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 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00103181
• Other study ID #: NSABP B-39/RTOG 0413
• Secondary ID: NSABP-B-39RTOG-0
• Status: Completed
• Phase: N/A
• Start date: March 2005
• Est. completion date: August 2018

Study information

• Verified date: April 2022
• Source: NSABP Foundation Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4216
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma in Situ

Intervention

Radiation:
• 3-dimensional conformal accelerated partial breast irradiation

• brachytherapy

• whole breast irradiation
Patients undergo radiation therapy once daily (days 1-5) for up to 7 weeks
• MammoSite or other single-entry intracavitary device

Locations

Country	Name	City	State
Canada	Cross Cancer Institute at University of Alberta	Edmonton	Alberta
Canada	London Regional Cancer Program at London Health Sciences Centre	London	Ontario
Canada	Hopital Notre-Dame du CHUM	Montreal	Quebec
Canada	Jewish General Hospital - Montreal	Montreal	Quebec
Canada	Montreal General Hospital	Montreal	Quebec
Canada	Royal Victoria Hospital - Montreal	Montreal	Quebec
Canada	Hopital du Saint-Sacrement - Quebec	Quebec City	Quebec
Canada	Saskatoon Cancer Centre at the University of Saskatchewan	Saskatoon	Saskatchewan
Canada	Odette Cancer Centre at Sunnybrook	Toronto	Ontario
Canada	British Columbia Cancer Agency - Vancouver Island Centre	Victoria	British Columbia
Canada	CancerCare Manitoba	Winnipeg	Manitoba
Ireland	University College Hospital	Galway
Israel	Tel-Aviv Sourasky Medical Center	Tel Aviv
United States	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio
United States	Summa Center for Cancer Care at Akron City Hospital	Akron	Ohio
United States	New York Oncology Hematology, PC at Albany Regional Cancer Care	Albany	New York
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	Saint John's Cancer Center at Saint John's Medical Center	Anderson	Indiana
United States	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan
United States	DeCesaris Cancer Institute at Anne Arundel Medical Center	Annapolis	Maryland
United States	Hope A Women's Cancer Center	Asheville	North Carolina
United States	Mission Hospitals - Memorial Campus	Asheville	North Carolina
United States	CCOP - Atlanta Regional	Atlanta	Georgia
United States	Northside Hospital Cancer Center	Atlanta	Georgia
United States	Auburn Radiation Oncology	Auburn	California
United States	Aurora Presbyterian Hospital	Aurora	Colorado
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	University of Colorado Cancer Center at UC Health Sciences Center	Aurora	Colorado
United States	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland
United States	Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center	Baltimore	Maryland
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	St. Agnes Hospital Cancer Center	Baltimore	Maryland
United States	CancerCare of Maine at Eastern Maine Medical Center	Bangor	Maine
United States	Barberton Citizens Hospital	Barberton	Ohio
United States	Good Shepherd Hospital	Barrington	Illinois
United States	Memorial Sloan-Kettering Cancer Center - Basking Ridge	Basking Ridge	New Jersey
United States	Mary Bird Perkins Cancer Center - Baton Rouge	Baton Rouge	Louisiana
United States	Ochsner Health Center - Bluebonnet	Baton Rouge	Louisiana
United States	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan
United States	UPMC Cancer Center at Beaver Medical Center	Beaver	Pennsylvania
United States	Texas Oncology, PA at Harris Center HEB	Bedford	Texas
United States	St. Joseph Cancer Center	Bellingham	Washington
United States	MeritCare Bemidji	Bemidji	Minnesota
United States	Alta Bates Summit Comprehensive Cancer Center	Berkeley	California
United States	St. Luke's Cancer Network at St. Luke's Hospital	Bethlehem	Pennsylvania
United States	Billings Clinic - Downtown	Billings	Montana
United States	UAB Comprehensive Cancer Center	Birmingham	Alabama
United States	Illinois CancerCare - Bloomington	Bloomington	Illinois
United States	Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus	Boca Raton	Florida
United States	Mountain States Tumor Institute at St. Luke's Regional Medical Center	Boise	Idaho
United States	Boston University Cancer Research Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Boulder Community Hospital	Boulder	Colorado
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Peninsula Medical Center	Burlingame	California
United States	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont
United States	Lahey Clinic Medical Center - Burlington	Burlington	Massachusetts
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	Radiation Oncology Centers - Cameron Park	Cameron Park	California
United States	Sands Cancer Center	Canandaigua	New York
United States	Aultman Cancer Center at Aultman Hospital	Canton	Ohio
United States	Illinois CancerCare - Canton	Canton	Illinois
United States	Mercy Cancer Center at Mercy San Juan Medical Center	Carmichael	California
United States	Illinois CancerCare - Carthage	Carthage	Illinois
United States	Sandra L. Maxwell Cancer Center	Cedar City	Utah
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina
United States	Roper St. Francis Cancer Center at Roper Hospital	Charleston	South Carolina
United States	West Virginia University Health Sciences Center - Charleston	Charleston	West Virginia
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina
United States	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina
United States	University of Virginia Cancer Center	Charlottesville	Virginia
United States	Creticos Cancer Center at Advocate Illinois Masonic Medical Center	Chicago	Illinois
United States	Enloe Cancer Center at Enloe Medical Center	Chico	California
United States	Clackamas Radiation Oncology Center	Clackamas	Oregon
United States	Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Cleveland Clinic Cancer Center at Fairview Hospital	Cleveland	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Henry Ford Macomb Hospital	Clinton Township	Michigan
United States	Kootenai Cancer Center - Coeur d'Alene	Coeur d'Alene	Idaho
United States	Memorial Hospital Cancer Center - Colorado Springs	Colorado Springs	Colorado
United States	Penrose Cancer Center at Penrose Hospital	Colorado Springs	Colorado
United States	Central Maryland Oncology Center	Columbia	Maryland
United States	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	Memorial Sloan-Kettering Cancer Center	Commack	New York
United States	Cancer Care Center at John Muir Health - Concord Campus	Concord	California
United States	Payson Center for Cancer Care at Concord Hospital	Concord	New Hampshire
United States	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota
United States	Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital	Cooperstown	New York
United States	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas
United States	NSMC Cancer Center - Peabody	Danvers	Massachusetts
United States	Geisinger Cancer Institute at Geisinger Health	Danville	Pennsylvania
United States	Genesis Regional Cancer Center at Genesis Medical Center	Davenport	Iowa
United States	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	Charles B. Eberhart Cancer Center at DeKalb Medical Center	Decatur	Georgia
United States	Texas Oncology, PA at Texas Cancer Center - Denton South	Denton	Texas
United States	Porter Adventist Hospital	Denver	Colorado
United States	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan
United States	Seacoast Cancer Center at Wentworth - Douglass Hospital	Dover	New Hampshire
United States	Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital	Downers Grove	Illinois
United States	Delaware County Regional Cancer Center at Delaware County Memorial Hospital	Drexel Hill	Pennsylvania
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	St. Luke's Hospital Cancer Care Center	Duluth	Minnesota
United States	Northeast Radiation Oncology Center	Dunmore	Pennsylvania
United States	Duke Cancer Institute	Durham	North Carolina
United States	CCOP - Hematology-Oncology Associates of Central New York	East Syracuse	New York
United States	Shore Regional Cancer Center at Memorial Hospital - Easton	Easton	Maryland
United States	Center for Cancer Treatment & Prevention at Sacred Heart Hospital	Eau Claire	Wisconsin
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Trinitas Comprehensive Cancer Center at Trinitas Hospital	Elizabeth	New Jersey
United States	Alexian Brothers Radiation Oncology	Elk Grove Village	Illinois
United States	Elkhart General Hospital	Elkhart	Indiana
United States	Union Hospital of Cecil County	Elkton	Maryland
United States	Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center	Englewood	New Jersey
United States	Swedish Medical Center	Englewood	Colorado
United States	Regional Cancer Center - Erie	Erie	Pennsylvania
United States	Willamette Valley Cancer Center - Eugene	Eugene	Oregon
United States	Illinois CancerCare - Eureka	Eureka	Illinois
United States	Center for Cancer Care at Exeter Hospital	Exeter	New Hampshire
United States	North Bay Cancer Center	Fairfield	California
United States	MeritCare Broadway	Fargo	North Dakota
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	McLaren Cancer Institute	Flint	Michigan
United States	Poudre Valley Radiation Oncology	Fort Collins	Colorado
United States	Parkview Regional Cancer Center at Parkview Health	Fort Wayne	Indiana
United States	Radiation Oncology Associates Southwest	Fort Wayne	Indiana
United States	Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital	Fort Worth	Texas
United States	MetroWest Medical Center - Framingham Union Hospital	Framingham	Massachusetts
United States	California Cancer Center - Woodward Park Office	Fresno	California
United States	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota
United States	University of Florida Shands Cancer Center	Gainesville	Florida
United States	Illinois CancerCare - Cottage	Galesburg	Illinois
United States	Illinois CancerCare - Galesburg	Galesburg	Illinois
United States	Georgetown Memorial Hospital	Georgetown	South Carolina
United States	Center for Cancer Care at Goshen General Hospital	Goshen	Indiana
United States	Altru Cancer Center at Altru Hospital	Grand Forks	North Dakota
United States	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	Three Rivers Community Hospital	Grants Pass	Oregon
United States	Great Falls Clinic - Main Facility	Great Falls	Montana
United States	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana
United States	North Colorado Medical Center	Greeley	Colorado
United States	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center	Green Bay	Wisconsin
United States	Legacy Mount Hood Medical Center	Gresham	Oregon
United States	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan
United States	PinnacleHealth Regional Cancer Center at Polyclinic Hospital	Harrisburg	Pennsylvania
United States	Helen and Harry Gray Cancer Center at Hartford Hospital	Hartford	Connecticut
United States	Illinois CancerCare - Havana	Havana	Illinois
United States	Kaiser Permanente Medical Center - Hayward	Hayward	California
United States	Pardee Memorial Hospital	Hendersonville	North Carolina
United States	High Point Regional Hospital	High Point	North Carolina
United States	Cancer Research Center of Hawaii	Honolulu	Hawaii
United States	Queen's Cancer Institute at Queen's Medical Center	Honolulu	Hawaii
United States	Straub Clinic and Hospital, Incorporated	Honolulu	Hawaii
United States	M. D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	St. Mary's Regional Cancer Center at St. Mary's Medical Center	Huntington	West Virginia
United States	Cape Cod Hospital	Hyannis	Massachusetts
United States	Cleveland Clinic Cancer Center	Independence	Ohio
United States	Central Indiana Cancer Centers - East	Indianapolis	Indiana
United States	Methodist Cancer Center at Methodist Hospital	Indianapolis	Indiana
United States	St. Vincent Indianapolis Hospital	Indianapolis	Indiana
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	Baylor Medical Center at Irving	Irving	Texas
United States	Cayuga Medical Center of Ithaca	Ithaca	New York
United States	University of Mississippi Cancer Clinic	Jackson	Mississippi
United States	Baptist Cancer Institute - Jacksonville	Jacksonville	Florida
United States	Baptist Medical Center South	Jacksonville	Florida
United States	Integrated Community Oncology Network at Southside Cancer Center	Jacksonville	Florida
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Integrated Community Oncology Network	Jacksonville Beach	Florida
United States	Queens Cancer Center of Queens Hospital	Jamaica	New York
United States	Ella Milbank Foshay Cancer Center at Jupiter Medical Center	Jupiter	Florida
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Kansas City Cancer Centers - North	Kansas City	Missouri
United States	Good Samaritan Cancer Center at Good Samaritan Hospital	Kearney	Nebraska
United States	Illinois CancerCare - Kewanee Clinic	Kewanee	Illinois
United States	Thompson Cancer Survival Center	Knoxville	Tennessee
United States	Franciscan Skemp Healthcare - La Crosse Campus	La Crosse	Wisconsin
United States	Rebecca and John Moores UCSD Cancer Center	La Jolla	California
United States	Lakeland Regional Cancer Center at Lakeland Regional Medical Center	Lakeland	Florida
United States	Breslin Cancer Center at Ingham Regional Medical Center	Lansing	Michigan
United States	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Central Maine Comprehensive Cancer Center at Central Maine Medical Center	Lewiston	Maine
United States	Texas Oncology, PA at Lake Vista Cancer Center	Lewisville	Texas
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Lucille P. Markey Cancer Center at University of Kentucky	Lexington	Kentucky
United States	Lima Memorial Hospital	Lima	Ohio
United States	St. Rita's Medical Center	Lima	Ohio
United States	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	St. Barnabas Medical Center Cancer Center	Livingston	New Jersey
United States	Sky Ridge Medical Center	Lone Tree	Colorado
United States	Hope Cancer Care Center at Longmont United Hospital	Longmont	Colorado
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California
United States	James Graham Brown Cancer Center at University of Louisville	Louisville	Kentucky
United States	Louisville Oncology at Norton Cancer Institute - Louisville	Louisville	Kentucky
United States	McKee Medical Center	Loveland	Colorado
United States	Joe Arrington Cancer Research and Treatment Center	Lubbock	Texas
United States	Illinois CancerCare - Macomb	Macomb	Illinois
United States	Dean Medical Center - Madison	Madison	Wisconsin
United States	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin
United States	Elliot Regional Cancer Center at Elliot Hospital	Manchester	New Hampshire
United States	CCOP - North Shore University Hospital	Manhasset	New York
United States	Immanuel St. Joseph's	Mankato	Minnesota
United States	MedCentral - Mansfield Hospital	Mansfield	Ohio
United States	Minnesota Oncology - Maplewood	Maplewood	Minnesota
United States	Kennestone Cancer Center at Wellstar Kennestone Hospital	Marietta	Georgia
United States	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Marlton	New Jersey
United States	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin
United States	Hillcrest Cancer Center at Hillcrest Hospital	Mayfield Heights	Ohio
United States	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois
United States	Dubs Cancer Center at Rogue Valley Medical Center	Medford	Oregon
United States	Providence Cancer Center at PMCC	Medford	Oregon
United States	Community Memorial Hospital Cancer Care Center	Menomonee Falls	Wisconsin
United States	Columbia Saint Mary's Hospital - Ozaukee	Mequon	Wisconsin
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	Columbia-Saint Mary's Cancer Care Center	Milwaukee	Wisconsin
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Providence Milwaukie Hospital	Milwaukie	Oregon
United States	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital	Minneapolis	Minnesota
United States	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana
United States	Trinity Cancer Center at Trinity Medical Center - 7th Street Campus	Moline	Illinois
United States	Illinois CancerCare - Monmouth	Monmouth	Illinois
United States	OSF Holy Family Medical Center	Monmouth	Illinois
United States	Intercommunity Cancer Center	Monroeville	Pennsylvania
United States	Community Hospital of the Monterey Peninsula Comprehensive Cancer Center	Monterey	California
United States	Edward Hospital Cancer Center	Naperville	Illinois
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Saint Peter's University Hospital	New Brunswick	New Jersey
United States	Hospital of Saint Raphael	New Haven	Connecticut
United States	Yale Cancer Center	New Haven	Connecticut
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	CCOP - Ochsner	New Orleans	Louisiana
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Community Cancer Center	Normal	Illinois
United States	Illinois CancerCare - Community Cancer Center	Normal	Illinois
United States	Norristown Regional Cancer Center	Norristown	Pennsylvania
United States	Norwalk Hospital	Norwalk	Connecticut
United States	Sutter Health - Western Division Cancer Research Group	Novato	California
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	Regional Cancer Center at Oconomowoc Memorial Hospital	Oconomowoc	Wisconsin
United States	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center	Ogden	Utah
United States	Alegant Health Cancer Center at Bergan Mercy Medical Center	Omaha	Nebraska
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Immanuel Medical Center	Omaha	Nebraska
United States	Methodist Estabrook Cancer Center	Omaha	Nebraska
United States	St. Joseph Hospital Regional Cancer Center - Orange	Orange	California
United States	Integrated Community Oncology Network - Orange Park	Orange Park	Florida
United States	Vince Lombardi Cancer Clinic - Oshkosh	Oshkosh	Wisconsin
United States	Oncology Hematology Associates of Central Illinois, PC - Ottawa	Ottawa	Illinois
United States	Florida Cancer Center - Palatka	Palatka	Florida
United States	Desert Regional Medical Center Comprehensive Cancer Center	Palm Springs	California
United States	Feather River Hospital Cancer Center	Paradise	California
United States	Advocate Lutheran General Cancer Care Center	Park Ridge	Illinois
United States	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois
United States	Illinois CancerCare - Pekin	Pekin	Illinois
United States	Arizona Center for Cancer Care - Peoria	Peoria	Arizona
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Oncology Hematology Associates of Central Illinois, PC - Peoria	Peoria	Illinois
United States	OSF St. Francis Medical Center	Peoria	Illinois
United States	Illinois CancerCare - Peru	Peru	Illinois
United States	Drexel University College of Medicine - Center City Hahnemann Campus	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania
United States	Frankford Hospital Cancer Center - Torresdale Campus	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Arizona Oncology Services Foundation	Phoenix	Arizona
United States	Allegheny Cancer Center at Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	UPMC - Shadyside	Pittsburgh	Pennsylvania
United States	Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center	Pomona	California
United States	St. Joseph Mercy Oakland	Pontiac	Michigan
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	Knight Cancer Institute at Oregon Health and Science University	Portland	Oregon
United States	Legacy Emanuel Hospital and Health Center and Children's Hospital	Portland	Oregon
United States	Legacy Good Samaritan Hospital & Comprehensive Cancer Center	Portland	Oregon
United States	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Naval Medical Center - Portsmouth	Portsmouth	Virginia
United States	Hudson Valley Oncology Associates	Poughkeepsie	New York
United States	Saint Francis Hospital Cancer Center	Poughkeepsie	New York
United States	CCOP - Kansas City	Prairie Village	Kansas
United States	Illinois CancerCare - Princeton	Princeton	Illinois
United States	Northmain Radiation Oncology	Providence	Rhode Island
United States	Rhode Island Hospital Comprehensive Cancer Center	Providence	Rhode Island
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	St. Mary - Corwin Regional Medical Center	Pueblo	Colorado
United States	All Saints Cancer Center at Wheaton Franciscan Healthcare	Racine	Wisconsin
United States	Cancer Centers of North Carolina - Raleigh	Raleigh	North Carolina
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center	Reading	Pennsylvania
United States	Mercy Regional Cancer Center at Mercy Medical Center	Redding	California
United States	Renown Institute for Cancer at Renown Regional Medical Center	Reno	Nevada
United States	Saint Mary's Regional Medical Center	Reno	Nevada
United States	Virginia Commonwealth University Massey Cancer Center	Richmond	Virginia
United States	Humphrey Cancer Center at North Memorial Outpatient Center	Robbinsdale	Minnesota
United States	Highland Hospital of Rochester	Rochester	New York
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Lipson Cancer and Blood Center at Rochester General Hospital	Rochester	New York
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	University Radiation Oncology at Parkridge Hospital	Rochester	New York
United States	Radiation Oncology Center - Roseville	Roseville	California
United States	Texas Oncology, PA at Texas Cancer Center Round Rock	Round Rock	Texas
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	Mercy General Hospital	Sacramento	California
United States	Radiological Associates of Sacramento Medical Group, Incorporated	Sacramento	California
United States	University of California Davis Cancer Center	Sacramento	California
United States	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan
United States	Flagler Cancer Center	Saint Augustine	Florida
United States	CentraCare Clinic - River Campus	Saint Cloud	Minnesota
United States	Dixie Regional Medical Center - East Campus	Saint George	Utah
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Park Nicollet Cancer Center	Saint Louis Park	Minnesota
United States	Regions Hospital Cancer Care Center	Saint Paul	Minnesota
United States	United Hospital	Saint Paul	Minnesota
United States	Salem Hospital Regional Cancer Care Services	Salem	Oregon
United States	Peninsula Regional Medical Center	Salisbury	Maryland
United States	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah
United States	LDS Hospital	Salt Lake City	Utah
United States	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah
United States	Cancer Care Centers of South Texas - Northeast	San Antonio	Texas
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Kaiser Permanente Medical Office -Vandever Medical Office	San Diego	California
United States	Sharp Memorial Hospital Cancer Center	San Diego	California
United States	California Pacific Medical Center - California Campus	San Francisco	California
United States	Doctors Medical Center - San Pablo Campus	San Pablo	California
United States	Arizona Breast Cancer Specialists	Scottsdale	Arizona
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	University Cancer Center at University of Washington Medical Center	Seattle	Washington
United States	Texas Oncology, PA at Texas Cancer Center - Sherman	Sherman	Texas
United States	Holy Cross Hospital	Silver Spring	Maryland
United States	Sanford Cancer Center at Sanford USD Medical Center	Sioux Falls	South Dakota
United States	Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center	Sleepy Hollow	New York
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Frederick R. and Betty M. Smith Cancer Treatment Center	Sparta	New Jersey
United States	Providence Cancer Center at Sacred Heart Medical Center	Spokane	Washington
United States	Illinois CancerCare - Spring Valley	Spring Valley	Illinois
United States	Cancer Institute at St. John's Hospital	Springfield	Illinois
United States	Community Hospital of Springfield and Clark County	Springfield	Ohio
United States	Stanford Cancer Center	Stanford	California
United States	Mount Nittany Medical Center	State College	Pennsylvania
United States	Saint Michael's Hospital Cancer Center	Stevens Point	Wisconsin
United States	Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land	Sugar Land	Texas
United States	Aurora Medical Center	Summit	Wisconsin
United States	Flower Hospital Cancer Center	Sylvania	Ohio
United States	SUNY Upstate Medical University Hospital	Syracuse	New York
United States	North Suburban Medical Center	Thornton	Colorado
United States	Medical University of Ohio Cancer Center	Toledo	Ohio
United States	St. Anne Mercy Hospital	Toledo	Ohio
United States	J. Phillip Citta Regional Cancer Center at Community Medical Center	Toms River	New Jersey
United States	Connecticut Oncology & Hematology - Torrington	Torrington	Connecticut
United States	St. Francis Regional Cancer Center	Trenton	New Jersey
United States	Legacy Meridian Park Hospital	Tualatin	Oregon
United States	Natalie Warren Bryant Cancer Center at St. Francis Hospital	Tulsa	Oklahoma
United States	Crozer-Chester Medical Center	Upland	Pennsylvania
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Solano Radiation Oncology Center	Vacaville	California
United States	Kaiser Permanente Medical Center - Vallejo	Vallejo	California
United States	Sutter Solano Medical Center	Vallejo	California
United States	Southwest Washington Medical Center Cancer Center	Vancouver	Washington
United States	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	John Muir/Mt. Diablo Comprehensive Cancer Center	Walnut Creek	California
United States	St. John Macomb Hospital	Warren	Michigan
United States	Central Dupage Cancer Center	Warrenville	Illinois
United States	Washington Cancer Institute at Washington Hospital Center	Washington	District of Columbia
United States	Waukesha Memorial Hospital Regional Cancer Center	Waukesha	Wisconsin
United States	University of Wisconcin Cancer Center at Aspirus Wausau Hospital	Wausau	Wisconsin
United States	West Allis Memorial Hospital	West Allis	Wisconsin
United States	Diagnostic and Treatment Center	Weston	Wisconsin
United States	Schiffler Cancer Center at Wheeling Hospital	Wheeling	West Virginia
United States	Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital	Whittier	California
United States	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania
United States	Coastal Carolina Radiation Oncology Center	Wilmington	North Carolina
United States	Forsyth Regional Cancer Center at Forsyth Medical Center	Winston-Salem	North Carolina
United States	Minnesota Oncology - Woodbury	Woodbury	Minnesota
United States	Cleveland Clinic - Wooster	Wooster	Ohio
United States	York Cancer Center at Apple Hill Medical Center	York	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
NSABP Foundation Inc	National Cancer Institute (NCI), Radiation Therapy Oncology Group, Southwest Oncology Group

Countries where clinical trial is conducted

United States,  Canada,  Ireland,  Israel, 

References & Publications (17)

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.

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 Bi

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. Epub 2007 Aug 10. — View Citation

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.

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. — View Citation

Dickler A. The MammoSite breast brachytherapy device: targeted delivery of breast brachytherapy. Future Oncol. 2005 Dec;1(6):799-804. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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 — View Citation

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. Review. — View Citation

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.241 — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-breast tumor recurrence (IBTR)		every 6 months for 5 years; annually thereafter for up to 10 years
Secondary	Overall survival		time from randomization to death due to any cause assessed up to 15 years
Secondary	Recurrence-free survival		time from randomization to recurrence assessed every 6 months for 5 years and annually thereafter for up to 10 years
Secondary	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
Secondary	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
Secondary	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