 11572

Other trials in United States

Canada34 sites

  • BCCA-Abbotsford Cancer Centre

    Abbotsford British Columbia, British Columbia, V2S 1K2

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

  • CSSS Champlain-Charles Le Moyne

    Greenfield Park, Quebec, J4V 2H1

  • QEII Health Sciences Centre/Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 2Y9

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • BCCA-Cancer Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

  • Waterloo Regional Health Network

    Kitchener, Ontario, N2G 1G3

  • Hopital de la Cite-de-la-Sante

    Laval, Quebec, H7M 3L9

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • Trillium Health Partners - Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

  • CIUSSSEMTL-Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • CHUM - Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

  • The Research Institute of the McGill University Health Centre (MUHC)

    Montreal, Quebec, H3H 2R9

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Ottawa Hospital and Cancer Center-General Campus

    Ottawa, Ontario, K1H 8L6

  • BCCA-Cancer Centre for the North

    Prince George, British Columbia, V2M 7E9

  • CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)

    Québec, Quebec, G1R 2J6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Niagara Health System-Saint Catharines General

    Saint Catharines, Ontario, L2S 0A9

  • Atlantic Health Sciences Corporation-Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Algoma District Cancer Program Sault Area Hospital

    Sault Ste. Marie, Ontario, P6B 0A8

  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

    Sherbrooke, Quebec, J1H 5N4

  • Doctor H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • BCCA-Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • BCCA-Vancouver Island Cancer Centre

    Victoria, British Columbia, V8R 6V5

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions
Breast Cancer
Being tested
Radiation, No Radiation
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadiationRadiation

    Radiotherapy given

  • No RadiationOther

    No radiotherapy given

Study groups in NCT03488693
Study groupRoleWhat they receive
No Regional RadiotherapyActive comparatorA. Whole Breast Irradiation (WBI) following BCS or; B. No Radiotherapy (RT) following mastectomy
Receives: Radiation: Radiation; Other: No Radiation
Regional RadiotherapyActive comparatorA. 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
Receives: Radiation: Radiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 9.5 years

Secondary outcomes (12)

  1. 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

    Measured: 9.5 years

  2. Compare the breast cancer mortality between patients that received regional RT or not.

    Defined as death due to BC

    Measured: 9.5 years

  3. 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

    Measured: 9.5 years

  4. 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

    Measured: 9.5 years

  5. 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

    Measured: 9.5 years

  6. Number and severity of adverse events using the current CTCAE version 4

    Measured: 9.5 years

  7. 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.

    Measured: 9.5 years

  8. 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.

    Measured: 9.5 years

  9. 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.

    Measured: 9.5 years

  10. 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

    Measured: 9.5 years

  11. 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.

    Measured: 9.5 years

  12. 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.

    Measured: 9.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2018
  2. Study start16 Oct 2018
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03488693
Sponsor's protocol ID
CCTG MA.39
Other IDs
NCI-2017-02047
Acronym
TAILOR RT
Status last verified
Jun 2026
First submitted
28 Mar 2018
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radiation and No Radiation in people with Breast Cancer, run by Canadian Cancer Trials Group at 485 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 485 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not (time frame: 9.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03488693.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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