Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

3,436

Participants

Timeline

Start Date

May 19, 2000

Primary Completion Date

April 25, 2005

Study Completion Date

January 27, 2010

Conditions
Breast AdenocarcinomaHER2 Positive Breast CarcinomaStage IA Breast Cancer AJCC v7Stage IB Breast Cancer AJCC v7Stage IIA Breast Cancer AJCC v6 and v7Stage IIB Breast Cancer AJCC v6 and v7Stage IIIA Breast Cancer AJCC v7
Interventions
DRUG

Aromatase Inhibition Therapy

Given orally

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Paclitaxel

Given IV

DRUG

Tamoxifen Citrate

Given orally

BIOLOGICAL

Trastuzumab

Given IV

Trial Locations (157)

10016

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

10029

Mount Sinai Hospital, New York

10032

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

NYP/Weill Cornell Medical Center, New York

10461

Montefiore Medical Center-Weiler Hospital, The Bronx

11030

North Shore University Hospital, Manhasset

11040

Long Island Jewish Medical Center, New Hyde Park

13210

State University of New York Upstate Medical University, Syracuse

13215

SUNY Upstate Medical Center-Community Campus, Syracuse

14263

Roswell Park Cancer Institute, Buffalo

14642

University of Rochester, Rochester

15224

West Penn Hospital, Pittsburgh

15232

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh

17822

Geisinger Medical Center, Danville

19096

Lankenau Medical Center, Wynnewood

19104

University of Pennsylvania/Abramson Cancer Center, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

20007

MedStar Georgetown University Hospital, Washington D.C.

21201

University of Maryland/Greenebaum Cancer Center, Baltimore

21287

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

22901

Sentara Martha Jefferson Hospital, Charlottesville

27103

Novant Health Forsyth Medical Center, Winston-Salem

27104

Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Winston-Salem

27157

Wake Forest University Health Sciences, Winston-Salem

27403

Cone Health Cancer Center, Greensboro

27599

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

27710

Duke University Medical Center, Durham

27893

Wilson Medical Center, Wilson

28801

Mission Hospital Inc-Memorial Campus, Asheville

29401

Roper Hospital, Charleston

29425

Medical University of South Carolina, Charleston

30322

Emory University Hospital/Winship Cancer Institute, Atlanta

30342

Atlanta Regional CCOP, Atlanta

30501

Northeast Georgia Medical Center-Gainesville, Gainesville

31404

Memorial Health University Medical Center, Savannah

32803

AdventHealth Orlando, Orlando

33612

Moffitt Cancer Center, Tampa

35233

University of Alabama at Birmingham Cancer Center, Birmingham

37232

Vanderbilt University/Ingram Cancer Center, Nashville

37660

Wellmont Holston Valley Hospital and Medical Center, Kingsport

37916

Thompson Cancer Survival Center, Knoxville

37920

University of Tennessee - Knoxville, Knoxville

38163

University of Tennessee Health Science Center, Memphis

39216

University of Mississippi Medical Center, Jackson

43210

Ohio State University Comprehensive Cancer Center, Columbus

43617

Toledo Community Hospital Oncology Program CCOP, Toledo

44106

Case Western Reserve University, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

45219

University of Cincinnati/Barrett Cancer Center, Cincinnati

46202

Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis

46628

Northern Indiana Cancer Research Consortium, South Bend

48075

Ascension Providence Hospitals - Southfield, Southfield

48106

Michigan Cancer Research Consortium NCORP, Ann Arbor

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

48201

Wayne State University/Karmanos Cancer Institute, Detroit

48202

Henry Ford Hospital, Detroit

49008

Kalamazoo Center for Medical Studies, Kalamazoo

49503

Cancer Research Consortium of West Michigan NCORP, Grand Rapids

50309

Iowa-Wide Oncology Research Coalition NCORP, Des Moines

51101

Siouxland Regional Cancer Center, Sioux City

52242

University of Iowa/Holden Comprehensive Cancer Center, Iowa City

53226

Froedtert and the Medical College of Wisconsin, Milwaukee

53792

University of Wisconsin Hospital and Clinics, Madison

55416

Metro Minnesota Community Oncology Research Consortium, Saint Louis Park

55455

University of Minnesota/Masonic Cancer Center, Minneapolis

55805

Essentia Health Cancer Center, Duluth

55905

Mayo Clinic, Rochester

56303

Coborn Cancer Center at Saint Cloud Hospital, Saint Cloud

57104

Sanford NCI Community Oncology Research Program of the North Central Plains, Sioux Falls

57701

Rapid City Regional Hospital, Rapid City

58122

Sanford Broadway Medical Center, Fargo

58201

Altru Cancer Center, Grand Forks

58501

Sanford Bismarck Medical Center, Bismarck

59102

Montana Cancer Consortium NCORP, Billings

60153

Loyola University Medical Center, Maywood

60611

Northwestern University, Chicago

60612

Rush University Medical Center, Chicago

University of Illinois, Chicago

60637

University of Chicago Comprehensive Cancer Center, Chicago

61801

Carle Cancer Center, Urbana

62526

Heartland Cancer Research NCORP, Decatur

63110

Washington University - Jewish, St Louis

Washington University School of Medicine, St Louis

63131

Missouri Baptist Medical Center, St Louis

63141

Saint Louis-Cape Girardeau CCOP, St Louis

65212

University of Missouri - Ellis Fischel, Columbia

65804

Cancer Research for the Ozarks NCORP, Springfield

66208

Kansas City NCI Community Oncology Research Program, Prairie Village

66606

Cotton O'Neil Cancer Center / Stormont Vail Health, Topeka

Saint Francis Hospital and Medical Center - Topeka, Topeka

66762

Via Christi Hospital-Pittsburg, Pittsburg

67214

Wichita NCI Community Oncology Research Program, Wichita

67401

Salina Regional Health Center, Salina

68106

Missouri Valley Cancer Consortium, Omaha

68198

University of Nebraska Medical Center, Omaha

68847

CHI Health Good Samaritan, Kearney

70112

Tulane University Health Sciences Center, New Orleans

70121

Ochsner Medical Center Jefferson, New Orleans

71103

Louisiana State University Health Sciences Center Shreveport, Shreveport

72205

University of Arkansas for Medical Sciences, Little Rock

73104

University of Oklahoma Health Sciences Center, Oklahoma City

78229

University of Texas Health Science Center at San Antonio, San Antonio

78234

Brooke Army Medical Center, Fort Sam Houston

79106

The Don and Sybil Harrington Cancer Center, Amarillo

80045

University of Colorado Hospital, Aurora

84112

Huntsman Cancer Institute/University of Utah, Salt Lake City

85006

Western Regional CCOP, Phoenix

85259

Mayo Clinic in Arizona, Scottsdale

85719

Banner University Medical Center - Tucson, Tucson

89102

University Medical Center of Southern Nevada, Las Vegas

90033

USC / Norris Comprehensive Cancer Center, Los Angeles

90404

The Angeles Clinic and Research Institute - Santa Monica Office, Santa Monica

91010

City of Hope Comprehensive Cancer Center, Duarte

91204

Glendale Memorial Hospital and Health Center, Glendale

92103

University of California San Diego, San Diego

92134

Naval Medical Center -San Diego, San Diego

92868

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange

93611

Community Cancer Institute, Clovis

93901

Salinas Valley Memorial, Salinas

93940

Community Hospital of Monterey Peninsula, Monterey

94115

UCSF Medical Center-Mount Zion, San Francisco

94304

Stanford Cancer Institute Palo Alto, Palo Alto

94538

Washington Hospital, Fremont

95355

Memorial Medical Center, Modesto

95405

Santa Rosa Memorial Hospital, Santa Rosa

95817

University of California Davis Comprehensive Cancer Center, Sacramento

96813

University of Hawaii Cancer Center, Honolulu

97213

Providence Portland Medical Center, Portland

98101

Virginia Mason Medical Center, Seattle

98112

Kaiser Permanente Washington, Seattle

98405

Northwest NCI Community Oncology Research Program, Tacoma

32224-9980

Mayo Clinic in Florida, Jacksonville

20889-5600

Walter Reed National Military Medical Center, Bethesda

02111

Tufts Medical Center, Boston

02114

Massachusetts General Hospital Cancer Center, Boston

02118

Boston Medical Center, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Dana-Farber Cancer Institute, Boston

01757

Milford Regional Medical Center, Milford

01608

Saint Vincent Hospital/Reliant Medical Group, Worcester

01655

University of Massachusetts Medical School, Worcester

03106

New Hampshire Oncology Hematology PA-Hooksett, Hooksett

03756

Dartmouth Hitchcock Medical Center, Lebanon

07631

Englewood Hospital and Medical Center, Englewood

07601

Hackensack University Medical Center, Hackensack

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

97403-1217

University of Oregon, Eugene

17033-0850

Penn State Milton S Hershey Medical Center, Hershey

02860

Memorial Hospital of Rhode Island, Pawtucket

02903

Rhode Island Hospital, Providence

77555-0565

University of Texas Medical Branch, Galveston

05201

Southwestern Vermont Medical Center, Bennington

05405

University of Vermont and State Agricultural College, Burlington

S7N 4H4

Saskatoon Cancer Centre, Saskatoon

Lima 34

Instituto Nacional de Enfermedades Neoplasicas, Lima

0002

University Of Pretoria, Pretoria

All Listed Sponsors
collaborator

Cancer and Leukemia Group B

NETWORK

collaborator

Eastern Cooperative Oncology Group

NETWORK

collaborator

Canadian Cancer Trials Group

NETWORK

collaborator

SWOG Cancer Research Network

NETWORK

lead

National Cancer Institute (NCI)

NIH

NCT00005970 - Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer | Biotech Hunter | Biotech Hunter