atezolizumab plus carboplatin plus nab-paclitaxel (n=88) vs. carboplatin plus nab-paclitaxel (n=86)
randomized controlled trial
atezolizumab plus carboplatine plus nab-paclitaxel
day 1 every 3 weeks plus carboplatine AUC 2 plus nab-paclitaxel 125mg/m2 weekly for 2 weeks every 3 weeks for 8 cycle
carboplatine plus nab-paclitaxel
carboplatine AUC 2 plus nab-paclitaxel 125mg/m2 weekly for 2 weeks every 3 weeks for 8 cycle
all patient received the treatment followed by surgery, and 4 cycles f AC/EC/FEC
es-BC - TNBC - NA - all population
open label
Addition of atezolizumab to neoadjuvant chemo (carboplatin plus nab-paclitaxel) did not improve pCR rate (secondary endpoint), 5 year EFS (primary endpoint) is not reported yet
IMpassion-031 (all population), 2020 NCT03197935
atezolizumab plus nab-paclitxel followed by doxorubicin plus cyclophosphamide (n=165) vs. placebo plus SoC (n=168)
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 - all population
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.