durvalumab followed by nab-paclitaxel
injection durvalumab 0.75g i.v. mono- therapy 2 weeks before start of chemotherapy (window-phase) followed by durvalumab 1.5g i.v. every 4weeks (q4 wks) plus nab- paclitaxel 125 mg/m2 weekly for 12 weeks, followed by durvalumab 1.5 g i.v./placebo q4 wks plus EC q2 wks for 4 cycles
placebo followed by nab-paclitaxel
injection of i.v./placebo 2 weeks before start of chemotherapy (window-phase) followed by placebo every 4weeks (q4 wks) plus nab- paclitaxel 125 mg/m2 weekly for 12 weeks, followed by placebo q4 wks plus EC q2 wks for 4 cycles
treatment given every 4 weeks in addition to nab-paclitaxel followed by standard dose-dense epirubicin/cyclophosphamide (EC)
es-BC - TNBC - NA - all population
patients with primary non-metastatic TNBC, centrally confirmed TNBC (triple-negative breast cancer) and sTils (stromal tumour-infiltrating lymphocyte)
double blind
multicenter (no more info)
P2/ two sided and Pre-planned safety interim analyse. Alpha = 0.2 (20%) no hierarchy/repartition only OS
this study did not demontrate that the addition of durvalumab to anthracycline-/taxane-based NACT significantly increases pCR rate particularly in patients treated with durvalumab alone before start of chemotherapy.