Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01125566




Registration number
NCT01125566
Ethics application status
Date submitted
10/05/2010
Date registered
18/05/2010
Date last updated
18/07/2019

Titles & IDs
Public title
LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment
Scientific 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
Secondary ID [1] 0 0
2009-015476-98
Secondary ID [2] 0 0
1200.75
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BIBW 2992
Treatment: Drugs - trastuzumab
Treatment: Drugs - vinorelbine
Treatment: Drugs - vinorelbine

Active comparator: Arm B: trastuzumab with vinorelbine - patients receive weekly intravenous infusion of trastuzumab and vinorelbine

Experimental: Arm A: BIBW 2992 with vinorelbine - patients receive BIBW 2992 tablets once daily combined with weekly intravenous infusion of vinorelbine


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

Treatment: Drugs: trastuzumab
patients receive trastuzumab 2mg/kg intravenously every week

Treatment: Drugs: vinorelbine
patients receive vinorelbine 25mg/m² intravenously every week

Treatment: Drugs: vinorelbine
patients receive vinorelbine 25mg/m² intravenously every week
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From randomisation (07Sep2010) to database lock (30Jul2018), up to 95 months.
Secondary outcome [2] 0 0
Best RECIST Assessment
Timepoint [2] 0 0
From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months
Secondary outcome [3] 0 0
Objective Response (OR)
Timepoint [3] 0 0
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)

Eligibility
Key inclusion 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 .
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/07/2018
Sample size
Target
Accrual to date
Final
508
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Port Macquarie Base Hospital (PMBH) - Port Macquarie
Recruitment hospital [2] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [3] 0 0
Peninsula Haematology & Oncology - Frankston
Recruitment hospital [4] 0 0
Maroondah Hospital - Ringwood East
Recruitment hospital [5] 0 0
Mount Medical Centre - Perth
Recruitment postcode(s) [1] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
3135 - Ringwood East
Recruitment postcode(s) [5] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
Argentina
State/province [10] 0 0
Buenos Aires
Country [11] 0 0
Argentina
State/province [11] 0 0
Capital Federal
Country [12] 0 0
Argentina
State/province [12] 0 0
Ciudad Autonoma de Bs As
Country [13] 0 0
Argentina
State/province [13] 0 0
Rosario
Country [14] 0 0
Austria
State/province [14] 0 0
Linz
Country [15] 0 0
Austria
State/province [15] 0 0
Wien
Country [16] 0 0
Belarus
State/province [16] 0 0
Grodno
Country [17] 0 0
Belarus
State/province [17] 0 0
Minsk Region
Country [18] 0 0
Belarus
State/province [18] 0 0
Minsk
Country [19] 0 0
Belarus
State/province [19] 0 0
Vitebsk
Country [20] 0 0
Belgium
State/province [20] 0 0
Bruxelles
Country [21] 0 0
Belgium
State/province [21] 0 0
Edegem
Country [22] 0 0
Belgium
State/province [22] 0 0
Liège
Country [23] 0 0
Brazil
State/province [23] 0 0
Cachoeiro de Itapemirim
Country [24] 0 0
Brazil
State/province [24] 0 0
Curitiba
Country [25] 0 0
Brazil
State/province [25] 0 0
Ijui
Country [26] 0 0
Brazil
State/province [26] 0 0
Porto Alegre
Country [27] 0 0
Brazil
State/province [27] 0 0
Rio de Janeiro
Country [28] 0 0
Brazil
State/province [28] 0 0
Santo André
Country [29] 0 0
Brazil
State/province [29] 0 0
Sao Paulo
Country [30] 0 0
Canada
State/province [30] 0 0
British Columbia
Country [31] 0 0
Canada
State/province [31] 0 0
New Brunswick
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
Canada
State/province [33] 0 0
Quebec
Country [34] 0 0
Chile
State/province [34] 0 0
Temuco
Country [35] 0 0
China
State/province [35] 0 0
Beijing
Country [36] 0 0
China
State/province [36] 0 0
Changchun
Country [37] 0 0
China
State/province [37] 0 0
Chengdu
Country [38] 0 0
China
State/province [38] 0 0
Fuzhou
Country [39] 0 0
China
State/province [39] 0 0
Guangzhou
Country [40] 0 0
China
State/province [40] 0 0
Haerbin
Country [41] 0 0
China
State/province [41] 0 0
Hangzhou
Country [42] 0 0
China
State/province [42] 0 0
Jinan
Country [43] 0 0
China
State/province [43] 0 0
Nanjing
Country [44] 0 0
China
State/province [44] 0 0
Shanghai
Country [45] 0 0
China
State/province [45] 0 0
Tianjin
Country [46] 0 0
China
State/province [46] 0 0
Wuhan
Country [47] 0 0
Czechia
State/province [47] 0 0
Ceske Budejovice
Country [48] 0 0
Czechia
State/province [48] 0 0
Olomouc
Country [49] 0 0
Czechia
State/province [49] 0 0
Prague 2
Country [50] 0 0
Czechia
State/province [50] 0 0
Praha 4
Country [51] 0 0
Egypt
State/province [51] 0 0
Cairo
Country [52] 0 0
Egypt
State/province [52] 0 0
Mansoura
Country [53] 0 0
France
State/province [53] 0 0
Amiens Cedex 1
Country [54] 0 0
France
State/province [54] 0 0
Angers Cedex 9
Country [55] 0 0
France
State/province [55] 0 0
Besançon Cedex
Country [56] 0 0
France
State/province [56] 0 0
Bordeaux
Country [57] 0 0
France
State/province [57] 0 0
Clermont-Ferrand Cedex
Country [58] 0 0
France
State/province [58] 0 0
Le Mans
Country [59] 0 0
France
State/province [59] 0 0
Nantes
Country [60] 0 0
France
State/province [60] 0 0
Paris
Country [61] 0 0
France
State/province [61] 0 0
Reims
Country [62] 0 0
France
State/province [62] 0 0
Rennes Cedex
Country [63] 0 0
France
State/province [63] 0 0
St Cloud
Country [64] 0 0
France
State/province [64] 0 0
Strasbourg Cedex
Country [65] 0 0
Germany
State/province [65] 0 0
Aachen
Country [66] 0 0
Germany
State/province [66] 0 0
Bonn
Country [67] 0 0
Germany
State/province [67] 0 0
Bottrop
Country [68] 0 0
Germany
State/province [68] 0 0
Deggendorf
Country [69] 0 0
Germany
State/province [69] 0 0
Erlangen
Country [70] 0 0
Germany
State/province [70] 0 0
Essen
Country [71] 0 0
Germany
State/province [71] 0 0
Hildesheim
Country [72] 0 0
Germany
State/province [72] 0 0
Köln
Country [73] 0 0
Germany
State/province [73] 0 0
Magdeburg
Country [74] 0 0
Germany
State/province [74] 0 0
München
Country [75] 0 0
Germany
State/province [75] 0 0
Oldenburg
Country [76] 0 0
Germany
State/province [76] 0 0
Rostock
Country [77] 0 0
Germany
State/province [77] 0 0
Wuppertal
Country [78] 0 0
India
State/province [78] 0 0
Ahmedabad
Country [79] 0 0
India
State/province [79] 0 0
Amravati
Country [80] 0 0
India
State/province [80] 0 0
Bangalore
Country [81] 0 0
India
State/province [81] 0 0
Bengaluru
Country [82] 0 0
India
State/province [82] 0 0
Chennai
Country [83] 0 0
India
State/province [83] 0 0
Hyderabad
Country [84] 0 0
India
State/province [84] 0 0
Kolkata
Country [85] 0 0
India
State/province [85] 0 0
Maharagama
Country [86] 0 0
India
State/province [86] 0 0
Nagpur
Country [87] 0 0
India
State/province [87] 0 0
Nashik
Country [88] 0 0
India
State/province [88] 0 0
Pune
Country [89] 0 0
India
State/province [89] 0 0
Visakhapatnam
Country [90] 0 0
Ireland
State/province [90] 0 0
Dubliin 9
Country [91] 0 0
Ireland
State/province [91] 0 0
Dublin 4
Country [92] 0 0
Ireland
State/province [92] 0 0
Dublin 7
Country [93] 0 0
Ireland
State/province [93] 0 0
Dublin 8
Country [94] 0 0
Israel
State/province [94] 0 0
Haifa
Country [95] 0 0
Israel
State/province [95] 0 0
Jerusalem
Country [96] 0 0
Israel
State/province [96] 0 0
Kfar Saba
Country [97] 0 0
Israel
State/province [97] 0 0
Tel Hashomer
Country [98] 0 0
Israel
State/province [98] 0 0
Tel-Aviv
Country [99] 0 0
Italy
State/province [99] 0 0
Ferrara
Country [100] 0 0
Italy
State/province [100] 0 0
Milan
Country [101] 0 0
Italy
State/province [101] 0 0
Monserrato (CA)
Country [102] 0 0
Japan
State/province [102] 0 0
Kanagawa, Isehara
Country [103] 0 0
Japan
State/province [103] 0 0
Osaka, Osaka
Country [104] 0 0
Japan
State/province [104] 0 0
Tokyo, Chuo-ku
Country [105] 0 0
Korea, Republic of
State/province [105] 0 0
Goyang
Country [106] 0 0
Korea, Republic of
State/province [106] 0 0
Seoul
Country [107] 0 0
Latvia
State/province [107] 0 0
Riga
Country [108] 0 0
Lebanon
State/province [108] 0 0
Lebanon
Country [109] 0 0
Lithuania
State/province [109] 0 0
Kaunas
Country [110] 0 0
Lithuania
State/province [110] 0 0
Vilnius
Country [111] 0 0
Mexico
State/province [111] 0 0
Colonia Centro
Country [112] 0 0
Netherlands
State/province [112] 0 0
Dordrecht
Country [113] 0 0
Netherlands
State/province [113] 0 0
Eindhoven
Country [114] 0 0
Netherlands
State/province [114] 0 0
Geleen
Country [115] 0 0
Netherlands
State/province [115] 0 0
Heerlen
Country [116] 0 0
Netherlands
State/province [116] 0 0
Maastricht
Country [117] 0 0
Netherlands
State/province [117] 0 0
Zwolle
Country [118] 0 0
Peru
State/province [118] 0 0
Cusco
Country [119] 0 0
Peru
State/province [119] 0 0
Lima
Country [120] 0 0
Peru
State/province [120] 0 0
Miraflores
Country [121] 0 0
Peru
State/province [121] 0 0
Trujillo
Country [122] 0 0
Poland
State/province [122] 0 0
Bialystok
Country [123] 0 0
Poland
State/province [123] 0 0
Bytom
Country [124] 0 0
Poland
State/province [124] 0 0
Gdansk
Country [125] 0 0
Poland
State/province [125] 0 0
Lodz
Country [126] 0 0
Poland
State/province [126] 0 0
Lublin
Country [127] 0 0
Poland
State/province [127] 0 0
Olsztyn
Country [128] 0 0
Poland
State/province [128] 0 0
Poznan
Country [129] 0 0
Poland
State/province [129] 0 0
Warsaw
Country [130] 0 0
Portugal
State/province [130] 0 0
Coimbra
Country [131] 0 0
Portugal
State/province [131] 0 0
Lisboa
Country [132] 0 0
Portugal
State/province [132] 0 0
Porto
Country [133] 0 0
Russian Federation
State/province [133] 0 0
Kazan
Country [134] 0 0
Russian Federation
State/province [134] 0 0
Moscow
Country [135] 0 0
Russian Federation
State/province [135] 0 0
Ryazan
Country [136] 0 0
Russian Federation
State/province [136] 0 0
Saint Petersburg
Country [137] 0 0
Singapore
State/province [137] 0 0
Singapore
Country [138] 0 0
Slovakia
State/province [138] 0 0
Bardejov
Country [139] 0 0
Slovakia
State/province [139] 0 0
Bratislava
Country [140] 0 0
Slovakia
State/province [140] 0 0
Poprad
Country [141] 0 0
Slovenia
State/province [141] 0 0
Ljubljana
Country [142] 0 0
South Africa
State/province [142] 0 0
Johannesburg
Country [143] 0 0
South Africa
State/province [143] 0 0
Kraaifontein
Country [144] 0 0
South Africa
State/province [144] 0 0
Port Elizabeth
Country [145] 0 0
South Africa
State/province [145] 0 0
Pretoria
Country [146] 0 0
South Africa
State/province [146] 0 0
Rondebosch, Cape Town
Country [147] 0 0
Spain
State/province [147] 0 0
Barcelona
Country [148] 0 0
Spain
State/province [148] 0 0
Las Palmas de Gran Canaria
Country [149] 0 0
Spain
State/province [149] 0 0
Madrid
Country [150] 0 0
Spain
State/province [150] 0 0
Santiago de Compostela
Country [151] 0 0
Spain
State/province [151] 0 0
Toledo
Country [152] 0 0
Spain
State/province [152] 0 0
Valencia
Country [153] 0 0
Sri Lanka
State/province [153] 0 0
Maharashtra
Country [154] 0 0
Taiwan
State/province [154] 0 0
Changhua
Country [155] 0 0
Taiwan
State/province [155] 0 0
Kaohsiung
Country [156] 0 0
Taiwan
State/province [156] 0 0
Taichung
Country [157] 0 0
Taiwan
State/province [157] 0 0
Tainan
Country [158] 0 0
Taiwan
State/province [158] 0 0
Taipei
Country [159] 0 0
Taiwan
State/province [159] 0 0
Taoyuan County
Country [160] 0 0
Turkey
State/province [160] 0 0
Ankara
Country [161] 0 0
Turkey
State/province [161] 0 0
Izmir
Country [162] 0 0
United Kingdom
State/province [162] 0 0
Dundee
Country [163] 0 0
United Kingdom
State/province [163] 0 0
London
Country [164] 0 0
United Kingdom
State/province [164] 0 0
Sutton
Country [165] 0 0
United Kingdom
State/province [165] 0 0
Woolwich, London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01125566