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
KEYNOTE-119 (PDL1 CPS>10), 2019 NCT02555657
pembrolizumab alone (n=96) vs. Standard of Care (SoC) (n=98)
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
KEYNOTE-119 (PDL1 CPS>1), 2019 NCT02555657
pembrolizumab alone (n=203) vs. Standard of Care (SoC) (n=202)
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