CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 508 enrolled
Drug / intervention
BIBW 2992 +3 moredrug
Likely dose
trastuzumab 2mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01125566
NCT01125566Phase 3Completed
CompareCT.gov

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

Boehringer Ingelheim·interventional·Posted May 18, 2010·Updated Jul 18, 2019

In Brief

A Phase 3 clinical trial evaluating BIBW 2992, trastuzumab, and 1 other intervention for Breast Neoplasms. Completed, enrolled 508 participants across 207 sites in 38 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesArgentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, China, Czechia, Egypt, France, Germany, India, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Mexico, Netherlands, Peru, Poland, Portugal, Russia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 18, 2010
Enrollment StartJun 22, 2010
Primary CompletionJun 8, 2013
Study CompletionJul 6, 2018
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 16.1 years ago

Interventions

BIBW 2992drug

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

trastuzumabdrug

patients receive trastuzumab 2mg/kg intravenously every week

vinorelbinedrug

patients receive vinorelbine 25mg/m² intravenously every week

vinorelbinedrug

patients receive vinorelbine 25mg/m² intravenously every week