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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.
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