At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 621 enrolled
Drug / intervention
neratinib +2 moredrug
Likely dose
Not stated in 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 STUDY OF NERATINIB PLUS CAPECITABINE VERSUS LAPATINIB PLUS CAPECITABINE IN PATIENTS WITH HER2+ METASTATIC BREAST CANCER WHO HAVE RECEIVED TWO OR MORE PRIOR HER2-DIRECTED REGIMENS IN THE METASTATIC SETTING (NALA)
In Brief
A Phase 3 clinical trial evaluating neratinib, capecitabine, and 1 other intervention for HER2+ Metastatic Breast Cancer (MBC). Completed, enrolled 621 participants across 252 sites in 28 countries.
Detailed Summary
This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHER2+ Metastatic Breast Cancer (MBC)
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Portugal, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 2013
Enrollment StartMar 2013
Primary CompletionSep 2018
Study CompletionDec 2019
TodayJul 2026
First PostedMar 11, 2013
Enrollment StartMar 29, 2013
Primary CompletionSep 28, 2018
Study CompletionDec 9, 2019
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 13.3 years ago
Interventions
neratinibdrug
capecitabinedrug
lapatinibdrug