Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

5,099

Participants

Timeline

Start Date

November 30, 2001

Primary Completion Date

March 31, 2005

Study Completion Date

June 30, 2015

Conditions
Breast Cancer
Interventions
DRUG

Herceptin

Herceptin will be given as a loading dose of 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks.

DRUG

Herceptin

Herceptin will be given as a loading dose of 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks.

Trial Locations (203)

29

Fundacion Arturo Lopez Perez, Santiago

1070

Hopital Universitaire Erasme, Brussels

1082

Semmelweis University, Budapest

1090

Universitaetsklinik fuer Innere Medizin I, Vienna

Academisch Ziekenhuis der Vrije Universiteit Brussel, Brussels

1118

Hospital Aleman de Buenos Aires, Buenos Aires

1122

National Institute of Oncology, Budapest

2020

Ziekenhuis Netwerk Antwerpen Middelheim, Antwerp

2121

Sandton Oncology Centre, Johannesburg

2193

Medical Oncology Centre of Rosebank, Johannesburg

3000

Hospitais da Universidade de Coimbra (HUC), Coimbra

Maternidade Byssaia Barreto, Coimbra

3100

Landeskrankenhaus St. Poelten, Sankt Pölten

3220

Saint John of God Hospital, Geelong

Andrew Love Cancer Centre, Geelong

3400

Hillerod Hospital, Hillerød

4001

Parklands Hospital, Durban

4350

Toowoomba Hospital, Toowoomba

4700

Centralsygehuset I Naestved, Næstved

4840

LKH Voecklabruck, Vöcklabruck

5000

Clinique Sainte Elisabeth, Namur

5001

Kantonspital Aarau, Aarau

6000

Mount Hospital, Perth

Centre Hospitalier Notre Dame - Reine Fabiola, Charleroi

6400

Sonderborg Sygehus, Sønderborg

6700

Centralsygehus I Esbjerg, Esbjerg

6807

Landeskrankenhaus Feldkirch, Feldkirch-Tisis

7100

Centre Hospitalier Universitaire de Tivoli, La Louvière

7331

Reseau Hospitalier De Medecine Sociale, Baudour

7400

Herning Central Hospital, Herning

7925

Groote Schuur Hospital, Cape Town

8000

Hospital Distrital De Faro, Faro

8400

Hospital Serruys Ziekenhuis, Ostend

9026

Landeskrankenhaus Klagenfurt, Klagenfurt

9500

LKH Villach, Villach

10126

Ospedale Ostetrico Ginecologica Sant Anna, Turin

Universita di Torino, Turin

10330

Chulalongkorn University Hospital, Bangkok

10400

Ramathibodi Hospital, Bangkok

10676

Evaggelismos Hospital, Athens

12051

Ospedale San Lazzaro, Alba

12100

Ospedale Santa Croce, Cuneo

13110

Sieff Hospital, Safed

13900

Ospedale degli Infermi - ASL 12, Biella

14076

Centre Regional Francois Baclesse, Caen

15009

Centro Oncologico De Galicia Jose Antonio Quirogay Pineyro, A Coruña

16132

Istituto Nazionale per la Ricerca sul Cancro, Genoa

18003

Hospital Universitario San Cecilio de Granada, Granada

19002

Hospital General Universitario De Guadalajara, Guadalajara

20089

Istituto Clinico Humanitas, Rozzano

20141

European Institute of Oncology, Milan

20162

Ospedale Niguarda Ca'Granda, Milan

20502

University Hospital of Malmoe, Malmo

21000

Clinical Hospital Center Split, Split

21005

Hospital Juan Ramon Jimenez, Huelva

22100

Ospedale Valduce, Como

23007

Hospital Cuidad de Jaen, Jaén

23900

Ospedale A. Manzoni, Lecco

24022

Ospedale Presenti Fenaroli, Alzano Lombardo

24100

Ospedali Riuniti di Bergamo, Bergamo

25124

Spedali Civili di Brescia, Brescia

27100

I.R.C.C.S. Policlinico San Matteo, Pavia

28006

Hospital de la Princesa, Madrid

32005

Complejo Hospitalario Santa Maria, Ourense

33081

Centro di Riferimento Oncologico - Aviano, Aviano

35020

Hospital de Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria

36001

Complejo Hospitalario de Pontevedra, Pontevedra

36204

Complexo Hospitalario Xeral de Vigo, Vigo Pontevedra

38010

Hospital Universitario Nuestra Senora de la Candelaria, Santa Cruz de Tenerife

38100

Primario U.O. di Oncologia Medica, Trento

38320

Hospital Universitario Canarias, San Cristóbal de La Laguna

41012

Ospedale B. Ramazzini, Carpi

41014

Hospital General Universitario Valencia, Valencia

41100

University of Modena Hospital and Reggio Emilia School of Medicine, Modena

42100

Azienda Ospedaliera, Reggio Emilia

43100

Azienda Ospedaliera Di Parma, Parma

45004

Hospital Virgen Del La Salud, Toledo

46100

Carlo Poma Hospital, Mantova

46600

Hospital De La Ribera, Alzira

47100

Morgagni-Pierantoni Ospedale, Forlì

50121

Universita Degli Studi Di Florence, Firenze (Florence)

50139

Azienda Ospedaliero Careggi, Florence

57072

Hopital Clinique Claude Bernard, Metz

57100

Presidio Ospedaliero, Livorno

59009

Hospital Universitario Miguel Servet, Zaragoza

71110

University of Crete School of Medicine, Heraklion

80637

Frauenklinik Vom Roten Kreuz, Munich

87042

Centre Hospital Regional Universitaire de Limoges, Limoges

107005

Moscow Oncology Hospital, Moscow

125284

P.A. Hertzen Research Oncology Institute, Moscow

308433

Johns Hopkins Singapore International Medical Centre, Singapore

430030

Tongji Medical University, Wuhan

A-6020

Innsbruck Universitaetsklinik, Innsbruck

A-4010

St. Vincent's Hospital, Linz Donau

A-5020

Landeskrankenanstalten - Salzburg, Salzburg

A-1160

Wilhelminenspital der Stadt Wien, Vienna

A-2700

A. oe. Krankenhaus Wiener Neustadt, Wiener Neustadt

B-1000

Institut Jules Bordet, Brussels

B-8500

Cazk Groeninghe - Campus St-Niklaas, Kortrijk

B-3000

U.Z. Gasthuisberg, Leuven

B 4000

Clinique Saint-Joseph, Liège

B-4000

CHU Liege - Domaine Universitaire du Sart Tilman, Liège

B-4800

Centre Hospitalier Peltzer-La Tourelle, Verviers

90035-003

Porto Alegre Hospital, Porto Alegre

90610-000

Hospital Sao Lucas da PUCRS, Porto Alegre

91330-490

Hospital Santa Rita, Porto Alegre

20560-120

Instituto Nacional de Cancer, Rio de Janeiro

09060-650

Faculdade De Medicina Do ABC, Santo André

T2N 4N2

Tom Baker Cancer Centre - Calgary, Calgary

V1Y 5L3

British Columbia Cancer Agency - Centre for the Southern Interior, Kelowna

V3V 1Z2

Fraser Valley Cancer Centre at British Columbia Cancer Agency, Surrey

V5Z 4E6

British Columbia Cancer Agency - Vancouver Cancer Centre, Vancouver

V8R 6V5

British Columbia Cancer Agency - Vancouver Island Cancer Centre, Victoria

R2H 2A6

CancerCare Manitoba, Winnipeg

L4M 6M2

Royal Victoria Hospital of Barrie, Barrie

L8V 5C2

Margaret and Charles Juravinski Cancer Centre, Hamilton

L5B 1B8

Trillium Health Centre - Mississauga Site, Mississauga

P6A 2C4

Algoma Regional Cancer Program at Sault Area Hospital, Sault Ste. Marie

L2R 5K3

Hotel Dieu Health Sciences Hospital - Niagara, St. Catharines

M4C 3E7

Toronto East General Hospital, Toronto

M5G 1X5

Mount Sinai Hospital - Toronto, Toronto

M5G 2M9

Princess Margaret Hospital, Toronto

N8W 2X3

Windsor Regional Cancer Centre at Windsor Regional Hospital, Windsor

C1A 8T5

Prince Edward Island Cancer Centre at Queen Elizabeth Hospital, Charlottetown

G1S 4L8

Hopital du Saint-Sacrement, Quebec, Québec

S4T 7T1

Allan Blair Cancer Centre at Pasqua Hospital, Regina

S7N 4H4

Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon

Unknown

Hospital Clinico San Borja Arriaran, Santiago

Hospital Dr. Sotero Del Rio, Santiago

Hospital Militar, Santiago

Instituto Nacional Del Cancer, Santiago

Queen Mary Hospital, Hong Kong

Tuen Mun Hospital, Hong Kong

Instituto Nacional De Cancerologia, Bogotá

Prince of Wales Hospital, Shatin, New Territories

Cork University Hospital, Cork

D-10117

Charite - Campus Charite Mitte, Berlin

D-45355

Evangelisches Bethesda Krankenhaus GmbH, Essen

D-79106

Universitaetsklinikum Freiburg, Freiburg im Breisgau

D-06097

Martin Luther Universitaet, Halle

D-30559

Henriettenstiftung Krankenhaus, Hanover

D-69115

Universitaets-Hautklinik Heidelberg, Heidelberg

D-76137

St. Vincentius-Kliniken, Karlsruhe

D-24105

University Hospital Schleswig-Holstein - Kiel Campus, Kiel

D-71229

Kreiskrankenhaus Leonberg - Frauenklinik, Leonberg

D-39120

Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg, Magdeburg

D-81675

Klinikum Rechts Der Isar - Technische Universitaet Muenchen, Munich

D-18059

Frauenklinik - Universitaetsklinikum Rostock am Klinikum Sudstadt, Rostock

D-89075

Universitaet Ulm, Ulm

D-65199

Dr. Horst-Schmidt-Kliniken, Wiesbaden

01010

Centro Medico, Guatemala City

Hospital Roosevelt, Guatemala City

H-1032

Fovarosi Onkormanyzat Szent Margit Korhaz, Okologia, Budapest

I-40139

Ospedale Bellaria, Bologna

09100

Ospedale Oncologico A. Businco, Cagliari

06122

Policlinico Monteluce, Perugia

00135

Ospedale San Filippo Neri, Rome

00144

Ospedale Sant' Eugenio, Rome

07100

Ospedale Civile ASL 1, Sassari

259-1193

Tokai University School Of Medicine, Kanagawa

113-8677

Tokyo Metropolitan - Komagome Hospital, Tokyo

6202 AZ

Academisch Ziekenhuis Maastricht, Maastricht

6131 BK

Maasland Hospital, Sittard

3508 TG

Diakonessenhuis Utrecht, Utrecht

80-211

Medical University of Gdansk, Gdansk

44-101

Oncologic Center, Gliwice

61-878

Medical University, Poznan

02-781

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw

3000-075

Instituto Portugues de Oncologia, Centro Regional de Coimbra, Coimbra

1099-023 Codex

Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A., Lisbon

1649-035

University Hospital of Santa Maria, Lisbon

0081

Pretoria - East Hospital, Lynnwood

110-744

Seoul National University Hospital, Seoul

120-752

Yonsei Cancer Center at Yonsei University Medical Center, Seoul

08003

Hospital Del Mar, Barcelona

G.C.

Hospital Insular de Gran Canaria, Las Palmas

08208

Consorci Hospitalari del Parc Tauli, Sabadell

E- 41013

Hospital Universidad Virgen Del Rocio, Seville

S-581 85

University Hospital of Linkoping, Linköping

S-43180

Sahlgrenska University Hospital - Molndal at Gothenburg University, Mölndal

S-171 76

Karolinska University Hospital - Huddinge, Stockholm

SE-901 87

Umea Universitet, Umeå

SE-75185

Uppsala University Hospital, Uppsala

CH-4031

Universitaetsspital-Basel, Basel

CH-3010

Inselspital Bern, Bern

CH-7000

Spitaeler Chur AG, Chur

CH-1011

Centre Hospitalier Universitaire Vaudois, Lausanne

CH-6850

Ospedale Beata Vergine, Mendrisio

CH-9007

Kantonsspital - St. Gallen, Sankt Gallen

CH-8091

UniversitaetsSpital Zuerich, Zurich

BD9 6RJ

Bradford Hospitals NHS Trust, Bradford

CM1 7ET

Broomfield Hospital, Chelmsford, Essex

CM16 6TN

Saint Margaret's Hospital, Epping Essex

DN33 2BA

Diana Princess of Wales Hospital, Grimsby

HD3 3EA

Huddersfield Royal Infirmary, Huddersfield, West Yorks

HU8 9HE

Princess Royal Hospital, Hull

LS16 6QB

Cookridge Hospital at Leeds Teaching Hospital NHS Trust, Leeds

W12 0NN

Imperial College of Medicine, London

TS4 3BW

James Cook University Hospital, Middlesbrough

NE4 6BE

Northern Centre for Cancer Treatment at Newcastle General Hospital, Newcastle upon Tyne

S1O 2SJ

Cancer Research Centre at Weston Park Hospital, Sheffield

BD20 6TD

Airedale General Hospital, West Yorkshire

SS0 0RY

Southend NHS Trust Hospital, Westcliff-on-Sea

All Listed Sponsors
collaborator

Breast International Group

OTHER

collaborator

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

collaborator

NCIC Clinical Trials Group

NETWORK

collaborator

ETOP IBCSG Partners Foundation

NETWORK

lead

Hoffmann-La Roche

INDUSTRY