Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

652

Participants

Timeline

Start Date

October 7, 2008

Primary Completion Date

August 1, 2012

Study Completion Date

July 27, 2022

Conditions
Breast Cancer
Interventions
BIOLOGICAL

trastuzumab

IV q weekly (loading dose 4mg/kg; subsequent doses 2mg/kg) or IV q 3 weekly (loading dose 8mg/kg, subsequent doses 6mg/kg).

DRUG

docetaxel

75mg/m2 IV q 3 weekly, day 1 of a 3 week cycle for 8 cycles plus G-CSF (when given together with lapatinib).

DRUG

lapatinib ditosylate

1250 mg once daily (while given with taxane). 1500mg once daily (when given alone after taxane completion).

DRUG

paclitaxel

80mg/m2 IV q weekly days 1, 8 and 15 of a 4-week cycle for 6 cycles.

Trial Locations (257)

100

Novartis Investigative Site, Taipei

112

Novartis Investigative Site, Taipei

404

Novartis Investigative Site, Taichung

500

Novartis Investigative Site, Changhua

736

Novartis Investigative Site, Tainan County

1090

Novartis Investigative Site, Jette

2060

Novartis Investigative Site, North Sydney

2170

Novartis Investigative Site, Liverpool

2485

Novartis Investigative Site, Tweed Heads

2606

Novartis Investigative Site, Garran

3000

Novartis Investigative Site, Santa Fe

3065

Novartis Investigative Site, Fitzroy

3128

Novartis Investigative Site, Box Hill

3690

Novartis Investigative Site, Wodonga

4000

Novartis Investigative Site, San Miguel de Tucumán

Novartis Investigative Site, Liège

4102

Novartis Investigative Site, Woolloongabba

5000

Novartis Investigative Site, Adelaide

Novartis Investigative Site, Namur

5037

Novartis Investigative Site, Kurralta Park

5042

Novartis Investigative Site, Bedford Park

6008

Novartis Investigative Site, Subiaco

7000

Novartis Investigative Site, Hobart

9000

Novartis Investigative Site, Ghent

10117

Novartis Investigative Site, Berlin

10367

Novartis Investigative Site, Berlin

10408

Novartis Investigative Site, Gyeonggi-do

10700

Novartis Investigative Site, Bangkok

13273

Novartis Investigative Site, Marseille

13326

Novartis Investigative Site, Cooperstown

14076

Novartis Investigative Site, Caen

14770

Novartis Investigative Site, Brandenburg

15009

Novartis Investigative Site, A Coruña

15208

Novartis Investigative Site, Poria – Neve Oved

15517

Novartis Investigative Site, Fürstenwalde

16132

Novartis Investigative Site, Genoa

17007

Novartis Investigative Site, Girona

20095

Novartis Investigative Site, Hamburg

20902

Novartis Investigative Site, Wheaton

21204

Novartis Investigative Site, Towson

22081

Novartis Investigative Site, Hamburg

22767

Novartis Investigative Site, Hamburg

23007

Novartis Investigative Site, Jaén

23320

Novartis Investigative Site, Chesapeake

23538

Novartis Investigative Site, Lübeck

24153

Novartis Investigative Site, Salem

26789

Novartis Investigative Site, Leer

27003

Novartis Investigative Site, Lugo

27403

Novartis Investigative Site, Greensboro

28007

Novartis Investigative Site, Madrid

28034

Novartis Investigative Site, Madrid

28040

Novartis Investigative Site, Madrid

28222

Novartis Investigative Site, Majadahonda (Madrid)

28223

Novartis Investigative Site, Pozuelo de Alarcon (Madrid)

28922

Novartis Investigative Site, Alcorcón

29210

Novartis Investigative Site, Columbia

30046

Novartis Investigative Site, Lawrenceville

30559

Novartis Investigative Site, Hanover

30901

Novartis Investigative Site, Augusta

31405

Novartis Investigative Site, Savannah

32457

Novartis Investigative Site, Porta Westfalica

33075

Novartis Investigative Site, Bordeaux

33077

Novartis Investigative Site, Bordeaux

33081

Novartis Investigative Site, Aviano (PN)

33470

Novartis Investigative Site, Loxahatchee Groves

33611

Novartis Investigative Site, Bielefeld

34655

Novartis Investigative Site, New Port Richey

34741

Novartis Investigative Site, Kissimmee

35423

Novartis Investigative Site, Lich

36043

Novartis Investigative Site, Fulda

38120

Novartis Investigative Site, Memphis

38642

Novartis Investigative Site, Goslar

40005

Novartis Investigative Site, Sumy

41013

Novartis Investigative Site, Seville

42551

Novartis Investigative Site, Velbert

44202

Novartis Investigative Site, Nantes

44691

Novartis Investigative Site, Wooster

44718

Novartis Investigative Site, Canton

45122

Novartis Investigative Site, Essen

46009

Novartis Investigative Site, Valencia

46237

Novartis Investigative Site, Indianapolis

46321

Novartis Investigative Site, Munster

46526

Novartis Investigative Site, Goshen

47150

Novartis Investigative Site, New Albany

47713

Novartis Investigative Site, Evansville

48653

Novartis Investigative Site, Coesfeld

49033

Novartis Investigative Site, Angers

49100

Novartis Investigative Site, Petah Tikva

Novartis Investigative Site, Dnipropetrovsk

49102

Novartis Investigative Site, Dnipro

50200

Novartis Investigative Site, Chiang Mai

51067

Novartis Investigative Site, Cologne

52621

Novartis Investigative Site, Ramat Gan

53113

Novartis Investigative Site, Bonn

53226

Novartis Investigative Site, Milwaukee

53840

Novartis Investigative Site, Troisdorf

56068

Novartis Investigative Site, Koblenz

58100

Novartis Investigative Site, Holon

58452

Novartis Investigative Site, Witten

59100

Novartis Investigative Site, Prato (PO)

59715

Novartis Investigative Site, Bozeman

60453

Novartis Investigative Site, Oak Lawn

60596

Novartis Investigative Site, Frankfurt am Main

60657

Novartis Investigative Site, Chicago

62450

Novartis Investigative Site, Cuernavaca

66100

Novartis Investigative Site, Chieti

66113

Novartis Investigative Site, Saarbrücken

67085

Novartis Investigative Site, Strasbourg

68803

Novartis Investigative Site, Grand Island

68845

Novartis Investigative Site, Kearney

68847

Novartis Investigative Site, Kearney

69115

Novartis Investigative Site, Heidelberg

70190

Novartis Investigative Site, Stuttgart

71913

Novartis Investigative Site, Hot Springs

73100

Novartis Investigative Site, Lecce

74370

Novartis Investigative Site, Metz-Tessy

75014

Novartis Investigative Site, Paris

79031

Novartis Investigative Site, Lviv

80204

Novartis Investigative Site, Denver

80907

Novartis Investigative Site, Colorado Springs

83022

Novartis Investigative Site, Rosenheim

83854

Novartis Investigative Site, Post Falls

84101

Novartis Investigative Site, Beersheba

84307

Novartis Investigative Site, Eggenfelden

85000

Novartis Investigative Site, Ciudad Obregón

85715

Novartis Investigative Site, Tucson

90640

Novartis Investigative Site, Montebello

90766

Novartis Investigative Site, Fürth

92346

Novartis Investigative Site, Highland

92637

Novartis Investigative Site, Weiden

93049

Novartis Investigative Site, Regensburg

94704

Novartis Investigative Site, Berkeley

96450

Novartis Investigative Site, Coburg

97227

Novartis Investigative Site, Portland

98004

Novartis Investigative Site, Bellevue

98034

Novartis Investigative Site, Kirkland

98109

Novartis Investigative Site, Seattle

98273

Novartis Investigative Site, Mount Vernon

98382

Novartis Investigative Site, Sequim

98405

Novartis Investigative Site, Tacoma

98801

Novartis Investigative Site, Wenatchee

99508

Novartis Investigative Site, Anchorage

153013

Novartis Investigative Site, Ivanovo

163045

Novartis Investigative Site, Arkhangelsk

197022

Novartis Investigative Site, Saint Petersburg

197758

Novartis Investigative Site, Saint Petersburg

355047

Novartis Investigative Site, Stavropol

390011

Novartis Investigative Site, Ryazan

398005

Novartis Investigative Site, Lipetsk

411001

Novartis Investigative Site, Pune

420029

Novartis Investigative Site, Kazan'

440010

Novartis Investigative Site, Nagpur

450054

Novartis Investigative Site, Ufa

560038

Novartis Investigative Site, Bangalore

610021

Novartis Investigative Site, Kirov

06830

Novartis Investigative Site, Greenwich

06489

Novartis Investigative Site, Southington

06902-3628

Novartis Investigative Site, Stamford

06611

Novartis Investigative Site, Trumbull

06708

Novartis Investigative Site, Waterbury

07834

Novartis Investigative Site, Denville

07054

Novartis Investigative Site, Parsippany

15212-4772

Novartis Investigative Site, Pittsburgh

C1405CUB

Novartis Investigative Site, Capital Federal

C1426ANZ

Novartis Investigative Site, Capital Federal

C1280AEB

Novartis Investigative Site, Ciudad Autonoma de Buenos Aires

B1920CMK

Novartis Investigative Site, La Plata

R8324EMB

Novartis Investigative Site, Cipolletti

R8500ACE

Novartis Investigative Site, Viedma

S2000KZE

Novartis Investigative Site, Rosario

T6G 1Z2

Novartis Investigative Site, Edmonton

V1Y 5L3

Novartis Investigative Site, Kelowna

V3V 1Z2

Novartis Investigative Site, Surrey

V5Z 4E6

Novartis Investigative Site, Vancouver

V8R 6V5

Novartis Investigative Site, Victoria

R3E 0V9

Novartis Investigative Site, Winnipeg

E1C 6Z8

Novartis Investigative Site, Moncton

E2L 4L2

Novartis Investigative Site, Saint John

L4M 6M2

Novartis Investigative Site, Barrie

P3E 5J1

Novartis Investigative Site, Greater Sudbury

L8V 5C2

Novartis Investigative Site, Hamilton

K7L 5P9

Novartis Investigative Site, Kingston

N6A 4L6

Novartis Investigative Site, London

L3Y 2P9

Novartis Investigative Site, Newmarket

K1H 8L6

Novartis Investigative Site, Ottawa

P6B 0A8

Novartis Investigative Site, Sault Ste. Marie

L2R 7C6

Novartis Investigative Site, St. Catharines

P7B 6V4

Novartis Investigative Site, Thunder Bay

C1A 8T5

Novartis Investigative Site, Charlottetown

H1T 2M4

Novartis Investigative Site, Montreal

H2L 4M1

Novartis Investigative Site, Montreal

H2W 1S6

Novartis Investigative Site, Montreal

G1S 4L8

Novartis Investigative Site, Québec

S4T 7T1

Novartis Investigative Site, Regina

S7N 4H4

Novartis Investigative Site, Saskatoon

01127

Novartis Investigative Site, Dresden

06120

Novartis Investigative Site, Halle

00189

Novartis Investigative Site, Rome

03039

Novartis Investigative Site, Sora (FR)

07100

Novartis Investigative Site, Sassari

464-8681

Novartis Investigative Site, Aichi

277-8577

Novartis Investigative Site, Chiba

791-0280

Novartis Investigative Site, Ehime

892-0833

Novartis Investigative Site, Kagoshima

241-8515

Novartis Investigative Site, Kanagawa

540-0006

Novartis Investigative Site, Osaka

565-0871

Novartis Investigative Site, Osaka

350-1298

Novartis Investigative Site, Saitama

362-0806

Novartis Investigative Site, Saitama

411-8777

Novartis Investigative Site, Shizuoka

104-8560

Novartis Investigative Site, Tokyo

113-8677

Novartis Investigative Site, Tokyo

CP 14080

Novartis Investigative Site, Mexico City

1091 AC

Novartis Investigative Site, Amsterdam

2625 AD

Novartis Investigative Site, Delft

3318 AT

Novartis Investigative Site, Dordrecht

6229 HX

Novartis Investigative Site, Maastricht

80-219

Novartis Investigative Site, Gdansk

93-509

Novartis Investigative Site, Lodz

10-226

Novartis Investigative Site, Olsztyn

10-513

Novartis Investigative Site, Olsztyn

09-400

Novartis Investigative Site, Płock

35-021

Novartis Investigative Site, Rzeszów

02-781

Novartis Investigative Site, Warsaw

04-125

Novartis Investigative Site, Warsaw

115 478

Novartis Investigative Site, Moscow

410-769

Novartis Investigative Site, Gyeonggi-do

03722

Novartis Investigative Site, Seoul

110-744

Novartis Investigative Site, Seoul

120-752

Novartis Investigative Site, Seoul

138-736

Novartis Investigative Site, Songpa-gu, Seoul

03010

Novartis Investigative Site, Alicante

08916

Novartis Investigative Site, Badalona

08036

Novartis Investigative Site, Barcelona

03202

Novartis Investigative Site, Elche

BH7 7DW

Novartis Investigative Site, Bournemouth

BN2 5BE

Novartis Investigative Site, Brighton

CM1 7ET

Novartis Investigative Site, Chelmsford

GL53 7AN

Novartis Investigative Site, Cheltenham

CO3 3NB

Novartis Investigative Site, Colchester

HU16 5JQ

Novartis Investigative Site, Cottingham, Hull

DE22 3NE

Novartis Investigative Site, Derby

N18 1QX

Novartis Investigative Site, Edmonton

GU2 7XX

Novartis Investigative Site, Guildford

HG2 7SX

Novartis Investigative Site, Harrogate

HD3 3EA

Novartis Investigative Site, Huddersfield

SW3 6JJ

Novartis Investigative Site, London

NE7 7DN

Novartis Investigative Site, Newcastle upon Tyne

NR4 7UY

Novartis Investigative Site, Norwich

NG5 1PB

Novartis Investigative Site, Nottingham

OX3 7LJ

Novartis Investigative Site, Oxford

BH15 2JB

Novartis Investigative Site, Poole, Dorset

S10 2SJ

Novartis Investigative Site, Sheffield

SY3 8XQ

Novartis Investigative Site, Shrewsbury

SM2 5PT

Novartis Investigative Site, Sutton

CF14 2TL

Novartis Investigative Site, Whitchurch, Cardiff

YO31 8HE

Novartis Investigative Site, York

Sponsors
All Listed Sponsors
collaborator

NCIC Clinical Trials Group

NETWORK

lead

Novartis Pharmaceuticals

INDUSTRY