At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 56 enrolled
Drug / intervention
Neratinib +4 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 Phase II Study of Neratinib Alone and in Combination With Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Neratinib, Fulvestrant, and 3 other interventions for Breast Neoplasms. Completed, enrolled 56 participants across 17 sites in 2 countries.
Detailed Summary
This phase II study will test cancer to see if it has a HER2 mutation and, if so, see how HER2 mutated cancer responds to treatment with neratinib.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesCanada, United States
CollaboratorsPuma Biotechnology, Inc., United States Department of Defense
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 2012
Enrollment StartDec 2012
Primary CompletionFeb 2021
Study CompletionMar 2021
TodayJul 2026
First PostedAug 22, 2012
Enrollment StartDec 11, 2012
Primary CompletionFeb 11, 2021
Study CompletionMar 11, 2021
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 13.9 years ago
Interventions
Neratinibdrug
Fulvestrantdrug
Trastuzumabdrug
Tumor biopsyprocedure
-Optional at baseline and disease progression
Research blood sampleprocedure
-Baseline, cycle 1 day 15, cycle 2 day 1, cycle 3 day 1, day 1 of each odd cycle, end of treatment (progression)