At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 18 enrolled
Drug / intervention
Trastuzumab +1 moredrug
Likely dose
Trastuzumab 4mg/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.
Phase I Open Label Trial to Assess Safety of BIBW 2992 in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer.
In Brief
A Phase 1 clinical trial evaluating Trastuzumab and BIBW 2992 for Breast Neoplasms. Completed, enrolled 18 participants across 5 sites.
Detailed Summary
Study to determine the Maximum Tolerated dose of BIBW 2992 given in combination with Herceptin®
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2009
First PostedAug 2009
Primary CompletionOct 2013
TodayJul 2026
First PostedAug 3, 2009
Enrollment StartAug 1, 2009
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 16.9 years ago
Interventions
Trastuzumabdrug
Load: 4mg/kg-maintain:2mg/kg/week
BIBW 2992drug
Increased dose cohorts from low dose to MTD