At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 112 enrolled
Drug / intervention
Vinorelbine +2 moredrug
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.
A Phase II, Randomised, Multi-Centre Study Evaluating Lapatinib in Combination With Vinorelbine or Capecitabine in Women With ErbB2 Overexpressing Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Vinorelbine, Lapatinib, and 1 other intervention for Cancer. Completed, enrolled 112 participants across 53 sites in 10 countries.
Detailed Summary
This is a randomized, parallel-arm, open-label, multi-centre, Phase II study to determine the efficacy and safety of lapatinib in combination with vinorelbine or capecitabine in women with ErbB2 overexpressing metastatic breast cancer (MBC) who have received no more than one chemotherapeutic regimen in the metastatic setting.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer
CountriesBulgaria, Chile, France, Germany, Greece, Italy, Mexico, Poland, Serbia, Spain
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2009
Enrollment StartNov 2009
Primary CompletionAug 2012
Study CompletionMar 2016
TodayJul 2026
First PostedNov 16, 2009
Enrollment StartNov 25, 2009
Primary CompletionAug 21, 2012
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 16.6 years ago
Interventions
Vinorelbinedrug
Vinorelbine
Lapatinibdrug
Lapatinib
Capecitabinedrug
Capecitabine