AzTrials
AzTrials

Breast CancerNCT00103181

Radiation Therapy (WBI Versus PBI) in Treating Women Who Have Undergone Surgery For Ductal Carcinoma In Situ or Stage I or Stage II Breast Cancer

A study testing 3-dimensional conformal accelerated partial breast irradiation, brachytherapy and whole breast irradiation in people with Breast Cancer, run by NSABP Foundation Inc at 387 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill any tumor cells that remain after surgery. It is not yet known whether whole breast radiation therapy is more effective than partial breast radiation therapy in treating breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
3-dimensional conformal accelerated partial breast irradiation, brachytherapy and whole breast irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,216 participants
Where
387 sitesin 4 countries
Study dates
Mar 2005to Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed ductal carcinoma in situ (DCIS*) or invasive* adenocarcinoma of the breast
  • Stage 0, I, or II disease
  • Stage II tumors must be ≤ 3 cm
  • Gross disease must be unifocal
  • Microscopic multifocality allowed provided total pathological tumor size is ≤ 3 cm
  • No proven multicentric carcinoma in more than 1 quadrant or separated by ≥ 4 cm
  • No non-epithelial breast malignancies (e.g., sarcoma or lymphoma) NOTE: *Patients who are 50 years of age and over with DCIS regardless of hormone receptor status AND patients with invasive breast cancer meeting all of the following criteria: ≥ 50 years of age, node-negative, and hormone-receptor positive status will not be enrolled in study after 12/30/2006
  • Prior axillary staging required for patients with invasive breast cancer, including 1 of the following:
  • Sentinel node biopsy alone (if sentinel node is negative)
  • Sentinel node biopsy followed by axillary dissection or sampling with ≥ 6 axillary nodes (if sentinel node is positive)
  • Axillary dissection alone with ≥ 6 axillary nodes
  • No more than 3 positive axillary nodes
  • No axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension
  • No positive non-axillary sentinel nodes (intramammary nodes are staged as axillary nodes)
  • No palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor
  • Must have undergone lumpectomy
  • Resected margins histologically free of tumor
  • Re-excision of surgical margins allowed
  • Target lumpectomy cavity clearly delineated AND target lumpectomy/whole breast reference volume ≤ 30% based on postoperative pre-randomization CT scan
  • Final surgery (i.e., lumpectomy, re-excision of margins, or axillary staging procedure) within the past 42 days
  • No suspicious microcalcifications, densities, or palpable abnormalities in the ipsilateral or contralateral breast unless biopsied and found to be benign
  • No Paget's disease of the nipple
  • No history of invasive breast cancer or DCIS
  • Prior lobular carcinoma in situ treated by surgery alone allowed
  • No synchronous bilateral invasive or non-invasive breast cancer
  • Partial breast irradiation deemed technically deliverable by radiation oncologist at a credentialed facility
  • Must have undergone a history and physical exam within the past 4 months AND a bilateral mammogram within the past 6 months
  • Hormone receptor status:
  • Estrogen receptor (ER) status known
  • Progesterone status known if ER analysis is negative
  • Marginal or borderline results are considered positive

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female

Menopausal status

  • Premenopausal or postmenopausal

Performance status

  • Not specified

Life expectancy

  • At least 10 years, excluding diagnosis of breast cancer

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective non-hormonal contraception
  • No other malignancy within the past 5 years except previously treated carcinoma in situ of the cervix or colon, melanoma in situ, or basal cell or squamous cell skin cancer
  • Deemed to be at low risk for recurrence
  • No collagen vascular disease (e.g., systemic lupus erythematosus or scleroderma), specifically dermatomyositis with a creatine phosphokinase (CPK) level above normal, or active skin rash
  • No psychiatric or addictive disorder that would preclude study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy for this malignancy

Chemotherapy

  • No prior chemotherapy for this malignancy
  • No concurrent chemotherapy during study radiotherapy

Endocrine therapy

  • No prior hormonal therapy for this malignancy unless total duration of hormonal therapy was no more than 28 days before randomization
  • Concurrent hormonal therapy allowed provided it is not administered during chemotherapy
  • No concurrent raloxifene, tamoxifen, or other selective estrogen receptor modulating drugs
  • No concurrent hormone replacement therapy
  • No concurrent Femring^®

Radiotherapy

  • No prior radiotherapy for this malignancy
  • No prior breast or thoracic radiotherapy
  • No concurrent brachytherapy boosts
  • No concurrent intensity modulated radiotherapy
  • No concurrent regional nodal irradiation

Surgery

  • See Disease Characteristics
  • No prior breast implants
  • Patients who have had implants removed are eligible

Other

  • No other concurrent anticancer therapy

Trial locations and contacts

387 sites in 4 countries.

313 sites in 4 countries

United States300 sites

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • New York Oncology Hematology, PC at Albany Regional Cancer Care

    Albany, New York, 12206

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87131-5636

  • Saint John's Cancer Center at Saint John's Medical Center

    Anderson, Indiana, 46016

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • DeCesaris Cancer Institute at Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • Hope A Women's Cancer Center

    Asheville, North Carolina, 28816

  • Northside Hospital Cancer Center

    Atlanta, Georgia, 30342-1611

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342

  • Auburn Radiation Oncology

    Auburn, California, 95603

  • Aurora Presbyterian Hospital

    Aurora, Colorado, 80012

  • University of Colorado Cancer Center at UC Health Sciences Center

    Aurora, Colorado, 80045

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60504

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • St. Agnes Hospital Cancer Center

    Baltimore, Maryland, 21229

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • CancerCare of Maine at Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Barberton Citizens Hospital

    Barberton, Ohio, 44203

  • Good Shepherd Hospital

    Barrington, Illinois, 60010

  • Memorial Sloan-Kettering Cancer Center - Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Ochsner Health Center - Bluebonnet

    Baton Rouge, Louisiana, 70809

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • UPMC Cancer Center at Beaver Medical Center

    Beaver, Pennsylvania, 15009

  • Texas Oncology, PA at Harris Center HEB

    Bedford, Texas, 76022

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • MeritCare Bemidji

    Bemidji, Minnesota, 56601

  • Alta Bates Summit Comprehensive Cancer Center

    Berkeley, California, 94704

  • St. Luke's Cancer Network at St. Luke's Hospital

    Bethlehem, Pennsylvania, 18015

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • UAB Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • Illinois CancerCare - Bloomington

    Bloomington, Illinois, 61701

  • Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus

    Boca Raton, Florida, 33486

  • Mountain States Tumor Institute at St. Luke's Regional Medical Center

    Boise, Idaho, 83712

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Boston University Cancer Research Center

    Boston, Massachusetts, 02118

  • Boulder Community Hospital

    Boulder, Colorado, 80301-9019

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Peninsula Medical Center

    Burlingame, California, 94010

  • Lahey Clinic Medical Center - Burlington

    Burlington, Massachusetts, 01805

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Radiation Oncology Centers - Cameron Park

    Cameron Park, California, 95682

  • Sands Cancer Center

    Canandaigua, New York, 14424

  • Illinois CancerCare - Canton

    Canton, Illinois, 61520

  • Aultman Cancer Center at Aultman Hospital

    Canton, Ohio, 44710-1799

  • Mercy Cancer Center at Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Illinois CancerCare - Carthage

    Carthage, Illinois, 62321

  • Sandra L. Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Roper St. Francis Cancer Center at Roper Hospital

    Charleston, South Carolina, 29401

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • West Virginia University Health Sciences Center - Charleston

    Charleston, West Virginia, 25304

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Creticos Cancer Center at Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Enloe Cancer Center at Enloe Medical Center

    Chico, California, 95926

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

  • Cleveland Clinic Cancer Center at Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Henry Ford Macomb Hospital

    Clinton Township, Michigan, 48038

  • Kootenai Cancer Center - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Memorial Hospital Cancer Center - Colorado Springs

    Colorado Springs, Colorado, 80909

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • Central Maryland Oncology Center

    Columbia, Maryland, 21044

  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210-1240

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Memorial Sloan-Kettering Cancer Center

    Commack, New York, 11725

  • Cancer Care Center at John Muir Health - Concord Campus

    Concord, California, 94524-4110

  • Payson Center for Cancer Care at Concord Hospital

    Concord, New Hampshire, 03301

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390

  • NSMC Cancer Center - Peabody

    Danvers, Massachusetts, 01923

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Genesis Regional Cancer Center at Genesis Medical Center

    Davenport, Iowa, 52803

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Charles B. Eberhart Cancer Center at DeKalb Medical Center

    Decatur, Georgia, 30033

  • Texas Oncology, PA at Texas Cancer Center - Denton South

    Denton, Texas, 76210

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Seacoast Cancer Center at Wentworth - Douglass Hospital

    Dover, New Hampshire, 03820

  • Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515-1500

  • Delaware County Regional Cancer Center at Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • St. Luke's Hospital Cancer Care Center

    Duluth, Minnesota, 55805

  • Northeast Radiation Oncology Center

    Dunmore, Pennsylvania, 18512

  • Duke Cancer Institute

    Durham, North Carolina, 27710

  • CCOP - Hematology-Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • Shore Regional Cancer Center at Memorial Hospital - Easton

    Easton, Maryland, 21601

  • Center for Cancer Treatment & Prevention at Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Trinitas Comprehensive Cancer Center at Trinitas Hospital

    Elizabeth, New Jersey, 07207

  • Alexian Brothers Radiation Oncology

    Elk Grove Village, Illinois, 60007

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital of Cecil County

    Elkton, Maryland, 21921

  • Swedish Medical Center

    Englewood, Colorado, 80110

  • Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Regional Cancer Center - Erie

    Erie, Pennsylvania, 16505

  • Willamette Valley Cancer Center - Eugene

    Eugene, Oregon, 97401

  • Illinois CancerCare - Eureka

    Eureka, Illinois, 61530

  • Center for Cancer Care at Exeter Hospital

    Exeter, New Hampshire, 03833

  • North Bay Cancer Center

    Fairfield, California, 94533

  • MeritCare Broadway

    Fargo, North Dakota, 58102

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • McLaren Cancer Institute

    Flint, Michigan, 48532

  • Poudre Valley Radiation Oncology

    Fort Collins, Colorado, 80528

  • Radiation Oncology Associates Southwest

    Fort Wayne, Indiana, 46804

  • Parkview Regional Cancer Center at Parkview Health

    Fort Wayne, Indiana, 46805

  • Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital

    Fort Worth, Texas, 76104

  • MetroWest Medical Center - Framingham Union Hospital

    Framingham, Massachusetts, 01702

  • California Cancer Center - Woodward Park Office

    Fresno, California, 93720

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • Illinois CancerCare - Cottage

    Galesburg, Illinois, 61401

  • Illinois CancerCare - Galesburg

    Galesburg, Illinois, 61401

  • Georgetown Memorial Hospital

    Georgetown, South Carolina, 29440

  • Center for Cancer Care at Goshen General Hospital

    Goshen, Indiana, 46526

  • Altru Cancer Center at Altru Hospital

    Grand Forks, North Dakota, 58201

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Three Rivers Community Hospital

    Grants Pass, Oregon, 97527

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • PinnacleHealth Regional Cancer Center at Polyclinic Hospital

    Harrisburg, Pennsylvania, 17110-2098

  • Helen and Harry Gray Cancer Center at Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • Illinois CancerCare - Havana

    Havana, Illinois, 62644

  • Kaiser Permanente Medical Center - Hayward

    Hayward, California, 94545

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • High Point Regional Hospital

    High Point, North Carolina, 27261

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Queen's Cancer Institute at Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital, Incorporated

    Honolulu, Hawaii, 96813

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • St. Mary's Regional Cancer Center at St. Mary's Medical Center

    Huntington, West Virginia, 25702

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • Cleveland Clinic Cancer Center

    Independence, Ohio, 44131

  • Methodist Cancer Center at Methodist Hospital

    Indianapolis, Indiana, 46202

  • Central Indiana Cancer Centers - East

    Indianapolis, Indiana, 46219

  • St. Vincent Indianapolis Hospital

    Indianapolis, Indiana, 46260

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • Baylor Medical Center at Irving

    Irving, Texas, 75061

  • Cayuga Medical Center of Ithaca

    Ithaca, New York, 14850

  • University of Mississippi Cancer Clinic

    Jackson, Mississippi, 39216

  • Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • Integrated Community Oncology Network at Southside Cancer Center

    Jacksonville, Florida, 32207

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Baptist Medical Center South

    Jacksonville, Florida, 32258

  • Integrated Community Oncology Network

    Jacksonville Beach, Florida, 32250

  • Queens Cancer Center of Queens Hospital

    Jamaica, New York, 11432

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Kansas City Cancer Centers - North

    Kansas City, Missouri, 64154

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska, 68848-1990

  • Illinois CancerCare - Kewanee Clinic

    Kewanee, Illinois, 61443

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Franciscan Skemp Healthcare - La Crosse Campus

    La Crosse, Wisconsin, 54601

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • Lakeland Regional Cancer Center at Lakeland Regional Medical Center

    Lakeland, Florida, 33805

  • Breslin Cancer Center at Ingham Regional Medical Center

    Lansing, Michigan, 48910

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Central Maine Comprehensive Cancer Center at Central Maine Medical Center

    Lewiston, Maine, 04240

  • Texas Oncology, PA at Lake Vista Cancer Center

    Lewisville, Texas, 75067

  • Central Baptist Hospital

    Lexington, Kentucky, 40503-9985

  • Lucille P. Markey Cancer Center at University of Kentucky

    Lexington, Kentucky, 40536-0093

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • St. Barnabas Medical Center Cancer Center

    Livingston, New Jersey, 07039

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Hope Cancer Care Center at Longmont United Hospital

    Longmont, Colorado, 80501

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

  • James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • Louisville Oncology at Norton Cancer Institute - Louisville

    Louisville, Kentucky, 40202

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410-1894

  • Illinois CancerCare - Macomb

    Macomb, Illinois, 61455

  • Dean Medical Center - Madison

    Madison, Wisconsin, 53717

  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Elliot Regional Cancer Center at Elliot Hospital

    Manchester, New Hampshire, 03103

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • Immanuel St. Joseph's

    Mankato, Minnesota, 56002

  • MedCentral - Mansfield Hospital

    Mansfield, Ohio, 44903

  • Minnesota Oncology - Maplewood

    Maplewood, Minnesota, 55109

  • Kennestone Cancer Center at Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

    Marlton, New Jersey, 08053

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • Hillcrest Cancer Center at Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Dubs Cancer Center at Rogue Valley Medical Center

    Medford, Oregon, 97504

  • Providence Cancer Center at PMCC

    Medford, Oregon, 97504

  • Community Memorial Hospital Cancer Care Center

    Menomonee Falls, Wisconsin, 53051

  • Columbia Saint Mary's Hospital - Ozaukee

    Mequon, Wisconsin, 53097

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Columbia-Saint Mary's Cancer Care Center

    Milwaukee, Wisconsin, 53211

  • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Trinity Cancer Center at Trinity Medical Center - 7th Street Campus

    Moline, Illinois, 61265

  • Illinois CancerCare - Monmouth

    Monmouth, Illinois, 61462

  • OSF Holy Family Medical Center

    Monmouth, Illinois, 61462

  • Intercommunity Cancer Center

    Monroeville, Pennsylvania, 15146

  • Community Hospital of the Monterey Peninsula Comprehensive Cancer Center

    Monterey, California, 93940

  • Edward Hospital Cancer Center

    Naperville, Illinois, 60540

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901

  • Hospital of Saint Raphael

    New Haven, Connecticut, 06511

  • Yale Cancer Center

    New Haven, Connecticut, 06520-8028

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Community Cancer Center

    Normal, Illinois, 61761

  • Illinois CancerCare - Community Cancer Center

    Normal, Illinois, 61761

  • Norristown Regional Cancer Center

    Norristown, Pennsylvania, 19401

  • Norwalk Hospital

    Norwalk, Connecticut, 06856

  • Sutter Health - Western Division Cancer Research Group

    Novato, California, 94945

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • Regional Cancer Center at Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Methodist Estabrook Cancer Center

    Omaha, Nebraska, 68114

  • Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegant Health Cancer Center at Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Creighton University Medical Center

    Omaha, Nebraska, 68131-2197

  • St. Joseph Hospital Regional Cancer Center - Orange

    Orange, California, 92868

  • Integrated Community Oncology Network - Orange Park

    Orange Park, Florida, 32073

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

  • Oncology Hematology Associates of Central Illinois, PC - Ottawa

    Ottawa, Illinois, 61350

  • Florida Cancer Center - Palatka

    Palatka, Florida, 32177

  • Desert Regional Medical Center Comprehensive Cancer Center

    Palm Springs, California, 92262

  • Feather River Hospital Cancer Center

    Paradise, California, 95969

  • Advocate Lutheran General Cancer Care Center

    Park Ridge, Illinois, 60068-1174

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Illinois CancerCare - Pekin

    Pekin, Illinois, 61603

  • Arizona Center for Cancer Care - Peoria

    Peoria, Arizona, 85381

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61615-7827

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • Illinois CancerCare - Peru

    Peru, Illinois, 61354

  • Drexel University College of Medicine - Center City Hahnemann Campus

    Philadelphia, Pennsylvania, 19102

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

  • Frankford Hospital Cancer Center - Torresdale Campus

    Philadelphia, Pennsylvania, 19114

  • Arizona Oncology Services Foundation

    Phoenix, Arizona, 85013

  • Allegheny Cancer Center at Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • UPMC - Shadyside

    Pittsburgh, Pennsylvania, 15213-2582

  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224-1791

  • Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center

    Pomona, California, 91767

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Legacy Good Samaritan Hospital & Comprehensive Cancer Center

    Portland, Oregon, 97210

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Legacy Emanuel Hospital and Health Center and Children's Hospital

    Portland, Oregon, 97227

  • Knight Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97239-3098

  • Naval Medical Center - Portsmouth

    Portsmouth, Virginia, 23708-2197

  • Hudson Valley Oncology Associates

    Poughkeepsie, New York, 12601

  • Saint Francis Hospital Cancer Center

    Poughkeepsie, New York, 12601

  • CCOP - Kansas City

    Prairie Village, Kansas, 66208

  • Illinois CancerCare - Princeton

    Princeton, Illinois, 61356

  • Rhode Island Hospital Comprehensive Cancer Center

    Providence, Rhode Island, 02903

  • Northmain Radiation Oncology

    Providence, Rhode Island, 02904

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • St. Mary - Corwin Regional Medical Center

    Pueblo, Colorado, 81004

  • All Saints Cancer Center at Wheaton Franciscan Healthcare

    Racine, Wisconsin, 53405

  • Cancer Centers of North Carolina - Raleigh

    Raleigh, North Carolina, 27607

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Mercy Regional Cancer Center at Mercy Medical Center

    Redding, California, 96049

  • Renown Institute for Cancer at Renown Regional Medical Center

    Reno, Nevada, 89502

  • Saint Mary's Regional Medical Center

    Reno, Nevada, 89503

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Humphrey Cancer Center at North Memorial Outpatient Center

    Robbinsdale, Minnesota, 55422-2900

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Highland Hospital of Rochester

    Rochester, New York, 14620

  • Lipson Cancer and Blood Center at Rochester General Hospital

    Rochester, New York, 14621

  • University Radiation Oncology at Parkridge Hospital

    Rochester, New York, 14626

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Radiation Oncology Center - Roseville

    Roseville, California, 95661

  • Texas Oncology, PA at Texas Cancer Center Round Rock

    Round Rock, Texas, 78681

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • Radiological Associates of Sacramento Medical Group, Incorporated

    Sacramento, California, 95815

Other trials in United States

Canada11 sites

  • Cross Cancer Institute at University of Alberta

    Edmonton, Alberta, T6G 1Z2

  • London Regional Cancer Program at London Health Sciences Centre

    London, Ontario, N6A 4L6

  • Hopital Notre-Dame du CHUM

    Montreal, Quebec, H2L 4M1

  • Royal Victoria Hospital - Montreal

    Montreal, Quebec, H3A 1A1

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Jewish General Hospital - Montreal

    Montreal, Quebec, H3T 1E2

  • Hopital du Saint-Sacrement - Quebec

    Québec, Quebec, G1S 4L8

  • Saskatoon Cancer Centre at the University of Saskatchewan

    Saskatoon, Saskatchewan, S7N 4H4

  • Odette Cancer Centre at Sunnybrook

    Toronto, Ontario, M4N 3M5

  • British Columbia Cancer Agency - Vancouver Island Centre

    Victoria, British Columbia, V8R 6V5

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Ireland1 site

  • University College Hospital

    Galway

Other trials in Ireland

Israel1 site

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

About this study

Official title: A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women With Stage 0, I, or II Breast Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill any tumor cells that remain after surgery. It is not yet known whether whole breast radiation therapy is more effective than partial breast radiation therapy in treating breast cancer.

PURPOSE: This randomized phase III trial is studying whole breast radiation therapy to see how well it works compared to partial breast radiation therapy in treating women who have undergone surgery for ductal carcinoma in situ or stage I or stage II breast cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Compare local tumor control in women with ductal carcinoma in situ or stage I or II breast cancer treated with adjuvant whole breast vs partial breast irradiation following lumpectomy.

Secondary

  • Compare overall survival, recurrence-free survival, and distant disease-free survival in patients treated with these regimens.
  • Compare the cosmetic result in patients treated with these regimens.
  • Compare fatigue and treatment-related symptoms in patients treated with these regimens.
  • Compare perceived convenience of care in patients treated with these regimens.
  • Compare acute and late toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (ductal carcinoma in situ [DCIS] only vs invasive and node negative vs invasive with 1-3 positive nodes), menopausal status (premenopausal vs postmenopausal), hormone receptor status (estrogen receptor [ER]-positive and/or progesterone receptor [PR]-positive vs ER-negative and PR-negative), intention to receive chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms. (Patients who are 50 years of age and over with DCIS regardless of hormone receptor status AND patients with invasive breast cancer meeting all of the following criteria: ≥ 50 years of age, node-negative, and hormone-receptor positive status will not be enrolled in study after 12/30/2006.)

  • Group 1: Patients undergo whole-breast irradiation (WBI) once daily, 5 days a week, for 5-7 weeks.
  • Group 2: Patients undergo partial-breast irradiation (PBI) twice daily on 5 days over a period of 5-10 days. This may be delivered by multi-catheter brachytherapy, single-entry intracavitary brachytherapy, or 3-D conformal radiotherapy.

Patients in both arms may receive adjuvant chemotherapy at least 2 weeks prior to initiation of WBI OR at least 2 weeks after completion of PBI at the discretion of the treating physician. Patients with ER-positive or PR-positive tumors may also receive hormonal therapy, beginning 3-12 weeks after completion of adjuvant chemotherapy (or before, during, or after completion of WBI or PBI for patients not receiving adjuvant chemotherapy) and continuing for at least 5 years.

After completion of study treatment, patients are followed at 1 and 6 months, every 6 months for 4.5 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 4,300 patients (2,150 per treatment arm) will be accrued for this study within 4.6 years. Note: Accrual closed on April 16, 2013, following approval of the Data Monitoring Committee to reduce the sample size from 4,300 to 4,214 patients.

Conditions
Breast Cancer
Being tested
3-dimensional conformal accelerated partial breast irradiation, brachytherapy, whole breast irradiation, MammoSite or other single-entry intracavitary device
Keywords
stage II breast cancer, ductal breast carcinoma in situ, breast cancer in situ, stage IA breast cancer, stage IB breast cancer
Medical subject headings
Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ

What participants receive

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

  • 3-dimensional conformal accelerated partial breast irradiationRadiation

  • brachytherapyRadiation

  • whole breast irradiationRadiation

    Patients undergo radiation therapy once daily (days 1-5) for up to 7 weeks

  • MammoSite or other single-entry intracavitary deviceRadiation

Study groups in NCT00103181
Study groupRoleWhat they receive
Group 1: WBIActive comparatorPatients undergo whole breast irradiation (WBI) once daily, 5 days a week for 5-7 weeks.
Receives: Radiation: whole breast irradiation
Group 2: PBIExperimentalPatients undergo partial-breast irradiation (PBI) twice daily on 5 days over a period of 5-10 days. This may be delivered by intracavitary brachytherapy, MammoSite or other single-entry intracavitary device, or 3-dimensional conformal accelerated partial breast irradiation.
Receives: Radiation: 3-dimensional conformal accelerated partial breast irradiation; Radiation: brachytherapy; Radiation: MammoSite or other single-entry intracavitary device

What is being measured

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

  1. In-breast tumor recurrence (IBTR)

    Measured: every 6 months for 5 years; annually thereafter for up to 10 years

Secondary outcomes (5)

  1. Overall survival

    Measured: time from randomization to death due to any cause assessed up to 15 years

  2. Recurrence-free survival

    Measured: time from randomization to recurrence assessed every 6 months for 5 years and annually thereafter for up to 10 years

  3. Distant disease-free survival

    Measured: time from randomization to event occurrence assessed every 6 months for 5 years and annually thereafter for up to 10 years

  4. Quality of life and patient-reported cosmesis by Breast Cancer Treatment Outcome Scale, MOS SF-36 Vitality, Convenience of Care scale, and symptoms

    Measured: measured at baseline, and 1 and 6 months and 1, 2, and 3 years after completion of study treatment

  5. Toxicity as assessed by adverse events during treatment

    Measured: at end of RT, and 4 weeks, 6 months, 12 months; every 6 months for years 2 through 5; and annually thereafter for up to 10 years

Timeline

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

  1. First posted8 Feb 2005 (estimated)
  2. Study startMar 2005
  3. Primary completionAug 2018
  4. Study completionAug 2018

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4,216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00103181
Sponsor's protocol ID
NSABP B-39/RTOG 0413
Other IDs
NSABP-B-39, RTOG-0413, SWOG-NSABP-B-39, NCI-2009-00698
Status last verified
Apr 2022
First submitted
7 Feb 2005
Last updated
14 Apr 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Croshaw R, Kim Y, Lappinen E, Julian T, Trombetta M. Avoiding mastectomy: accelerated partial breast irradiation for breast cancer patients with pacemakers or defibrillators. Ann Surg Oncol. 2011 Nov;18(12):3500-5. doi: 10.1245/s10434-011-1784-2. Epub 2011 May 24.

    PubMed 21607774

  • Hasan Y, Kim L, Wloch J, Chi Y, Liang J, Martinez A, Yan D, Vicini F. Comparison of planned versus actual dose delivered for external beam accelerated partial breast irradiation using cone-beam CT and deformable registration. Int J Radiat Oncol Biol Phys. 2011 Aug 1;80(5):1473-6. doi: 10.1016/j.ijrobp.2010.04.013. Epub 2010 Jul 23.

    PubMed 20656415

  • Hepel JT, Tokita M, MacAusland SG, Evans SB, Hiatt JR, Price LL, DiPetrillo T, Wazer DE. Toxicity of three-dimensional conformal radiotherapy for accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1290-6. doi: 10.1016/j.ijrobp.2009.01.009. Epub 2009 Apr 22.

    PubMed 19395195

  • Kainz K, White J, Herman J, Li XA. Investigation of helical tomotherapy for partial-breast irradiation of prone-positioned patients. Int J Radiat Oncol Biol Phys. 2009 May 1;74(1):275-82. doi: 10.1016/j.ijrobp.2008.11.028.

    PubMed 19362247

  • Langen KM, Buchholz DJ, Burch DR, Burkavage R, Limaye AU, Meeks SL, Kupelian PA, Ruchala KJ, Haimerl J, Henderson D, Olivera GH. Investigation of accelerated partial breast patient alignment and treatment with helical tomotherapy unit. Int J Radiat Oncol Biol Phys. 2008 Mar 15;70(4):1272-80. doi: 10.1016/j.ijrobp.2007.11.019. Epub 2008 Jan 22.

    PubMed 18207666

  • Wojcicka JB, Lasher DE, Malcom R, Fortier G. Clinical and dosimetric experience with MammoSite-based brachytherapy under the RTOG 0413 protocol. J Appl Clin Med Phys. 2007 Oct 24;8(4):176-184. doi: 10.1120/jacmp.v8i4.2654.

    PubMed 18449152

  • Akbari M, Russo SA, Jacobson JS, et al.: Association of women's local treatment decisions with local recurrence risk and life expectancy. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2035, S228-9, 2006.

  • Burch D, Langen KM, Buchholz D, et al.: Partial breast irradiation with helical tomotherapy using RTOG 0413 planning constraints. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2047, S235-6, 2006.

  • Hiatt JR, Evans SB, Price LL, Cardarelli GA, Dipetrillo TA, Wazer DE. Dose-modeling study to compare external beam techniques from protocol NSABP B-39/RTOG 0413 for patients with highly unfavorable cardiac anatomy. Int J Radiat Oncol Biol Phys. 2006 Aug 1;65(5):1368-74. doi: 10.1016/j.ijrobp.2006.03.060.

    PubMed 16863924

  • Bovi JA, Li XA, White J, et al.: Comparison of three partial breast irradiation techniques: treatment effectiveness based upon biological models. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-1061, S181, 2005.

  • Dickler A. The MammoSite breast brachytherapy device: targeted delivery of breast brachytherapy. Future Oncol. 2005 Dec;1(6):799-804. doi: 10.2217/14796694.1.6.799.

    PubMed 16556059

  • Sanghani M, Wazer DE. Patient selection for NSABP B-39/RTOG 0413: have we posed the right questions in the right way? Brachytherapy. 2007 Apr-Jun;6(2):119-22. doi: 10.1016/j.brachy.2007.01.002. No abstract available.

    PubMed 17434104

  • Julian TB, Costantino JP, Vicini FA, et al.: Early toxicity results with 3D conformal external beam therapy (CEBT) from the NSABP B-39/RTOG 0413 accelerated partial breast irradiation (APBI) trial. [Abstract] J Clin Oncol 29 (Suppl 15): A-1011, 2011.

  • Jain AK, Vallow LA, Gale AA, Buskirk SJ. Does three-dimensional external beam partial breast irradiation spare lung tissue compared with standard whole breast irradiation? Int J Radiat Oncol Biol Phys. 2009 Sep 1;75(1):82-8. doi: 10.1016/j.ijrobp.2008.10.041. Epub 2009 Feb 21.

    PubMed 19231103

  • Tendulkar RD, Chellman-Jeffers M, Rybicki LA, Rim A, Kotwal A, Macklis R, Obi BB. Preoperative breast magnetic resonance imaging in early breast cancer: implications for partial breast irradiation. Cancer. 2009 Apr 15;115(8):1621-30. doi: 10.1002/cncr.24172.

    PubMed 19224552

Questions about this trial

What is this clinical trial studying?

A study testing 3-dimensional conformal accelerated partial breast irradiation, brachytherapy and whole breast irradiation in people with Breast Cancer, run by NSABP Foundation Inc at 387 sites in 4 countries.

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

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 387 sites in United States, Canada, Ireland, Israel. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

In-breast tumor recurrence (IBTR) (time frame: every 6 months for 5 years; annually thereafter for up to 10 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 NCT00103181, which also lists 19 linked publications.

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 14 Apr 2022.

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