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

NCT ID: NCT01125566

Last Updated: 2019-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 508 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-22
• Study Completion Date: 2018-07-06

Brief Summary

To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment

Conditions

Breast Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm B: trastuzumab with vinorelbine

patients receive weekly intravenous infusion of trastuzumab and vinorelbine

Group Type: ACTIVE_COMPARATOR

trastuzumab

Intervention Type: DRUG

patients receive trastuzumab 2mg/kg intravenously every week

vinorelbine

Intervention Type: DRUG

patients receive vinorelbine 25mg/m² intravenously every week

Arm A: BIBW 2992 with vinorelbine

patients receive BIBW 2992 tablets once daily combined with weekly intravenous infusion of vinorelbine

Group Type: EXPERIMENTAL

BIBW 2992

Intervention Type: DRUG

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

vinorelbine

Intervention Type: DRUG

patients receive vinorelbine 25mg/m² intravenously every week

Interventions

BIBW 2992

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

Intervention Type: DRUG

trastuzumab

patients receive trastuzumab 2mg/kg intravenously every week

Intervention Type: DRUG

vinorelbine

patients receive vinorelbine 25mg/m² intravenously every week

Intervention Type: DRUG

vinorelbine

patients receive vinorelbine 25mg/m² intravenously every week

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed diagnosis of HER2-overexpression breast cancer
• Stage IV metastatic disease
• Must have progressed on one prior trastuzumab treatment
• no more than one prior trastuzumab based therapy regimen (either adjuvant or first-line)
• Must have received anthracycline and/or taxane based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer
• Must have (archived) tumour tissue sample available for central re-assessment of HER2-status
• At least one measurable lesion according to RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 .

Exclusion Criteria

• Prior treatment with Epidermal Growth Factor Receptor/Human Epidermal Growth Factor Receptor(EGFR/HER2)-targeted small molecules or antibodies other than trastuzumab
• Prior treatment with vinorelbine
• Known pre-existing interstitial lung disease
• Active brain metastases
• History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomisation.
• Cardiac left ventricular function with resting ejection fraction of less than 50%.
• Patients unable to comply with the protocol.
• Any contraindications for therapy with vinorelbine or trastuzumab.
• Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs.
• Use of any investigational drug within 4 weeks of randomisation.
• Inadequate hepatic, renal and haematologic organ function

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Achieve Clinical Research, LLC

Birmingham, Alabama, United States

Ironwood Cancer and Research Centers

Chandler, Arizona, United States

Robert A. Moss MD, FACP, Inc

Fountain Valley, California, United States

St. Jude Heritage Healthcare

Fullerton, California, United States

University of California

Los Angeles, California, United States

Cancer Care Associates Medical Group, Inc

Redondo Beach, California, United States

Santa Barbara Hematology Oncology Medical Group, Inc

Santa Barbara, California, United States

Central Coast Medical Oncology Corporation

Santa Maria, California, United States

North Shore Cancer Research Associates

Skokie, Illinois, United States

Cedar Valley Cancer Center

Waterloo, Iowa, United States

Pro Health Care Associated

Lake Success, New York, United States

Hope Women's Cancer Center

Asheville, North Carolina, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Utah Cancer Specialists Cancer Center

Salt Lake City, Utah, United States

Instituto Medico de Asistencia e Investigaciones S. A.

Buenos Aires, , Argentina

Hospital Britanico

Capital Federal, , Argentina

Sanatorio de la Provodencia

Ciudad Autonoma de Bs As, , Argentina

Sanatorio Parque

Rosario, , Argentina

Port Macquarie Base Hospital (PMBH)

Port Macquarie, New South Wales, Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Peninsula Haematology & Oncology

Frankston, Victoria, Australia

Maroondah Hospital

Ringwood East, Victoria, Australia

Mount Medical Centre

Perth, Western Australia, Australia

Ordensklinikum Linz GmbH - Barmherzige Schwestern

Linz, , Austria

Kaiser Franz Josef Spital Vienna

Vienna, , Austria

Grodno Regional Clinical Hospital

Grodno, , Belarus

Public Health Inst. Minsk City Clinical Oncology Dispensary

Minsk, , Belarus

N. N. Alexandrov National Cancer Center of Belarus

Minsk Region, , Belarus

Vitebsk Regional Clinical Oncology Dispensary

Vitebsk, , Belarus

Brussels - HOSP Jules Bordet

Brussels, , Belgium

Edegem - UNIV UZ Antwerpen

Edegem, , Belgium

Liège - HOSP St-Joseph

Liège, , Belgium

Centro de Pesquisas Clínicas em Oncología

Cachoeiro de Itapemirim, , Brazil

Hospital Santa Cruz

Curitiba, , Brazil

Associacao Hospital de Caridade de Ijui

Ijuí, , Brazil

Associação Hospitalar Moinhos de Vento

Porto Alegre, , Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, , Brazil

Centro de Novos Tratamentos CliniOnco

Porto Alegre, , Brazil

Instituto Nacional do Câncer - INCA

Rio de Janeiro, , Brazil

Faculdade de Medicina do ABC

Santo André, , Brazil

Centro de Referência da Saude da Mulher-Hosp Perola Byington

São Paulo, , Brazil

BC Cancer Agency - Vancouver

Vancouver, British Columbia, Canada

Dr. Leon Richard Oncology Centre

Moncton, New Brunswick, Canada

Grand River Regional Cancer Centre

Kitchener, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Hopital Notre-Dame du CHUM

Montreal, Quebec, Canada

CHU de Quebec-Universite Laval Research Centre

Québec, , Canada

Instituto Clínico Oncológico del Sur - ICOS

Temuco, , Chile

Cancer Hospital of Chinese Academy of Medical Science

Beijing, , China

Peking Union Medical College Hospital

Beijing, , China

Peking University People's Hospital

Beijing, , China

307 Hospital of PLA

Beijing, , China

Chinese PLA General Hospital

Beijing, , China

First Hospital of Jilin University

Changchun, , China

West China Hospital

Chengdu, , China

Fujian Provincial Tumor Hospital

Fuzhou, , China

Sun Yat-Sen University Cancer Center

Guangzhou, , China

Guangdong Provincial People's Hospital

Guangzhou, , China

NanFang Hosptial

Guangzhou, , China

The Third Affiliated Hospital of Harbin Medical University

Haerbin, , China

The First Affiliated Hospital, Zhejiang University

Hangzhou, , China

Zhejiang Cancer Hospital

Hangzhou, , China

Qilu Hospital, Shangdong University

Jinan, , China

the 81th Hospital of PLA

Nanjing, , China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Fudan University Shanghai Cancer Center

Shanghai, , China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, , China

Wuhan Union Hospital

Wuhan, , China

Hospital Ceske Budejovice

České Budějovice, , Czechia

University Hospital Olomouc

Olomouc, , Czechia

General Faculty Hospital, Prague

Prague, , Czechia

MEDICON a.s., Praha 4

Prague, , Czechia

Oncology Centre- Mansoura University

Al Mansurah, , Egypt

El Manial Specialized Hospital

Cairo, , Egypt

HOP Amiens-Picardie Sud

Amiens, , France

CTR P Papin, Onco, Angers

Angers, , France

HOP Jean Minjoz

Besançon, , France

CLI Bordeaux Nord Aquitaine

Bordeaux, , France

CTR J Perrin, Onco, Clermont-Ferrand

Clermont-Ferrand, , France

HOP Victor Hugo

Le Mans, , France

CTR Catherine de Sienne

Nantes, , France

HOP Saint-Louis

Paris, , France

INS Jean Godinot, Onco, Reims

Reims, , France

CTR Eugène Marquis

Rennes, , France

CTR René Huguenin

Saint-Cloud, , France

CTR Paul Strauss

Strasbourg, , France

Universitätsklinikum Aachen, AöR

Aachen, , Germany

Medizinisches Zentrum Bonn

Bonn, , Germany

OnkoDok GbR

Bottrop, , Germany

Universitätsklinikum Köln (AöR)

Cologne, , Germany

St. Elisabeth-Krankenhaus

Cologne, , Germany

DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKU

Deggendorf, , Germany

Universitätsklinikum Erlangen

Erlangen, , Germany

Kliniken Essen - Mitte gGmbH

Essen, , Germany

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

Hildesheim, , Germany

Universitätsklinikum Magdeburg AöR

Magdeburg, , Germany

Klinikum der Universität München - Campus Innenstadt

München, , Germany

Klinikum rechts der Isar der Technischen Universität München

München, , Germany

Onkologische Praxis Oldenburg

Oldenburg, , Germany

Universitätsfrauenklinik am Klinikum Südstadt

Rostock, , Germany

Facharzt für Innere Medizin

Wuppertal, , Germany

Gujarat Cancer and Research Institute

Ahmedabad, , India

Sujan Surgical Cancer Hospital

Amravati, , India

KIDWAI memoraial Institute of oncology

Bangalore, , India

Sri Venkateshwara Hospital

Bengaluru, , India

Dr. Rai Memorial Cancer Centre

Chennai, , India

Bibi General Hospital and Cancer Centre

Hyderabad, , India

Orchid Nursing Home

Kolkata, , India

Natinal Cancer Institute

Maharagama, , India

Central India Cancer Research Institute

Nagpur, , India

Curie Manavata Cancer centre

Nashik, , India

Jehangir Hospital Oncology Department

Pune, , India

K.E.M Hospital

Pune, , India

King George Hospital

Visakhapatnam, , India

Beaumont Hospital

Dubliin 9, , Ireland

Mater Misericordiae University Hospital

Dublin, , Ireland

St James's Hospital

Dublin, , Ireland

St Vincent's University Hospital

Dublin, , Ireland

Rambam Medical Center

Haifa, , Israel

Shaare Zedek Medical Center, Jerusalem 91031

Jerusalem, , Israel

Meir Medical Center

Kfar Saba, , Israel

Sourasky Medical Center

Tel Aviv, , Israel

The Chaim Sheba Medical Center Tel Hashomer

Tel Litwinsky, , Israel

Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

Ferrara, , Italy

Istituto Europeo di Oncologia

Milan, , Italy

P.O. Monserrato

Monserrato (CA), , Italy

Tokai University Hospital

Kanagawa, Isehara, , Japan

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka, Osaka, , Japan

National Cancer Center Hospital

Tokyo, Chuo-ku, , Japan

P. Stradins Clinical Univ. Hospital, Oncology Clinic

Riga, , Latvia

Riga East Univ. Hospital, Oncology Centre

Riga, , Latvia

Hammoud Hospital University Medical Centre (HHUMC)

Lebanon, , Lebanon

Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos

Kaunas, , Lithuania

National Cancer Institute, Vilnius

Vilnius, , Lithuania

Hospital de Jesus

Colonia Centro, , Mexico

Albert SchweitzerZiekenhuis

Dordrecht, , Netherlands

Máxima Medisch Centrum, locatie Eindhoven

Eindhoven, , Netherlands

Zuyderland Medisch Centrum

Geleen, , Netherlands

Zuyderland Medisch Centrum

Heerlen, , Netherlands

METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht

Maastricht, , Netherlands

Isala Zwolle

Zwolle, , Netherlands

Hospital Nacional Adolfo Guevara Velasco

Cusco, , Peru

Clinica San Judas Tadeo

Lima, , Peru

Instituto Oncologico Miraflores S.A.

Miraflores, , Peru

Clinica Peruano Americana de Trujillo

Trujillo, , Peru

Bialystock's Oncology Center

Bialystok, , Poland

Wojewodzki Specialist Hospital No. 4, Bytom

Bytom, , Poland

University Clinical Center, Gdansk

Gdansk, , Poland

Provincial Specialist M. Kopernik Hospital

Lodz, , Poland

Ziemia Lubelska Oncological Center, Lublin

Lublin, , Poland

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

Olsztyn, , Poland

Wielkopolskie Oncology Centre n.a. Maria Sklodowska-Courie

Poznan, , Poland

Military Medical Institute

Warsaw, , Poland

Instituto Português de Oncologia de Coimbra Francisco Gentil

Coimbra, , Portugal

CHUC, EPE - CHC-Maternidade Bissaya Barreto

Coimbra, , Portugal

IPO Lisboa Francisco Gentil, EPE

Lisbon, , Portugal

Centro Hospitalar São João,EPE

Porto, , Portugal

IPO Porto Francisco Gentil, EPE

Porto, , Portugal

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

Kazan', , Russia

N.A. Semashko Central Clinical Hospital, Moscow

Moscow, , Russia

GUZ "Regional Clinical Oncology Dispensary"

Ryazan, , Russia

Regional Clinical Oncology Dispensary

Saint Petersburg, , Russia

National University Hospital

Singapore, , Singapore

National Cancer Centre

Singapore, , Singapore

Johns Hopkins Singapore International Medical Center

Singapore, , Singapore

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

Bardejov, , Slovakia

National Institute of Oncology, Bratislava

Bratislava, , Slovakia

POKO Policlinic Dept. of Clinical Oncology

Poprad, , Slovakia

Institute of Oncology Ljubljana

Ljubljana, , Slovenia

WCR CMJAH Clinical Trial Site

Johannesburg, , South Africa

Medical Oncology Centre of Rosebank

Johannesburg, , South Africa

GVI oncology Medi Clinic

Kraaifontein, , South Africa

Langenhoven Drive Oncology Centre

Port Elizabeth, , South Africa

Wilgers oncology

Pretoria, , South Africa

Rondebosch Oncology Centre

Rondebosch, Cape Town, , South Africa

National Cancer Center

Goyang, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Hospital del Mar

Barcelona, , Spain

Hospital Universitari Dexeus

Barcelona, , Spain

Hospital Vall d'Hebron

Barcelona, , Spain

Complejo Hospitalario Universitario Insular - Materno Infantil

Las Palmas de Gran Canaria, , Spain

Hospital Clínico San Carlos

Madrid, , Spain

Hospital Clínico de Santiago

Santiago de Compostela, , Spain

Hospital Virgen de la Salud

Toledo, , Spain

Hospital Arnau de Vilanova

Valencia, , Spain

Shatabdi Superspeciality Hospital

Maharashtra, , Sri Lanka

Chang-Hua Christian Hospital

Changhua, , Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

NCKUH

Tainan City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Mackay Memorial Hospital

Taipei, , Taiwan

Taipe Veterans General Hospital

Taipei, , Taiwan

Koo Foundation Sun Yet-Sen Cancer Center

Taipei, , Taiwan

Chang Gung Memorial Hospital(TaoYuan)

Taoyuan, , Taiwan

Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari ABD

Ankara, , Turkey (Türkiye)

Ege Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali

Izmir, , Turkey (Türkiye)

Ninewells Hospital & Medical School

Dundee, , United Kingdom

Guy's Hospital

London, , United Kingdom

The Royal Marsden Hospital

Sutton, , United Kingdom

Queen Elizabeth Hospital

Woolwich, London, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belarus; Belgium; Brazil; Canada; Chile; China; Czechia; Egypt; France; Germany; India; Ireland; Israel; Italy; Japan; Latvia; Lebanon; Lithuania; Mexico; Netherlands; Peru; Poland; Portugal; Russia; Singapore; Slovakia; Slovenia; South Africa; South Korea; Spain; Sri Lanka; Taiwan; Turkey (Türkiye); United Kingdom

References

Harbeck N, Huang CS, Hurvitz S, Yeh DC, Shao Z, Im SA, Jung KH, Shen K, Ro J, Jassem J, Zhang Q, Im YH, Wojtukiewicz M, Sun Q, Chen SC, Goeldner RG, Uttenreuther-Fischer M, Xu B, Piccart-Gebhart M; LUX-Breast 1 study group. Afatinib plus vinorelbine versus trastuzumab plus vinorelbine in patients with HER2-overexpressing metastatic breast cancer who had progressed on one previous trastuzumab treatment (LUX-Breast 1): an open-label, randomised, phase 3 trial. Lancet Oncol. 2016 Mar;17(3):357-366. doi: 10.1016/S1470-2045(15)00540-9. Epub 2016 Jan 26.

Reference Type: DERIVED

PMID: 26822398 (View on PubMed)

Other Identifiers

2009-015476-98

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1200.75

Identifier Type: -

Identifier Source: org_study_id