Overview

Study of Safety and Efficacy of Durvalumab in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer Patients

Status:
Completed

Trial end date:
2020-03-24

Target enrollment:

Participant gender:

Summary

The expression of PD-L1 in breast cancer has been previously demonstrated (Ghebeh et al 2006). In addition, PD-L1 has been shown to work as a "molecular shield", by protecting cancer cells from cytotoxic T-cells and chemotherapy induced apoptosis (Ghebeh et al 2008) suggesting to combine PD-L1 blockade with chemotherapy. This trial will test Durvalumab in combination with Paclitaxel on metastatic triple-negative breast cancer patients. The safety profile of Durvalumab as a monotherapy has been previously established (lu et al 2015). In this trial the safety profile and tolerability of Durvalumab given in combination of Paclitaxel will be tested. In addition, the efficacy of this combination on metastatic breast cancer will be monitored.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

King Faisal Specialist Hospital & Research Center

Collaborator:

AstraZeneca

Treatments:

Albumin-Bound Paclitaxel
Antibodies, Monoclonal
Durvalumab
Paclitaxel