At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 622 enrolled
Drug / intervention
pembrolizumab +4 morebiological
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 Randomized Open-Label Phase III Study of Single Agent Pembrolizumab Versus Single Agent Chemotherapy Per Physician's Choice for Metastatic Triple Negative Breast Cancer (mTNBC) - (KEYNOTE-119)
In Brief
A Phase 3 clinical trial evaluating pembrolizumab, capecitabine, and 3 other interventions for Metastatic Triple Negative Breast Cancer. Completed, enrolled 622 participants.
Detailed Summary
In this study, participants with metastatic triple negative breast cancer (mTNBC) will be randomly assigned to receive either single agent pembrolizumab or single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines, consisting of either capecitabine, eribulin, gemcitabine, or vinorelbine. The primary study hypothesis is that pembrolizumab extends overall survival compared to TPC.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Triple Negative Breast Cancer
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2015
Enrollment StartOct 2015
Primary CompletionApr 2019
Study CompletionNov 2020
TodayJul 2026
First PostedSep 21, 2015
Enrollment StartOct 13, 2015
Primary CompletionApr 11, 2019
Study CompletionNov 10, 2020
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 10.8 years ago
Interventions
pembrolizumabbiological
capecitabinedrug
eribulindrug
gemcitabinedrug
vinorelbinedrug