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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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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
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 website
https://clinicaltrials.gov/ct2/show/NCT01125566
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01125566