At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 296 enrolled
Drug / intervention
Lapatinib +1 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.
A Randomized, Multicenter, Open-Label, Phase III Study of Lapatinib in Combination With Trastuzumab Versus Lapatinib Monotherapy in Subjects With HER2-positive Metastatic Breast Cancer Whose Disease Has Progressed on Trastuzumab-Containing Regimens
In Brief
A Phase 3 clinical trial evaluating Lapatinib and Trastuzumab for Neoplasms, Breast. Completed, enrolled 296 participants across 145 sites in 13 countries.
Detailed Summary
This study will evaluate and compare the safety and efficacy of lapatinib in combination with trastuzumab versus lapatinib monotherapy in subjects with HER2-positive metastatic breast cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Breast
CountriesAustria, Bulgaria, Canada, Croatia, Czechia, Finland, Germany, Greece, Italy, Poland, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2005
First PostedMay 2006
Primary CompletionJun 2007
Study CompletionOct 2010
TodayJul 2026
First PostedMay 3, 2006
Enrollment StartNov 1, 2005
Primary CompletionJun 1, 2007
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 20.2 years ago
Interventions
Lapatinibdrug
oral lapatinib once daily
Trastuzumabbiological
IV trastuzumab 2mg/kg weekly after 4mg/kg loading dose