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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
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.
durvalumab alone (n=88) vs. placebo (n=86)
randomized controlled trial
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.
pembrolizumab alone (n=784) vs. placebo (n=390)
randomized controlled trial
pembrolizumab
infusion of pembrolizumab (200 mg) every 3 weeks
placebo
infusion of placebo every 3 weeks
the two groups then received an additional four cycles of pembrolizumab or placebo, and both groups received doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide, after definitive surgery, the patients received adjuvant pembrolizumab or placebo every 3 weeks for up to nine cycles. No crossover was permitted between the phases.
es-BC - TNBC - NA - all population
double blind
from 181 sites (plus 2 satellite sites) in 21 countries
P3/ one sided (0,025) two interim analysis. Repartition 0,005 pCR 0,02 EFS
Among patients with early triple-negative breast cancer, the percentage with a pathological complete response was significantly higher among those who received pembrolizumab plus neoadjuvant chemotherapy than among those who received placebo plus neoadjuvant chemotherapy. results for final EFS are not yet published
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
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