At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 45 enrolled
Drug / intervention
HKI-272 +1 moredrug
Likely dose
trastuzumab 4 mg/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 Phase I/II Study of HKI-272 in Combination With Trastuzumab (Herceptin) in Subjects With Advanced Breast Cancer
In Brief
A Phase 2 clinical trial evaluating HKI-272 and trastuzumab for Advanced Breast Cancer. Completed, enrolled 45 participants across 14 sites in 4 countries.
Detailed Summary
The purpose of this study is to determine the safety and efficacy of HKI-272 (neratinib) in combination with trastuzumab in patients with advanced breast cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Breast Cancer
CountriesChina, France, Switzerland, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2006
Enrollment StartApr 2007
Primary CompletionJul 2009
Study CompletionMar 2018
TodayJul 2026
First PostedNov 10, 2006
Enrollment StartApr 4, 2007
Primary CompletionJul 31, 2009
Study CompletionMar 2, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 19.6 years ago
Interventions
HKI-272drug
HKI-272 by mouth
trastuzumabdrug
trastuzumab 4 mg/kg IV as a loading dose followed by trastuzumab 2 mg/kg weekly thereafter