atezolizumab plus nab-paclitxel followed by doxorubicin plus cyclophosphamide (n=78) vs. placebo plus SoC (n=76)
randomized controlled trial
Atezolizumab plus nab-paclitaxel followed by doxorubicin and cyclophosphamide with filgrastim or pegfilgrastim support
atezolizumab at 840 mg every 2 weeks plus nab- paclitaxel (at 125 mg/m2 once per week for 12 weeks), followed by doxorubicin at 60 mg/m2 and cyclophosphamide at 600 mg/m2 every 2 weeks, with filgrastim or pegfilgrastim support for 8 weeks, breast surgery
placebo plus nab-paclitaxel followed by doxorubicin and cyclophosphamide with filgrastim or pegfilgrastim support
placebo every 2 weeks plus nab- paclitaxel (at 125 mg/m2 once per week for 12 weeks), followed by doxorubicin at 60 mg/m2 and cyclophosphamide at 600 mg/m2 every 2 weeks, with filgrastim or pegfilgrastim support for 8 weeks, breast surgery
es-BC - TNBC - NA - PDL1 positive
PD-L1 (>1%) status as measured by the VENTANA SP142 assay
double-blind
75 academic and community sites in 13 countries
P3/ one sided and one interim analysis. Same alpha (0.0184) for both coprimary endpoint, no testing strategy for secondary endpoints
In patients with early-stage TNBC, neoadjuvant treatment with atezolizumab in combination with nab-paclitaxel and anthracycline-based chemotherapy significantly improved pathological complete response rates