At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 50 enrolled
Drug / intervention
BIBW 2992drug
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.
An Open Label Phase II Trial to Assess the Efficacy and Safety of a Once Daily Oral Dose of 50 mg BIBW 2992 in Two Cohorts of Patients With HER2-negative Metastatic Breast Cancer After Failure of no More Than Two Chemotherapy Regimen
In Brief
A Phase 2 clinical trial evaluating BIBW 2992 for Breast Neoplasms. Completed, enrolled 50 participants across 14 sites in 2 countries.
Detailed Summary
The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW 2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with HER2-negative breast cancer after failure of no more than three regimen of prior chemotherapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesBelgium, Germany
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2006
First PostedJan 2007
Primary CompletionMay 2009
TodayJul 2026
First PostedJan 23, 2007
Enrollment StartNov 1, 2006
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 19.4 years ago
Interventions
BIBW 2992drug
high dose once daily