A Study of AC Followed by a Combination of Paclitaxel Plus Trastuzumab or Lapatinib or Both Given Before Surgery to Patients With Operable HER2 Positive Invasive Breast Cancer

PHASE3UnknownINTERVENTIONAL
Enrollment

529

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

June 30, 2012

Study Completion Date

March 31, 2017

Conditions
Invasive Breast Cancer
Interventions
DRUG

doxorubicin

60 mg/m2 IV every 21 days for cycles 1-4

DRUG

cyclophosphamide

600 mg/m2 IV every 21 days for cycles 1-4

DRUG

paclitaxel

80 mg/m2 IV on days 1, 8, and 15 every 28 days for cycles 5-8

DRUG

trastuzumab

First dose: 4 mg/kg IV, subsequent doses: 2 mg/kg IV weekly beginning on day 1 of the first paclitaxel cycle until 1-7 days before surgery

DRUG

lapatinib

Group 2: 1250 mg PO daily beginning on day 1 of the first paclitaxel cycle until 1 day before surgery. Group 3: 750 mg PO daily beginning on day 1 of the first paclitaxel cycle until 1 day before surgery.

Trial Locations (110)

12206

New York Oncology Hematology PC-Albany, Albany

12801

Cancer Center at Glens Falls Hospital, Glens Falls

13057

CCOP, Hematology-Oncology Associates of CNY, Syracuse

15212

Allegheny General Hospital/Allegheny-Singer Research Institute, Pittsburgh

NSABP Foundation, Inc., Pittsburgh

15213

University of Pittsburgh, Pittsburgh

15224

Western Pennsylvania Hospital, Pittsburgh

17033

Hershey Medical Center, Hershey

18105

Lehigh Valley Hospital, Allentown

18501

Mercy Hospital, Scranton

19096

CCOP, Main Line Health, Wynnewood

19612

Reading Hospital & Medical Center, West Reading

20016

Sibley Memorial Hospital, Washington D.C.

21204

Greater Baltimore Medical Center, Baltimore

21237

Franklin Square Hospital Center, Baltimore

23298

MBCCOP, Virginia Commonwealth University, Richmond

26003

Wheeling Hospital, Wheeling

26101

Camden-Clark Memorial Hospital, Parkersburg

27157

Wake Forest University School of Medicine, Winston-Salem

27215

Alamance Regional Medical Center, Burlington

27302

Alamance Regional Medical Center - Off site Clinic, Mebane

28203

CCOP, Southeast Cancer Control Consortium, Charlotte

28302

University of North Carolina at Chapel Hill, Chapel Hill

29303

CCOP, Upstate Carolina, Spartanburg

30912

MBCCOP, Medical College of Georgia Research Institute, Augusta

31701

Phoebe Putney Memorial Hospital, Albany

32806

MD Anderson Cancer Center, Orlando

36608

MBCCOP, Gulf Coast, Mobile

37909

Thompson Cancer Survival Center-Dowell Springs, Knoxville

40202

NortonHealtcare Inc., Louisville

40536

University of Kentucky Medical Center, Lexington

43017

Ohio State University, Columbus

43215

CCOP, Columbus, OH, Columbus

44106

Case Western Reserve/University Hospitals-Ireland Cancer Cntr., Cleveland

44304

Akron City Hospital, Akron

44710

Aultman Hospital, Canton

45429

CCOP, Dayton, OH, Dayton

46260

St. Vincent Hospital and Health Care Center, Indianapolis

46601

CCOP, Northern Indiana Cancer Research Consortium, South Bend

48073

CCOP, William Beaumont Hospital, Royal Oak

48106

CCOP, Michigan Cancer Research Consortium, Ann Arbor

48202

Henry Ford Health System, Detroit

Henry Ford Hospital, Detroit

48910

Michigan State University - Breslin Cancer Center, Lansing

49007

CCOP, Kalamazoo, MI, Kalamazoo

49503

CCOP, Grand Rapids Clnical Oncology Program, Grand Rapids

51101

CCOP, Sioux Community Cancer consortium, Sioux City

52242

University of Iowa, Iowa City

52501

CCOP, Des Moines, IA, Des Moines

53226

Medical College of Wisconsin, Milwaukee

54449

CCOP, Marshfield Clinic, Marshfield

55415

Hennepin County Medical Center, Minneapolis

55416

CCOP, Metro-Minnesota, Minneapolis

57104

Sanford Cancer Center, Souix Falls

59101

CCOP, Montana Cancer Consortium, Billings

60007

Cancer Institute at Alexian Brothers Hospital Network, Elk Grove

60566

Edward Hospital, Naperville

60585

Edward Cancer Center Plainfield, Plainfield

60612

Rush University Medical Center, Chicago

61801

CCOP, Carle Cancer Center, Urbana

62526

Decatur Memorial Hospital, Decatur

CCOP, Central Illinois, Springfield

63110

Saint Louis UniversityHealth Sciences Center, St Louis

63131

CCOP, Heartland Cancer Research, St Louis

64131

CCOP, Kansas City (Administrative Only), Kansas City

65203

University of Missouri-Ellis Fischel, Columbia

65804

CCOP, Ozark Health Ventures LLC, Springfield

67214

CCOP, Wichita KS, Wichita

70121

CCOP, Ochsner Clinic Foundation, New Orleans

74136

CCOP, Missouri Valley Consortium, Omaha

CCOP, Oklahoma, Tulsa

78229

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

79410

Joe Arrington Cancer Research & Treatment Center, Lubbock

80026

Kaiser Permanente Rock Creek, Lafayette

80045

University of Colorado Cancer Center, Aurora

80205

Kaiser Permanente-Franklin, Denver

80224

CCOP-Colorado Cancer Research Prog. Inc.(Administrative Only), Denver

80909

Memorial Hospital, Colorado Springs

83706

CCOP, Northwest, Tacoma

83814

Kootenai Cancer Center, Coeur d'Alene

90801

University of California, Irvine Medical Center, Long Beach

90813

Pacific Shores Medical Group, Long Beach

92037

Scripps Cancer Center-San Diego, La Jolla

92120

Kaiser Permanente-San Diego, San Diego

92262

Desert Regional Medical Center Comprehensive Cancer Center, Palm Springs

92868

St. Joseph Hospital, Orange

94304

Stanford University Medical Center, Palo Alto

94589

Kaiser Permanente-Vallejo, Vallejo

95403

Santa Rosa Memorial Hospital, Santa Rosa

95816

Sutter Medical Center, Sacramento

96813

University of Hawaii, Honolulu

96819

Kaiser Permanente Hawaii - Moanalua Med Center, Honolulu

98109

Puget Sound Oncology Consortium, Seattle

99519

CCOP, Virginia Mason, Seattle

06102

Hartford Hospital, Hartford

06360

Eastern Connecticut Hematology & Oncology Associates, Norwich

02118

Boston Medical Center, Boston

48075-9975

Providence Hospital - Southfield, Southfield

08901

Cancer Institute of New Jersey, New Brunswick

07112

Newark Beth Israel Medical Center, Newark

17882-2170

Geisinger Clinic, Danville

19141-3098

Albert Einstein Healthcare Network, Philadelphia

26506-9162

West Virginia University Hospitals Inc., Morgantown

M4N 3M5

Odette Cancer Centre, Toronto

H3A 1A1

Royal Victoria Hospital, Montreal

H3T 1E2

Jewish General Hospital, Montreal

H3T 1M5

St. Mary's Hospital Center, Montreal

Unknown

University of Montreal Hospital Group, Montreal

G1S 4L8

Centre Hospitalier Affilie Universitaire De Quebec, Hospital du St-Sacrement, Québec

00936

MBCCOP, San Juan, Puerto Rico, San Juan

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

NSABP Foundation Inc

NETWORK