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 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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: brachytherapy; Radiation: whole breast irradiation; Radiation: 3-dimensional conformal accelerated partial breast irradiation; Radiation: MammoSite or other single-entry intracavitary device

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.

• Study Type: Interventional
• Enrollment (Actual): 4216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute at University of Alberta
  • British Columbia
    • Victoria, British Columbia, Canada, V8R 6V5
      • British Columbia Cancer Agency - Vancouver Island Centre
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • CancerCare Manitoba
  • Ontario
    • London, Ontario, Canada, N6A 4L6
      • London Regional Cancer Program at London Health Sciences Centre
    • Toronto, Ontario, Canada, M4N 3M5
      • Odette Cancer Centre at Sunnybrook
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital
    • Montreal, Quebec, Canada, H3A 1A1
      • Royal Victoria Hospital - Montreal
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital - Montreal
    • Montreal, Quebec, Canada, H2L 4M1
      • Hopital Notre-Dame du CHUM
    • Quebec City, Quebec, Canada, G1S 4L8
      • Hopital du Saint-Sacrement - Quebec
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatoon Cancer Centre at the University of Saskatchewan
• Ireland
  • Galway, Ireland
    • University College Hospital
• Israel
  • Tel Aviv, Israel, 64239
    • Tel-Aviv Sourasky Medical Center
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • UAB Comprehensive Cancer Center
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Arizona Center for Cancer Care - Peoria
    • Phoenix, Arizona, United States, 85013
      • Arizona Oncology Services Foundation
    • Scottsdale, Arizona, United States, 85259-5499
      • Mayo Clinic Scottsdale
    • Scottsdale, Arizona, United States, 85258
      • Arizona Breast Cancer Specialists
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • California
    • Auburn, California, United States, 95603
      • Auburn Radiation Oncology
    • Berkeley, California, United States, 94704
      • Alta Bates Summit Comprehensive Cancer Center
    • Burlingame, California, United States, 94010
      • Peninsula Medical Center
    • Cameron Park, California, United States, 95682
      • Radiation Oncology Centers - Cameron Park
    • Carmichael, California, United States, 95608
      • Mercy Cancer Center at Mercy San Juan Medical Center
    • Chico, California, United States, 95926
      • Enloe Cancer Center at Enloe Medical Center
    • Concord, California, United States, 94524-4110
      • Cancer Care Center at John Muir Health - Concord Campus
    • Duarte, California, United States, 91010-3000
      • City of Hope Comprehensive Cancer Center
    • Fairfield, California, United States, 94533
      • North Bay Cancer Center
    • Fresno, California, United States, 93720
      • California Cancer Center - Woodward Park Office
    • Hayward, California, United States, 94545
      • Kaiser Permanente Medical Center - Hayward
    • La Jolla, California, United States, 92093-0658
      • Rebecca and John Moores UCSD Cancer Center
    • Los Angeles, California, United States, 90095-1781
      • Jonsson Comprehensive Cancer Center at UCLA
    • Monterey, California, United States, 93940
      • Community Hospital of the Monterey Peninsula Comprehensive Cancer Center
    • Novato, California, United States, 94945
      • Sutter Health - Western Division Cancer Research Group
    • Oakland, California, United States, 94609
      • CCOP - Bay Area Tumor Institute
    • Orange, California, United States, 92868
      • St. Joseph Hospital Regional Cancer Center - Orange
    • Palm Springs, California, United States, 92262
      • Desert Regional Medical Center Comprehensive Cancer Center
    • Paradise, California, United States, 95969
      • Feather River Hospital Cancer Center
    • Pomona, California, United States, 91767
      • Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
    • Redding, California, United States, 96049
      • Mercy Regional Cancer Center at Mercy Medical Center
    • Roseville, California, United States, 95661
      • Radiation Oncology Center - Roseville
    • Sacramento, California, United States, 95815
      • Radiological Associates of Sacramento Medical Group, Incorporated
    • Sacramento, California, United States, 95819
      • Mercy General Hospital
    • Sacramento, California, United States, 95817
      • University of California Davis Cancer Center
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital Cancer Center
    • San Diego, California, United States, 92108
      • Kaiser Permanente Medical Office -Vandever Medical Office
    • San Francisco, California, United States, 94118
      • California Pacific Medical Center - California Campus
    • San Pablo, California, United States, 94806
      • Doctors Medical Center - San Pablo Campus
    • Stanford, California, United States, 94305-5824
      • Stanford Cancer Center
    • Vacaville, California, United States, 95687
      • Solano Radiation Oncology Center
    • Vallejo, California, United States, 94589
      • Sutter Solano Medical Center
    • Vallejo, California, United States, 94589
      • Kaiser Permanente Medical Center - Vallejo
    • Walnut Creek, California, United States, 94598
      • John Muir/Mt. Diablo Comprehensive Cancer Center
    • Whittier, California, United States, 90602
      • Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center at UC Health Sciences Center
    • Aurora, Colorado, United States, 80012
      • Aurora Presbyterian Hospital
    • Boulder, Colorado, United States, 80301-9019
      • Boulder Community Hospital
    • Colorado Springs, Colorado, United States, 80933
      • Penrose Cancer Center at Penrose Hospital
    • Colorado Springs, Colorado, United States, 80909
      • Memorial Hospital Cancer Center - Colorado Springs
    • Denver, Colorado, United States, 80210
      • Porter Adventist Hospital
    • Englewood, Colorado, United States, 80110
      • Swedish Medical Center
    • Fort Collins, Colorado, United States, 80528
      • Poudre Valley Radiation Oncology
    • Greeley, Colorado, United States, 80631
      • North Colorado Medical Center
    • Lone Tree, Colorado, United States, 80124
      • Sky Ridge Medical Center
    • Longmont, Colorado, United States, 80501
      • Hope Cancer Care Center at Longmont United Hospital
    • Loveland, Colorado, United States, 80539
      • McKee Medical Center
    • Pueblo, Colorado, United States, 81004
      • St. Mary - Corwin Regional Medical Center
    • Thornton, Colorado, United States, 80229
      • North Suburban Medical Center
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport Hospital
    • Hartford, Connecticut, United States, 06102-5037
      • Helen and Harry Gray Cancer Center at Hartford Hospital
    • New Haven, Connecticut, United States, 06511
      • Hospital of Saint Raphael
    • New Haven, Connecticut, United States, 06520-8028
      • Yale Cancer Center
    • Norwalk, Connecticut, United States, 06856
      • Norwalk Hospital
    • Torrington, Connecticut, United States, 06790
      • Connecticut Oncology & Hematology - Torrington
  • Delaware
    • Newark, Delaware, United States, 19713
      • CCOP - Christiana Care Health Services
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Cancer Institute at Washington Hospital Center
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
    • Gainesville, Florida, United States, 32610-0232
      • University of Florida Shands Cancer Center
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic - Jacksonville
    • Jacksonville, Florida, United States, 32207
      • Baptist Cancer Institute - Jacksonville
    • Jacksonville, Florida, United States, 32207
      • Integrated Community Oncology Network at Southside Cancer Center
    • Jacksonville, Florida, United States, 32258
      • Baptist Medical Center South
    • Jacksonville Beach, Florida, United States, 32250
      • Integrated Community Oncology Network
    • Jupiter, Florida, United States, 33458
      • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
    • Lakeland, Florida, United States, 33805
      • Lakeland Regional Cancer Center at Lakeland Regional Medical Center
    • Miami Beach, Florida, United States, 33140
      • CCOP - Mount Sinai Medical Center
    • Orange Park, Florida, United States, 32073
      • Integrated Community Oncology Network - Orange Park
    • Palatka, Florida, United States, 32177
      • Florida Cancer Center - Palatka
    • Saint Augustine, Florida, United States, 32086
      • Flagler Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30342-1611
      • Northside Hospital Cancer Center
    • Atlanta, Georgia, United States, 30342
      • CCOP - Atlanta Regional
    • Decatur, Georgia, United States, 30033
      • Charles B. Eberhart Cancer Center at DeKalb Medical Center
    • Marietta, Georgia, United States, 30060
      • Kennestone Cancer Center at Wellstar Kennestone Hospital
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Cancer Research Center of Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Queen's Cancer Institute at Queen's Medical Center
    • Honolulu, Hawaii, United States, 96813
      • Straub Clinic and Hospital, Incorporated
  • Idaho
    • Boise, Idaho, United States, 83712
      • Mountain States Tumor Institute at St. Luke's Regional Medical Center
    • Coeur d'Alene, Idaho, United States, 83814
      • Kootenai Cancer Center - Coeur d'Alene
  • Illinois
    • Aurora, Illinois, United States, 60504
      • Rush-Copley Cancer Care Center
    • Barrington, Illinois, United States, 60010
      • Good Shepherd Hospital
    • Bloomington, Illinois, United States, 61701
      • Illinois CancerCare - Bloomington
    • Canton, Illinois, United States, 61520
      • Illinois CancerCare - Canton
    • Carthage, Illinois, United States, 62321
      • Illinois CancerCare - Carthage
    • Chicago, Illinois, United States, 60657
      • Creticos Cancer Center at Advocate Illinois Masonic Medical Center
    • Downers Grove, Illinois, United States, 60515-1500
      • Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital
    • Elk Grove Village, Illinois, United States, 60007
      • Alexian Brothers Radiation Oncology
    • Eureka, Illinois, United States, 61530
      • Illinois CancerCare - Eureka
    • Galesburg, Illinois, United States, 61401
      • Illinois CancerCare - Galesburg
    • Galesburg, Illinois, United States, 61401
      • Illinois CancerCare - Cottage
    • Havana, Illinois, United States, 62644
      • Illinois CancerCare - Havana
    • Kewanee, Illinois, United States, 61443
      • Illinois CancerCare - Kewanee Clinic
    • Macomb, Illinois, United States, 61455
      • Illinois CancerCare - Macomb
    • Maywood, Illinois, United States, 60153
      • Cardinal Bernardin Cancer Center at Loyola University Medical Center
    • Moline, Illinois, United States, 61265
      • Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
    • Monmouth, Illinois, United States, 61462
      • Illinois CancerCare - Monmouth
    • Monmouth, Illinois, United States, 61462
      • OSF Holy Family Medical Center
    • Naperville, Illinois, United States, 60540
      • Edward Hospital Cancer Center
    • Normal, Illinois, United States, 61761
      • Community Cancer Center
    • Normal, Illinois, United States, 61761
      • Illinois CancerCare - Community Cancer Center
    • Ottawa, Illinois, United States, 61350
      • Oncology Hematology Associates of Central Illinois, PC - Ottawa
    • Park Ridge, Illinois, United States, 60068-1174
      • Advocate Lutheran General Cancer Care Center
    • Pekin, Illinois, United States, 61554
      • Cancer Treatment Center at Pekin Hospital
    • Pekin, Illinois, United States, 61603
      • Illinois CancerCare - Pekin
    • Peoria, Illinois, United States, 61636
      • Methodist Medical Center of Illinois
    • Peoria, Illinois, United States, 61615
      • CCOP - Illinois Oncology Research Association
    • Peoria, Illinois, United States, 61615
      • Oncology Hematology Associates of Central Illinois, PC - Peoria
    • Peoria, Illinois, United States, 61615-7827
      • OSF St. Francis Medical Center
    • Peru, Illinois, United States, 61354
      • Illinois CancerCare - Peru
    • Princeton, Illinois, United States, 61356
      • Illinois CancerCare - Princeton
    • Spring Valley, Illinois, United States, 61362
      • Illinois CancerCare - Spring Valley
    • Springfield, Illinois, United States, 62702
      • Cancer Institute at St. John's Hospital
    • Urbana, Illinois, United States, 61801
      • CCOP - Carle Cancer Center
    • Warrenville, Illinois, United States, 60555
      • Central Dupage Cancer Center
  • Indiana
    • Anderson, Indiana, United States, 46016
      • Saint John's Cancer Center at Saint John's Medical Center
    • Elkhart, Indiana, United States, 46515
      • Elkhart General Hospital
    • Fort Wayne, Indiana, United States, 46805
      • Parkview Regional Cancer Center at Parkview Health
    • Fort Wayne, Indiana, United States, 46804
      • Radiation Oncology Associates Southwest
    • Goshen, Indiana, United States, 46526
      • Center for Cancer Care at Goshen General Hospital
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Indianapolis Hospital
    • Indianapolis, Indiana, United States, 46202
      • Methodist Cancer Center at Methodist Hospital
    • Indianapolis, Indiana, United States, 46219
      • Central Indiana Cancer Centers - East
    • South Bend, Indiana, United States, 46601
      • Memorial Hospital of South Bend
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Genesis Regional Cancer Center at Genesis Medical Center
    • Des Moines, Iowa, United States, 50309
      • John Stoddard Cancer Center at Iowa Methodist Medical Center
    • Iowa City, Iowa, United States, 52242-1002
      • Holden Comprehensive Cancer Center at University of Iowa
  • Kansas
    • Prairie Village, Kansas, United States, 66208
      • CCOP - Kansas City
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0093
      • Lucille P. Markey Cancer Center at University of Kentucky
    • Lexington, Kentucky, United States, 40503-9985
      • Central Baptist Hospital
    • Louisville, Kentucky, United States, 40202
      • Louisville Oncology at Norton Cancer Institute - Louisville
    • Louisville, Kentucky, United States, 40202
      • James Graham Brown Cancer Center at University of Louisville
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Mary Bird Perkins Cancer Center - Baton Rouge
    • Baton Rouge, Louisiana, United States, 70809
      • Ochsner Health Center - Bluebonnet
    • New Orleans, Louisiana, United States, 70121
      • CCOP - Ochsner
  • Maine
    • Bangor, Maine, United States, 04401
      • CancerCare of Maine at Eastern Maine Medical Center
    • Lewiston, Maine, United States, 04240
      • Central Maine Comprehensive Cancer Center at Central Maine Medical Center
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • DeCesaris Cancer Institute at Anne Arundel Medical Center
    • Baltimore, Maryland, United States, 21231-2410
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Baltimore, Maryland, United States, 21229
      • St. Agnes Hospital Cancer Center
    • Baltimore, Maryland, United States, 21201
      • Greenebaum Cancer Center at University of Maryland Medical Center
    • Baltimore, Maryland, United States, 21237
      • Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
    • Columbia, Maryland, United States, 21044
      • Central Maryland Oncology Center
    • Easton, Maryland, United States, 21601
      • Shore Regional Cancer Center at Memorial Hospital - Easton
    • Elkton, Maryland, United States, 21921
      • Union Hospital of Cecil County
    • Salisbury, Maryland, United States, 21801
      • Peninsula Regional Medical Center
    • Silver Spring, Maryland, United States, 20910
      • Holy Cross Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02118
      • Boston University Cancer Research Center
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic Medical Center - Burlington
    • Danvers, Massachusetts, United States, 01923
      • NSMC Cancer Center - Peabody
    • Framingham, Massachusetts, United States, 01702
      • Metrowest Medical Center - Framingham Union Hospital
    • Hyannis, Massachusetts, United States, 02601
      • Cape Cod Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48106-0995
      • Saint Joseph Mercy Cancer Center
    • Battle Creek, Michigan, United States, 49017
      • Battle Creek Health System Cancer Care Center
    • Clinton Township, Michigan, United States, 48038
      • Henry Ford Macomb Hospital
    • Dearborn, Michigan, United States, 48123-2500
      • Oakwood Cancer Center at Oakwood Hospital and Medical Center
    • Detroit, Michigan, United States, 48202
      • Josephine Ford Cancer Center at Henry Ford Hospital
    • Detroit, Michigan, United States, 48201-1379
      • Barbara Ann Karmanos Cancer Institute
    • Flint, Michigan, United States, 48503
      • Genesys Hurley Cancer Institute
    • Flint, Michigan, United States, 48532
      • McLaren Cancer Institute
    • Grand Rapids, Michigan, United States, 49503
      • Butterworth Hospital at Spectrum Health
    • Grand Rapids, Michigan, United States, 49503
      • CCOP - Grand Rapids
    • Grosse Pointe Woods, Michigan, United States, 48236
      • Van Elslander Cancer Center at St. John Hospital and Medical Center
    • Kalamazoo, Michigan, United States, 49007
      • Bronson Methodist Hospital
    • Kalamazoo, Michigan, United States, 49001
      • Borgess Medical Center
    • Kalamazoo, Michigan, United States, 49007-3731
      • West Michigan Cancer Center
    • Lansing, Michigan, United States, 48910
      • Breslin Cancer Center at Ingham Regional Medical Center
    • Pontiac, Michigan, United States, 48341-2985
      • St. Joseph Mercy Oakland
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital - Royal Oak Campus
    • Saginaw, Michigan, United States, 48601
      • Seton Cancer Institute at Saint Mary's - Saginaw
    • Warren, Michigan, United States, 48093
      • St. John Macomb Hospital
  • Minnesota
    • Bemidji, Minnesota, United States, 56601
      • MeritCare Bemidji
    • Burnsville, Minnesota, United States, 55337
      • Fairview Ridges Hospital
    • Coon Rapids, Minnesota, United States, 55433
      • Mercy and Unity Cancer Center at Mercy Hospital
    • Duluth, Minnesota, United States, 55805
      • St. Luke's Hospital Cancer Care Center
    • Edina, Minnesota, United States, 55435
      • Fairview Southdale Hospital
    • Fridley, Minnesota, United States, 55432
      • Mercy and Unity Cancer Center at Unity Hospital
    • Mankato, Minnesota, United States, 56002
      • Immanuel St. Joseph's
    • Maplewood, Minnesota, United States, 55109
      • Minnesota Oncology - Maplewood
    • Minneapolis, Minnesota, United States, 55407
      • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
    • Robbinsdale, Minnesota, United States, 55422-2900
      • Humphrey Cancer Center at North Memorial Outpatient Center
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Cancer Center
    • Saint Cloud, Minnesota, United States, 56303
      • CentraCare Clinic - River Campus
    • Saint Louis Park, Minnesota, United States, 55416
      • CCOP - Metro-Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • Park Nicollet Cancer Center
    • Saint Paul, Minnesota, United States, 55102
      • United Hospital
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital Cancer Care Center
    • Waconia, Minnesota, United States, 55387
      • Ridgeview Medical Center
    • Woodbury, Minnesota, United States, 55125
      • Minnesota Oncology - Woodbury
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Cancer Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64154
      • Kansas City Cancer Centers - North
  • Montana
    • Billings, Montana, United States, 59107-7000
      • Billings Clinic - Downtown
    • Great Falls, Montana, United States, 59405
      • Great Falls Clinic - Main Facility
    • Great Falls, Montana, United States, 59405
      • Sletten Cancer Institute at Benefis Healthcare
    • Missoula, Montana, United States, 59807
      • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
  • Nebraska
    • Kearney, Nebraska, United States, 68848-1990
      • Good Samaritan Cancer Center at Good Samaritan Hospital
    • Omaha, Nebraska, United States, 68122
      • Immanuel Medical Center
    • Omaha, Nebraska, United States, 68124
      • Alegant Health Cancer Center at Bergan Mercy Medical Center
    • Omaha, Nebraska, United States, 68131-2197
      • Creighton University Medical Center
    • Omaha, Nebraska, United States, 68114
      • Methodist Estabrook Cancer Center
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • CCOP - Nevada Cancer Research Foundation
    • Reno, Nevada, United States, 89503
      • Saint Mary's Regional Medical Center
    • Reno, Nevada, United States, 89502
      • Renown Institute for Cancer at Renown Regional Medical Center
  • New Hampshire
    • Concord, New Hampshire, United States, 03301
      • Payson Center for Cancer Care at Concord Hospital
    • Dover, New Hampshire, United States, 03820
      • Seacoast Cancer Center at Wentworth - Douglass Hospital
    • Exeter, New Hampshire, United States, 03833
      • Center for Cancer Care at Exeter Hospital
    • Lebanon, New Hampshire, United States, 03756-0002
      • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • Manchester, New Hampshire, United States, 03103
      • Elliot Regional Cancer Center at Elliot Hospital
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan-Kettering Cancer Center - Basking Ridge
    • Elizabeth, New Jersey, United States, 07207
      • Trinitas Comprehensive Cancer Center at Trinitas Hospital
    • Englewood, New Jersey, United States, 07631
      • Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center
    • Livingston, New Jersey, United States, 07039
      • St. Barnabas Medical Center Cancer Center
    • Marlton, New Jersey, United States, 08053
      • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
    • New Brunswick, New Jersey, United States, 08901
      • Saint Peter's University Hospital
    • Newark, New Jersey, United States, 07112
      • Newark Beth Israel Medical Center
    • Sparta, New Jersey, United States, 07871
      • Frederick R. and Betty M. Smith Cancer Treatment Center
    • Toms River, New Jersey, United States, 08755
      • J. Phillip Citta Regional Cancer Center at Community Medical Center
    • Trenton, New Jersey, United States, 08629
      • St. Francis Regional Cancer Center
    • Voorhees, New Jersey, United States, 08043
      • Cancer Institute of New Jersey at Cooper - Voorhees
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131-5636
      • University of New Mexico Cancer Center
  • New York
    • Albany, New York, United States, 12206
      • New York Oncology Hematology, PC at Albany Regional Cancer Care
    • Buffalo, New York, United States, 14263-0001
      • Roswell Park Cancer Institute
    • Canandaigua, New York, United States, 14424
      • Sands Cancer Center
    • Commack, New York, United States, 11725
      • Memorial Sloan-Kettering Cancer Center
    • Cooperstown, New York, United States, 13326
      • Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
    • East Syracuse, New York, United States, 13057
      • CCOP - Hematology-Oncology Associates of Central New York
    • Ithaca, New York, United States, 14850
      • Cayuga Medical Center of Ithaca
    • Jamaica, New York, United States, 11432
      • Queens Cancer Center of Queens Hospital
    • Manhasset, New York, United States, 11030
      • CCOP - North Shore University Hospital
    • New Hyde Park, New York, United States, 11040
      • Long Island Jewish Medical Center
    • Poughkeepsie, New York, United States, 12601
      • Saint Francis Hospital Cancer Center
    • Poughkeepsie, New York, United States, 12601
      • Hudson Valley Oncology Associates
    • Rochester, New York, United States, 14642
      • James P. Wilmot Cancer Center at University of Rochester Medical Center
    • Rochester, New York, United States, 14620
      • Highland Hospital of Rochester
    • Rochester, New York, United States, 14621
      • Lipson Cancer and Blood Center at Rochester General Hospital
    • Rochester, New York, United States, 14626
      • University Radiation Oncology at Parkridge Hospital
    • Sleepy Hollow, New York, United States, 10591
      • Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University Hospital
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mission Hospitals - Memorial Campus
    • Asheville, North Carolina, United States, 28816
      • Hope A Women's Cancer Center
    • Charlotte, North Carolina, United States, 28232-2861
      • Blumenthal Cancer Center at Carolinas Medical Center
    • Charlotte, North Carolina, United States, 28233-3549
      • Presbyterian Cancer Center at Presbyterian Hospital
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Institute
    • Hendersonville, North Carolina, United States, 28791
      • Pardee Memorial Hospital
    • High Point, North Carolina, United States, 27261
      • High Point Regional Hospital
    • Raleigh, North Carolina, United States, 27607
      • Cancer Centers of North Carolina - Raleigh
    • Wilmington, North Carolina, United States, 28401
      • Coastal Carolina Radiation Oncology Center
    • Winston-Salem, North Carolina, United States, 27103
      • Forsyth Regional Cancer Center at Forsyth Medical Center
  • North Dakota
    • Fargo, North Dakota, United States, 58102
      • MeritCare Broadway
    • Grand Forks, North Dakota, United States, 58201
      • Altru Cancer Center at Altru Hospital
  • Ohio
    • Akron, Ohio, United States, 44307
      • McDowell Cancer Center at Akron General Medical Center
    • Akron, Ohio, United States, 44309-2090
      • Summa Center for Cancer Care at Akron City Hospital
    • Barberton, Ohio, United States, 44203
      • Barberton Citizens Hospital
    • Canton, Ohio, United States, 44710-1799
      • Aultman Cancer Center at Aultman Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer Center
    • Cleveland, Ohio, United States, 44106-5065
      • Case Comprehensive Cancer Center
    • Cleveland, Ohio, United States, 44111
      • Cleveland Clinic Cancer Center at Fairview Hospital
    • Columbus, Ohio, United States, 43215
      • CCOP - Columbus
    • Columbus, Ohio, United States, 43210-1240
      • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
    • Independence, Ohio, United States, 44131
      • Cleveland Clinic Cancer Center
    • Lima, Ohio, United States, 45804
      • Lima Memorial Hospital
    • Lima, Ohio, United States, 45801
      • St. Rita's Medical Center
    • Mansfield, Ohio, United States, 44903
      • MedCentral - Mansfield Hospital
    • Mayfield Heights, Ohio, United States, 44124
      • Hillcrest Cancer Center at Hillcrest Hospital
    • Springfield, Ohio, United States, 45505
      • Community Hospital of Springfield and Clark County
    • Sylvania, Ohio, United States, 43560
      • Flower Hospital Cancer Center
    • Toledo, Ohio, United States, 43614
      • Medical University of Ohio Cancer Center
    • Toledo, Ohio, United States, 43623
      • St. Anne Mercy Hospital
    • Wooster, Ohio, United States, 44691
      • Cleveland Clinic - Wooster
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Natalie Warren Bryant Cancer Center at St. Francis Hospital
  • Oregon
    • Clackamas, Oregon, United States, 97015
      • Clackamas Radiation Oncology Center
    • Eugene, Oregon, United States, 97401
      • Willamette Valley Cancer Center - Eugene
    • Grants Pass, Oregon, United States, 97527
      • Three Rivers Community Hospital
    • Gresham, Oregon, United States, 97030
      • Legacy Mount Hood Medical Center
    • Medford, Oregon, United States, 97504
      • Dubs Cancer Center at Rogue Valley Medical Center
    • Medford, Oregon, United States, 97504
      • Providence Cancer Center at PMCC
    • Milwaukie, Oregon, United States, 97222
      • Providence Milwaukie Hospital
    • Portland, Oregon, United States, 97239-3098
      • Knight Cancer Institute at Oregon Health and Science University
    • Portland, Oregon, United States, 97210
      • Legacy Good Samaritan Hospital & Comprehensive Cancer Center
    • Portland, Oregon, United States, 97213-2967
      • Providence Cancer Center at Providence Portland Medical Center
    • Portland, Oregon, United States, 97225
      • CCOP - Columbia River Oncology Program
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent Medical Center
    • Portland, Oregon, United States, 97227
      • Legacy Emanuel Hospital and Health Center and Children's Hospital
    • Salem, Oregon, United States, 97309-5014
      • Salem Hospital Regional Cancer Care Services
    • Tualatin, Oregon, United States, 97062
      • Legacy Meridian Park Hospital
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
      • UPMC Cancer Center at Beaver Medical Center
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's Cancer Network at St. Luke's Hospital
    • Danville, Pennsylvania, United States, 17822-0001
      • Geisinger Cancer Institute at Geisinger Health
    • Drexel Hill, Pennsylvania, United States, 19026
      • Delaware County Regional Cancer Center at Delaware County Memorial Hospital
    • Dunmore, Pennsylvania, United States, 18512
      • Northeast Radiation Oncology Center
    • Erie, Pennsylvania, United States, 16505
      • Regional Cancer Center - Erie
    • Harrisburg, Pennsylvania, United States, 17110-2098
      • PinnacleHealth Regional Cancer Center at Polyclinic Hospital
    • Monroeville, Pennsylvania, United States, 15146
      • Intercommunity Cancer Center
    • Norristown, Pennsylvania, United States, 19401
      • Norristown Regional Cancer Center
    • Philadelphia, Pennsylvania, United States, 19111-2497
      • Fox Chase Cancer Center - Philadelphia
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University College of Medicine - Center City Hahnemann Campus
    • Philadelphia, Pennsylvania, United States, 19107-5541
      • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
    • Philadelphia, Pennsylvania, United States, 19114
      • Frankford Hospital Cancer Center - Torresdale Campus
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Cancer Center at Allegheny General Hospital
    • Pittsburgh, Pennsylvania, United States, 15224-1791
      • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
    • Pittsburgh, Pennsylvania, United States, 15213-2582
      • UPMC - Shadyside
    • Reading, Pennsylvania, United States, 19612-6052
      • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
    • State College, Pennsylvania, United States, 16803
      • Mount Nittany Medical Center
    • Upland, Pennsylvania, United States, 19013
      • Crozer-Chester Medical Center
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
    • York, Pennsylvania, United States, 17405
      • York Cancer Center at Apple Hill Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital Comprehensive Cancer Center
    • Providence, Rhode Island, United States, 02904
      • Northmain Radiation Oncology
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Hollings Cancer Center at Medical University of South Carolina
    • Charleston, South Carolina, United States, 29401
      • Roper St. Francis Cancer Center at Roper Hospital
    • Georgetown, South Carolina, United States, 29440
      • Georgetown Memorial Hospital
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Rapid City Regional Hospital
    • Sioux Falls, South Dakota, United States, 57117-5039
      • Sanford Cancer Center at Sanford USD Medical Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37916
      • Thompson Cancer Survival Center
    • Nashville, Tennessee, United States, 37232-6838
      • Vanderbilt-Ingram Cancer Center
  • Texas
    • Bedford, Texas, United States, 76022
      • Texas Oncology, PA at Harris Center HEB
    • Dallas, Texas, United States, 75390
      • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
    • Denton, Texas, United States, 76210
      • Texas Oncology, PA at Texas Cancer Center - Denton South
    • Fort Worth, Texas, United States, 76104
      • Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
    • Houston, Texas, United States, 77030-4009
      • M. D. Anderson Cancer Center at University of Texas
    • Irving, Texas, United States, 75061
      • Baylor Medical Center at Irving
    • Lewisville, Texas, United States, 75067
      • Texas Oncology, PA at Lake Vista Cancer Center
    • Lubbock, Texas, United States, 79410-1894
      • Joe Arrington Cancer Research and Treatment Center
    • Round Rock, Texas, United States, 78681
      • Texas Oncology, PA at Texas Cancer Center Round Rock
    • San Antonio, Texas, United States, 78229-3900
      • University of Texas Health Science Center at San Antonio
    • San Antonio, Texas, United States, 78217
      • Cancer Care Centers of South Texas - Northeast
    • Sherman, Texas, United States, 75090
      • Texas Oncology, PA at Texas Cancer Center - Sherman
    • Sugar Land, Texas, United States, 77479
      • Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
  • Utah
    • Cedar City, Utah, United States, 84720
      • Sandra L. Maxwell Cancer Center
    • Ogden, Utah, United States, 84403
      • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
    • Provo, Utah, United States, 84604
      • Utah Valley Regional Medical Center - Provo
    • Saint George, Utah, United States, 84770
      • Dixie Regional Medical Center - East Campus
    • Salt Lake City, Utah, United States, 84143
      • LDS Hospital
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute at University of Utah
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialists at UCS Cancer Center
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Fletcher Allen Health Care - University Health Center Campus
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Cancer Center
    • Portsmouth, Virginia, United States, 23708-2197
      • Naval Medical Center - Portsmouth
    • Richmond, Virginia, United States, 23298-0037
      • Virginia Commonwealth University Massey Cancer Center
  • Washington
    • Bellingham, Washington, United States, 98225
      • St. Joseph Cancer Center
    • Seattle, Washington, United States, 98109-1023
      • Seattle Cancer Care Alliance
    • Seattle, Washington, United States, 98195
      • University Cancer Center at University of Washington Medical Center
    • Spokane, Washington, United States, 99204
      • Providence Cancer Center at Sacred Heart Medical Center
    • Vancouver, Washington, United States, 98664
      • Southwest Washington Medical Center Cancer Center
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • West Virginia University Health Sciences Center - Charleston
    • Huntington, West Virginia, United States, 25702
      • St. Mary's Regional Cancer Center at St. Mary's Medical Center
    • Wheeling, West Virginia, United States, 26003
      • Schiffler Cancer Center at Wheeling Hospital
  • Wisconsin
    • Eau Claire, Wisconsin, United States, 54701
      • Center for Cancer Treatment & Prevention at Sacred Heart Hospital
    • Green Bay, Wisconsin, United States, 54307-3508
      • St. Vincent Hospital Regional Cancer Center
    • Green Bay, Wisconsin, United States, 54311
      • Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
    • La Crosse, Wisconsin, United States, 54601
      • Franciscan Skemp Healthcare - La Crosse Campus
    • Madison, Wisconsin, United States, 53792-6164
      • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
    • Madison, Wisconsin, United States, 53717
      • Dean Medical Center - Madison
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Clinic - Marshfield Center
    • Menomonee Falls, Wisconsin, United States, 53051
      • Community Memorial Hospital Cancer Care Center
    • Mequon, Wisconsin, United States, 53097
      • Columbia Saint Mary's Hospital - Ozaukee
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin Cancer Center
    • Milwaukee, Wisconsin, United States, 53211
      • Columbia-Saint Mary's Cancer Care Center
    • Milwaukee, Wisconsin, United States, 53215
      • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
    • Oconomowoc, Wisconsin, United States, 53066
      • Regional Cancer Center at Oconomowoc Memorial Hospital
    • Oshkosh, Wisconsin, United States, 54904
      • Vince Lombardi Cancer Clinic - Oshkosh
    • Racine, Wisconsin, United States, 53405
      • All Saints Cancer Center at Wheaton Franciscan Healthcare
    • Stevens Point, Wisconsin, United States, 54481
      • Saint Michael's Hospital Cancer Center
    • Summit, Wisconsin, United States, 53066
      • Aurora Medical Center
    • Waukesha, Wisconsin, United States, 53188
      • Waukesha Memorial Hospital Regional Cancer Center
    • Wausau, Wisconsin, United States, 54401
      • University of Wisconcin Cancer Center at Aspirus Wausau Hospital
    • West Allis, Wisconsin, United States, 53227
      • West Allis Memorial Hospital
    • Weston, Wisconsin, United States, 54476
      • Diagnostic and Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: WBI; Patients undergo whole breast irradiation (WBI) once daily, 5 days a week for 5-7 weeks.	Radiation: whole breast irradiation; Patients undergo radiation therapy once daily (days 1-5) for up to 7 weeks
Experimental: Group 2: PBI; Patients 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.	Radiation: brachytherapy; Radiation: 3-dimensional conformal accelerated partial breast irradiation; Radiation: MammoSite or other single-entry intracavitary device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In-breast tumor recurrence (IBTR)	every 6 months for 5 years; annually thereafter for up to 10 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	time from randomization to death due to any cause assessed up to 15 years
Recurrence-free survival	time from randomization to recurrence assessed every 6 months for 5 years and annually thereafter for up to 10 years
Distant disease-free survival	time from randomization to event occurrence assessed every 6 months for 5 years and annually thereafter for up to 10 years
Quality of life and patient-reported cosmesis by Breast Cancer Treatment Outcome Scale, MOS SF-36 Vitality, Convenience of Care scale, and symptoms	measured at baseline, and 1 and 6 months and 1, 2, and 3 years after completion of study treatment
Toxicity as assessed by adverse events during treatment	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

Collaborators and Investigators

• Sponsor: NSABP Foundation Inc
• Collaborators: National Cancer Institute (NCI); Southwest Oncology Group; Radiation Therapy Oncology Group

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Bovi J, Qi XS, White J, Li XA. Comparison of three accelerated partial breast irradiation techniques: treatment effectiveness based upon biological models. Radiother Oncol. 2007 Sep;84(3):226-32. doi: 10.1016/j.radonc.2007.07.004. Epub 2007 Aug 10.
• 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.
• 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.
• 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.
• 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.
• Patel RR, Christensen ME, Hodge CW, Adkison JB, Das RK. Clinical outcome analysis in "high-risk" versus "low-risk" patients eligible for national surgical adjuvant breast and bowel B-39/radiation therapy oncology group 0413 trial: five-year results. Int J Radiat Oncol Biol Phys. 2008 Mar 15;70(4):970-3. doi: 10.1016/j.ijrobp.2007.12.005.
• Al-Hallaq H, Mell L, Advani S, et al.: Magnetic resonance imaging (MRI) identifies multifocal and multicentric disease in breast cancer patients eligible for the NSABP B-39/RTOG 0413 partial breast irradiation (PBI) trial. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-1086, S179-S180, 2006.
• Vicini FA, Cecchini RS, White JR, Arthur DW, Julian TB, Rabinovitch RA, Kuske RR, Ganz PA, Parda DS, Scheier MF, Winter KA, Paik S, Kuerer HM, Vallow LA, Pierce LJ, Mamounas EP, McCormick B, Costantino JP, Bear HD, Germain I, Gustafson G, Grossheim L, Petersen IA, Hudes RS, Curran WJ Jr, Bryant JL, Wolmark N. Long-term primary results of accelerated partial breast irradiation after breast-conserving surgery for early-stage breast cancer: a randomised, phase 3, equivalence trial. Lancet. 2019 Dec 14;394(10215):2155-2164. doi: 10.1016/S0140-6736(19)32514-0. Epub 2019 Dec 5.

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: February 7, 2005
• First Submitted That Met QC Criteria: February 7, 2005
• First Posted (Estimate): February 8, 2005

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: stage II breast cancer; stage IA breast cancer; stage IB breast cancer; breast cancer in situ; ductal breast carcinoma in situ
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Carcinoma in Situ; Breast Neoplasms
• Other Study ID Numbers: NSABP B-39/RTOG 0413; NSABP-B-39; RTOG-0413; SWOG-NSABP-B-39; NCI-2009-00698 (Registry Identifier: CTRP (Clinical Trials Reporting Program))