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
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage II breast cancer, ductal breast carcinoma in situ, breast cancer in situ, stage IA breast cancer, stage IB breast cancer
Eligibility Criteria
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
Sites / Locations
- UAB Comprehensive Cancer Center
- Arizona Center for Cancer Care - Peoria
- Arizona Oncology Services Foundation
- Arizona Breast Cancer Specialists
- Mayo Clinic Scottsdale
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Auburn Radiation Oncology
- Alta Bates Summit Comprehensive Cancer Center
- Peninsula Medical Center
- Radiation Oncology Centers - Cameron Park
- Mercy Cancer Center at Mercy San Juan Medical Center
- Enloe Cancer Center at Enloe Medical Center
- Cancer Care Center at John Muir Health - Concord Campus
- City of Hope Comprehensive Cancer Center
- North Bay Cancer Center
- California Cancer Center - Woodward Park Office
- Kaiser Permanente Medical Center - Hayward
- Rebecca and John Moores UCSD Cancer Center
- Jonsson Comprehensive Cancer Center at UCLA
- Community Hospital of the Monterey Peninsula Comprehensive Cancer Center
- Sutter Health - Western Division Cancer Research Group
- CCOP - Bay Area Tumor Institute
- St. Joseph Hospital Regional Cancer Center - Orange
- Desert Regional Medical Center Comprehensive Cancer Center
- Feather River Hospital Cancer Center
- Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
- Mercy Regional Cancer Center at Mercy Medical Center
- Radiation Oncology Center - Roseville
- Radiological Associates of Sacramento Medical Group, Incorporated
- University of California Davis Cancer Center
- Mercy General Hospital
- Kaiser Permanente Medical Office -Vandever Medical Office
- Sharp Memorial Hospital Cancer Center
- California Pacific Medical Center - California Campus
- Doctors Medical Center - San Pablo Campus
- Stanford Cancer Center
- Solano Radiation Oncology Center
- Kaiser Permanente Medical Center - Vallejo
- Sutter Solano Medical Center
- John Muir/Mt. Diablo Comprehensive Cancer Center
- Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
- Aurora Presbyterian Hospital
- University of Colorado Cancer Center at UC Health Sciences Center
- Boulder Community Hospital
- Memorial Hospital Cancer Center - Colorado Springs
- Penrose Cancer Center at Penrose Hospital
- Porter Adventist Hospital
- Swedish Medical Center
- Poudre Valley Radiation Oncology
- North Colorado Medical Center
- Sky Ridge Medical Center
- Hope Cancer Care Center at Longmont United Hospital
- McKee Medical Center
- St. Mary - Corwin Regional Medical Center
- North Suburban Medical Center
- Bridgeport Hospital
- Helen and Harry Gray Cancer Center at Hartford Hospital
- Hospital of Saint Raphael
- Yale Cancer Center
- Norwalk Hospital
- Connecticut Oncology & Hematology - Torrington
- CCOP - Christiana Care Health Services
- Washington Cancer Institute at Washington Hospital Center
- Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
- University of Florida Shands Cancer Center
- Integrated Community Oncology Network
- Baptist Cancer Institute - Jacksonville
- Integrated Community Oncology Network at Southside Cancer Center
- Mayo Clinic - Jacksonville
- Baptist Medical Center South
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
- Lakeland Regional Cancer Center at Lakeland Regional Medical Center
- CCOP - Mount Sinai Medical Center
- Integrated Community Oncology Network - Orange Park
- Florida Cancer Center - Palatka
- Flagler Cancer Center
- Northside Hospital Cancer Center
- CCOP - Atlanta Regional
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
- Kennestone Cancer Center at Wellstar Kennestone Hospital
- Cancer Research Center of Hawaii
- Queen's Cancer Institute at Queen's Medical Center
- Straub Clinic and Hospital, Incorporated
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
- Kootenai Cancer Center - Coeur d'Alene
- Rush-Copley Cancer Care Center
- Good Shepherd Hospital
- Illinois CancerCare - Bloomington
- Illinois CancerCare - Canton
- Illinois CancerCare - Carthage
- Creticos Cancer Center at Advocate Illinois Masonic Medical Center
- Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital
- Alexian Brothers Radiation Oncology
- Illinois CancerCare - Eureka
- Illinois CancerCare - Cottage
- Illinois CancerCare - Galesburg
- Illinois CancerCare - Havana
- Illinois CancerCare - Kewanee Clinic
- Illinois CancerCare - Macomb
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
- Illinois CancerCare - Monmouth
- OSF Holy Family Medical Center
- Edward Hospital Cancer Center
- Community Cancer Center
- Illinois CancerCare - Community Cancer Center
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Advocate Lutheran General Cancer Care Center
- Cancer Treatment Center at Pekin Hospital
- Illinois CancerCare - Pekin
- OSF St. Francis Medical Center
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- Illinois CancerCare - Peru
- Illinois CancerCare - Princeton
- Illinois CancerCare - Spring Valley
- Cancer Institute at St. John's Hospital
- CCOP - Carle Cancer Center
- Central Dupage Cancer Center
- Saint John's Cancer Center at Saint John's Medical Center
- Elkhart General Hospital
- Radiation Oncology Associates Southwest
- Parkview Regional Cancer Center at Parkview Health
- Center for Cancer Care at Goshen General Hospital
- Methodist Cancer Center at Methodist Hospital
- Central Indiana Cancer Centers - East
- St. Vincent Indianapolis Hospital
- Memorial Hospital of South Bend
- Genesis Regional Cancer Center at Genesis Medical Center
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Holden Comprehensive Cancer Center at University of Iowa
- CCOP - Kansas City
- Central Baptist Hospital
- Lucille P. Markey Cancer Center at University of Kentucky
- James Graham Brown Cancer Center at University of Louisville
- Louisville Oncology at Norton Cancer Institute - Louisville
- Mary Bird Perkins Cancer Center - Baton Rouge
- Ochsner Health Center - Bluebonnet
- CCOP - Ochsner
- CancerCare of Maine at Eastern Maine Medical Center
- Central Maine Comprehensive Cancer Center at Central Maine Medical Center
- DeCesaris Cancer Institute at Anne Arundel Medical Center
- Greenebaum Cancer Center at University of Maryland Medical Center
- St. Agnes Hospital Cancer Center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
- Central Maryland Oncology Center
- Shore Regional Cancer Center at Memorial Hospital - Easton
- Union Hospital of Cecil County
- Peninsula Regional Medical Center
- Holy Cross Hospital
- Massachusetts General Hospital
- Boston University Cancer Research Center
- Lahey Clinic Medical Center - Burlington
- NSMC Cancer Center - Peabody
- MetroWest Medical Center - Framingham Union Hospital
- Cape Cod Hospital
- Saint Joseph Mercy Cancer Center
- Battle Creek Health System Cancer Care Center
- Henry Ford Macomb Hospital
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Barbara Ann Karmanos Cancer Institute
- Josephine Ford Cancer Center at Henry Ford Hospital
- Genesys Hurley Cancer Institute
- McLaren Cancer Institute
- Butterworth Hospital at Spectrum Health
- CCOP - Grand Rapids
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Breslin Cancer Center at Ingham Regional Medical Center
- St. Joseph Mercy Oakland
- William Beaumont Hospital - Royal Oak Campus
- Seton Cancer Institute at Saint Mary's - Saginaw
- St. John Macomb Hospital
- MeritCare Bemidji
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- St. Luke's Hospital Cancer Care Center
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Immanuel St. Joseph's
- Minnesota Oncology - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Humphrey Cancer Center at North Memorial Outpatient Center
- Mayo Clinic Cancer Center
- CentraCare Clinic - River Campus
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- Regions Hospital Cancer Care Center
- United Hospital
- Ridgeview Medical Center
- Minnesota Oncology - Woodbury
- University of Mississippi Cancer Clinic
- Kansas City Cancer Centers - North
- Billings Clinic - Downtown
- Great Falls Clinic - Main Facility
- Sletten Cancer Institute at Benefis Healthcare
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Good Samaritan Cancer Center at Good Samaritan Hospital
- Methodist Estabrook Cancer Center
- Immanuel Medical Center
- Alegant Health Cancer Center at Bergan Mercy Medical Center
- Creighton University Medical Center
- CCOP - Nevada Cancer Research Foundation
- Renown Institute for Cancer at Renown Regional Medical Center
- Saint Mary's Regional Medical Center
- Payson Center for Cancer Care at Concord Hospital
- Seacoast Cancer Center at Wentworth - Douglass Hospital
- Center for Cancer Care at Exeter Hospital
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Elliot Regional Cancer Center at Elliot Hospital
- Memorial Sloan-Kettering Cancer Center - Basking Ridge
- Trinitas Comprehensive Cancer Center at Trinitas Hospital
- Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center
- St. Barnabas Medical Center Cancer Center
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
- Saint Peter's University Hospital
- Newark Beth Israel Medical Center
- Frederick R. and Betty M. Smith Cancer Treatment Center
- J. Phillip Citta Regional Cancer Center at Community Medical Center
- St. Francis Regional Cancer Center
- Cancer Institute of New Jersey at Cooper - Voorhees
- University of New Mexico Cancer Center
- New York Oncology Hematology, PC at Albany Regional Cancer Care
- Roswell Park Cancer Institute
- Sands Cancer Center
- Memorial Sloan-Kettering Cancer Center
- Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
- CCOP - Hematology-Oncology Associates of Central New York
- Cayuga Medical Center of Ithaca
- Queens Cancer Center of Queens Hospital
- CCOP - North Shore University Hospital
- Long Island Jewish Medical Center
- Hudson Valley Oncology Associates
- Saint Francis Hospital Cancer Center
- Highland Hospital of Rochester
- Lipson Cancer and Blood Center at Rochester General Hospital
- University Radiation Oncology at Parkridge Hospital
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
- SUNY Upstate Medical University Hospital
- Mission Hospitals - Memorial Campus
- Hope A Women's Cancer Center
- Blumenthal Cancer Center at Carolinas Medical Center
- Presbyterian Cancer Center at Presbyterian Hospital
- Duke Cancer Institute
- Pardee Memorial Hospital
- High Point Regional Hospital
- Cancer Centers of North Carolina - Raleigh
- Coastal Carolina Radiation Oncology Center
- Forsyth Regional Cancer Center at Forsyth Medical Center
- MeritCare Broadway
- Altru Cancer Center at Altru Hospital
- McDowell Cancer Center at Akron General Medical Center
- Summa Center for Cancer Care at Akron City Hospital
- Barberton Citizens Hospital
- Aultman Cancer Center at Aultman Hospital
- Case Comprehensive Cancer Center
- Cleveland Clinic Cancer Center at Fairview Hospital
- Cleveland Clinic Taussig Cancer Center
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
- CCOP - Columbus
- Cleveland Clinic Cancer Center
- St. Rita's Medical Center
- Lima Memorial Hospital
- MedCentral - Mansfield Hospital
- Hillcrest Cancer Center at Hillcrest Hospital
- Community Hospital of Springfield and Clark County
- Flower Hospital Cancer Center
- Medical University of Ohio Cancer Center
- St. Anne Mercy Hospital
- Cleveland Clinic - Wooster
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Clackamas Radiation Oncology Center
- Willamette Valley Cancer Center - Eugene
- Three Rivers Community Hospital
- Legacy Mount Hood Medical Center
- Dubs Cancer Center at Rogue Valley Medical Center
- Providence Cancer Center at PMCC
- Providence Milwaukie Hospital
- Legacy Good Samaritan Hospital & Comprehensive Cancer Center
- Providence Cancer Center at Providence Portland Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Legacy Emanuel Hospital and Health Center and Children's Hospital
- Knight Cancer Institute at Oregon Health and Science University
- Salem Hospital Regional Cancer Care Services
- Legacy Meridian Park Hospital
- UPMC Cancer Center at Beaver Medical Center
- St. Luke's Cancer Network at St. Luke's Hospital
- Geisinger Cancer Institute at Geisinger Health
- Delaware County Regional Cancer Center at Delaware County Memorial Hospital
- Northeast Radiation Oncology Center
- Regional Cancer Center - Erie
- PinnacleHealth Regional Cancer Center at Polyclinic Hospital
- Intercommunity Cancer Center
- Norristown Regional Cancer Center
- Drexel University College of Medicine - Center City Hahnemann Campus
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Fox Chase Cancer Center - Philadelphia
- Frankford Hospital Cancer Center - Torresdale Campus
- Allegheny Cancer Center at Allegheny General Hospital
- UPMC - Shadyside
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
- McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
- Mount Nittany Medical Center
- Crozer-Chester Medical Center
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- York Cancer Center at Apple Hill Medical Center
- Rhode Island Hospital Comprehensive Cancer Center
- Northmain Radiation Oncology
- Roper St. Francis Cancer Center at Roper Hospital
- Hollings Cancer Center at Medical University of South Carolina
- Georgetown Memorial Hospital
- Rapid City Regional Hospital
- Sanford Cancer Center at Sanford USD Medical Center
- Thompson Cancer Survival Center
- Vanderbilt-Ingram Cancer Center
- Texas Oncology, PA at Harris Center HEB
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
- Texas Oncology, PA at Texas Cancer Center - Denton South
- Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
- M. D. Anderson Cancer Center at University of Texas
- Baylor Medical Center at Irving
- Texas Oncology, PA at Lake Vista Cancer Center
- Joe Arrington Cancer Research and Treatment Center
- Texas Oncology, PA at Texas Cancer Center Round Rock
- Cancer Care Centers of South Texas - Northeast
- University of Texas Health Science Center at San Antonio
- Texas Oncology, PA at Texas Cancer Center - Sherman
- Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
- Sandra L. Maxwell Cancer Center
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center - East Campus
- Utah Cancer Specialists at UCS Cancer Center
- Huntsman Cancer Institute at University of Utah
- LDS Hospital
- Fletcher Allen Health Care - University Health Center Campus
- University of Virginia Cancer Center
- Naval Medical Center - Portsmouth
- Virginia Commonwealth University Massey Cancer Center
- St. Joseph Cancer Center
- Seattle Cancer Care Alliance
- University Cancer Center at University of Washington Medical Center
- Providence Cancer Center at Sacred Heart Medical Center
- Southwest Washington Medical Center Cancer Center
- West Virginia University Health Sciences Center - Charleston
- St. Mary's Regional Cancer Center at St. Mary's Medical Center
- Schiffler Cancer Center at Wheeling Hospital
- Center for Cancer Treatment & Prevention at Sacred Heart Hospital
- St. Vincent Hospital Regional Cancer Center
- Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
- Franciscan Skemp Healthcare - La Crosse Campus
- Dean Medical Center - Madison
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
- Marshfield Clinic - Marshfield Center
- Community Memorial Hospital Cancer Care Center
- Columbia Saint Mary's Hospital - Ozaukee
- Columbia-Saint Mary's Cancer Care Center
- Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
- Medical College of Wisconsin Cancer Center
- Regional Cancer Center at Oconomowoc Memorial Hospital
- Vince Lombardi Cancer Clinic - Oshkosh
- All Saints Cancer Center at Wheaton Franciscan Healthcare
- Saint Michael's Hospital Cancer Center
- Aurora Medical Center
- Waukesha Memorial Hospital Regional Cancer Center
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
- West Allis Memorial Hospital
- Diagnostic and Treatment Center
- Cross Cancer Institute at University of Alberta
- British Columbia Cancer Agency - Vancouver Island Centre
- CancerCare Manitoba
- London Regional Cancer Program at London Health Sciences Centre
- Odette Cancer Centre at Sunnybrook
- Hopital Notre-Dame du CHUM
- Royal Victoria Hospital - Montreal
- Montreal General Hospital
- Jewish General Hospital - Montreal
- Hopital du Saint-Sacrement - Quebec
- Saskatoon Cancer Centre at the University of Saskatchewan
- University College Hospital
- Tel-Aviv Sourasky Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Group 1: WBI
Group 2: PBI
Patients undergo whole breast irradiation (WBI) once daily, 5 days a week for 5-7 weeks.
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.