LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment
- Conditions
- Breast Neoplasms
- Interventions
- Registration Number
- NCT01125566
- Lead Sponsor
- Boehringer Ingelheim
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 508
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: BIBW 2992 with vinorelbine BIBW 2992 patients receive BIBW 2992 tablets once daily combined with weekly intravenous infusion of vinorelbine Arm B: trastuzumab with vinorelbine vinorelbine patients receive weekly intravenous infusion of trastuzumab and vinorelbine Arm B: trastuzumab with vinorelbine trastuzumab patients receive weekly intravenous infusion of trastuzumab and vinorelbine Arm A: BIBW 2992 with vinorelbine vinorelbine patients receive BIBW 2992 tablets once daily combined with weekly intravenous infusion of vinorelbine
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by investigator according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment.
Only data collected until the cut-off date for RECIST 1.1 based endpoints (08Jun2013) were considered.
Progression of disease was determined if at least 1 of the following criteria applied:
* At least a 20% increase in the sum of the diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm
* Appearance of 1 or more new lesions
* Unequivocal progression of existing non-target lesions
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) From randomisation (07Sep2010) to database lock (30Jul2018), up to 95 months. OS is defined as time from randomisation to death irrespective of the cause of the death.
For patients who had not died up to the cut-off date (03Sep2013), the date they were last known to be alive was derived from the patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomisation date.Best RECIST Assessment From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months Best RECIST assessment is defined as CR, PR, stable disease (SD), progressive disease (PD) or not evaluable by investigator (RECIST version 1.1).
CR for target lesions (TL): Disappearance of all target lesions.
CR for non-target lesions (NTL): Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\<10mm short axis).
PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters.
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest SoD while on study.
PD: At least a 20% increase in the SoD of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must also demonstrate an absolute increase of a least 5mm. Appearance of one or more new lesions.Objective Response (OR) Post baseline tumour-imaging was performed at Week 8, 16, 24, 32, 40, 48, 56 and then every 12 weeks (Until final data-base lock on 30 Jul 2018; Up to 95 months) OR is defined as complete response (CR) and partial response (PR). Assessed by investigator according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. Complete Response (CR) for target lesions (TL): Disappearance of all target lesions.
Complete Response (CR) for non-target lesions (NTL): Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\<10mm short axis)
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.
Other factors which add to the overall response of an imaging timepoint as PR are as below:-
* CR in TL, but non-CR/Non-PD in NTL leads to PR
* CR in TL, but not evaluated NTL leads to PR
* PR in TL, but non-PD NTL or not all evaluated NTL leads to PR
Trial Locations
- Locations (206)
Ordensklinikum Linz GmbH - Barmherzige Schwestern
🇦🇹Linz, Austria
Sanatorio Parque
🇦🇷Rosario, Argentina
Ironwood Cancer and Research Centers
🇺🇸Chandler, Arizona, United States
Peninsula Haematology & Oncology
🇦🇺Frankston, Victoria, Australia
Maroondah Hospital
🇦🇺Ringwood East, Victoria, Australia
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
Kaiser Franz Josef Spital Vienna
🇦🇹Wien, Austria
Grodno Regional Clinical Hospital
🇧🇾Grodno, Belarus
N. N. Alexandrov National Cancer Center of Belarus
🇧🇾Minsk Region, Belarus
Public Health Inst. Minsk City Clinical Oncology Dispensary
🇧🇾Minsk, Belarus
Liège - HOSP St-Joseph
🇧🇪Liège, Belgium
Centro de Pesquisas Clínicas em Oncología
🇧🇷Cachoeiro de Itapemirim, Brazil
Brussels - HOSP Jules Bordet
🇧🇪Bruxelles, Belgium
Edegem - UNIV UZ Antwerpen
🇧🇪Edegem, Belgium
Hospital Santa Cruz
🇧🇷Curitiba, Brazil
Faculdade de Medicina do ABC
🇧🇷Santo André, Brazil
Associação Hospitalar Moinhos de Vento
🇧🇷Porto Alegre, Brazil
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Centro de Novos Tratamentos CliniOnco
🇧🇷Porto Alegre, Brazil
Centro de Referência da Saude da Mulher-Hosp Perola Byington
🇧🇷Sao Paulo, Brazil
BC Cancer Agency - Vancouver
🇨🇦Vancouver, British Columbia, Canada
Peking Union Medical College Hospital
🇨🇳Beijing, China
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
CHU de Quebec-Universite Laval Research Centre
🇨🇦Quebec, Canada
St. Elisabeth-Krankenhaus
🇩🇪Köln, Germany
National Cancer Center
🇰🇷Goyang, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
Oncology Centre- Mansoura University
🇪🇬Mansoura, Egypt
HOP Amiens-Picardie Sud
🇫🇷Amiens Cedex 1, France
CLI Bordeaux Nord Aquitaine
🇫🇷Bordeaux, France
Tokai University Hospital
🇯🇵Kanagawa, Isehara, Japan
Ziemia Lubelska Oncological Center, Lublin
🇵🇱Lublin, Poland
CTR J Perrin, Onco, Clermont-Ferrand
🇫🇷Clermont-Ferrand Cedex, France
HOP Saint-Louis
🇫🇷Paris, France
Gynäk.-onkol. Gem.praxis, Dr. Uleer, Hildesheim
🇩🇪Hildesheim, Germany
Gujarat Cancer and Research Institute
🇮🇳Ahmedabad, India
Sourasky Medical Center
🇮🇱Tel-Aviv, Israel
St Vincent's University Hospital
🇮🇪Dublin 4, Ireland
Rambam Medical Center
🇮🇱Haifa, Israel
The Chaim Sheba Medical Center Tel Hashomer
🇮🇱Tel Hashomer, Israel
Mater Misericordiae University Hospital
🇮🇪Dublin 7, Ireland
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
National Cancer Center Hospital
🇯🇵Tokyo, Chuo-ku, Japan
Máxima Medisch Centrum, locatie Eindhoven
🇳🇱Eindhoven, Netherlands
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht
🇳🇱Maastricht, Netherlands
Wilgers oncology
🇿🇦Pretoria, South Africa
Wojewodzki Specialist Hospital No. 4, Bytom
🇵🇱Bytom, Poland
Oncology Centre of Olsztyn "KOPERNIK" Sp. z.o.o.
🇵🇱Olsztyn, Poland
National Cancer Centre
🇸🇬Singapore, Singapore
CHUC, EPE - CHC-Maternidade Bissaya Barreto
🇵🇹Coimbra, Portugal
IPO Porto Francisco Gentil, EPE
🇵🇹Porto, Portugal
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung, Taiwan
Regional Clinical Oncology Dispensary
🇷🇺Saint Petersburg, Russian Federation
Koo Foundation Sun Yet-Sen Cancer Center
🇨🇳Taipei, Taiwan
Cancer Care Associates Medical Group, Inc
🇺🇸Redondo Beach, California, United States
Central Coast Medical Oncology Corporation
🇺🇸Santa Maria, California, United States
Cedar Valley Cancer Center
🇺🇸Waterloo, Iowa, United States
Pro Health Care Associated
🇺🇸Lake Success, New York, United States
Port Macquarie Base Hospital (PMBH)
🇦🇺Port Macquarie, New South Wales, Australia
Associacao Hospital de Caridade de Ijui
🇧🇷Ijui, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
🇧🇷Porto Alegre, Brazil
Instituto Nacional do Câncer - INCA
🇧🇷Rio de Janeiro, Brazil
Grand River Regional Cancer Centre
🇨🇦Kitchener, Ontario, Canada
Hopital Notre-Dame du CHUM
🇨🇦Montreal, Quebec, Canada
Instituto Clínico Oncológico del Sur - ICOS
🇨🇱Temuco, Chile
Cancer Hospital of Chinese Academy of Medical Science
🇨🇳Beijing, China
Peking University People's Hospital
🇨🇳Beijing, China
First Hospital of Jilin University
🇨🇳Changchun, China
307 Hospital of PLA
🇨🇳Beijing, China
West China Hospital
🇨🇳Chengdu, China
Fujian Provincial Tumor Hospital
🇨🇳Fuzhou, China
Sun Yat-Sen University Cancer Center
🇨🇳Guangzhou, China
The First Affiliated Hospital, Zhejiang University
🇨🇳Hangzhou, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, China
NanFang Hosptial
🇨🇳Guangzhou, China
The Third Affiliated Hospital of Harbin Medical University
🇨🇳Haerbin, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, China
Qilu Hospital, Shangdong University
🇨🇳Jinan, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China
Hospital Ceske Budejovice
🇨🇿Ceske Budejovice, Czechia
Wuhan Union Hospital
🇨🇳Wuhan, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, China
University Hospital Olomouc
🇨🇿Olomouc, Czechia
General Faculty Hospital, Prague
🇨🇿Prague 2, Czechia
MEDICON a.s., Praha 4
🇨🇿Praha 4, Czechia
El Manial Specialized Hospital
🇪🇬Cairo, Egypt
CTR P Papin, Onco, Angers
🇫🇷Angers Cedex 9, France
HOP Jean Minjoz
🇫🇷Besançon Cedex, France
HOP Victor Hugo
🇫🇷Le Mans, France
INS Jean Godinot, Onco, Reims
🇫🇷Reims, France
CTR Catherine de Sienne
🇫🇷Nantes, France
CTR Eugène Marquis
🇫🇷Rennes Cedex, France
CTR Paul Strauss
🇫🇷Strasbourg Cedex, France
CTR René Huguenin
🇫🇷St Cloud, France
Universitätsklinikum Aachen, AöR
🇩🇪Aachen, Germany
OnkoDok GbR
🇩🇪Bottrop, Germany
Medizinisches Zentrum Bonn
🇩🇪Bonn, Germany
DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKU
🇩🇪Deggendorf, Germany
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
Universitätsklinikum Magdeburg AöR
🇩🇪Magdeburg, Germany
Kliniken Essen - Mitte gGmbH
🇩🇪Essen, Germany
Universitätsklinikum Köln (AöR)
🇩🇪Köln, Germany
Klinikum der Universität München - Campus Innenstadt
🇩🇪München, Germany
Onkologische Praxis Oldenburg
🇩🇪Oldenburg, Germany
Klinikum rechts der Isar der Technischen Universität München
🇩🇪München, Germany
Universitätsfrauenklinik am Klinikum Südstadt
🇩🇪Rostock, Germany
Facharzt für Innere Medizin
🇩🇪Wuppertal, Germany
St James's Hospital
🇮🇪Dublin 8, Ireland
Meir Medical Center
🇮🇱Kfar Saba, Israel
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
P. Stradins Clinical Univ. Hospital, Oncology Clinic
🇱🇻Riga, Latvia
Hammoud Hospital University Medical Centre (HHUMC)
🇱🇧Lebanon, Lebanon
Zuyderland Medisch Centrum
🇳🇱Heerlen, Netherlands
Isala Zwolle
🇳🇱Zwolle, Netherlands
Hospital Nacional Adolfo Guevara Velasco
🇵🇪Cusco, Peru
Provincial Specialist M. Kopernik Hospital
🇵🇱Lodz, Poland
Military Medical Institute
🇵🇱Warsaw, Poland
Wielkopolskie Oncology Centre n.a. Maria Sklodowska-Courie
🇵🇱Poznan, Poland
IPO Lisboa Francisco Gentil, EPE
🇵🇹Lisboa, Portugal
GUZ "Regional Clinical Oncology Dispensary"
🇷🇺Ryazan, Russian Federation
National University Hospital
🇸🇬Singapore, Singapore
Institute of Oncology Ljubljana
🇸🇮Ljubljana, Slovenia
Medical Oncology Centre of Rosebank
🇿🇦Johannesburg, South Africa
GVI oncology Medi Clinic
🇿🇦Kraaifontein, South Africa
Langenhoven Drive Oncology Centre
🇿🇦Port Elizabeth, South Africa
Rondebosch Oncology Centre
🇿🇦Rondebosch, Cape Town, South Africa
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Mount Medical Centre
🇦🇺Perth, Western Australia, Australia
Vitebsk Regional Clinical Oncology Dispensary
🇧🇾Vitebsk, Belarus
Sujan Surgical Cancer Hospital
🇮🇳Amravati, India
KIDWAI memoraial Institute of oncology
🇮🇳Bangalore, India
Sri Venkateshwara Hospital
🇮🇳Bengaluru, India
Curie Manavata Cancer centre
🇮🇳Nashik, India
Bibi General Hospital and Cancer Centre
🇮🇳Hyderabad, India
Orchid Nursing Home
🇮🇳Kolkata, India
Natinal Cancer Institute
🇮🇳Maharagama, India
Dr. Rai Memorial Cancer Centre
🇮🇳Chennai, India
Central India Cancer Research Institute
🇮🇳Nagpur, India
Jehangir Hospital Oncology Department
🇮🇳Pune, India
K.E.M Hospital
🇮🇳Pune, India
King George Hospital
🇮🇳Visakhapatnam, India
Beaumont Hospital
🇮🇪Dubliin 9, Ireland
Istituto Europeo di Oncologia
🇮🇹Milan, Italy
Osaka Medical Center for Cancer and Cardiovascular Diseases
🇯🇵Osaka, Osaka, Japan
Riga East Univ. Hospital, Oncology Centre
🇱🇻Riga, Latvia
Shaare Zedek Medical Center, Jerusalem 91031
🇮🇱Jerusalem, Israel
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
🇮🇹Ferrara, Italy
P.O. Monserrato
🇮🇹Monserrato (CA), Italy
Hospital de Jesus
🇲🇽Colonia Centro, Mexico
Instituto Oncologico Miraflores S.A.
🇵🇪Miraflores, Peru
University Clinical Center, Gdansk
🇵🇱Gdansk, Poland
Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos
🇱🇹Kaunas, Lithuania
National Cancer Institute, Vilnius
🇱🇹Vilnius, Lithuania
Albert SchweitzerZiekenhuis
🇳🇱Dordrecht, Netherlands
Instituto Português de Oncologia de Coimbra Francisco Gentil
🇵🇹Coimbra, Portugal
St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"
🇷🇺Kazan, Russian Federation
Clinica San Judas Tadeo
🇵🇪Lima, Peru
N.A. Semashko Central Clinical Hospital, Moscow
🇷🇺Moscow, Russian Federation
Bialystock's Oncology Center
🇵🇱Bialystok, Poland
Clinica Peruano Americana de Trujillo
🇵🇪Trujillo, Peru
Centro Hospitalar São João,EPE
🇵🇹Porto, Portugal
POKO Policlinic Dept. of Clinical Oncology
🇸🇰Poprad, Slovakia
WCR CMJAH Clinical Trial Site
🇿🇦Johannesburg, South Africa
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Complejo Hospitalario Universitario Insular - Materno Infantil
🇪🇸Las Palmas de Gran Canaria, Spain
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
Hospital Clínico de Santiago
🇪🇸Santiago de Compostela, Spain
Hospital Virgen de la Salud
🇪🇸Toledo, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitari Dexeus
🇪🇸Barcelona, Spain
Shatabdi Superspeciality Hospital
🇱🇰Maharashtra, Sri Lanka
Chang-Hua Christian Hospital
🇨🇳Changhua, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Chang Gung Memorial Hospital(TaoYuan)
🇨🇳Taoyuan County, Taiwan
Ninewells Hospital & Medical School
🇬🇧Dundee, United Kingdom
Hospital Arnau de Vilanova
🇪🇸Valencia, Spain
Taipe Veterans General Hospital
🇨🇳Taipei, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
NCKUH
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Mackay Memorial Hospital
🇨🇳Taipei, Taiwan
Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari ABD
🇹🇷Ankara, Turkey
Ege Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali
🇹🇷Izmir, Turkey
The Royal Marsden Hospital
🇬🇧Sutton, United Kingdom
Queen Elizabeth Hospital
🇬🇧Woolwich, London, United Kingdom
Chinese PLA General Hospital
🇨🇳Beijing, China
St. Jude Heritage Healthcare
🇺🇸Fullerton, California, United States
North Shore Cancer Research Associates
🇺🇸Skokie, Illinois, United States
Hope Women's Cancer Center
🇺🇸Asheville, North Carolina, United States
Achieve Clinical Research, LLC
🇺🇸Birmingham, Alabama, United States
Robert A. Moss MD, FACP, Inc
🇺🇸Fountain Valley, California, United States
Santa Barbara Hematology Oncology Medical Group, Inc
🇺🇸Santa Barbara, California, United States
University of California
🇺🇸Los Angeles, California, United States
Utah Cancer Specialists Cancer Center
🇺🇸Salt Lake City, Utah, United States
St Vincent's Hospital Melbourne
🇦🇺Fitzroy, Victoria, Australia
Dr. Leon Richard Oncology Centre
🇨🇦Moncton, New Brunswick, Canada
Guy's Hospital
🇬🇧London, United Kingdom
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
the 81th Hospital of PLA
🇨🇳Nanjing, China