Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy

Study ID	NCT00769379
Status	Recruiting
Phase	3
Source	ClinicalTrials.gov

Started	Nov 1 2008
Last Updated	Feb 2 2010
Estimated Completion	Feb 2 2010

About this clinical study

Summary

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective with or without trastuzumab in treating ductal carcinoma in situ.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with or without trastuzumab in treating women with ductal carcinoma in situ who have undergone lumpectomy.

Condition / Disease

Breast Cancer

Therapy

trastuzumab
radiation therapy

Study Outcomes

Time from randomization to ipsilateral invasive breast cancer, ipsilateral skin cancer recurrence, or ipsilateral ductal carcinoma in situ (DCIS)
Invasive or DCIS disease-free survival as assessed by time to local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral breast cancer, second primary cancer (other than squamous cell and b ...
Time from randomization to first diagnosis of a local, regional or distant recurrence regardless of any intervening contralateral or other second primary cancer
Time from randomization to first diagnosis of regional or distant recurrence
Time from randomization to first diagnosis of contralateral invasive or DCIS breast cancer
Time from randomization to death from any cause
Incidence of post-treatment amenorrhea (absence of menstrual period for at least 12 months) at 18 months in women who were premenopausal at the time of study entry
Correlation of cMYC-amplification status with trastuzumab (Herceptin��) in addition to radiotherapy
Correlation of PI3 kinase gene mutation status with trastuzumab in addition to radiotherapy

Description

OBJECTIVES:

Primary

To determine the value of radiotherapy with vs without trastuzumab (Herceptin��) in preventing subsequent occurrence of ipsilateral breast cancer recurrence, ipsilateral skin cancer recurrence, or ipsilateral ductal carcinoma in situ (DCIS) in women with HER2-positive DCIS resected by lumpectomy.

Secondary

To determine the value of these regimens in prolonging invasive or DCIS disease-free survival.

To determine the value of these regimens in increasing invasive or DCIS recurrence-free interval.

To determine the value of these regimens in improving regional or distant recurrence.

To determine the value of these regimens in improving the incidence of contralateral invasive or DCIS breast cancer.

To determine the value of these regimens in improving overall survival.

To explore the effect of trastuzumab on ovarian function.

To determine if the benefit of trastuzumab added to radiotherapy will be significantly higher in cMYC-amplified tumors than in the cMYC nonamplified subset.

To determine if the benefit of trastuzumab added to radiotherapy will be less in tumors with mutations in the PI3 kinase gene than in tumors without PI3 kinase gene mutations.

OUTLINE: Patients are stratified according to menopausal status (pre- vs post-), plan for hormonal therapy (yes vs no), and nuclear grade (low or intermediate vs high). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo standard whole breast irradiation (WBI) over 5-6 weeks.

Arm II: Patients receive trastuzumab (Herceptin��) IV over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in arm I.

Tumor tissue samples are analyzed for mRNA and DNA copy numbers of HER2, cMYC, and other candidate predictive genes; PI3K gene mutation status; other candidate predictors of trastuzumab response; and candidate prognostic markers of ductal carcinoma in situ.

After completion of study therapy, patients are followed every 6 months for 5 years and then every 12 months for 5 years.

Overview

Gender	female

Target Enrollment	2000

Recruiting Healthy Volunteers	No

Locations

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center	Columbus	Ohio
Aultman Cancer Center at Aultman Hospital	Canton	OH
Barberton Citizens Hospital	Barberton	OH
Adena Regional Medical Center	Chillicothe	OH
St. Alexius Medical Center Cancer Center	Bismarck	ND
Medcenter One Hospital Cancer Care Center	Bismarck	ND
MeritCare Broadway	Fargo	ND
Mid Dakota Clinic, PC	Bismarck	ND
Blanchard Valley Medical Associates	Findlay	OH
Cancer Treatment Center	Wooster	OH
Charles F. Kettering Memorial Hospital	Dayton	OH
Clinton Memorial Hospital	Wilmington	OH
Community Hospital of Springfield and Clark County	Springfield	OH
CCOP - Toledo Community Hospital	Toledo	OH
CCOP - Dayton	Dayton	OH
Case Comprehensive Cancer Center	Cleveland	OH
CCOP - Columbus	Columbus	OH
CCOP - MeritCare Hospital	Fargo	ND
Bismarck Cancer Center	Bismarck	ND
Winthrop University Hospital
Annie Penn Cancer Center	Reidsville	NC
Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	NC
Tucker Center for Cancer Care at Orange Regional Medical Center	Middletown	NY
Saint Francis Hospital Cancer Center	Poughkeepsie	NY
Nalitt Cancer Institute at Staten Island University Hospital	Staten Island	NY
New York Oncology Hematology, PC at Albany Regional Cancer Care	Albany	NY
Roswell Park Cancer Institute	Buffalo	NY
CaroMont Cancer Center at Gaston Memorial Hospital	Gastonia	NC
Iredell Memorial Hospital	Statesville	NC
Randolph Hospital	Asheboro	NC
Rutherford Hospital	Rutherfordton	NC
Wake Forest University Comprehensive Cancer Center	Winston Salem	NC
Moses Cone Regional Cancer Center at Wesley Long Community Hospital	Greensboro	NC
Mission Hospitals - Memorial Campus	Asheville	NC
Kinston Medical Specialists	Kinston	NC
Marion L. Shepard Cancer Center at Beaufort County Hospital	Washington	NC
David L. Rike Cancer Center at Miami Valley Hospital	Dayton	OH
Doctors Hospital at Ohio Health	Columbus	OH
St. Anne Mercy Hospital	Toledo	OH
St. Charles Mercy Hospital	Oregon	OH
St. Luke's Hospital	Bethlehem	PA
Samaritan North Cancer Care Center	Dayton	OH
Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	OH
North Coast Cancer Care, Incorporated	Sandusky	OH
Northwest Ohio Oncology Center	Maumee	OH
Riverside Methodist Hospital Cancer Care	Columbus	OH
St. Rita's Medical Center	Lima	OH
St. Vincent Mercy Medical Center	Toledo	OH
UVMC Cancer Care Center at Upper Valley Medical Center	Troy	OH
Wayne Hospital	Greenville	OH
Integris Oncology Services	Oklahoma City	OK
Toledo Hospital
Toledo Clinic, Incorporated - Main Clinic	Toledo	OH
Strecker Cancer Center at Marietta Memorial Hospital	Marietta	OH
Summa Center for Cancer Care at Akron City Hospital	Akron	OH
Mount Carmel St. Ann's Cancer Center	Westerville	OH
Mount Carmel Health - West Hospital	Columbus	OH
Grady Memorial Hospital
Grandview Hospital	Dayton	OH
Grant Medical Center Cancer Care	Columbus	OH
Good Samaritan Hospital
Genesis - Good Samaritan Hospital	Zanesville	OH
Fairfield Medical Center	Lancaster	OH
Flower Hospital Cancer Center	Sylvania	OH
Fulton County Health Center	Wauseon	OH
Hematology Oncology Center	Elyria	OH
Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	OH
Mercy Hospital of Tiffin	Tiffin	OH
Mercy Medical Center	Baltimore	MD
Middletown Regional Hospital	Middletown	OH
Medical University of Ohio Cancer Center	Toledo	OH
McDowell Cancer Center at Akron General Medical Center	Akron	OH
Lima Memorial Hospital
Mary Rutan Hospital	Bellefontaine	OH
Long Island Jewish Medical Center	New Hyde Park	NY
Dyson Center for Cancer Care at Vassar Brothers Medical Center	Poughkeepsie	NY
Kansas City Cancer Centers - South	Kansas City	MO
Midwest Hematology Oncology Group, Incorporated	Saint Louis	MO
Missouri Baptist Cancer Center	Saint Louis	MO
Kansas City Cancer Centers - North	Kansas City	MO
Hulston Cancer Center at Cox Medical Center South	Springfield	MO
CCOP - St. Louis-Cape Girardeau	Saint Louis	MO
David C. Pratt Cancer Center at St. John's Mercy	St Louis	MO
Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	MO
Saint Francis Medical Center	Cape Girardeau	MO
Saint Louis University Cancer Center	Saint Louis	MO
Bozeman Deaconess Cancer Center	Bozeman	MT
CCOP - Montana Cancer Consortium	Billings	MT
Glacier Oncology, PLLC	Kalispell	MT
Billings Clinic - Downtown	Billings	MT
Big Sky Oncology	Great Falls	Mt
St. John's Regional Health Center
St. John's Regional Medical Center
CCOP - Cancer Research for the Ozarks	Springfield	MO
Arch Medical Services, Incorporated at Center for Cancer Care and Research	Saint Louis	MO
MeritCare Bemidji	Bemidji	MN
Miller - Dwan Medical Center	Duluth	MN
Minnesota Oncology Hematology, PA - Maplewood	Maplewood	MN
Mercy and Unity Cancer Center at Unity Hospital	Minneapolis	MN
Mercy and Unity Cancer Center at Mercy Hospital	Minneapolis	MN
Hennepin County Medical Center - Minneapolis	Minneapolis	MN
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center	Minneapolis	MN
Hutchinson Area Health Care	Hutchinson	MN
Minnesota Oncology Hematology, PA - Woodbury	Saint Paul	MN
Park Nicollet Cancer Center	Saint Louis Park	MN
United Hospital	St. Paul	MN
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital	Minneapolis	MN
Regional Cancer Center at Singing River Hospital	Pascagoula	MS
St. Luke's Hospital Cancer Care Center	Duluth	MN
St. Francis Cancer Center at St. Francis Medical Center	Shakopee	MN
Regions Hospital Cancer Care Center	Saint Paul	MN
Ridgeview Medical Center	Waconia	MN
Great Falls Clinic - Main Facility	Great Falls	MT
Guardian Oncology and Center for Wellness	Missoula	MT
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Marlton	NJ
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare	Vineland	NJ
Frederick R. and Betty M. Smith Cancer Treatment Center	Sparta	NJ
CentraState Medical Center	Freehold	NJ
Carol G. Simon Cancer Center at Morristown Memorial Hospital	Morristown	NJ
Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	NJ
Cancer Institute of New Jersey at Hamilton	Hamilton Square	NJ
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	NJ
Newark Beth Israel Medical Center	Newark	NJ
Overlook Hospital	Summit	NJ
CCOP - Hematology-Oncology Associates of Central New York	East Syracuse	NY
CCOP - North Shore University Hospital	Manhasset	NY
Don Monti Comprehensive Cancer Center at North Shore University Hospital	Manhasset	NY
University of New Mexico Cancer Center	Albuquerque	NM
University of New Mexico Cancer Center - South	Las Cruces	NM
Saint Peter's University Hospital	New Brunswick	NJ
Hematology Oncology Associates, PC	Albuquerque	NM
Seacoast Cancer Center at Wentworth - Douglass Hospital	Dover	NH
Kingsbury Center for Cancer Care at Cheshire Medical Center	Keene	NH
Sletten Cancer Institute at Benefis Healthcare	Great Falls	MT
St. James Healthcare Cancer Care	Butte	MT
St. Peter's Hospital	Helena	MT
Northern Rockies Radiation Oncology Center	Billings	MT
Montana Cancer Specialists at Montana Cancer Center	Missoula	MT
Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	MT
Kalispell Medical Oncology at KRMC	Kalispell	MT
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	MT
St. Vincent Healthcare Cancer Care Services	Billings	MT
Alegant Health Cancer Center at Bergan Mercy Medical Center	Omaha	NE
Immanuel Medical Center
Methodist Estabrook Cancer Center	Omaha	NE
Renown Institute for Cancer at Renown Regional Medical Center	Reno	NV
Good Samaritan Cancer Center at Good Samaritan Hospital	Kearney	NE
Creighton University Medical Center	Omaha	NE
Cancer Resource Center - Lincoln	Lincoln	NE
CCOP - Missouri Valley Cancer Consortium	Omaha	NE
Adventist Medical Center	Portland	OR
CCOP - Columbia River Oncology Program	Portland	OR
Overlake Cancer Center at Overlake Hospital Medical Center	Bellevue	WA
Providence Centralia Hospital	Centralia	WA
Providence St. Peter Hospital Regional Cancer Center	Olympia	WA
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital	Yakima	WA
MultiCare Regional Cancer Center at Tacoma General Hospital	Tacoma	WA
Fred Hutchinson Cancer Research Center	Seattle	WA
Good Samaritan Cancer Center	Puyallup	WA
Group Health Central Hospital	Seattle	WA
Southwest Washington Medical Center Cancer Center	Vancouver	WA
St. Clare Hospital	Lakewood	WA
Valley Medical Center
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital	Huntington	WV
Mary Babb Randolph Cancer Center at West Virginia University Hospitals	Morgantown	WV
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	WA
St. Mary Regional Cancer Center at St. Mary Medical Center	Walla Walla	WA
St. Francis Hospital	Evanston	IL
St. Joseph Cancer Center	Bellingham	WA
Franciscan Cancer Center at St. Joseph Medical Center	Tacoma	WA
CCOP - Virginia Mason Research Center	Seattle	WA
Peninsula Cancer Institute - Newport News Office	Newport News	VA
Peninsula Cancer Institute - Williamsburg Office	Williamsburg	VA
Riverside Middle Peninsula Cancer Center	Gloucester	VA
Naval Medical Center - Portsmouth	Portsmouth	VA
Lynchburg Hematology-Oncology Clinic	Lynchburg	VA
Mountainview Medical	Montpelier	VT
Danville Regional Medical Center	Danville	VA
Fredericksburg Oncology, Incorporated	Fredericksburg	VA
Southwest Virginia Regional Cancer Center at Wellmonth Health	Norton	VA
University of Virginia Cancer Center	Charlottesville	VA
Cancer Care Northwest - Spokane South	Spokane	WA
Cascade Cancer Center at Evergreen Hospital Medical Center	Kirkland	WA
CCOP - Northwest	Tacoma	WA
Auburn Regional Center for Cancer Care	Auburn	WA
Allenmore Hospital	Tacoma	WA
Virginia Commonwealth University Massey Cancer Center	Richmond	VA
Virginia Oncology Associates - Hampton	Hampton	VA
Princeton Community Hospital
Schiffler Cancer Center at Wheeling Hospital	Wheeling	WV
Oncology Alliance, SC - Milwaukee - East	Milwaukee	WI
Regional Cancer Center at Oconomowoc Memorial Hospital	Oconomowoc	WI
Saint Joseph's Hospital	Marshfield	WI
Ministry Medical Group at Saint Mary's Hospital	Rhinelander	WI
Medical Consultants, Limited	Milwaukee	WI
Marshfield Clinic - Wisconsin Rapids Center	Wisconsin Rapids	WI
Marshfield Clinic Cancer Care at Regional Cancer Center	Eau Claire	WI
Medical College of Wisconsin Cancer Center	Milwaukee	WI
Saint Michael's Hospital Cancer Center	Stevens Point	WI
St. Mary's Hospital Medical Center - Green Bay	Green Bay	WI
Waukesha Memorial Hospital Regional Cancer Center	Waukesha	WI
Wheaton Franciscan Cancer Care - St. Joseph	Milwaukee	WI
Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	WY
Vince Lombardi Cancer Clinic - Oshkosh	Oshkosh	WI
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center	Green Bay	WI
St. Vincent Hospital Regional Cancer Center	Green Bay	WI
University of Wisconcin Cancer Center at Aspirus Wausau Hospital	Wausau	WI
Marshfield Clinic - Weston Center	Weston	WI
Marshfield Clinic - Marshfield Center	Marshfield	WI
Columbia Saint Mary's Hospital - Ozaukee	Mequon	WI
Columbia-Saint Mary's Cancer Care Center	Milwaukee	WI
Fox Valley Hematology and Oncology - East Grant Street	Appleton	WI
Center for Cancer Treatment & Prevention at Sacred Heart Hospital	Eau Claire	WI
Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	WI
United Hospital Center	Clarksburg	WV
Aurora Sinai Medical Center	Milwaukee	WI
Aurora Women's Pavilion of West Allis Memorial Hospital	Milwaukee	WI
Green Bay Oncology, Limited - Oconto Falls	Oconto Falls	WI
Green Bay Oncology, Limited - Sturgeon Bay	Sturgeon Bay	WI
Marshfield Clinic - Chippewa Center	Chippewa Falls	WI
Marshfield Clinic - Indianhead Center	Rice Lake	WI
Marshfield Clinic - Lakeland Center	Minocqua	WI
Holy Family Memorial Medical Center Cancer Care Center	Manitowoc	WI
Gundersen Lutheran Center for Cancer and Blood	La Crosse	WI
Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	WI
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center	Green Bay	WI
Fletcher Allen Health Care - University Health Center Campus	Burlington	VT
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center	Ogden	UT
Geisinger Medical Group - Scenery Park	State College	PA
Hematology and Oncology Associates of Northeastern Pennsylvania	Dunmore	PA
Joan Karnell Cancer Center at Pennsylvania Hospital	Philadelphia	PA
Geisinger Cancer Institute at Geisinger Health	Danville	PA
Frankford Hospital Cancer Center - Torresdale Campus	Philadelphia	PA
Ephrata Cancer Center at Ephrata Community Hospital	Ephrata	PA
Fox Chase Cancer Center - Philadelphia	Philadelphia	PA
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	PA
Lankenau Cancer Center at Lankenau Hospital	Wynnewood	PA
Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	PA
Richard G. Laube Cancer Center at ACMH	Kittanning	PA
Rosenfeld Cancer Center at Abington Memorial Hospital	Abington	PA
Mount Nittany Medical Center	State College	PA
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest	Allentown	PA
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center	Reading	PA
Mercy Hospital Cancer Center - Scranton	Scranton	PA
Chester County Hospital	West Chester	PA
Charles A. & Betty Bott Cancer Center at Holy Redeemer Hospital	Huntingdon Valley	PA
Legacy Meridian Park Hospital
Legacy Mount Hood Medical Center	Gresham	OR
Providence Cancer Center at Providence Portland Medical Center	Portland	OR
Legacy Good Samaritan Hospital & Comprehensive Cancer Center	Portland	OR
Legacy Emanuel Hospital and Health Center and Children's Hospital	Portland	OR
Celilo Cancer Center at Mid-Columbia Medical Center	The Dalles	OR
Kaiser Permanente Health Care - Portland	Portland	OR
Knight Cancer Institute at Oregon Health and Science University	Portland	OR
Providence Milwaukie Hospital	Milwaukie	OR
Providence St. Vincent Medical Center	Portland	OR
Cancer Center at Phoenixville Hospital	Phoenixville	PA
Cancer Center of Paoli Memorial Hospital	Paoli	PA
CCOP - Main Line Health	Wynnewood	PA
Bryn Mawr Hospital	Bryn Mawr	PA
Allegheny Cancer Center at Allegheny General Hospital	Pittsburgh	PA
Willamette Valley Cancer Center - Eugene	Eugene	OR
Albert Einstein Cancer Center	Philadelphia	PA
St. Joseph Medical Center	Kansas City	MO
St. Luke's Cancer Network at St. Luke's Hospital	Bethlehem	PA
Texas Oncology, PA at Texas Cancer Center - Arlington South	Arlington	Texas
Texas Oncology, PA at Texas Cancer Center - Denton South	Denton	Texas
Texas Oncology, PA at Texas Cancer Center - Sherman	Sherman	TX
Texas Oncology, PA at Harris Center HEB	Bedford	TX
Medical City Dallas Hospital	Dallas	TX
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital	Fort Worth	TX
Longview Cancer Center	Longview	TX
M. D. Anderson Cancer Center at University of Texas	Houston	TX
Texas Oncology, PA at Texas Cancer Center Dallas Southwest	Dallas	TX
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land	Sugar Land	TX
Sandra L. Maxwell Cancer Center	Cedar City	UT
Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	UT
Utah Valley Regional Medical Center - Provo	Provo	UT
Logan Regional Hospital	Logan	UT
LDS Hospital	Salt Lake City	UT
West Texas Cancer Center	Odessa	TX
Dixie Regional Medical Center - East Campus	Saint George	UT
Joe Arrington Cancer Research and Treatment Center	Lubbock	TX
Doctor's Hospital of Laredo	Laredo	TX
CCOP - Greenville	Greenville	SC
CCOP - Upstate Carolina	Spartanburg	SC
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	SC
AnMed Cancer Center	Anderson	SC
York Cancer Center at Apple Hill Medical Center	York	PA
UPMC Cancer Centers	Pittsburgh	PA
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital	Pittsburgh	PA
Hollings Cancer Center at Medical University of South Carolina	Charleston	SC
Roper St. Francis Cancer Center at Roper Hospital	Charleston	SC
Thompson Cancer Survival Center	Knoxville	TN
U.T. Medical Center Cancer Institute	Knoxville	TN
CCOP - Scott and White Hospital	Temple	TX
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center	Kingsport	Tennessee
Sanford Cancer Center at Sanford USD Medical Center	Sioux Falls	SD
Avera Cancer Institute	Sioux Falls	SD
Medical X-Ray Center, PC	Sioux Falls	SD
HealthEast Cancer Care at St. John's Hospital	Saint Paul	MN
Fairview Southdale Hospital
Radiation Oncology Centers - Cameron Park	Shingle Springs	CA
Radiological Associates of Sacramento Medical Group, Incorporated	Sacramento	CA
Rebecca and John Moores UCSD Cancer Center	La Jolla	CA
Radiation Oncology Center - Roseville	Roseville	CA
Providence Saint Joseph Medical Center - Burbank	Burbank	CA
Mercy General Hospital	Sacramento	CA
North Bay Cancer Center	Fairfield	CA
Palo Alto Medical Foundation	Palo Alto	CA
Salinas Valley Memorial Hospital	Salinas	CA
Solano Radiation Oncology Center	Vacaville	CA
Valley Care Medical Center	Pleasanton	CA
Valley Medical Oncology Consultants - Castro Valley	Castro Valley	CA
Valley Medical Oncology Consultants - Pleasanton	Pleasanton	CA
Tom K Lee, Incorporated	Oakland	CA
Stanford Cancer Center	Stanford	CA
South Sacramento Kaiser-Permanente Medical Center	Sacramento	CA
St. Joseph Hospital Regional Cancer Center - Orange	Orange	CA
Mercy Cancer Center at Mercy San Juan Medical Center	Carmichael	CA
Larry G Strieff MD Medical Corporation	Oakland	CA
Kaiser Permanente Medical Center - Richmond	Richmond	CA
Kaiser Permanente Medical Center - Roseville	Roseville	CA
Kaiser Permanente Medical Center - Sacramento	Sacramento	CA
Kaiser Permanente Medical Center - Redwood City	Redwood City	CA
Kaiser Permanente Medical Center - Oakland	Oakland	CA
Kaiser Permanente - Deer Valley	Antioch	CA
Kaiser Permanente - Fremont	Fremont	CA
Kaiser Permanente Medical Center - Hayward	Hayward	CA
Kaiser Permanente Medical Center - San Francisco Geary Campus	San Francisco	CA
Kaiser Permanente Medical Center - Santa Clara Kiely Campus	Santa Clara	CA
Kaiser Permanente Medical Center - Walnut Creek	Walnut Creek	CA
Kaiser Permanente Medical Facility - Stockton	Stockton	CA
Kaiser Permanente Medical Office -Vandever Medical Office	San Diego	CA
Kaiser Permanente Medical Center - Vallejo	Vallejo	CA
Kaiser Permanente Medical Center - South San Francisco	South San Francisco	CA
Kaiser Permanente Medical Center - Santa Rosa	Santa Rosa	CA
Kaiser Permanente Medical Center - Santa Teresa	San Jose	CA
Valley Medical Oncology	Fremont	CA
Aurora Presbyterian Hospital
CCOP - Christiana Care Health Services	Newark	DE
Tunnell Cancer Center at Beebe Medical Center	Lewes	DE
Washington Cancer Institute at Washington Hospital Center	Washington	DC
Praxair Cancer Center at Danbury Hospital	Danbury	CT
Eastern Connecticut Hematology and Oncology Associates	Norwich	CT
Swedish Medical Center
University of Colorado Cancer Center at UC Health Sciences Center	Aurora	CO
Carl and Dorothy Bennett Cancer Center at Stamford Hospital	Stamford	CT
Baptist Cancer Institute - Jacksonville	Jacksonville	FL
Center for Cancer Care and Research at Watson Clinic, LLP	Lakeland	FL
CCOP - Atlanta Regional	Atlanta	GA
Charles B. Eberhart Cancer Center at DeKalb Medical Center	Decatur	GA
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia
Robert and Carol Weissman Cancer Center at Martin Memorial	Stuart	FL
M.D. Anderson Cancer Center at Orlando	Orlando	FL
Florida Hospital Cancer Institute at Florida Hospital Orlando	Orlando	FL
Florida Institute of Research, Medicine and Surgery Cancer Center	Orlando	Florida
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center	Grand Junction	CO
St. Mary - Corwin Regional Medical Center	Pueblo	CO
Memorial Hospital Cancer Center - Colorado Springs	Colorado Springs	CO
North Colorado Medical Center	Greeley	CO
North Suburban Medical Center	Thornton	CO
McKee Medical Center	Loveland	CO
Hope Cancer Care Center at Longmont United Hospital	Longmont	CO
Boulder Community Hospital
CCOP - Colorado Cancer Research Program	Denver	CO
Exempla Lutheran Medical Center	Wheat Ridge	CO
Penrose Cancer Center at Penrose Hospital	Colorado Springs	CO
Porter Adventist Hospital	Denver	CO
Sky Ridge Medical Center	Lone Tree	CO
St. Anthony Central Hospital	Denver	CO
St. Joseph Hospital	Denver	CO
Rose Medical Center	Denver	CO
Rocky Mountain Cancer Centers - Aurora	Aurora	CO
Poudre Valley Radiation Oncology	Fort Collins	CO
Presbyterian - St. Luke's Medical Center	Denver	CO
Kaiser Foundation Hospital - San Rafael	San Rafael	CA
Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	CA
Natalie Warren Bryant Cancer Center at St. Francis Hospital	Tulsa	OK
Amsterdam Community Cancer Program	Amsterdam	NY
New York Oncology Hematology, PC at Albany Medical Center	Albany	NY
Kootenai Cancer Center - Coeur d'Alene	Coeur D Alene	ID
Middlesex Hospital Cancer Center	Middletown	CT
Olympic Medical Center	Port Angeles	WA
Providence Cancer Center at Sacred Heart Medical Center	Spokane	WA
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital	Parkersburg	WV
New York Oncology Hematology, PC - Hudson	Hudson	NY
New York Oncology Hematology, PC - Latham	Latham	NY
CCOP - Kansas City	Kansas City	MO
Heartland Regional Medical Center	St Joseph	MO
Independence Regional Health Center
Shawnee Mission Medical Center	Shawnee Mission	KS
Menorah Medical Center	Overland Park	KS
Riverview Cancer Care Medical Associates, PC	Rexford	NY
Samaritan Hospital at Northeast Health	Troy	NY
Green Mountain Oncology Group	Bennington	VT
Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center	Dubois	Pennsylvania
Joliet Oncology-Hematology Associates, Limited - West	Joliet	IL
Sutter Cancer Center at Roseville Medical Center	Roseville	CA
Sutter Cancer Center	Sacramento	CA
Meeker County Memorial Hospital	Litchfield	MN
San Juan City Hospital	San Juan
Broward General Medical Center Cancer Center	Fort Lauderdale	FL
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital	Cape Girardeau	MO
Central Wisconsin Cancer Program at Agnesian HealthCare	Fond Du Lac	WI
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - West	Boca Raton	Florida
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus	Boca Raton	Florida
Jordan Hospital Club Cancer Center	Plymouth	MA
AtlantiCare Cancer Care Institute at AtlantiCare Regional Medical Center - Mainland Campus	Pomona	New Jersey
Charles R. Wood Cancer Center at Glens Falls Hospital	Glens Falls	NY
Northwest Community Hospital
Lakeland Regional Cancer Center at Lakeland Regional Medical Center	Lakeland	FL
MBCCOP - Gulf Coast	Mobile	AL
Florida Cancer Specialists - Sarasota Downtown	Sarasota	FL
Liberty Hospital	Liberty	MO
North Kansas City Hospital
California Cancer Center - Woodward Park Office	Fresno	CA
Camino Medical Group - Treatment Center	Mountain View	CA
Cancer Care Associates	Oklahoma City	OK
Breastlink Medical Group, Incorporated at Long Beach Memorial Medical Center	Long Beach	CA
Bay Area Breast Surgeons, Incorporated	Oakland	CA
Premiere Oncology of Arizona	Scottsdale	AZ
Alta Bates Summit Medical Center - Summit Campus	Oakland	CA
Auburn Radiation Oncology	Auburn	CA
CCOP - Bay Area Tumor Institute	Oakland	CA
City of Hope Comprehensive Cancer Center	Duarte	CA
El Camino Hospital Cancer Center	Mountain View	CA
Glendale Memorial Hospital Comprehensive Cancer Center	Glendale	CA
Highland General Hospital	Oakland	CA
Eden Medical Center	Castro Valley	CA
East Bay Radiation Oncology Center	Castro Valley	CA
Contra Costa Regional Medical Center	Martinez	CA
Doctors Medical Center - San Pablo Campus	San Pablo	CA
Arizona Oncology Services Foundation	Phoenix	AZ
Arizona Oncology - Tucson	Tucson	AZ
Cleo Craig Cancer Research Clinic	Lawton	OK
Cedar Valley Medical Specialists, PC - West Ridgeway Avenue	Waterloo	IA
Breslin Cancer Center at Ingham Regional Medical Center	Lansing	MI
Truman Medical Center - Hospital Hill	Kansas City	MO
Saint Luke's Cancer Institute at Saint Luke's Hospital	Kansas City	MO
Parvin Radiation Oncology	Kansas City	MO
Research Medical Center
Great Lakes Cancer Institute at McLaren Regional Medical Center	Flint	MI
Lapeer Regional Hospital	Lapeer	MI
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital	Fairbanks	AK
Providence Cancer Center	Anchorage	AK
Arizona Breast Cancer Specialists	Scottsdale	Arizona
Providence Cancer Center at Providence Hospital	Mobile	AL
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio
Wayne Memorial Hospital, Incorporated	Goldsboro	NC
Virginia K. Crosson Cancer Center at St. Jude Medical Center	Fullerton	CA
Gwinnett Medical Center
Harbin Clinic Cancer Center - Medical Oncology	Rome	GA
Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	KS
Wesley Medical Center
Central Baptist Hospital	Lexington	KY
Southwest Medical Center	Liberal	KS
Lawrence Memorial Hospital	Lawrence	KS
CCOP - Wichita	Wichita	KS
Cotton-O'Neil Cancer Center	Topeka	KS
Kansas City Cancer Centers - Southwest	Shawnee Mission	KS
Lucille P. Markey Cancer Center at University of Kentucky	Lexington	KY
Mary Bird Perkins Cancer Center - Baton Rouge	Baton Rouge	LA
York Hospital's Oncology Treatment Center	York	ME
Greater Baltimore Medical Center Cancer Center	Towson	MD
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center	Rosedale	MD
CancerCare of Maine at Eastern Maine Medical Center	Bangor	ME
Pennington Cancer Center at Baton Rouge General	Baton Rouge	LA
MBCCOP - LSU Health Sciences Center	New Orleans	LA
Medical Center of Louisiana - New Orleans	New Orleans	LA
Cancer Center of Kansas, PA - Winfield	Winfield	KS
Cancer Center of Kansas, PA - Wellington	Wellington	KS
Medical Oncology and Hematology Associates at John Stoddard Cancer Center	Des Moines	IA
Medical Oncology and Hematology Associates at Mercy Cancer Center	Des Moines	IA
Mercy Cancer Center at Mercy Medical Center - Des Moines	Des Moines	IA
Medical Oncology and Hematology Associates - West Des Moines	West Des Moines	IA
McFarland Clinic, PC	Ames	IA
John Stoddard Cancer Center at Iowa Lutheran Hospital	Des Moines	IA
John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	IA
McCreery Cancer Center at Ottumwa Regional	Ottumwa	IA
Mercy Cancer Center at Mercy Medical Center - North Iowa	Mason City	IA
Mercy Capitol Hospital	Des Moines	IA
Associates in Womens Health, PA - North Review	Wichita	KS
Cancer Center of Kansas, PA - Dodge City	Dodge City	KS
Cancer Center of Kansas, PA - El Dorado	El Dorado	KS
St. Luke's Regional Medical Center	Sioux City	IA
Siouxland Hematology-Oncology Associates, LLP	Sioux City	IA
Mercy Medical Center - Sioux City	Sioux City	IA
Mercy Regional Cancer Center at Mercy Medical Center	Cedar Rapids	IA
Peninsula Regional Medical Center	Salisbury	MD
St. Agnes Hospital Cancer Center	Baltimore	MD
Mercy General Health Partners	Muskegon	MI
Mercy Memorial Hospital - Monroe	Monroe	MI
Metro Health Hospital	Wyoming	MI
Mecosta County Medical Center	Big Rapids	MI
Lakeland Regional Cancer Care Center - St. Joseph	Saint Joseph	MI
Hickman Cancer Center at Bixby Medical Center	Adrian	MI
Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	MI
Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	MI
Munson Medical Center
Providence Cancer Institute at Providence Hospital - Southfield Campus	Southfield	MI
CCOP - Metro-Minnesota	Minneapolis	MN
Duluth Clinic Cancer Center - Duluth	Duluth	MN
Fairview Ridges Hospital	Burnsville	MN
CCOP - Duluth	Duluth	MN
William Beaumont Hospital - Royal Oak Campus	Royal Oak	MI
Upper Michigan Cancer Center at Marquette General Hospital	Marquette	MI
West Michigan Cancer Center	Kalamazoo	MI
Haematology-Oncology Associates of Ohio and Michigan, PC	Lambertville	MI
Green Bay Oncology, Limited - Escanaba	Ludington	MI
Commonwealth Hematology-Oncology, PC - Concord	Stoneham	MA
Commonwealth Hematology-Oncology, PC - Weymouth	Weymouth	MA
Hudner Oncology Center at Saint Anne's Hospital - Fall River	Fall River	MA
Commonwealth Hematology-Oncology, PC - Quincy	Quincy	MA
Boston University Cancer Research Center	Boston	MA
Union Hospital Cancer Program at Union Hospital	Elkton	MD
Addison Gilbert Hospital	Gloucester	MA
Berkshire Hematology Oncology, PC	Pittsfield	MA
Lahey Clinic Medical Center - Burlington	Burlington	MA
Barbara Ann Karmanos Cancer Institute
CCOP - Grand Rapids	Grand Rapids	MI
Clemens Regional Medical Center	Mount Clemens	Michigan
Dickinson County Healthcare System	Iron Mountain	MI
Butterworth Hospital at Spectrum Health	Grand Rapids	MI
Bronson Methodist Hospital	Kalamazoo	MI
Battle Creek Health System Cancer Care Center	Battle Creek	MI
Borgess Medical Center	Kalamazoo	MI
Iowa Blood and Cancer Care	Cedar Rapids	IA
Holden Comprehensive Cancer Center at University of Iowa	Iowa City	IA
Creticos Cancer Center at Advocate Illinois Masonic Medical Center	Chicago	IL
Decatur Memorial Hospital Cancer Care Institute	Decatur	IL
Delnor Community Hospital - Geneva
Community Hospital of Ottawa	Ottawa	IL
Community Cancer Center	Normal	IL
BroMenn Regional Medical Center	Normal	IL
Cancer Treatment Center at Pekin Hospital	Pekin	IL
CCOP - Illinois Oncology Research Association	Peoria	IL
Edward Hospital Cancer Center	Naperville	IL
Elmhurst Memorial Hospital	Lombard	IL
Graham Hospital
Illinois Valley Community Hospital
Ingalls Cancer Care Center at Ingalls Memorial Hospital	Harvey	IL
Good Samaritan Regional Health Center	Mount Vernon	IL
Galesburg Cottage Hospital
Eureka Community Hospital	Eureka	IL
Galesburg Clinic, PC	Galesburg	IL
Alexian Brothers Radiation Oncology	Elk Grove Village	IL
Advocate Christ Medical Center	Oak Lawn	IL
Northside Hospital Cancer Center	Atlanta	GA
Phoebe Cancer Center at Phoebe Putney Memorial Hospital	Albany	GA
Piedmont Hospital	Atlanta	GA
Northeast Georgia Medical Center	Gainesville	GA
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler	Savannah	GA
John B. Amos Cancer Center	Columbus	GA
Kennestone Cancer Center at Wellstar Kennestone Hospital	Marietta	GA
Medical Center of Central Georgia	Macon	GA
Saint Joseph's Hospital of Atlanta	Atlanta	GA
Southern Regional Medical Center
Queen's Cancer Institute at Queen's Medical Center	Honolulu	HI
Straub Clinic and Hospital, Incorporated	Honolulu	HI
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center	Boise	ID
Maui Memorial Medical Center	Wailuku	HI
Kapiolani Medical Center at Pali Momi	Aiea	HI
WellStar Cobb Hospital	Austell	GA
Cancer Research Center of Hawaii	Honolulu	HI
InterCommunity Cancer Center of Western Illinois	Galesburg	IL
John H. Stroger, Jr. Hospital of Cook County	Chicago	IL
Memorial Hospital of South Bend	South Bend	IN
Methodist Cancer Center at Methodist Hospital	Indianapolis	IN
Parkview Regional Cancer Center at Parkview Health	Fort Wayne	IN
Howard Community Hospital	Kokomo	IN
Elkhart General Hospital	Elkhart	IN
Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	IN
Central Indiana Cancer Centers - East	Indianapolis	IN
Community Hospital	Munster	IN
Radiation Oncology Associates Southwest	Fort Wayne	IN
Reid Hospital & Health Care Services	Richmond	IN
Covenant Cancer Treatment Center	Waterloo	IA
Genesis Regional Cancer Center at Genesis Medical Center	Davenport	IA
Hematology Oncology Associates of the Quad Cities	Bettendorf	IA
Cedar Rapids Oncology Associates	Cedar Rapids	IA
CCOP - Iowa Oncology Research Association	Des Moines	IA
St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	IN
St. Vincent Indianapolis Hospital	Indianapolis	IN
CCOP - Northern Indiana CR Consortium	South Bend	IN
Bloomington Hospital Regional Cancer Institute	Bloomington	IN
Methodist Medical Center of Illinois
Oncology Hematology Associates of Central Illinois, PC - Peoria	Peoria	IL
OSF St. Francis Medical Center	Peoria	IL
Memorial Hospital	Carthage	IL
McDonough District Hospital	Macomb	IL
La Grange Oncology Associates - Geneva	Naperville	IL
Mason District Hospital
Perry Memorial Hospital	Princeton	IL
Proctor Hospital	Peoria	IL
St. Margaret's Hospital	Spring Valley	IL
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus	Moline	IL
Valley Cancer Center	Spring Valley	IL
Saint Anthony's Hospital at Saint Anthony's Health Center	Alton	IL
Rush University Medical Center	Chicago	IL
Regional Cancer Center at Memorial Medical Center	Springfield	IL
Resurrection Medical Center
Clinton Memorial Hospital

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed ductal carcinoma in situ (DCIS)

Mixed DCIS and lobular carcinoma in situ (LCIS) allowed

HER2 receptor-positive as determined by central testing

Must have undergone resection by lumpectomy and meets the following criteria:

Margins of the resected specimen must be histologically free of DCIS (re-excision to obtain clear margins allowed)

No more than 120 days since the last surgery for excision of DCIS (lumpectomy or re-excision of lumpectomy margins)

None of the following allowed:

Patients who require mastectomy

Invasive (including microinvasion staged as T1mic) breast cancer (DCIS "suspicious" for microinvasion, but not confirmed, allowed)

Nodal staging of pN1 (including pN1mi) (axillary staging not required)

DCIS present in more than one quadrant (multicentric)

Masses or clusters of calcification that are clinically or mammographically suspicious unless biopsied and proven to be benign

Contralateral breast cancer (including DCIS)

History of breast cancer, including DCIS (history of LCIS allowed)

Hormone receptor status:

Estrogen receptor and/or progesterone receptor-positive or -negative

Must submit tumor block for correlative studies

PATIENT CHARACTERISTICS:

Pre- or postmenopausal

ECOG performance status 0-1

Life expectancy �� 10 years (excluding diagnosis of DCIS)

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use effective non-hormonal contraception during and for 6 months after completion of treatment with trastuzumab (Herceptin��)

No psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements

No cardiac disease that would preclude the use of study treatment drugs, including, but not limited to, any of the following:

Active cardiac disease

Angina pectoris that requires the use of anti-anginal medication

Ventricular arrhythmias except for benign premature ventricular contractions controlled by medication

Conduction abnormality requiring a pacemaker

Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication

Clinically significant valvular disease

History of cardiac disease

Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular function

Documented congestive heart failure

Documented cardiomyopathy

No uncontrolled hypertension (i.e., systolic BP > 180 mm Hg and/or diastolic BP > 100 mm Hg) (hypertension that is well controlled on medication allowed)

No other nonmalignant systemic disease that would preclude a patient from receiving trastuzumab or radiotherapy or would prevent prolonged follow-up

No other malignancies unless patient has been disease-free �� 5 years and at low risk for recurrence, except for treated carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, or basal cell or squamous cell carcinoma of the skin

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

No prior whole or partial breast irradiation

No prior anthracycline chemotherapy for any malignancy

No investigational agents within the past 30 days

No other cancer therapy until the time of first cancer recurrence or second primary cancer

Contact