At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 209 enrolled
Drug / intervention
LCL161 +1 moredrug
Likely dose
LCL161 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 Phase II Multi-center, Open-label, Neoadjuvant, Randomized Study of Weekly Paclitaxel With or Without LCL161 in Patients With Triple Negative Breast Cancer
In Brief
A Phase 2 clinical trial evaluating LCL161 and paclitaxel for Breast Cancer. Completed, enrolled 209 participants across 50 sites in 12 countries.
Detailed Summary
To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer whose tumors are positive for a defined pattern of gene expression
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustralia, Brazil, Czechia, Germany, Ireland, Italy, Russia, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartAug 2012
Primary CompletionSep 2014
TodayJul 2026
First PostedJun 12, 2012
Enrollment StartAug 1, 2012
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.1 years ago
Interventions
LCL161drug
LCL161 was available as 300 mg, tablets, which was supplied in child-resistant bottles.
paclitaxeldrug
Commercially available paclitaxel was sourced locally by each study site. Generic paclitaxel could be used for study treatment. iv 80mg/m2