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Brief Title: LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment
Official Title: LUX-Breast 1; An Open Label, Randomised Phase III Trial of BIBW 2992 and Vinorelbine Versus Trastuzumab and Vinorelbine in Patients With Metastatic HER2-overexpressing Breast Cancer Failing One Prior Trastuzumab Treatment
Study ID: NCT01125566
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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, 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
Vitebsk Regional Clinical Oncology Dispensary, Vitebsk, , Belarus
Brussels - HOSP Jules Bordet, Bruxelles, , 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, Ijui, , 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, Sao 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, Quebec, , 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, Ceske Budejovice, , Czechia
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
Oncology Centre- Mansoura University, Mansoura, , Egypt
HOP Amiens-Picardie Sud, Amiens Cedex 1, , France
CTR P Papin, Onco, Angers, Angers Cedex 9, , France
HOP Jean Minjoz, Besançon Cedex, , France
CLI Bordeaux Nord Aquitaine, Bordeaux, , France
CTR J Perrin, Onco, Clermont-Ferrand, Clermont-Ferrand Cedex, , 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 Cedex, , France
CTR René Huguenin, St Cloud, , France
CTR Paul Strauss, Strasbourg Cedex, , France
Universitätsklinikum Aachen, AöR, Aachen, , Germany
Medizinisches Zentrum Bonn, Bonn, , Germany
OnkoDok GbR, Bottrop, , 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 Köln (AöR), Köln, , Germany
St. Elisabeth-Krankenhaus, Köln, , 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
St Vincent's University Hospital, Dublin 4, , Ireland
Mater Misericordiae University Hospital, Dublin 7, , Ireland
St James's Hospital, Dublin 8, , Ireland
Rambam Medical Center, Haifa, , Israel
Shaare Zedek Medical Center, Jerusalem 91031, Jerusalem, , Israel
Meir Medical Center, Kfar Saba, , Israel
The Chaim Sheba Medical Center Tel Hashomer, Tel Hashomer, , Israel
Sourasky Medical Center, Tel-Aviv, , 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
National Cancer Center, Goyang, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
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, Lisboa, , 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, , Russian Federation
N.A. Semashko Central Clinical Hospital, Moscow, Moscow, , Russian Federation
GUZ "Regional Clinical Oncology Dispensary", Ryazan, , Russian Federation
Regional Clinical Oncology Dispensary, Saint Petersburg, , Russian Federation
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
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, , Taiwan
Kaohsiung Veterans General Hospital, Kaohsiung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
NCKUH, Tainan, , 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 County, , Taiwan
Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari ABD, Ankara, , Turkey
Ege Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali, Izmir, , Turkey
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
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR