At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 594 enrolled
Drug / intervention
Sunitinib malate +1 moredrug
Likely dose
Sunitinib malate 37.5 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 3 Study Of Docetaxel In Combination With Sunitinib Versus Docetaxel In The First-Line Treatment Of Advanced Breast Cancer Patients
In Brief
A Phase 3 clinical trial evaluating Sunitinib malate and Taxotere for Breast Neoplasms. Completed, enrolled 594 participants across 144 sites in 27 countries.
Detailed Summary
This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib combined with docetaxel versus docetaxel, administered as first-line treatment, in patients with unresectable locally recurrent or metastatic breast cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesArgentina, Australia, Austria, Belgium, Canada, Colombia, Czechia, Finland, France, Germany, Hungary, Ireland, Italy, Netherlands, Panama, Poland, Portugal, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2006
Enrollment StartFeb 2007
Primary CompletionFeb 2010
Study CompletionJul 2011
TodayJul 2026
First PostedOct 31, 2006
Enrollment StartFeb 1, 2007
Primary CompletionFeb 1, 2010
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 19.7 years ago
Interventions
Sunitinib malatedrug
Sunitinib 37.5 mg daily by oral capsule in schedule 2/1 with Docetaxel 75 mg/m2 every 3 weeks or 37. 5 mg daily in continuous dosing (in absence of docetaxel)
Taxoteredrug
Docetaxel 100 mg/m2 every 3 weeks in the comparator arm