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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
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United States of America
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Alabama
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London
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Sutton
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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