At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 40 enrolled
Drug / intervention
Pembrolizumab +1 moredrug
Likely dose
Pembrolizumab 200 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.
Phase II Study Of Single-dose Cyclophosphamide +Pembrolizumab In Patients With Metastatic Triple Negative Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab and Cyclophosphamide for Triple Negative Breast Cancer. Completed, enrolled 40 participants across 5 sites.
Detailed Summary
The purpose of this study is to evaluate pembrolizumab therapy in patients with triple-negative breast cancer (TNBC) who have received at least one prior line of therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTriple Negative Breast Cancer
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartOct 2016
Primary CompletionMay 2022
Study CompletionMay 2023
TodayJul 2026
First PostedMay 11, 2016
Enrollment StartOct 18, 2016
Primary CompletionMay 1, 2022
Study CompletionMay 1, 2023
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 10.1 years ago
Interventions
Pembrolizumabdrug
Subjects will be treated every 3 weeks with 200 mg of pembrolizumab via a 30 minute infusion.
Cyclophosphamidedrug
A single 300 mg/m2 dose of cyclophosphamide IV over 30-60 minutes will be administered on Day 1 of this study.