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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 plus SoC (n=566) vs. placebo plus SoC (n=281)
randomized controlled trial
Pembrolizumab plus chemotherapy
200 mg of pembrolizumab every 3 weeks in combination with one of three chemotherapy options for up to 35 cycles plus chemotherapy ((nab-paclitaxel 100 mg/m2 on days 1, 8, and 15, every 28 days; paclitaxel 90 mg/m2 on days 1, 8, and 15, every 28 days; or gemcitabine 1000 mg/m2 plus carboplatin area under the curve 2 on days 1 and 8, every 21 days).
placebo plus chemotherapy
placebo plus chemotherapy for up to 35 cycles plus chemotherapy ((nab-paclitaxel 100 mg/m2 on days 1, 8, and 15, every 28 days; paclitaxel 90 mg/m2 on days 1, 8, and 15, every 28 days; or gemcitabine 1000 mg/m2 plus carboplatin area under the curve 2 on days 1 and 8, every 21 days). nab-paclitaxel (34%) paclitaxel (11%) gemcitabine/carboplatine (55%)
Crossover between treatment groups was not permitted. % in all population: nab-paclitaxel (31.6%) paclitaxel (13.5%) gemcitabine/carboplatine (54.9%)
mBC - TNBC - L1 - all population
PD-L1 status by immunohistochemistry at a central laboratory (an archival tumour sample was used with permission from the study
Double blind
209 sites in 29 countries in Europe, North America, Asia, Australia and New Zealand, and Latin Ameri
P3/ one sided (0.025) and two interim analysis (stopped). Split between progression- free survival (0·005), overall survival (0·018), and objective response rate (0·002) endpoints. Hierachical testing strategy for PFS : CPS of 10 or more > CPS of 1 or more > ITT population.
Pembrolizumab–chemotherapy showed a significant and clinically meaningful improvement in progression-free survival versus placebo–chemotherapy among patients with metastatic triple-negative breast cancer with CPS of 10 or more.
pembrolizumab plus SoC (n=425) vs. placebo plus SoC (n=211)
randomized controlled trial
Pembrolizumab plus chemotherapy
200 mg of pembrolizumab every 3 weeks in combination with one of three chemotherapy options for up to 35 cycles plus chemotherapy for up to 35 cycles plus chemotherapy ((nab-paclitaxel 100 mg/m2 on days 1, 8, and 15, every 28 days; paclitaxel 90 mg/m2 on days 1, 8, and 15, every 28 days; or gemcitabine 1000 mg/m2 plus carboplatin area under the curve 2 on days 1 and 8, every 21 days).
placebo plus chemotherapy
placebo plus chemotherapy for up to 35 cycles plus chemotherapy ((nab-paclitaxel 100 mg/m2 on days 1, 8, and 15, every 28 days; paclitaxel 90 mg/m2 on days 1, 8, and 15, every 28 days; or gemcitabine 1000 mg/m2 plus carboplatin area under the curve 2 on days 1 and 8, every 21 days). nab-paclitaxel (35%) paclitaxel (10%) gemcitabine/carboplatine (55%)
Crossover between treatment groups was not permitted. nab-paclitaxel (38.8%) paclitaxel (13.2%) gemcitabine/carboplatine (54.7%)
mBC - TNBC - L1 - PDL1 positive
PD-L1 status by immunohistochemistry at a central laboratory (an archival tumour sample was used with permission from the study
Double blind
209 sites in 29 countries in Europe, North America, Asia, Australia and New Zealand, and Latin Ameri
P3/ one sided (0.025) and two interim analysis (stopped). Split between progression- free survival (0·005), overall survival (0·018), and objective response rate (0·002) endpoints. Hierachical testing strategy for PFS : CPS of 10 or more > CPS of 1 or more > ITT population.
Pembrolizumab–chemotherapy showed a significant and clinically meaningful improvement in progression-free survival versus placebo–chemotherapy among patients with metastatic triple-negative breast cancer with CPS of 10 or more.
pembrolizumab plus SoC (n=220) vs. placebo plus SoC (n=103)
randomized controlled trial
Pembrolizumab plus chemotherapy
200 mg of pembrolizumab every 3 weeks in combination with one of three chemotherapy options for up to 35 cycles plus chemotherapy ((nab-paclitaxel 100 mg/m2 on days 1, 8, and 15, every 28 days; paclitaxel 90 mg/m2 on days 1, 8, and 15, every 28 days; or gemcitabine 1000 mg/m2 plus carboplatin area under the curve 2 on days 1 and 8, every 21 days).
placebo plus chemotherapy
placebo plus chemotherapy for up to 35 cycles plus chemotherapy ((nab-paclitaxel 100 mg/m2 on days 1, 8, and 15, every 28 days; paclitaxel 90 mg/m2 on days 1, 8, and 15, every 28 days; or gemcitabine 1000 mg/m2 plus carboplatin area under the curve 2 on days 1 and 8, every 21 days). nab-paclitaxel (29%) paclitaxel (15%) gemcitabine/carboplatine (56%)
Crossover between treatment groups was not permitted. nab-paclitaxel (30.7%) paclitaxel (13.6%) gemcitabine/carboplatine (55.7%)
mBC - TNBC - L1 - PDL1 positive
PD-L1 status by immunohistochemistry at a central laboratory (an archival tumour sample was used with permission from the study
Double blind
209 sites in 29 countries in Europe, North America, Asia, Australia and New Zealand, and Latin Ameri
P3/ one sided (0.025) and two interim analysis (stopped). Split between progression- free survival (0·005), overall survival (0·018), and objective response rate (0·002) endpoints. Hierachical testing strategy for PFS : CPS of 10 or more > CPS of 1 or more > ITT population.
Pembrolizumab–chemotherapy showed a significant and clinically meaningful improvement in progression-free survival versus placebo–chemotherapy among patients with metastatic triple-negative breast cancer with CPS of 10 or more.
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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