Overview

Neoadjuvant Pembrolizumab(Pbr)/Nab-Paclitaxel Followed by Pbr/Epirubicin/Cyclophosphamide in TNBC

Status:
Completed
Trial end date:
2021-01-22
Target enrollment:
Participant gender:
Summary
Despite its aggressiveness and high incidence, to date, no targeted therapies exist for the treatment of triple negative breast cancer (TNBC). Emerging evidence suggests a crucial role of tumor immunology on outcome for this entity. Checkpoint inhibitors like pembrolizumab, which target immune cells within the tumor, might therefore have an important impact on therapy response and outcome in these high risk patients. We propose a phase II study exploring pathological complete response and the safety of the combination of pembrolizumab and nab-paclitaxel as well as the combination of pembrolizumab with epirubicin and cyclophosphamide in the neoadjuvant setting for women with early TNBC. After completion of this study an extension will be determined.
Phase:
Phase 2
Details
Lead Sponsor:
Institut fuer Frauengesundheit
Collaborators:
Celgene Corporation
Merck Sharp & Dohme Corp.
Treatments:
Albumin-Bound Paclitaxel
Cyclophosphamide
Epirubicin
Paclitaxel
Pembrolizumab