Home » Trials » SLCTR/2012/003
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
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SLCTR Registration Number
SLCTR/2012/003
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
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
Public Title of Trial
Phase III Trial of Vinorelbine+BIBW 2992 vs Vinorelbine+Herceptin in BC Patients After Failing Herceptin Treatment
Disease or Health Condition(s) Studied
Metastatic Breast Cancer
Scientific Acronym
LUX Breast 1
Public Acronym
LUX Breast 1
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
CTRI/2010/091/001360 (Clinical Trials Registry India), NCT01125566 (clinicaltrials.gov)
What is the research question being addressed?
To determine whether BIBW 2992 and vinorelbine i.v. prolongs progression-free survival (PFS) in comparison to trastuzumab and vinorelbine ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 3
Intervention(s) planned
BIBW 2992 - once daily combined with weekly intravenous infusion of vinorelbine
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Progression-free survival, defined as the time from the date of randomisation to the date of disease progression, or to the date of death if a patient died earlier |
[ Every 8 weeks till disease progression or start of new anti cancer therapy ] |
Secondary outcome(s)
|
1.
Overall survival- Best -RECIST assessment and safety -Tumour shrinkage -Maintenance of body weight and ECOG performance status -Incidence of brain metastases -Health-related quality of life pharmacokinetics of BIBW 2992 |
[ Life time ] |
Target number/sample size
790
Countries of recruitment
Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, Germany, India, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Peru, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Taiwan, Province of China, United States
Anticipated start date
2012-04-19
Anticipated end date
2016-03-31
Date of first enrollment
2012-03-11
Date of study completion
Recruitment status
Terminated
Funding source
Boehringer Ingelheim India (Pvt) Ltd
Regulatory approvals
Status
Approved
Date of Approval
2011-12-14
Approval number
Not Available
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Sachin S. Sadekar
Project Manager
Boehringer Ingelheim India Pvt Ltd, 1102, Hallmark Business Plaza, Near Gurunanak Hospital, Bandra (E), Mumbai 400051
912226456477 912226456163
sachin.sadekar.ext@boehringer-ingelheim.com
Contact Person for Public Queries
Prof Asita De Selva
Director
Clinical Trials Unit, Faculty of Medicine, University of Kelaniya
0094777377227
asita@sltnet.lk
Primary study sponsor/organization
Boehringer Ingelheim India (Pvt) Ltd
1102, Hallmark Business Plaza, Near Gurunanak Hospital, Bandra (E), Mumbai 400051
912226456477 912226456163
sachin.sadekar.ext@boehringer-ingelheim.com
www.boehringer-ingelheim.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
