At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,840 enrolled
Drug / intervention
neratinib +1 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 Randomized, Double-Blind, Placebo-Controlled Trial Of Neratinib (HKI-272) After Trastuzumab In Women With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer
In Brief
A Phase 3 clinical trial evaluating neratinib and placebo for Breast Cancer. Completed, enrolled 2,840 participants across 494 sites in 40 countries.
Detailed Summary
The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustralia, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, North Macedonia, Peru, Poland, Romania, Serbia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, The Bahamas, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2009
Enrollment StartJul 2009
Primary CompletionAug 2014
Study CompletionOct 2019
TodayJul 2026
First PostedApr 9, 2009
Enrollment StartJul 9, 2009
Primary CompletionAug 21, 2014
Study CompletionOct 4, 2019
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 17.2 years ago
Interventions
neratinibdrug
placeboother