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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
pembrolizumab alone (n=312) vs. Standard of Care (SoC) (n=310)
randomized controlled trial
Pembrolizumab
200 mg pembrolizumab administered intravenously every3 weeks
chemotherapy (single agent)
investigator-choice chemotherapy (capecitabine, eribulin,gemcitabine, or vinorelbine; 60% enrolment cap for each).
chemotherapy group were not permitted to crossover to receive pembrolizumab.
mBC - TNBC - L2 - all population
Participants were excluded if they had active CNSmetastases or carcinomatous meningitis
open label
150 medical centres in 31 countries
P3/ one sided and one interim analysis. Repartition between OS CPS 10 and 1 and then hierarchical testing procedure with all randomized population
Pembrolizumab did not significantly improve overall survival in patients with previously treatedmetastatic triple-negative breast cancer versus chemotherapy
pembrolizumab alone (n=203) vs. Standard of Care (SoC) (n=202)
randomized controlled trial
Pembrolizumab
200 mg pembrolizumab administered intravenously every3 weeks
chemotherapy (single agent)
investigator-choice chemotherapy (capecitabine, eribulin,gemcitabine, or vinorelbine; 60% enrolment cap for each).
chemotherapy group were not permitted to crossover to receive pembrolizumab.
mBC - TNBC - L2 - PDL1 positive
Participants were excluded if they had active CNSmetastases or carcinomatous meningitis
open label
150 medical centres in 31 countries
P3/ one sided and one interim analysis. Repartition between OS CPS 10 and 1 and then hierarchical testing procedure with all randomized population
Pembrolizumab did not significantly improve overall survival in patients with previously treatedmetastatic triple-negative breast cancer versus chemotherapy
pembrolizumab alone (n=96) vs. Standard of Care (SoC) (n=98)
randomized controlled trial
Pembrolizumab
200 mg pembrolizumab administered intravenously every3 weeks
chemotherapy (single agent)
investigator-choice chemotherapy (capecitabine, eribulin,gemcitabine, or vinorelbine; 60% enrolment cap for each).
chemotherapy group were not permitted to crossover to receive pembrolizumab.
mBC - TNBC - L2 - PDL1 positive
Participants were excluded if they had active CNSmetastases or carcinomatous meningitis
open label
150 medical centres in 31 countries
P3/ one sided and one interim analysis. Repartition between OS CPS 10 and 1 and then hierarchical testing procedure with all randomized population
Pembrolizumab did not significantly improve overall survival in patients with previously treatedmetastatic triple-negative breast cancer versus chemotherapy
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