A randomized phase II study to investigate the addition of PD L1 antibody MEDI4736 to a taxane anthracycline containing chemotherapy in triple negative breast cancer (TNBC).
Introduction
A randomized, double-blind, multicenter phase II study to compare the pathological complete response rate (pCR = ypT0 ypN0) of neoadjuvant treatment with sequentially administered nab-paclitaxel followed by EC +/- PD-L1 antibody MEDI4736 in patients with early breast cancer (TNBC).
News
Status: Recruitment completed
Design
This is a multicenter, prospective, randomized, double-blinded, placebo controlled phase II study to test the addition of immunotherapy with the PD-L1 antibody MEDI4736 to standard taxane/anthracycline - based neoadjuvant therapy in patients with untreated early triple negative breast cancer.
Patients will be randomized in a 1:1 ratio to
MEDI4736 / Placebo
Part 1: MEDI4736/Placebo in combination with nab-paclitaxel 125 mg/m² every week for 12 weeks
Part 2: MEDI4736/Placebo in combination with epirubicin 90mg/m² plus cyclophosphamide 600 mg/m² every 2 weeks for 4 cycles
