At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 3,166 enrolled
Drug / intervention
lapatinib +1 moredrug
Likely dose
lapatinib 1500 mgfrom 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, Double-blind, Multicenter, Placebo-controlled Study of Adjuvant Lapatinib (GW572016) in Women With Early-Stage ErbB2 Overexpressing Breast Cancer
In Brief
A Phase 3 clinical trial evaluating lapatinib and placebo for Neoplasms, Breast. Completed, enrolled 3,166 participants across 439 sites in 33 countries.
Detailed Summary
This study was designed to evaluate and compare the safety and efficacy of an oral dual tyrosine kinase inhibitor, lapatinib, versus placebo in women with early-stage ErbB2-overexpressing breast cancer who have completed their primary neoadjuvant or adjuvant chemotherapy and have no clinical or radiographic evidence of disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Breast
CountriesArgentina, Australia, Belgium, Brazil, Canada, Chile, China, Croatia, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Latvia, Lithuania, Mexico, New Zealand, Peru, Philippines, Poland, Russia, Slovakia, South Africa, South Korea, Spain, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2006
First PostedSep 2006
Primary CompletionSep 2011
Study CompletionJul 2013
TodayJul 2026
First PostedSep 11, 2006
Enrollment StartAug 1, 2006
Primary CompletionSep 1, 2011
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 19.8 years ago
Interventions
lapatinibdrug
Lapatinib 1500 mg (6 tablets) daily for 12 months
placeboother
6 tablets daily for 12 months