Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in ErbB2 (HER2) Positive Metastatic Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

540

Participants

Timeline

Start Date

April 14, 2009

Primary Completion Date

June 11, 2012

Study Completion Date

March 22, 2018

Conditions
Metastases, Brain
Interventions
DRUG

capecitabine

oral medication; daily dose divided into morning and evening dose and taken for 14 days of 21 day cycle

DRUG

lapatinib

oral medication; daily dose taken once a day

DRUG

trastuzumab

infusion therapy; loading dose of 8mg/kg, followed by 6mg/kg given every 3 weeks

Trial Locations (164)

1082

Novartis Investigative Site, Budapest

1122

Novartis Investigative Site, Budapest

1125

Novartis Investigative Site, Budapest

1180

Novartis Investigative Site, Brussels

2020

Novartis Investigative Site, Antwerp

2800

Novartis Investigative Site, Tatabánya

7400

Novartis Investigative Site, Kaposvár

8200

Novartis Investigative Site, Veszprém

9100

Novartis Investigative Site, Sint-Niklaas

10003

Novartis Investigative Site, Cáceres

10330

Novartis Investigative Site, Bangkok

10400

Novartis Investigative Site, Bangkok

11047

Novartis Investigative Site, Jerez (Cadiz)

14076

Novartis Investigative Site, Caen

14169

Novartis Investigative Site, Berlin

14467

Novartis Investigative Site, Potsdam

14770

Novartis Investigative Site, Brandenburg

15009

Novartis Investigative Site, A Coruña

15706

Novartis Investigative Site, Santiago de Compostela

18547

Novartis Investigative Site, Neo Faliro

20007

Novartis Investigative Site, Washington D.C.

20052

Novartis Investigative Site, Monza

20095

Novartis Investigative Site, Hamburg

21100

Novartis Investigative Site, Varese

22081

Novartis Investigative Site, Hamburg

23562

Novartis Investigative Site, Lübeck

24047

Novartis Investigative Site, Treviglio (BG)

25030

Novartis Investigative Site, Besançon

25198

Novartis Investigative Site, Lleida

26504

Novartis Investigative Site, Pátrai

27710

Novartis Investigative Site, Durham

28034

Novartis Investigative Site, Madrid

28040

Novartis Investigative Site, Madrid

28041

Novartis Investigative Site, Madrid

28100

Novartis Investigative Site, Novara

28209

Novartis Investigative Site, Bremen

29010

Novartis Investigative Site, Málaga

33021

Novartis Investigative Site, Hollywood

33065

Novartis Investigative Site, Coral Springs

33100

Novartis Investigative Site, Udine

33486

Novartis Investigative Site, Boca Raton

35760

Novartis Investigative Site, Saint-Grégoire

38100

Novartis Investigative Site, Trento

40138

Novartis Investigative Site, Bologna

40139

Novartis Investigative Site, Bologna

41013

Novartis Investigative Site, Seville

41014

Novartis Investigative Site, Seville

42271

Novartis Investigative Site, Saint-Priest-en-Jarez

42551

Novartis Investigative Site, Velbert

44623

Novartis Investigative Site, Herne

46010

Novartis Investigative Site, Valencia

46236

Novartis Investigative Site, Bottrop

47014

Novartis Investigative Site, Meldola (FC)

47166

Novartis Investigative Site, Duisburg

47574

Novartis Investigative Site, Goch

47900

Novartis Investigative Site, Rimini

49933

Novartis Investigative Site, Angers

50200

Novartis Investigative Site, Chiang Mai

50935

Novartis Investigative Site, Cologne

51056

Novartis Investigative Site, Reims

51067

Novartis Investigative Site, Cologne

51100

Novartis Investigative Site, Reims

52146

Novartis Investigative Site, Würselen

54100

Novartis Investigative Site, Nancy

55043

Novartis Investigative Site, Lido Di Camaiore (LU)

55131

Novartis Investigative Site, Mainz

56000

Novartis Investigative Site, Vannes

56126

Novartis Investigative Site, Pisa

58452

Novartis Investigative Site, Witten

59187

Novartis Investigative Site, Dechy

59405

Novartis Investigative Site, Great Falls

60389

Novartis Investigative Site, Frankfurt am Main

60555

Novartis Investigative Site, Warrenville

63023

Novartis Investigative Site, Fermo (AP)

63110

Novartis Investigative Site, St Louis

64109

Novartis Investigative Site, Bayonne

65199

Novartis Investigative Site, Wiesbaden

67000

Novartis Investigative Site, Strasbourg

67346

Novartis Investigative Site, Speyer

68000

Novartis Investigative Site, Colmar

70006

Novartis Investigative Site, Metairie

72401

Novartis Investigative Site, Jonesboro

75651

Novartis Investigative Site, Paris

81675

Novartis Investigative Site, Munich

81925

Novartis Investigative Site, Munich

83022

Novartis Investigative Site, Rosenheim

84000

Novartis Investigative Site, Avignon

84028

Novartis Investigative Site, Landshut

84307

Novartis Investigative Site, Eggenfelden

85338

Novartis Investigative Site, Goodyear

85715

Novartis Investigative Site, Tucson

88212

Novartis Investigative Site, Ravensburg

90110

Novartis Investigative Site, Songkhla

90449

Novartis Investigative Site, Nuremberg

90766

Novartis Investigative Site, Fürth

92801

Novartis Investigative Site, Anaheim

93105

Novartis Investigative Site, Santa Barbara

95816

Novartis Investigative Site, Sacramento

97070

Novartis Investigative Site, Würzburg

117997

Novartis Investigative Site, Moscow

163045

Novartis Investigative Site, Arkhangelsk

170008

Novartis Investigative Site, Tver'

173016

Novartis Investigative Site, Veliky Novgorod

185035

Novartis Investigative Site, Petrozavodsk

188663

Novartis Investigative Site, Vsevolozhsk

197022

Novartis Investigative Site, Saint Petersburg

197758

Novartis Investigative Site, Saint Petersburg

249036

Novartis Investigative Site, Obninsk

390011

Novartis Investigative Site, Ryazan

394062

Novartis Investigative Site, Voronezh

420029

Novartis Investigative Site, Kazan'

454087

Novartis Investigative Site, Chelyabinsk

603081

Novartis Investigative Site, Nizhny Novgorod

610021

Novartis Investigative Site, Kirov

94904-2007

Novartis Investigative Site, Greenbrae

08043

Novartis Investigative Site, Voorhees Township

8000 Aarhus C

Novartis Investigative Site, Aarhus

06120

Novartis Investigative Site, Halle

115 26

Novartis Investigative Site, Athens

115 28

Novartis Investigative Site, Athens

145 64

Novartis Investigative Site, N. Kifisia, Athens

185 37

Novartis Investigative Site, Peiraius

Unknown

Novartis Investigative Site, Thessaloniki

00144

Novartis Investigative Site, Rome

06132

Novartis Investigative Site, Perugia

85-796

Novartis Investigative Site, Bydgoszcz

41-902

Novartis Investigative Site, Bytom

44-101

Novartis Investigative Site, Gliwice

62-500

Novartis Investigative Site, Konin

93-509

Novartis Investigative Site, Lodz

10-228

Novartis Investigative Site, Olsztyn

35-021

Novartis Investigative Site, Rzeszów

51-124

Novartis Investigative Site, Wroclaw

53-413

Novartis Investigative Site, Wroclaw

115 478

Novartis Investigative Site, Moscow

143 423

Novartis Investigative Site, Moscow Region

08003

Novartis Investigative Site, Barcelona

08035

Novartis Investigative Site, Barcelona

08907

Novartis Investigative Site, Hospitalet de Llobregat (Barcelona)

07010

Novartis Investigative Site, Palma de Mallorca

07198

Novartis Investigative Site, Palma de Mallorca

03186

Novartis Investigative Site, Torrevieja (Alicante)

SE-171 76

Novartis Investigative Site, Stockholm

SE-751 85

Novartis Investigative Site, Uppsala

SE-351 85

Novartis Investigative Site, Vaxjo

SE-721 89

Novartis Investigative Site, Västerås

EH4 2XU

Novartis Investigative Site, Edinburgh

B18 7QH

Novartis Investigative Site, Birmingham

AB25 2ZN

Novartis Investigative Site, Aberdeen

DE13 0RB

Novartis Investigative Site, Burton-on-Trent

HU16 5JQ

Novartis Investigative Site, Cottingham, Hull

HD3 3EA

Novartis Investigative Site, Huddersfield

IP4 5PD

Novartis Investigative Site, Ipswich

EC1A 7BE

Novartis Investigative Site, London

NW3 2QG

Novartis Investigative Site, London

SW17 0QT

Novartis Investigative Site, London

ME16 9QQ

Novartis Investigative Site, Maidstone

NG5 1PB

Novartis Investigative Site, Nottingham

PE3 9GZ

Novartis Investigative Site, Peterborough

S10 2SJ

Novartis Investigative Site, Sheffield

SY3 8XQ

Novartis Investigative Site, Shrewsbury

SO16 6YD

Novartis Investigative Site, Southampton

WV10 0QP

Novartis Investigative Site, Wolverhampton

BN11 2DH

Novartis Investigative Site, Worthing

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY