AzTrials
AzTrials

Ductal Breast CarcinomaPhase 3NCT03414970

Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer

A Phase 3 study testing Radiation Therapy, Questionnaire Administration and Quality-of-Life Assessment in people with Ductal Breast Carcinoma and Invasive Breast Carcinoma, run by Alliance for Clinical Trials in Oncology at 859 sites in 2 countries.

Active, not recruiting

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

Official record

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Trial summary

This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Radiation Therapy, Questionnaire Administration and Quality-of-Life Assessment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
898 participants
Where
859 sitesin 2 countries
Study dates
12 Mar 2018to Aug 2035
Phase
Phase 3

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed invasive carcinoma of the breast of any of the following histologies (ductal, lobular, mammary, medullary, or tubular); patients with metaplastic breast cancer are not eligible
  • Patients will be staged according to the TNM staging system
  • For patients not receiving neoadjuvant chemotherapy, pathologic staging must be T0N1-2a, T1N1-2a, T2N1-2a, T3N0-2a, and all M0 status
  • For patients receiving neoadjuvant chemotherapy, clinical pre-chemo staging and post mastectomy pathological staging is required for all patients; patients who have received neoadjuvant chemotherapy and are pathologically cT0-2 and N0 are only eligible if biopsy-proven clinically N1 or N2 disease is documented prior to the start of neoadjuvant chemotherapy; cT3N0 patients or ypT3N0 patients who receive neoadjuvant chemotherapy may be eligible based on clinical or pathological T stage, and do not require pathologically positive lymph nodes
  • Note: Higher of the clinical or pathological T and N stage are used for final staging, if receiving neoadjuvant chemotherapy; all patients with clinical, radiographic or pathological T4, N3 or involved internal mammary disease (N1b, N1c, and N2b) are not eligible. N1mic patients are eligible.
  • No prior therapeutic radiation therapy to the chest, neck or axilla; prior radioactive oral iodine is permitted
Show all 24Show fewer
  • No prior history of ipsilateral breast cancer (invasive disease or ductal breast carcinoma in situ [DCIS]); lobular carcinoma in situ (LCIS) and benign breast disease is allowed
  • No history of prior or concurrent contralateral invasive breast cancer; benign breast disease, LCIS or DCIS of contralateral breast is allowed
  • No active collagen vascular diseases, such as: systemic lupus erythematous, scleroderma, or dermatomyositis
  • Negative inked histologic margins from mastectomy pathology (no invasive cells at margin). Patients with DCIS at margin are eligible.
  • No significant post mastectomy complications in the ipsilateral breast requiring an unplanned re-operation or admission for intravenous (IV) antibiotics; re-operation for margins evaluation, nodal completion and routine reconstruction is acceptable
  • Radiation oncologist intends to treat all target volumes and respect all normal tissues in accordance with the dosimetric constraints described (simulation before registration recommended)
  • Radiation oncologist is planning to treat regional lymph nodes including internal mammary nodes and meet acceptable protocol dosimetric requirements
  • Radiation oncologist is NOT planning to utilize a chest wall/scar boost
  • Patient must have undergone immediate reconstruction at the time of mastectomy or be planning to undergo reconstruction within 18 months after radiation
  • Treating physician and patient must plan to start radiation treatment within the timeframes specified in protocol.
  • If a tissue expander is utilized it needs to be a fluid filled expander, NO air expander (unless completely deflated) during radiation therapy
  • For patients with diabetes, hemoglobin A1C test must have been performed =< 90 days prior to registration
  • No co-existing medical conditions with life expectancy < 5 years
  • No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix
  • Negative pregnancy test (serum or urine HCG) in women of child-bearing potential ≤ 7 days prior to registration. Patients who have received a bilateral tubal ligation still require a negative pregnancy test for eligibility. A female of childbearing potential is a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 12 consecutive months
  • Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy
  • Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1
  • Patients must be able to read and comprehend English, in order to be able to complete study questionnaires; however, patients participating through Canadian Cancer Trials Group (CCTG) institutions who can read and comprehend French are eligible

Who cannot join

None listed.

Trial locations and contacts

859 sites in 2 countries.

313 sites in 2 countries

United States300 sites

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

  • Riverwood Healthcare Center

    Aitkin, Minnesota, 56431

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

  • Mayo Clinic Health System in Albert Lea

    Albert Lea, Minnesota, 56007

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • Lovelace Radiation Oncology

    Albuquerque, New Mexico, 87109

  • New Mexico Oncology Hematology Consultants

    Albuquerque, New Mexico, 87109

  • Inova Alexandria Hospital

    Alexandria, Virginia, 22304

  • Northside Hospital-Alpharetta

    Alpharetta, Georgia, 30005

  • AdventHealth Altamonte

    Altamonte Springs, Florida, 32701

  • Saint Anthony's Health

    Alton, Illinois, 62002

  • UPMC Altoona

    Altoona, Pennsylvania, 16601

  • American Fork Hospital / Huntsman Intermountain Cancer Center

    American Fork, Utah, 84003

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic PC - Ames

    Ames, Iowa, 50010

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, 99504

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, 94531

  • Mission Hope Medical Oncology - Arroyo Grande

    Arroyo Grande, California, 93420

  • PCR Oncology

    Arroyo Grande, California, 93420

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

  • Northwest Wisconsin Cancer Center

    Ashland, Wisconsin, 54806

  • Grady Health System

    Atlanta, Georgia, 30303

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • Northside Hospital

    Atlanta, Georgia, 30342

  • John Fitzgerald Kennedy Medical Center

    Atlantis, Florida, 33462

  • Hematology Oncology Associates of Central New York-Auburn

    Auburn, New York, 13021

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Saint Alphonsus Medical Center-Baker City

    Baker City, Oregon, 97814

  • Saint Louis Cancer and Breast Institute-Ballwin

    Ballwin, Missouri, 63011

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • Flaget Memorial Hospital

    Bardstown, Kentucky, 40004

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Louisiana Hematology Oncology Associates

    Baton Rouge, Louisiana, 70817

  • Our Lady of the Lake Medical Oncology

    Baton Rouge, Louisiana, 70817

  • Woman's Hospital

    Baton Rouge, Louisiana, 70817

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • McLaren Cancer Institute-Bay City

    Bay City, Michigan, 48706

  • Northwell Health Imbert Cancer Center

    Bay Shore, New York, 11706

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122

  • UPMC-Heritage Valley Health System Beaver

    Beaver, Pennsylvania, 15009

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

  • Overlake Medical Center

    Bellevue, Washington, 98004

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Saint Charles Health System

    Bend, Oregon, 97701

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • 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

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • Parkland Health Center-Bonne Terre

    Bonne Terre, Missouri, 63628

  • McFarland Clinic PC-Boone

    Boone, Iowa, 50036

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Boulder Community Foothills Hospital

    Boulder, Colorado, 80303

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

  • Harrison Medical Center

    Bremerton, Washington, 98310

  • Wellmont Bristol Regional Medical Center

    Bristol, Tennessee, 37620

  • Wellmont Medical Associates-Bristol

    Bristol, Virginia, 24201

  • Ascension Southeast Wisconsin Hospital - Elmbrook Campus

    Brookfield, Wisconsin, 53045

  • New York-Presbyterian/Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

  • Henry Ford Cancer Institute-Downriver

    Brownstown, Michigan, 48183

  • Saint Joseph Regional Cancer Center

    Bryan, Texas, 77802

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

  • Loyola Center for Health at Burr Ridge

    Burr Ridge, Illinois, 60527

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

  • Sands Cancer Center

    Canandiaqua, New York, 14424

  • Northside Hospital-Cherokee

    Canton, Georgia, 30115

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • Carlisle Regional Cancer Center

    Carlisle, Pennsylvania, 17015

  • Saint Anthony Regional Hospital

    Carroll, Iowa, 51401

  • Carson Tahoe Regional Medical Center

    Carson City, Nevada, 89703

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

  • AdventHealth Celebration

    Celebration, Florida, 34747

  • Rocky Mountain Cancer Centers - Centennial

    Centennial, Colorado, 80112

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

  • Geauga Hospital

    Chardon, Ohio, 44024

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • West Virginia University Charleston Division

    Charleston, West Virginia, 25304

  • Erlanger Medical Center

    Chattanooga, Tennessee, 37403

  • Memorial Hospital

    Chattanooga, Tennessee, 37404

  • Cheyenne Regional Medical Center-West

    Cheyenne, Wyoming, 82001

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

  • McLaren Cancer Institute-Clarkston

    Clarkston, Michigan, 48346

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Coffeyville Regional Medical Center

    Coffeyville, Kansas, 67337

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

  • Central Maryland Radiation Oncology in Howard County

    Columbia, Maryland, 21044

  • University of Missouri - Ellis Fischel

    Columbia, Missouri, 65212

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

  • Commonwealth Cancer Center-Corbin

    Corbin, Kentucky, 40701

  • The West Clinic - Corinth

    Corinth, Mississippi, 38834

  • City of Hope Corona

    Corona, California, 92879

  • UC Irvine Health Cancer Center-Newport

    Costa Mesa, California, 92627

  • Jennie Edmundson Memorial Hospital

    Council Bluffs, Iowa, 51502

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

  • Mary Bird Perkins Cancer Center - Covington

    Covington, Louisiana, 70433

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • Northside Hospital-Forsyth

    Cumming, Georgia, 30041

  • Carle on Vermilion

    Danville, Illinois, 61832

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Beaumont Hospital - Dearborn

    Dearborn, Michigan, 48124

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

  • 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

  • Delaware Radiation Oncology

    Delaware, Ohio, 43015

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Cancer Center of Colorado at Sloan's Lake

    Denver, Colorado, 80204

  • Denver Health Medical Center

    Denver, Colorado, 80204

  • National Jewish Health-Main Campus

    Denver, Colorado, 80206

  • The Women's Imaging Center

    Denver, Colorado, 80209

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

  • SCL Health Saint Joseph Hospital

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

  • Rose Medical Center

    Denver, Colorado, 80220

  • Western Surgical Care

    Denver, Colorado, 80220

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Broadlawns Medical Center

    Des Moines, Iowa, 50314

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Essentia Health Saint Mary's - Detroit Lakes Clinic

    Detroit Lakes, Minnesota, 56501

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Epic Care-Dublin

    Dublin, California, 94568

  • Kaiser Permanente Dublin

    Dublin, California, 94568

  • Dublin Methodist Hospital

    Dublin, Ohio, 43016

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Northeast Radiation Oncology Center

    Dunmore, Pennsylvania, 18512

  • Mercy Medical Center

    Durango, Colorado, 81301

  • Southwest Oncology PC

    Durango, Colorado, 81301

  • Hematology Oncology Associates of Central New York-East Syracuse

    East Syracuse, New York, 13057

  • Memorial Sloan Kettering Westchester

    East White Plains, New York, 10604

  • University of Maryland Shore Medical Center at Easton

    Easton, Maryland, 21601

  • HSHS Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Mayo Clinic Health System-Eau Claire Clinic

    Eau Claire, Wisconsin, 54701

  • Saint Elizabeth Medical Center South

    Edgewood, Kentucky, 41017

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Arnot Ogden Medical Center/Falck Cancer Center

    Elmira, New York, 14905

  • Mercy Cancer Center-Elyria

    Elyria, Ohio, 44035

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • Epic Care Partners in Cancer Care

    Emeryville, California, 94608

  • Walter Knox Memorial Hospital

    Emmett, Idaho, 83617

  • Mountain Blue Cancer Care Center - Swedish

    Englewood, Colorado, 80113

  • Rocky Mountain Cancer Centers - Swedish

    Englewood, Colorado, 80113

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • The Melanoma and Skin Cancer Institute

    Englewood, Colorado, 80113

  • Saint Elizabeth Hospital

    Enumclaw, Washington, 98022

  • Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

  • Ephrata Community Hospital

    Ephrata, Pennsylvania, 17522

  • Green Bay Oncology - Escanaba

    Escanaba, Michigan, 49829

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Exeter Hospital

    Exeter, New Hampshire, 03833

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Inova Fair Oaks Hospital

    Fairfax, Virginia, 22033

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota, 58103

  • Sanford South University Medical Center

    Fargo, North Dakota, 58103

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • Farmington Health Center

    Farmington, Utah, 84025

  • Beaumont Hospital - Farmington Hills

    Farmington Hills, Michigan, 48336

  • UPMC Cancer Center at UPMC Horizon

    Farrell, Pennsylvania, 16121

  • Piedmont Fayette Hospital

    Fayetteville, Georgia, 30214

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • Lake Region Healthcare Corporation-Cancer Care

    Fergus Falls, Minnesota, 56537

  • McLaren Cancer Institute-Flint

    Flint, Michigan, 48532

  • Saint Agnes Hospital/Agnesian Cancer Center

    Fond du Lac, Wisconsin, 54935

  • Aurora Health Center-Fond du Lac

    Fond du Lac, Wisconsin, 54937

  • McFarland Clinic PC-Trinity Cancer Center

    Fort Dodge, Iowa, 50501

  • Trinity Regional Medical Center

    Fort Dodge, Iowa, 50501

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

  • Saint Elizabeth Fort Thomas

    Fort Thomas, Kentucky, 41075

  • Essentia Health - Fosston

    Fosston, Minnesota, 56542

  • Beebe South Coastal Health Campus

    Frankford, Delaware, 19945

  • Vanderbilt-Ingram Cancer Center at Franklin

    Franklin, Tennessee, 37067

  • Vanderbilt-Ingram Cancer Center Cool Springs

    Franklin, Tennessee, 37067

  • Ascension Saint Francis - Reiman Cancer Center

    Franklin, Wisconsin, 53132

  • Kaiser Permanente-Fremont

    Fremont, California, 94538

  • Fresno Cancer Center

    Fresno, California, 93720

  • Kaiser Permanente-Fresno

    Fresno, California, 93720

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

  • University of Florida Health Science Center - Gainesville

    Gainesville, Florida, 32610

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • The West Clinic - Wolf River

    Germantown, Tennessee, 38138

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • MultiCare Gig Harbor Medical Park

    Gig Harbor, Washington, 98335

  • UM Baltimore Washington Medical Center/Tate Cancer Center

    Glen Burnie, Maryland, 21061

  • Glens Falls Hospital

    Glens Falls, New York, 12801

  • Valley View Hospital Cancer Center

    Glenwood Springs, Colorado, 81601

  • Mountain Blue Cancer Care Center

    Golden, Colorado, 80401

  • National Jewish Health-Western Hematology Oncology

    Golden, Colorado, 80401

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Altru Cancer Center

    Grand Forks, North Dakota, 58201

  • CHI Health Saint Francis

    Grand Island, Nebraska, 68803

Other trials in United States

Canada13 sites

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • CISSS de l'Outaouais

    Gatineau, Quebec, J8P 7H2

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • BCCA-Cancer Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • CIUSSSEMTL-Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • CHUM - Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Stronach Regional Health Centre at Southlake

    Newmarket, Ontario, L3Y 2P9

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

    Québec, Quebec, G1R 2J6

  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • BCCA-Vancouver Island Cancer Centre

    Victoria, British Columbia, V8R 6V5

Other trials in Canada

About this study

Official title: RT CHARM: Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation With Breast Reconstruction

This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells that remain after surgery and have fewer side effects.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate whether the reconstruction complication rate at 24 months post radiation is non-inferior with hypofractionation.

SECONDARY OBJECTIVES:

  1. To evaluate the incidence of acute and late radiation complications, based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 toxicity.

II. To evaluate the local and local regional recurrence rate. III. To compare reconstruction complication rates based on reconstruction method (autologous +/- implant versus [vs] implant only) and timing of reconstruction received (immediate vs. intent for delayed).

TERTIARY OBJECTIVES:

  1. To evaluate reconstructed breast photographic cosmetic scores with hypofractionated radiation compared to standard fractionation 24 months after radiation.

II. To evaluate reconstructed breast photographic cosmetic scores 24 months after radiation based on the method and timing of reconstruction received.

III. To estimate the incidence of arm lymphedema by treatment arm. IV. To compare physical well-being, psychosocial well-being, sexual well-being, satisfaction with breast/nipples/abdomen, and satisfaction with overall outcome between the treatment arms at 24 months after radiation.

  1. To estimate patient satisfaction with trial participation by treatment arm as measured by the Was It Worth It Questionnaire at 24 months after radiation.

VI. To compare the direct and indirect patient costs for radiation therapy by treatment arm.

VII. To compare patient reported total health care service utilization 12 months after the completion of radiation.

VIII. To compare the economic impact of treatment. IX. To analyze polymorphisms in MDM2 and in genes including TP53, ATM, TGFB1, IL4, IL6, and IL10 and determine correlations with a higher likelihood of adverse radiation reactions (radiation sensitivity) and with toxicities.

  1. To analyze polymorphisms in MDM2 and in genes including TP53, ATM, TGFB1, IL4, IL6, and IL10 to determine correlations with secondary endpoints such as local-regional control.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients undergo radiation therapy daily on Monday-Friday for 5-6 weeks.

GROUP II: Patients undergo hypofractionated radiation therapy daily on Monday-Friday for 3-4 weeks.

After completion of study, patients are followed up for 5 years.

Being tested
Radiation Therapy, Questionnaire Administration, Quality-of-Life Assessment, Laboratory Biomarker Analysis, Hypofractionated Radiation Therapy
Medical subject headings
Carcinoma, Ductal, Breast, Carcinoma, Lobular, Breast Neoplasms

What participants receive

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

  • Radiation TherapyRadiation

    Undergo RT

  • Questionnaire AdministrationOther

    Ancillary studies

  • Quality-of-Life AssessmentOther

    Ancillary studies

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Hypofractionated Radiation TherapyRadiation

    Undergo hypofractionated RT

Study groups in NCT03414970
Study groupRoleWhat they receive
Group I (radiation therapy)Active comparatorPatients undergo radiation therapy daily on Monday-Friday for 5-6 weeks.
Receives: Radiation: Radiation Therapy; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Laboratory Biomarker Analysis
Group II (hypofractionated radiation therapy)ExperimentalPatients undergo hypofractionated radiation therapy daily on Monday-Friday for 3-4 weeks.
Receives: Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Laboratory Biomarker Analysis; Radiation: Hypofractionated Radiation Therapy

What is being measured

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

  1. Proportion of Breast Reconstruction Complications

    The primary endpoint of this trial is the rate of ipsilateral breast reconstruction complications defined (in the protocol in 10.0. Measurement of effect) as; Capsular contracture (Baker Grade III or IV only), Complete failure of the implant/skin flap, Unplanned admission for reconstruction related issue(s) including but not limited to infection, wound healing complication or pain, Unplanned return to the operating room for recon related issue including but not limited to infection, prosthesis exposure, failed reconstruction, implant removal, wound healing complications or contracture management. Note: Routine revisions such as dog-ear corrections, fat grafting, and contralateral breast revision will be recorded, but not counted towards the primary endpoint; ii) Complications related to the contralateral breast will be collected but will not count towards the assessment of the primary endpoint, ipsilateral breast complications will be counted towards the primary endpoint.

    Measured: 24 months

Secondary outcomes (10)

  1. Incidence of Acute and Late Radiation Complications Based on Common Terminology Criteria for Adverse Events 4.0 Toxicity

    The proportion of patients with acute or late radiation complications, will be estimated separately by treatment arm and will be compared across the two arms using two-sample test of proportions (Z test) with a two-sided alternative.

    Measured: 5 years

  2. Local and Local Regional Recurrence

    The cumulative incidence of local and local regional recurrence will be estimated separately by treatment arm using the cumulative incidence function treating death as the competing risk and will be compared using Gray's test.

    Measured: 3 years

  3. Local and Local Regional Recurrence-free Survival

    Local and local regional recurrence free survival rate at three years will be summarized for each arm using the Kaplan-Meier estimators, and will be compared using a log rank test. Any recurrence or death will be considered an event.

    Measured: 3 years

  4. Reconstruction Complication Rates Based on Reconstruction Method (Autologous +/- Implant Versus [vs.] Implant Only) and Timing of Reconstruction Received (Immediate vs. Intent for Delayed)

    Between-arm differences in reconstruction complication rates will be assessed separately within each of the six subgroups based on type and timing of reconstruction. Between-arm differences in complication rates will also be assessed within the two broader subgroups of patients who receive implant only and those who receive autologous based reconstruction. Within each subgroup, the comparison will be done using a two-sample Z test of proportions with a two-sided alternative.

    Measured: Up to 5 years

  5. Reconstructed Breast Photographic Cosmetic Scores

    Two year photographic cosmetic scores will be summarized by treatment arm and will be compared across the treatment arms using a Wilcoxon rank-sum test with a two-sided alternative. The proportions of patients with poor global cosmetic score (defined as a cosmetic score of 3: poor or large difference) at 24 months after radiation will be summarized separately by treatment arm and will be compared using a two-sample test of proportions with a two-sided alternative.

    Measured: At 24 months

  6. Reconstructed Breast Photographic Cosmetic Scores Based on the Method and Timing of Reconstruction Received

    Two year photographic cosmetic scores and the proportions of patients with poor global cosmetic score will be assessed separately by timing and method of reconstruction subgroups using similar method described above.

    Measured: At 24 months

  7. Incidence of Arm Lymphedema as Measured by Percent Change in Ipsilateral Arm Volume Post-radiation From Its Pre-radiation Volume

    The proportions of patients with arm lymphedema (defined as a change of 10% or greater in ipsilateral arm volume from the pre-radiation therapy [RT] volume) at 2 year post radiation will be summarized and will be compared across the two treatment arms using a two-sample test of proportions (Z test) with a two-sided alternative. Change in ipsilateral arm volume at each of the following time-points: 6, 12, 24 and 60 months post-radiation (relative to pre-RT) will be compared using a two sample t-test with a two-sided alternative. The changes in arm volume at these time points will also be analyzed as a repeated measure using a linear mixed model with patient as the random effect.

    Measured: Up to 5 years

  8. Physical Well-being, Psychosocial Well-being, Sexual Well-being, Satisfaction With Breast/Nipples/Abdomen, and Satisfaction With Overall Outcome

    Change in Lymphedema and Breast Cancer Questionnaire and Breast Lymphedema scores at 24 months post-radiation (relative to pre-RT) and patient satisfaction scores as measured by the Breast Questionnaire overall outcome scale will be summarized and will be compared across the treatment arms using a two-sample t-test with a two-sided alternative. Linear mixed models will also be used to assess these scores longitudinally.

    Measured: At to 24 months

  9. Patient Satisfaction With Trial Participation by Treatment Arm as Measured by the Was It Worth It Questionnaire

    Was It Worth It questionnaire responses to each of the five questions at 24 months will be summarized and the will be compared across treatment arms using a chi-square tests with a two-sided alternative.

    Measured: At 24 months

  10. Economic Analyses

    Direct costs of medical care to each patient will be estimated using utilization information from the health care expense survey and the health care utilization survey, along with publicly available Medicare reimbursement rates. In particular, based on the reported number of outpatient visits to the radiation oncologist, medical oncologist, surgeon who performed mastectomy, plastic surgeon or physical therapist, and the number of visits to the emergency room, the number of hospital admissions, and the number of surgical procedures to breast reconstruction, Medicare reimbursement rates can be used to estimate what the direct cost to each patient would be if that patient were covered by Medicare. Generalized linear models will then be used to model these costs as a function of treatment, time on study, and all available baseline patient characteristics to assess the extent to which estimated direct cost is impacted by the type of radiation dosing.

    Measured: Up to 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 posted30 Jan 2018
  2. Study start12 Mar 2018
  3. Primary completion1 Feb 2024
  4. Study completionAug 2035 (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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
898 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03414970
Sponsor's protocol ID
A221505
Other IDs
NCI-2017-00817
Status last verified
Feb 2026
First submitted
17 Jan 2018
Last updated
24 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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