LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment

PHASE3CompletedINTERVENTIONAL
Enrollment

508

Participants

Timeline

Start Date

June 22, 2010

Primary Completion Date

June 8, 2013

Study Completion Date

July 6, 2018

Conditions
Breast Neoplasms
Interventions
DRUG

BIBW 2992

patients receive BIBW 2992 tablets once daily and can reduce dose for adverse event management

DRUG

trastuzumab

patients receive trastuzumab 2mg/kg intravenously every week

DRUG

vinorelbine

patients receive vinorelbine 25mg/m² intravenously every week

DRUG

vinorelbine

patients receive vinorelbine 25mg/m² intravenously every week

Trial Locations (207)

84

Hospital Nacional Adolfo Guevara Velasco, Cusco

100

National Taiwan University Hospital, Taipei

112

Koo Foundation Sun Yet-Sen Cancer Center, Taipei

333

Chang Gung Memorial Hospital(TaoYuan), Taoyuan

704

NCKUH, Tainan City

807

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

1000

Brussels - HOSP Jules Bordet, Brussels

Institute of Oncology Ljubljana, Ljubljana

1002

P. Stradins Clinical Univ. Hospital, Oncology Clinic, Riga

1079

Riga East Univ. Hospital, Oncology Centre, Riga

1100

Kaiser Franz Josef Spital Vienna, Vienna

2193

WCR CMJAH Clinical Trial Site, Johannesburg

2196

Medical Oncology Centre of Rosebank, Johannesburg

2444

Port Macquarie Base Hospital (PMBH), Port Macquarie

2650

Edegem - UNIV UZ Antwerpen, Edegem

3065

St Vincent's Hospital Melbourne, Fitzroy

3135

Maroondah Hospital, Ringwood East

3199

Peninsula Haematology & Oncology, Frankston

4000

Liège - HOSP St-Joseph, Liège

4020

Ordensklinikum Linz GmbH - Barmherzige Schwestern, Linz

6000

Mount Medical Centre, Perth

6045

Langenhoven Drive Oncology Centre, Port Elizabeth

7570

GVI oncology Medi Clinic, Kraaifontein

7700

Rondebosch Oncology Centre, Rondebosch, Cape Town

10449

Mackay Memorial Hospital, Taipei

11042

Pro Health Care Associated, Lake Success

11217

Taipe Veterans General Hospital, Taipei

11553

El Manial Specialized Hospital, Cairo

15706

Hospital Clínico de Santiago, Santiago de Compostela

18059

Universitätsfrauenklinik am Klinikum Südstadt, Rostock

19107

Thomas Jefferson University, Philadelphia

20141

Istituto Europeo di Oncologia, Milan

25030

HOP Jean Minjoz, Besançon

26121

Onkologische Praxis Oldenburg, Oldenburg

28040

Hospital Clínico San Carlos, Madrid

28806

Hope Women's Cancer Center, Asheville

31096

Rambam Medical Center, Haifa

31134

Gynäk.-onkol. Gem.praxis, Dr. Uleer, Hildesheim, Hildesheim

33300

CLI Bordeaux Nord Aquitaine, Bordeaux

35016

Complejo Hospitalario Universitario Insular - Materno Infantil, Las Palmas de Gran Canaria

35042

CTR Eugène Marquis, Rennes

35216

Achieve Clinical Research, LLC, Birmingham

35516

Oncology Centre- Mansoura University, Al Mansurah

39108

Universitätsklinikum Magdeburg AöR, Magdeburg

40705

Taichung Veterans General Hospital, Taichung

42105

Facharzt für Innere Medizin, Wuppertal

44124

Azienda Ospedaliera Universitaria Arcispedale Sant'Anna, Ferrara

44202

CTR Catherine de Sienne, Nantes

44281

Meir Medical Center, Kfar Saba

45004

Hospital Virgen de la Salud, Toledo

45136

Kliniken Essen - Mitte gGmbH, Essen

46015

Hospital Arnau de Vilanova, Valencia

46236

OnkoDok GbR, Bottrop

49933

CTR P Papin, Onco, Angers, Angers

50006

Chang-Hua Christian Hospital, Changhua

50009

Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos, Kaunas

50701

Cedar Valley Cancer Center, Waterloo

50931

Universitätsklinikum Köln (AöR), Cologne

50935

St. Elisabeth-Krankenhaus, Cologne

51000

INS Jean Godinot, Onco, Reims, Reims

52074

Universitätsklinikum Aachen, AöR, Aachen

52621

The Chaim Sheba Medical Center Tel Hashomer, Tel Litwinsky

53111

Medizinisches Zentrum Bonn, Bonn

60076

North Shore Cancer Research Associates, Skokie

63011

CTR J Perrin, Onco, Clermont-Ferrand, Clermont-Ferrand

64239

Sourasky Medical Center, Tel Aviv

67065

CTR Paul Strauss, Strasbourg

72000

HOP Victor Hugo, Le Mans

75475

HOP Saint-Louis, Paris

80054

HOP Amiens-Picardie Sud, Amiens

80337

Klinikum der Universität München - Campus Innenstadt, München

81362

Kaohsiung Veterans General Hospital, Kaohsiung City

81675

Klinikum rechts der Isar der Technischen Universität München, München

84106

Utah Cancer Specialists Cancer Center, Salt Lake City

85224

Ironwood Cancer and Research Centers, Chandler

90095

University of California, Los Angeles

90277

Cancer Care Associates Medical Group, Inc, Redondo Beach

91031

Shaare Zedek Medical Center, Jerusalem 91031, Jerusalem

91054

Universitätsklinikum Erlangen, Erlangen

92210

CTR René Huguenin, Saint-Cloud

92708

Robert A. Moss MD, FACP, Inc, Fountain Valley

92835

St. Jude Heritage Healthcare, Fullerton

93105

Santa Barbara Hematology Oncology Medical Group, Inc, Santa Barbara

93454

Central Coast Medical Oncology Corporation, Santa Maria

94469

DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKU, Deggendorf

100021

Cancer Hospital of Chinese Academy of Medical Science, Beijing

100032

Peking Union Medical College Hospital, Beijing

100044

Peking University People's Hospital, Beijing

100071

307 Hospital of PLA, Beijing

100853

Chinese PLA General Hospital, Beijing

119228

National University Hospital, Singapore

129128

N.A. Semashko Central Clinical Hospital, Moscow, Moscow

130021

First Hospital of Jilin University, Changchun

150081

The Third Affiliated Hospital of Harbin Medical University, Haerbin

169610

National Cancer Centre, Singapore

191104

Regional Clinical Oncology Dispensary, Saint Petersburg

200025

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai

200033

Fudan University Shanghai Cancer Center, Shanghai

210002

the 81th Hospital of PLA, Nanjing

210603

Vitebsk Regional Clinical Oncology Dispensary, Vitebsk

220013

Public Health Inst. Minsk City Clinical Oncology Dispensary, Minsk

223040

N. N. Alexandrov National Cancer Center of Belarus, Minsk Region

230017

Grodno Regional Clinical Hospital, Grodno

250012

Qilu Hospital, Shangdong University, Jinan

300060

Tianjin Medical University Cancer Institute and Hospital, Tianjin

308433

Johns Hopkins Singapore International Medical Center, Singapore

310009

The First Affiliated Hospital, Zhejiang University, Hangzhou

310022

Zhejiang Cancer Hospital, Hangzhou

350014

Fujian Provincial Tumor Hospital, Fuzhou

380016

Gujarat Cancer and Research Institute, Ahmedabad

390011

"GUZ Regional Clinical Oncology Dispensary", Ryazan

411001

Jehangir Hospital Oncology Department, Pune

411011

K.E.M Hospital, Pune

420029

"St.Auton.Heal.Inst.Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan", Kazan'

422002

Shatabdi Superspeciality Hospital, Maharashtra

422004

Curie Manavata Cancer centre, Nashik

430022

Wuhan Union Hospital, Wuhan

444606

Sujan Surgical Cancer Hospital, Amravati

510060

Sun Yat-Sen University Cancer Center, Guangzhou

510080

Guangdong Provincial People's Hospital, Guangzhou

510515

NanFang Hosptial, Guangzhou

530002

King George Hospital, Visakhapatnam

560029

KIDWAI memoraial Institute of oncology, Bangalore

560068

Sri Venkateshwara Hospital, Bengaluru

600018

Dr. Rai Memorial Cancer Centre, Chennai

610041

West China Hospital, Chengdu

700054

Orchid Nursing Home, Kolkata

C1425AWC

Instituto Medico de Asistencia e Investigaciones S. A., Buenos Aires

C1280AEB

Hospital Britanico, Capital Federal

C1050AAK

Sanatorio de la Provodencia, Ciudad Autonoma de Bs As

S2000DSK

Sanatorio Parque, Rosario

29308-014

Centro de Pesquisas Clínicas em Oncología, Cachoeiro de Itapemirim

80420-090

Hospital Santa Cruz, Curitiba

98700-000

Associacao Hospital de Caridade de Ijui, Ijuí

90035-001

Associação Hospitalar Moinhos de Vento, Porto Alegre

90050-170

Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre

90430-090

Centro de Novos Tratamentos CliniOnco, Porto Alegre

20560-120

Instituto Nacional do Câncer - INCA, Rio de Janeiro

09060-650

Faculdade de Medicina do ABC, Santo André

01317-000

Centro de Referência da Saude da Mulher-Hosp Perola Byington, São Paulo

V5Z 4E6

BC Cancer Agency - Vancouver, Vancouver

E1C 8X3

Dr. Leon Richard Oncology Centre, Moncton

N2G 1G3

Grand River Regional Cancer Centre, Kitchener

K1H 8L6

The Ottawa Hospital, Ottawa

M5G 2M9

Princess Margaret Cancer Centre, Toronto

H2L 4M1

Hopital Notre-Dame du CHUM, Montreal

G1S 4L8

CHU de Quebec-Universite Laval Research Centre, Québec

Unknown

Instituto Clínico Oncológico del Sur - ICOS, Temuco

Natinal Cancer Institute, Maharagama

Beaumont Hospital, Dubliin 9

Mater Misericordiae University Hospital, Dublin

St James's Hospital, Dublin

St Vincent's University Hospital, Dublin

Hammoud Hospital University Medical Centre (HHUMC), Lebanon

Clinica San Judas Tadeo, Lima

Instituto Oncologico Miraflores S.A., Miraflores

Clinica Peruano Americana de Trujillo, Trujillo

Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari ABD, Ankara

Ege Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali, Izmir

370 87

Hospital Ceske Budejovice, České Budějovice

775 20

University Hospital Olomouc, Olomouc

128 08

General Faculty Hospital, Prague, Prague

140 44

MEDICON a.s., Praha 4, Prague

500 024

Bibi General Hospital and Cancer Centre, Hyderabad

440 010

Central India Cancer Research Institute, Nagpur

09042

P.O. Monserrato, Monserrato (CA)

259-1193

Tokai University Hospital, Kanagawa, Isehara

537-8511

Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Osaka

104-0045

National Cancer Center Hospital, Tokyo, Chuo-ku

08660

National Cancer Institute, Vilnius, Vilnius

06090

Hospital de Jesus, Colonia Centro

3318 AT

Albert SchweitzerZiekenhuis, Dordrecht

3651 BM

Máxima Medisch Centrum, locatie Eindhoven, Eindhoven

6162 BG

Zuyderland Medisch Centrum, Geleen

6419 PC

Zuyderland Medisch Centrum, Heerlen

6229 HX

METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht, Maastricht

8025 BP

Isala Zwolle, Zwolle

15-027

Bialystock's Oncology Center, Bialystok

41-902

Wojewodzki Specialist Hospital No. 4, Bytom, Bytom

80-211

University Clinical Center, Gdansk, Gdansk

93-513

Provincial Specialist M. Kopernik Hospital, Lodz

20-099

Ziemia Lubelska Oncological Center, Lublin, Lublin

10-513

"Oncology Centre of Olsztyn KOPERNIK Sp. z.o.o.", Olsztyn

61-866

Wielkopolskie Oncology Centre n.a. Maria Sklodowska-Courie, Poznan

04 141

Military Medical Institute, Warsaw

3000-075

Instituto Português de Oncologia de Coimbra Francisco Gentil, Coimbra

3041-801

CHUC, EPE - CHC-Maternidade Bissaya Barreto, Coimbra

1099-023

IPO Lisboa Francisco Gentil, EPE, Lisbon

420-451

Centro Hospitalar São João,EPE, Porto

4200-072

IPO Porto Francisco Gentil, EPE, Porto

085 01

St. Jacobs Hosp.Outpat.Pneumology&Phthisiology Dept,Bardejov, Bardejov

833 10

National Institute of Oncology, Bratislava, Bratislava

058 01

POKO Policlinic Dept. of Clinical Oncology, Poprad

0041

Wilgers oncology, Pretoria

410-769

National Cancer Center, Goyang

02841

Korea University Anam Hospital, Seoul

110-744

Seoul National University Hospital, Seoul

120-752

Severance Hospital, Seoul

135-710

Samsung Medical Center, Seoul

138-736

Asan Medical Center, Seoul

08003

Hospital del Mar, Barcelona

08028

Hospital Universitari Dexeus, Barcelona

08035

Hospital Vall d'Hebron, Barcelona

DD1 9SY

Ninewells Hospital & Medical School, Dundee

SE1 9RT

Guy's Hospital, London

SM2 5PT

The Royal Marsden Hospital, Sutton

SE18 4QH

Queen Elizabeth Hospital, Woolwich, London

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY