At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 302 enrolled
Drug / intervention
ABI-007 +1 moredrug
Likely dose
ABI-007 300 mgfrom 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 Randomized Phase II Study of Weekly or Every 3 Weeks ABI-007 Versus Every 3 Weeks Taxotere as First Line Therapy of Stage IV (Metastatic) Breast Cancer
In Brief
A Phase 2 clinical trial evaluating ABI-007 and Docetaxel for Metastatic Breast Cancer. Completed, enrolled 302 participants across 1 site.
Detailed Summary
This was an open-label study conducted comparing the toxicity and antitumor activity of ABI-007 (Abraxane®, nab®-paclitaxel) to docetaxel (Taxotere).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesUkraine
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2005
First PostedJan 2006
Primary CompletionMar 2008
Study CompletionJul 2011
TodayJul 2026
First PostedJan 11, 2006
Enrollment StartNov 1, 2005
Primary CompletionMar 1, 2008
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.5 years ago
Interventions
ABI-007drug
ABI-007 administered by intravenous infusion over 30 minutes at one of three different dosing levels (100, 150 or 300 mg/m\^2) with a treatment cycle length of either 3 or 4 weeks depending upon treatment arm assignment.
Docetaxeldrug
Docetaxel dosed q3w at 100 mg/m\^2