At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 563 enrolled
Drug / intervention
Neratinib +3 moredrug
Likely dose
Colestipol 2 gfrom 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.
An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide
In Brief
A Phase 2 clinical trial evaluating Neratinib, Loperamide, and 2 other interventions for Early Stage HER2+ Breast Cancer. Completed, enrolled 563 participants across 58 sites in 7 countries.
Detailed Summary
An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated with Neratinib and Loperamide or other prophylactic measures.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEarly Stage HER2+ Breast Cancer
CountriesAustralia, Austria, Canada, France, Germany, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartFeb 2015
First PostedMar 2015
Primary CompletionApr 2021
TodayJul 2026
First PostedMar 27, 2015
Enrollment StartFeb 1, 2015
Primary CompletionApr 22, 2021
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 11.3 years ago
Interventions
Neratinibdrug
Loperamidedrug
Colestipoldrug
2 g twice daily with or without food for one 28 day cycle
Budesonidedrug
9 mg extended release tablets once daily with or without food for 28 days