At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 540 enrolled
Drug / intervention
capecitabine +2 moredrug
Likely dose
trastuzumab 8mg/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.
A Randomized, Multicentre, Open-Label, Phase III Study of Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in Patients With Anthracycline- or Taxane-Exposed ErbB2-Positive Metastatic Breast Cancer
In Brief
A Phase 3 clinical trial evaluating capecitabine, lapatinib, and 1 other intervention for Metastases, Brain. Completed, enrolled 540 participants across 164 sites in 14 countries.
Detailed Summary
This open label study was designed to evaluate Lapatinib effect on incidence of brain metastases in ErbB2 (HER2) positive metastatic breast cancer patients exposed to prior taxanes or anthracyclines.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastases, Brain
CountriesBelgium, Denmark, France, Germany, Greece, Hungary, Italy, Poland, Russia, Spain, Sweden, Thailand, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2009
Enrollment StartApr 2009
Primary CompletionJun 2012
Study CompletionMar 2018
TodayJul 2026
First PostedJan 12, 2009
Enrollment StartApr 14, 2009
Primary CompletionJun 11, 2012
Study CompletionMar 22, 2018
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 17.5 years ago
Interventions
capecitabinedrug
oral medication; daily dose divided into morning and evening dose and taken for 14 days of 21 day cycle
lapatinibdrug
oral medication; daily dose taken once a day
trastuzumabdrug
infusion therapy; loading dose of 8mg/kg, followed by 6mg/kg given every 3 weeks