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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.
breast cancer - adjuvant
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 paclitxel followed by doxorubicin plus cyclophosphamide (n=69) vs. paclitaxel followed by doxorubicin plus cyclophosphamide (n=181)
randomized controlled trial
pembrolizumab plus paclitxel followed by doxorubicin plus cyclophosphamide
200mg intravenous pembrolizumab every 3weeks for 4 cycles plus standard NACT: 80 mg/m2 intravenous paclitaxel weekly for 12 weeks, followed by 4 cycles of 60 mg/m2 doxorubicin plus 600 mg/m2 intravenous cyclophosphamide every 2 to 3 weeks (AC).
paclitaxel followed by doxorubicin plus cyclophosphamide
standard NACT: 80 mg/m2 intravenous paclitaxel weekly for 12 weeks, followed by 4 cycles of 60 mg/m2 doxorubicin plus 600 mg/m2 intravenous cyclophosphamide every 2 to 3 weeks (AC).
If patients had an infusion reaction despite corticosteroid premedications, switching to nab-paclitaxel was allowed.
es-BC - HER2 negative - (neo)adjuvant (NA)
stage II or III breast cancer and primary tumors larger than 2.5 cmby clinical examination or larger than 2.0cmby imaging
open label
multicenter
P2 /two sided 0,05; BAYESIAN STUDY
the study did not meet its primary endpoint pCR
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.
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
atezolizumab plus nab-paclitaxel (n=451) vs. Standard of Care (SoC) (n=451)
randomized controlled trial
atezolizumab plus nab-paclitaxel
atezolizumab at a dose of 840 mg, administered intravenously, on days 1 and 15 and received nab-paclitaxel at a dose of 100 mg per square meter of body-sur- face area, administered intravenously, on days 1, 8, and 15 of every 28-day cycle
placebo plus nab-paclitaxel
placebo, administered intravenously, on days 1 and 15 and received nab-paclitaxel at a dose of 100 mg per square meter of body-sur- face area, administered intravenously, on days 1, 8, and 15 of every 28-day cycle
Dose reductions of atezolizumab or placebo were not permitted; No crossover is allowed.
mBC - TNBC - L1 - all population
double blind
246 academic centres and community oncology practices in 41 countries
P3/ two sided and two interim analysis. Repartition between coprimary endpoints, and hierarchy for OS (ITT then PDL1)
Atezolizumab plus nab-paclitaxel prolonged progression-free survival among patientswith metastatic triple-negative breast cancer in both the intention-to-treat populationand the PD-L1–positive subgroup.
atezolizumab plus paclitaxel (n=431) vs. Standard of Care (SoC) (n=220)
randomized controlled trial
Atezolizumab plus paclitaxel
atezolizumab at a dose of 840 mg on days 1 and 15 of every 28-day treatment cycle plus paclitaxel : 90 mg/m2 of paclitaxel on days 1, 8, and 15 of every 28-day cycle,
placebo plus paclitaxel
paclitaxel : 90 mg/m2 of paclitaxel on days 1, 8, and 15 of every 28-day cycle,
Patients received dexamethasone at least the first two infusions of paclitaxel (8-10mg or less).
mBC - TNBC - L1 - all population
double blind
multicenter, 150 sites in Europe, North and South America, Asia and Africa
P3 / all tests were performed at 2-sided with alpha at 0.05 with testing for secondary endpoints conducted hierarchically, using a fixed sequence testing approach. Each hypothesis was tested if all previous were rejected, order : PFS (PD-L1 pos pop) > PFS (ITT pop) > OS ((PD-L1 pos pop) > OS (ITT pop) > ORR (PD-L1 pos response evaluable pop) > ORR (response evaluable pop) / interim analysis for OS at the data cut off of the PFS (alpha level : 0.012 for OS interim analysis, and 0.046 for OS final analysis)
Atezolizumab plus paclitaxel did not significantly reduce the risk of cancer progression and death, when compared with paclitaxel plus placebo
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.
atezolizumab plus nab-paclitaxel (n=185) vs. Standard of Care (SoC) (n=184)
randomized controlled trial
atezolizumab plus nab-paclitaxel
atezolizumab at a dose of 840 mg, administered intravenously, on days 1 and 15 and received nab-paclitaxel at a dose of 100 mg per square meter of body-sur- face area, administered intravenously, on days 1, 8, and 15 of every 28-day cycle
placebo plus nab-paclitaxel
placebo, administered intravenously, on days 1 and 15 and received nab-paclitaxel at a dose of 100 mg per square meter of body-sur- face area, administered intravenously, on days 1, 8, and 15 of every 28-day cycle
Dose reductions of atezolizumab or placebo were not permitted;No crossover is allowed.
mBC - TNBC - L1 - PDL1 positive
double blind
246 academic centres and community oncology practices in 41 countries
P3/ two sided and two interim analysis. Repartition between coprimary endpoints, and hierarchy for OS (ITT then PDL1)
Atezolizumab plus nab-paclitaxel prolonged progression-free survival among patientswith metastatic triple-negative breast cancer in both the intention-to-treat populationand the PD-L1–positive subgroup.
atezolizumab plus paclitaxel (n=191) vs. Standard of Care (SoC) (n=101)
randomized controlled trial
Atezolizumab plus paclitaxel
atezolizumab at a dose of 840 mg on days 1 and 15 of every 28-day treatment cycle plus paclitaxel : 90 mg/m2 of paclitaxel on days 1, 8, and 15 of every 28-day cycle,
placebo plus paclitaxel
paclitaxel : 90 mg/m2 of paclitaxel on days 1, 8, and 15 of every 28-day cycle,
Patients received dexamethasone at least the first two infusions of paclitaxel (8-10mg or less).
mBC - TNBC - L1 - PDL1 positive
double blind
multicenter, 150 sites in Europe, North and South America, Asia and Africa
P3 / all tests were performed at 2-sided with alpha at 0.05 with testing for secondary endpoints conducted hierarchically, using a fixed sequence testing approach. Each hypothesis was tested if all previous were rejected, order : PFS (PD-L1 pos pop) > PFS (ITT pop) > OS ((PD-L1 pos pop) > OS (ITT pop) > ORR (PD-L1 pos response evaluable pop) > ORR (response evaluable pop) / interim analysis for OS at the data cut off of the PFS (alpha level : 0.012 for OS interim analysis, and 0.046 for OS final analysis)
Atezolizumab plus paclitaxel did not significantly reduce the risk of cancer progression and death, when compared with paclitaxel plus placebo
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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