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

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

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

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms
• Intervention / Treatment: Drug: trastuzumab; Drug: vinorelbine; Drug: BIBW 2992

• Study Type: Interventional
• Enrollment (Actual): 508
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1425AWC
    • Instituto Medico de Asistencia e Investigaciones S. A.
  • Capital Federal, Argentina, C1280AEB
    • Hospital Britanico
  • Ciudad Autonoma de Bs As, Argentina, C1050AAK
    • Sanatorio de la Provodencia
  • Rosario, Argentina, S2000DSK
    • Sanatorio Parque
• Australia
  • New South Wales
    • Port Macquarie, New South Wales, Australia, 2444
      • Port Macquarie Base Hospital (PMBH)
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • St Vincent's Hospital Melbourne
    • Frankston, Victoria, Australia, 3199
      • Peninsula Haematology & Oncology
    • Ringwood East, Victoria, Australia, 3135
      • Maroondah Hospital
  • Western Australia
    • Perth, Western Australia, Australia, 6000
      • Mount Medical Centre
• Austria
  • Linz, Austria, 4020
    • Ordensklinikum Linz GmbH - Barmherzige Schwestern
  • Wien, Austria, 1100
    • Kaiser Franz Josef Spital Vienna
• Belarus
  • Grodno, Belarus, 230017
    • Grodno Regional Clinical Hospital
  • Minsk, Belarus, 220013
    • Public Health Inst. Minsk City Clinical Oncology Dispensary
  • Minsk Region, Belarus, 223040
    • N. N. Alexandrov National Cancer Center of Belarus
  • Vitebsk, Belarus, 210603
    • Vitebsk Regional Clinical Oncology Dispensary
• Belgium
  • Bruxelles, Belgium, 1000
    • Brussels - HOSP Jules Bordet
  • Edegem, Belgium, 2650
    • Edegem - UNIV UZ Antwerpen
  • Liège, Belgium, 4000
    • Liège - HOSP St-Joseph
• Brazil
  • Cachoeiro de Itapemirim, Brazil, 29308-014
    • Centro de Pesquisas Clínicas em Oncologia
  • Curitiba, Brazil, 80420-090
    • Hospital Santa Cruz
  • Ijui, Brazil, 98700-000
    • Associacao Hospital de Caridade de Ijui
  • Porto Alegre, Brazil, 90050-170
    • Irmandade da Santa Casa de Misericordia de Porto Alegre
  • Porto Alegre, Brazil, 90035-001
    • Associacao Hospitalar Moinhos de Vento
  • Porto Alegre, Brazil, 90430-090
    • Centro de Novos Tratamentos CliniOnco
  • Rio de Janeiro, Brazil, 20560-120
    • Instituto Nacional Do Câncer - Inca
  • Santo André, Brazil, 09060-650
    • Faculdade de Medicina do ABC
  • Sao Paulo, Brazil, 01317-000
    • Centro de Referência da Saude da Mulher-Hosp Perola Byington
• Canada
  • Quebec, Canada, G1S 4L8
    • CHU de Quebec-Universite Laval Research Centre
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • BC Cancer Agency - Vancouver
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 8X3
      • Dr. Leon Richard Oncology Centre
  • Ontario
    • Kitchener, Ontario, Canada, N2G 1G3
      • Grand River Regional Cancer Centre
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H2L 4M1
      • Hopital Notre-Dame du CHUM
• Chile
  • Temuco, Chile
    • Instituto Clínico Oncológico del Sur - ICOS
• China
  • Beijing, China, 100071
    • 307 Hospital of PLA
  • Beijing, China, 100853
    • Chinese PLA General Hospital
  • Beijing, China, 100044
    • Peking University People's Hospital
  • Beijing, China, 100032
    • Peking Union Medical College Hospital
  • Beijing, China, 100021
    • Cancer Hospital of Chinese Academy of Medical Science
  • Changchun, China, 130021
    • First Hospital of Jilin University
  • Chengdu, China, 610041
    • West China Hospital
  • Fuzhou, China, 350014
    • Fujian Provincial Tumor Hospital
  • Guangzhou, China, 510060
    • Sun Yat-sen University Cancer Center
  • Guangzhou, China, 510080
    • Guangdong Provincial People's Hospital
  • Guangzhou, China, 510515
    • NanFang Hosptial
  • Haerbin, China, 150081
    • The Third Affiliated Hospital of Harbin Medical University
  • Hangzhou, China, 310022
    • Zhejiang Cancer Hospital
  • Hangzhou, China, 310009
    • The First Affiliated Hospital, Zhejiang University
  • Jinan, China, 250012
    • Qilu Hospital, Shangdong University
  • Nanjing, China, 210002
    • the 81th Hospital of PLA
  • Shanghai, China, 200025
    • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  • Shanghai, China, 200033
    • Fudan University Shanghai Cancer Center
  • Tianjin, China, 300060
    • Tianjin Medical University Cancer Institute and Hospital
  • Wuhan, China, 430022
    • Wuhan Union Hospital
• Czechia
  • Ceske Budejovice, Czechia, 370 87
    • Hospital Ceské Budejovice
  • Olomouc, Czechia, 775 20
    • University Hospital Olomouc
  • Prague 2, Czechia, 128 08
    • General Faculty Hospital, Prague
  • Praha 4, Czechia, 140 44
    • MEDICON a.s., Praha 4
• Egypt
  • Cairo, Egypt, 11553
    • El Manial Specialized Hospital
  • Mansoura, Egypt, 35516
    • Oncology Centre- Mansoura University
• France
  • Amiens Cedex 1, France, 80054
    • HOP Amiens-Picardie Sud
  • Angers Cedex 9, France, 49933
    • CTR P Papin, Onco, Angers
  • Besançon Cedex, France, 25030
    • HOP Jean Minjoz
  • Bordeaux, France, 33300
    • CLI Bordeaux Nord Aquitaine
  • Clermont-Ferrand Cedex, France, 63011
    • CTR J Perrin, Onco, Clermont-Ferrand
  • Le Mans, France, 72000
    • HOP Victor Hugo
  • Nantes, France, 44202
    • CTR Catherine de Sienne
  • Paris, France, 75475
    • HOP Saint-Louis
  • Reims, France, 51000
    • INS Jean Godinot, Onco, Reims
  • Rennes Cedex, France, 35042
    • CTR Eugène Marquis
  • St Cloud, France, 92210
    • CTR René Huguenin
  • Strasbourg Cedex, France, 67065
    • CTR Paul Strauss
• Germany
  • Aachen, Germany, 52074
    • Universitätsklinikum Aachen, AöR
  • Bonn, Germany, 53111
    • Medizinisches Zentrum Bonn
  • Bottrop, Germany, 46236
    • OnkoDok GbR
  • Deggendorf, Germany, 94469
    • DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKU
  • Erlangen, Germany, 91054
    • Universitatsklinikum Erlangen
  • Essen, Germany, 45136
    • Kliniken Essen - Mitte gGmbH
  • Hildesheim, Germany, 31134
    • Gynäk.-onkol. Gem.praxis, Dr. Uleer, Hildesheim
  • Köln, Germany, 50935
    • St. Elisabeth-Krankenhaus
  • Köln, Germany, 50931
    • Universitätsklinikum Köln (AöR)
  • Magdeburg, Germany, 39108
    • Universitätsklinikum Magdeburg AöR
  • München, Germany, 81675
    • Klinikum Rechts Der Isar Der Technischen Universität München
  • München, Germany, 80337
    • Klinikum der Universität München - Campus Innenstadt
  • Oldenburg, Germany, 26121
    • Onkologische Praxis Oldenburg
  • Rostock, Germany, 18059
    • Universitätsfrauenklinik am Klinikum Südstadt
  • Wuppertal, Germany, 42105
    • Facharzt für Innere Medizin
• India
  • Ahmedabad, India, 380016
    • Gujarat Cancer and Research Institute
  • Amravati, India, 444606
    • Sujan Surgical Cancer Hospital
  • Bangalore, India, 560029
    • KIDWAI memoraial Institute of oncology
  • Bengaluru, India, 560068
    • Sri Venkateshwara Hospital
  • Chennai, India, 600018
    • Dr. Rai Memorial Cancer Centre
  • Hyderabad, India, 500 024
    • Bibi General Hospital and Cancer Centre
  • Kolkata, India, 700054
    • Orchid Nursing Home
  • Maharagama, India
    • Natinal Cancer Institute
  • Nagpur, India, 440 010
    • Central India Cancer Research Institute
  • Nashik, India, 422004
    • Curie Manavata Cancer Centre
  • Pune, India, 411001
    • Jehangir Hospital Oncology Department
  • Pune, India, 411011
    • K.E.M Hospital
  • Visakhapatnam, India, 530002
    • King George Hospital
• Ireland
  • Dubliin 9, Ireland
    • Beaumont Hospital
  • Dublin 4, Ireland
    • St Vincent's University Hospital
  • Dublin 7, Ireland
    • Mater Misericordiae University Hospital
  • Dublin 8, Ireland
    • St James's Hospital
• Israel
  • Haifa, Israel, 31096
    • Rambam Medical Center
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center, Jerusalem 91031
  • Kfar Saba, Israel, 44281
    • Meir Medical Center
  • Tel Hashomer, Israel, 52621
    • The Chaim Sheba Medical Center Tel HaShomer
  • Tel-Aviv, Israel, 64239
    • Sourasky Medical Center
• Italy
  • Ferrara, Italy, 44124
    • Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
  • Milan, Italy, 20141
    • Istituto Europeo di Oncologia
  • Monserrato (CA), Italy, 09042
    • P.O. Monserrato
• Japan
  • Kanagawa, Isehara, Japan, 259-1193
    • Tokai University Hospital
  • Osaka, Osaka, Japan, 537-8511
    • Osaka Medical Center for Cancer and Cardiovascular Diseases
  • Tokyo, Chuo-ku, Japan, 104-0045
    • National Cancer Center Hospital
• Korea, Republic of
  • Goyang, Korea, Republic of, 410-769
    • National Cancer Center
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
• Latvia
  • Riga, Latvia, 1002
    • P. Stradins Clinical Univ. Hospital, Oncology Clinic
  • Riga, Latvia, 1079
    • Riga East Univ. Hospital, Oncology Centre
• Lebanon
  • Lebanon, Lebanon
    • Hammoud Hospital University Medical Centre (HHUMC)
• Lithuania
  • Kaunas, Lithuania, 50009
    • Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos
  • Vilnius, Lithuania, 08660
    • National Cancer Institute, Vilnius
• Mexico
  • Colonia Centro, Mexico, 06090
    • Hospital de Jesús
• Netherlands
  • Dordrecht, Netherlands, 3318 AT
    • Albert SchweitzerZiekenhuis
  • Eindhoven, Netherlands, 3651 BM
    • Máxima Medisch Centrum, locatie Eindhoven
  • Geleen, Netherlands, 6162 BG
    • Zuyderland Medisch Centrum
  • Heerlen, Netherlands, 6419 PC
    • Zuyderland Medisch Centrum
  • Maastricht, Netherlands, 6229 HX
    • METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht
  • Zwolle, Netherlands, 8025 BP
    • Isala Zwolle
• Peru
  • Cusco, Peru, 84
    • Hospital Nacional Adolfo Guevara Velasco
  • Lima, Peru
    • Clinica San Judas Tadeo
  • Miraflores, Peru
    • Instituto Oncologico Miraflores S.A.
  • Trujillo, Peru
    • Clinica Peruano Americana de Trujillo
• Poland
  • Bialystok, Poland, 15-027
    • Bialystock's Oncology Center
  • Bytom, Poland, 41-902
    • Wojewodzki Specialist Hospital No. 4, Bytom
  • Gdansk, Poland, 80-211
    • University Clinical Center, Gdansk
  • Lodz, Poland, 93-513
    • Provincial Specialist M. Kopernik Hospital
  • Lublin, Poland, 20-099
    • Ziemia Lubelska Oncological Center, Lublin
  • Olsztyn, Poland, 10-513
    • Oncology Centre of Olsztyn "KOPERNIK" Sp. z.o.o.
  • Poznan, Poland, 61-866
    • Wielkopolskie Oncology Centre n.a. Maria Sklodowska-Courie
  • Warsaw, Poland, 04 141
    • Military Medical Institute
• Portugal
  • Coimbra, Portugal, 3000-075
    • Instituto Português de Oncologia de Coimbra Francisco Gentil
  • Coimbra, Portugal, 3041-801
    • CHUC, EPE - CHC-Maternidade Bissaya Barreto
  • Lisboa, Portugal, 1099-023
    • IPO Lisboa Francisco Gentil, EPE
  • Porto, Portugal, 4200-072
    • IPO Porto Francisco Gentil, EPE
  • Porto, Portugal, 420-451
    • Centro Hospitalar São João,EPE
• Russian Federation
  • Kazan, Russian Federation, 420029
    • St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"
  • Moscow, Russian Federation, 129128
    • N.A. Semashko Central Clinical Hospital, Moscow
  • Ryazan, Russian Federation, 390011
    • GUZ "Regional Clinical Oncology Dispensary"
  • Saint Petersburg, Russian Federation, 191104
    • Regional Clinical Oncology Dispensary
• Singapore
  • Singapore, Singapore, 308433
    • Johns Hopkins Singapore International Medical Center
  • Singapore, Singapore, 169610
    • National Cancer Centre
  • Singapore, Singapore, 119228
    • National University Hospital
• Slovakia
  • Bardejov, Slovakia, 085 01
    • St. Jacobs Hosp.Outpat.Pneumology&Phthisiology Dept,Bardejov
  • Bratislava, Slovakia, 833 10
    • National Institute of Oncology, Bratislava
  • Poprad, Slovakia, 058 01
    • POKO Policlinic Dept. of Clinical Oncology
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Institute of Oncology Ljubljana
• South Africa
  • Johannesburg, South Africa, 2193
    • WCR CMJAH Clinical Trial Site
  • Johannesburg, South Africa, 2196
    • Medical Oncology Centre of Rosebank
  • Kraaifontein, South Africa, 7570
    • GVI oncology Medi Clinic
  • Port Elizabeth, South Africa, 6045
    • Langenhoven Drive Oncology Centre
  • Pretoria, South Africa, 0041
    • Wilgers oncology
  • Rondebosch, Cape Town, South Africa, 7700
    • Rondebosch Oncology Centre
• Spain
  • Barcelona, Spain, 08003
    • Hospital Del Mar
  • Barcelona, Spain, 08028
    • Hospital Universitari Dexeus
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron
  • Las Palmas de Gran Canaria, Spain, 35016
    • Complejo Hospitalario Universitario Insular - Materno Infantil
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Santiago de Compostela, Spain, 15706
    • Hospital Clínico de Santiago
  • Toledo, Spain, 45004
    • Hospital Virgen de la Salud
  • Valencia, Spain, 46015
    • Hospital Arnau de Vilanova
• Sri Lanka
  • Maharashtra, Sri Lanka, 422002
    • Shatabdi Superspeciality Hospital
• Taiwan
  • Changhua, Taiwan, 50006
    • Chang-Hua Christian Hospital
  • Kaohsiung, Taiwan, 81362
    • Kaohsiung Veterans General Hospital
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 704
    • NCKUH
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital
  • Taipei, Taiwan, 11217
    • Taipe Veterans General Hospital
  • Taipei, Taiwan, 112
    • Koo Foundation Sun Yet-Sen Cancer Center
  • Taoyuan County, Taiwan, 333
    • Chang Gung Memorial Hospital(TaoYuan)
• Turkey
  • Ankara, Turkey
    • Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari ABD
  • Izmir, Turkey
    • Ege Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali
• United Kingdom
  • Dundee, United Kingdom, DD1 9SY
    • Ninewells Hospital & Medical School
  • London, United Kingdom, SE1 9RT
    • Guy's Hospital
  • Sutton, United Kingdom, SM2 5PT
    • The Royal Marsden Hospital
  • Woolwich, London, United Kingdom, SE18 4QH
    • Queen Elizabeth Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Achieve Clinical Research, LLC
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Ironwood Cancer and Research Centers
  • California
    • Fountain Valley, California, United States, 92708
      • Robert A. Moss MD, FACP, Inc
    • Fullerton, California, United States, 92835
      • St. Jude Heritage Healthcare
    • Los Angeles, California, United States, 90095
      • University of California
    • Redondo Beach, California, United States, 90277
      • Cancer Care Associates Medical Group, Inc
    • Santa Barbara, California, United States, 93105
      • Santa Barbara Hematology Oncology Medical Group, Inc
    • Santa Maria, California, United States, 93454
      • Central Coast Medical Oncology Corporation
  • Illinois
    • Skokie, Illinois, United States, 60076
      • North Shore Cancer Research Associates
  • Iowa
    • Waterloo, Iowa, United States, 50701
      • Cedar Valley Cancer Center
  • New York
    • Lake Success, New York, United States, 11042
      • Pro Health Care Associated
  • North Carolina
    • Asheville, North Carolina, United States, 28806
      • Hope Women's Cancer Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialists Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm B: trastuzumab with vinorelbine; patients receive weekly intravenous infusion of trastuzumab and vinorelbine	Drug: trastuzumab; patients receive trastuzumab 2mg/kg intravenously every week; Drug: vinorelbine; patients receive vinorelbine 25mg/m² intravenously every week
Experimental: Arm A: BIBW 2992 with vinorelbine; patients receive BIBW 2992 tablets once daily combined with weekly intravenous infusion of vinorelbine	Drug: vinorelbine; patients receive vinorelbine 25mg/m² intravenously every week; Drug: BIBW 2992; patients receive BIBW 2992 tablets once daily and can reduce dose for adverse event management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	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	From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	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.	From randomisation (07Sep2010) to database lock (30Jul2018), up to 95 months.
Best RECIST Assessment	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.	From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months
Objective Response (OR)	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	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)

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2010
• Primary Completion (Actual): June 8, 2013
• Study Completion (Actual): July 6, 2018

Study Registration Dates

• First Submitted: May 10, 2010
• First Submitted That Met QC Criteria: May 17, 2010
• First Posted (Estimate): May 18, 2010

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 4, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Protein Kinase Inhibitors; Trastuzumab; Vinorelbine; Afatinib
• Other Study ID Numbers: 1200.75; 2009-015476-98 (EudraCT Number)