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
2 other identifiers
interventional
508
35 countries
201
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2010
Longer than P75 for phase_3
201 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2010
CompletedFirst Posted
Study publicly available on registry
May 18, 2010
CompletedStudy Start
First participant enrolled
June 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2013
CompletedResults Posted
Study results publicly available
August 21, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2018
CompletedJuly 18, 2019
July 1, 2019
3 years
May 10, 2010
June 6, 2014
July 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Overall Survival (OS)
From randomisation (07Sep2010) to database lock (30Jul2018), up to 95 months.
Best RECIST Assessment
From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months
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)
Study Arms (2)
Arm B: trastuzumab with vinorelbine
ACTIVE COMPARATORpatients receive weekly intravenous infusion of trastuzumab and vinorelbine
Arm A: BIBW 2992 with vinorelbine
EXPERIMENTALpatients receive BIBW 2992 tablets once daily combined with weekly intravenous infusion of vinorelbine
Interventions
patients receive BIBW 2992 tablets once daily and can reduce dose for adverse event management
patients receive trastuzumab 2mg/kg intravenously every week
patients receive vinorelbine 25mg/m² intravenously every week
Eligibility Criteria
You may qualify if:
- 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 .
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (207)
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216, United States
Ironwood Cancer and Research Centers
Chandler, Arizona, 85224, United States
Robert A. Moss MD, FACP, Inc
Fountain Valley, California, 92708, United States
St. Jude Heritage Healthcare
Fullerton, California, 92835, United States
University of California
Los Angeles, California, 90095, United States
Cancer Care Associates Medical Group, Inc
Redondo Beach, California, 90277, United States
Santa Barbara Hematology Oncology Medical Group, Inc
Santa Barbara, California, 93105, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454, United States
North Shore Cancer Research Associates
Skokie, Illinois, 60076, United States
Cedar Valley Cancer Center
Waterloo, Iowa, 50701, United States
Pro Health Care Associated
Lake Success, New York, 11042, United States
Hope Women's Cancer Center
Asheville, North Carolina, 28806, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Utah Cancer Specialists Cancer Center
Salt Lake City, Utah, 84106, United States
Instituto Medico de Asistencia e Investigaciones S. A.
Buenos Aires, C1425AWC, Argentina
Hospital Britanico
Capital Federal, C1280AEB, Argentina
Sanatorio de la Provodencia
Ciudad Autonoma de Bs As, C1050AAK, Argentina
Sanatorio Parque
Rosario, S2000DSK, Argentina
Port Macquarie Base Hospital (PMBH)
Port Macquarie, New South Wales, 2444, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
Peninsula Haematology & Oncology
Frankston, Victoria, 3199, Australia
Maroondah Hospital
Ringwood East, Victoria, 3135, Australia
Mount Medical Centre
Perth, Western Australia, 6000, Australia
Ordensklinikum Linz GmbH - Barmherzige Schwestern
Linz, 4020, Austria
Kaiser Franz Josef Spital Vienna
Vienna, 1100, Austria
Grodno Regional Clinical Hospital
Grodno, 230017, Belarus
Public Health Inst. Minsk City Clinical Oncology Dispensary
Minsk, 220013, Belarus
N. N. Alexandrov National Cancer Center of Belarus
Minsk Region, 223040, Belarus
Vitebsk Regional Clinical Oncology Dispensary
Vitebsk, 210603, Belarus
Brussels - HOSP Jules Bordet
Brussels, 1000, Belgium
Edegem - UNIV UZ Antwerpen
Edegem, 2650, Belgium
Liège - HOSP St-Joseph
Liège, 4000, Belgium
Centro de Pesquisas Clínicas em Oncología
Cachoeiro de Itapemirim, 29308-014, Brazil
Hospital Santa Cruz
Curitiba, 80420-090, Brazil
Associacao Hospital de Caridade de Ijui
Ijuí, 98700-000, Brazil
Associação Hospitalar Moinhos de Vento
Porto Alegre, 90035-001, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, 90050-170, Brazil
Centro de Novos Tratamentos CliniOnco
Porto Alegre, 90430-090, Brazil
Instituto Nacional do Câncer - INCA
Rio de Janeiro, 20560-120, Brazil
Faculdade de Medicina do ABC
Santo André, 09060-650, Brazil
Centro de Referência da Saude da Mulher-Hosp Perola Byington
São Paulo, 01317-000, Brazil
BC Cancer Agency - Vancouver
Vancouver, British Columbia, V5Z 4E6, Canada
Dr. Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3, Canada
Grand River Regional Cancer Centre
Kitchener, Ontario, N2G 1G3, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Hopital Notre-Dame du CHUM
Montreal, Quebec, H2L 4M1, Canada
CHU de Quebec-Universite Laval Research Centre
Québec, G1S 4L8, Canada
Instituto Clínico Oncológico del Sur - ICOS
Temuco, Chile
Cancer Hospital of Chinese Academy of Medical Science
Beijing, 100021, China
Peking Union Medical College Hospital
Beijing, 100032, China
Peking University People's Hospital
Beijing, 100044, China
307 Hospital of PLA
Beijing, 100071, China
Chinese PLA General Hospital
Beijing, 100853, China
First Hospital of Jilin University
Changchun, 130021, China
West China Hospital
Chengdu, 610041, China
Fujian Provincial Tumor Hospital
Fuzhou, 350014, China
Sun Yat-Sen University Cancer Center
Guangzhou, 510060, China
Guangdong Provincial People's Hospital
Guangzhou, 510080, China
NanFang Hosptial
Guangzhou, 510515, China
The Third Affiliated Hospital of Harbin Medical University
Haerbin, 150081, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, 310009, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Qilu Hospital, Shangdong University
Jinan, 250012, China
the 81th Hospital of PLA
Nanjing, 210002, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200025, China
Fudan University Shanghai Cancer Center
Shanghai, 200033, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060, China
Wuhan Union Hospital
Wuhan, 430022, China
Hospital Ceske Budejovice
České Budějovice, 370 87, Czechia
University Hospital Olomouc
Olomouc, 775 20, Czechia
General Faculty Hospital, Prague
Prague, 128 08, Czechia
MEDICON a.s., Praha 4
Prague, 140 44, Czechia
Oncology Centre- Mansoura University
Al Mansurah, 35516, Egypt
El Manial Specialized Hospital
Cairo, 11553, Egypt
HOP Amiens-Picardie Sud
Amiens, 80054, France
CTR P Papin, Onco, Angers
Angers, 49933, France
HOP Jean Minjoz
Besançon, 25030, France
CLI Bordeaux Nord Aquitaine
Bordeaux, 33300, France
CTR J Perrin, Onco, Clermont-Ferrand
Clermont-Ferrand, 63011, France
HOP Victor Hugo
Le Mans, 72000, France
CTR Catherine de Sienne
Nantes, 44202, France
HOP Saint-Louis
Paris, 75475, France
INS Jean Godinot, Onco, Reims
Reims, 51000, France
CTR Eugène Marquis
Rennes, 35042, France
CTR René Huguenin
Saint-Cloud, 92210, France
CTR Paul Strauss
Strasbourg, 67065, France
Universitätsklinikum Aachen, AöR
Aachen, 52074, Germany
Medizinisches Zentrum Bonn
Bonn, 53111, Germany
OnkoDok GbR
Bottrop, 46236, Germany
Universitätsklinikum Köln (AöR)
Cologne, 50931, Germany
St. Elisabeth-Krankenhaus
Cologne, 50935, Germany
DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKU
Deggendorf, 94469, Germany
Universitätsklinikum Erlangen
Erlangen, 91054, Germany
Kliniken Essen - Mitte gGmbH
Essen, 45136, Germany
Gynäk.-onkol. Gem.praxis, Dr. Uleer, Hildesheim
Hildesheim, 31134, Germany
Universitätsklinikum Magdeburg AöR
Magdeburg, 39108, Germany
Klinikum der Universität München - Campus Innenstadt
München, 80337, Germany
Klinikum rechts der Isar der Technischen Universität München
München, 81675, Germany
Onkologische Praxis Oldenburg
Oldenburg, 26121, Germany
Universitätsfrauenklinik am Klinikum Südstadt
Rostock, 18059, Germany
Facharzt für Innere Medizin
Wuppertal, 42105, Germany
Gujarat Cancer and Research Institute
Ahmedabad, 380016, India
Sujan Surgical Cancer Hospital
Amravati, 444606, India
KIDWAI memoraial Institute of oncology
Bangalore, 560029, India
Sri Venkateshwara Hospital
Bengaluru, 560068, India
Dr. Rai Memorial Cancer Centre
Chennai, 600018, India
Bibi General Hospital and Cancer Centre
Hyderabad, 500 024, India
Orchid Nursing Home
Kolkata, 700054, India
Natinal Cancer Institute
Maharagama, India
Central India Cancer Research Institute
Nagpur, 440 010, India
Curie Manavata Cancer centre
Nashik, 422004, India
Jehangir Hospital Oncology Department
Pune, 411001, India
K.E.M Hospital
Pune, 411011, India
King George Hospital
Visakhapatnam, 530002, 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, 31096, Israel
Shaare Zedek Medical Center, Jerusalem 91031
Jerusalem, 91031, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Sourasky Medical Center
Tel Aviv, 64239, Israel
The Chaim Sheba Medical Center Tel Hashomer
Tel Litwinsky, 52621, Israel
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
Ferrara, 44124, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
P.O. Monserrato
Monserrato (CA), 09042, Italy
Tokai University Hospital
Kanagawa, Isehara, 259-1193, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Osaka, 537-8511, Japan
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045, Japan
P. Stradins Clinical Univ. Hospital, Oncology Clinic
Riga, 1002, Latvia
Riga East Univ. Hospital, Oncology Centre
Riga, 1079, Latvia
Hammoud Hospital University Medical Centre (HHUMC)
Lebanon, Lebanon
Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos
Kaunas, 50009, Lithuania
National Cancer Institute, Vilnius
Vilnius, 08660, Lithuania
Hospital de Jesus
Colonia Centro, 06090, Mexico
Albert SchweitzerZiekenhuis
Dordrecht, 3318 AT, Netherlands
Máxima Medisch Centrum, locatie Eindhoven
Eindhoven, 3651 BM, Netherlands
Zuyderland Medisch Centrum
Geleen, 6162 BG, Netherlands
Zuyderland Medisch Centrum
Heerlen, 6419 PC, Netherlands
METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht
Maastricht, 6229 HX, Netherlands
Isala Zwolle
Zwolle, 8025 BP, Netherlands
Hospital Nacional Adolfo Guevara Velasco
Cusco, 84, 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, 15-027, Poland
Wojewodzki Specialist Hospital No. 4, Bytom
Bytom, 41-902, Poland
University Clinical Center, Gdansk
Gdansk, 80-211, Poland
Provincial Specialist M. Kopernik Hospital
Lodz, 93-513, Poland
Ziemia Lubelska Oncological Center, Lublin
Lublin, 20-099, Poland
Oncology Centre of Olsztyn "KOPERNIK" Sp. z.o.o.
Olsztyn, 10-513, Poland
Wielkopolskie Oncology Centre n.a. Maria Sklodowska-Courie
Poznan, 61-866, Poland
Military Medical Institute
Warsaw, 04 141, Poland
Instituto Português de Oncologia de Coimbra Francisco Gentil
Coimbra, 3000-075, Portugal
CHUC, EPE - CHC-Maternidade Bissaya Barreto
Coimbra, 3041-801, Portugal
IPO Lisboa Francisco Gentil, EPE
Lisbon, 1099-023, Portugal
Centro Hospitalar São João,EPE
Porto, 420-451, Portugal
IPO Porto Francisco Gentil, EPE
Porto, 4200-072, Portugal
St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"
Kazan', 420029, Russia
N.A. Semashko Central Clinical Hospital, Moscow
Moscow, 129128, Russia
GUZ "Regional Clinical Oncology Dispensary"
Ryazan, 390011, Russia
Regional Clinical Oncology Dispensary
Saint Petersburg, 191104, Russia
National University Hospital
Singapore, 119228, Singapore
National Cancer Centre
Singapore, 169610, Singapore
Johns Hopkins Singapore International Medical Center
Singapore, 308433, Singapore
St. Jacobs Hosp.Outpat.Pneumology&Phthisiology Dept,Bardejov
Bardejov, 085 01, Slovakia
National Institute of Oncology, Bratislava
Bratislava, 833 10, Slovakia
POKO Policlinic Dept. of Clinical Oncology
Poprad, 058 01, Slovakia
Institute of Oncology Ljubljana
Ljubljana, 1000, Slovenia
WCR CMJAH Clinical Trial Site
Johannesburg, 2193, South Africa
Medical Oncology Centre of Rosebank
Johannesburg, 2196, South Africa
GVI oncology Medi Clinic
Kraaifontein, 7570, South Africa
Langenhoven Drive Oncology Centre
Port Elizabeth, 6045, South Africa
Wilgers oncology
Pretoria, 0041, South Africa
Rondebosch Oncology Centre
Rondebosch, Cape Town, 7700, South Africa
National Cancer Center
Goyang, 410-769, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Severance Hospital
Seoul, 120-752, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitari Dexeus
Barcelona, 08028, Spain
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Complejo Hospitalario Universitario Insular - Materno Infantil
Las Palmas de Gran Canaria, 35016, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital Clínico de Santiago
Santiago de Compostela, 15706, Spain
Hospital Virgen de la Salud
Toledo, 45004, Spain
Hospital Arnau de Vilanova
Valencia, 46015, Spain
Shatabdi Superspeciality Hospital
Maharashtra, 422002, Sri Lanka
Chang-Hua Christian Hospital
Changhua, 50006, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
NCKUH
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Mackay Memorial Hospital
Taipei, 10449, Taiwan
Taipe Veterans General Hospital
Taipei, 11217, Taiwan
Koo Foundation Sun Yet-Sen Cancer Center
Taipei, 112, Taiwan
Chang Gung Memorial Hospital(TaoYuan)
Taoyuan, 333, 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, DD1 9SY, United Kingdom
Guy's Hospital
London, SE1 9RT, United Kingdom
The Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
Queen Elizabeth Hospital
Woolwich, London, SE18 4QH, United Kingdom
Related Publications (1)
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.
PMID: 26822398DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The Data Monitoring Committee recommended termination of recruitment due to low likelihood of the study meeting its primary objectives.
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2010
First Posted
May 18, 2010
Study Start
June 22, 2010
Primary Completion
June 8, 2013
Study Completion
July 6, 2018
Last Updated
July 18, 2019
Results First Posted
August 21, 2014
Record last verified: 2019-07