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taselisib plus letrozole (n=166) vs. letrozole (n=168)
randomized controlled trial
taselisib plus letrozole
taselisib: PO 4mg on a 5days-on, 2-days off for a total of 16 weeks / letrozole: PO 2.5mg/day
placebo plus letrozole
letrozole: PO 2.5mg/day
es-BC - HR-positive - 1st line (L1)
Exclusion criteria: metastatic or inoperable or bilateral or multicentric BC
double blind
85 hospitals in 22 countries worldwide
P2 / 2-sided at 20% -> split between objective response: 16% and pathological complete response: 4%. No adjustement for multiple comparison. No interim analysis.
The study was closed due to accrual follow-up ended at least visit 1mo after surgery.
buparlisib plus fulvestrant (n=427) vs. fulvestrant (n=424)
randomized controlled trial
buparlisib plus fulvestrant
buparlisib: PO 100mg/day starting on day 15 of cycle 1 to receive / fulvestrant: IM 500mg on days 1 and 15 of cycle 1 and on day 1 of subsequent 28-day cycles.
placebo plus fulvestrant
fulvestrant: IM 500mg on days 1 and 15 of cycle 1 and on day 1 of subsequent 28-day cycles.
la/mBC - HR positive
double blind
from 267 centres in 29 countries (Asia, Australia, Europe, North and South America, South Africa)
P3 / alpha at 1-sided at 0.025 -> split between PFS (main): p=0.02, then only if PFS (main) is significant, test of the PFS (full pop) p=0.014. For PFS (PI3K activated) p=0.005 but if PFS (main) is significant: p=0.01). / For OS (main): p=0.001 if PFS main is significant and OS (full pop) is not significant or p=0.015 if PFS (main), PFS (full pop) and OS (full pop) are all significant. For OS with PI3K activated, p=0.01 if PFS (main) and PFS (PI3K activated) are significant or p=0.005 if only PFS (PI3K activated) is significant. For OS (full pop), p=0.014 if only PFS (main) is sifnificant, or p=0.015 if PFS (main), PFS (full pop) and OS (main) are significant
buparlisib improve PFS, however it did not improve OS
alpelisib plus letrozole (n=131) vs. letrozole (n=126)
randomized controlled trial
alpelisib plus letrozole
alpelisib: PO 300mg/per day / letrozole: PO 2.5mg/per day (all trt were self-administered)
letrozole
letrozole: PO 2.5mg/per day (all trt were self-administered)
la/mBC - HR positive - (neo)adjuvant (NA)
Enrollment in the buparlisib arm was discontinued on December 22, 2015, due to the nontolerable toxicity profile associated with buparlisib; patients randomized after this date were assigned 1:1 to either alpelisib plus letrozole or placebo plus letrozole.
double blind
at 87 centers in 17 countries
P2 / Bayesian methods
Exploratory results
alpelisib plus letrozole (n=-9) vs. letrozole (n=126)
randomized controlled trial
alpelisib plus letrozole
alpelisib: PO 300mg/per day / letrozole: PO 2.5mg/per day (all trt were self-administered)
letrozole
letrozole: PO 2.5mg/per day (all trt were self-administered)
la/mBC - HR positive - (neo)adjuvant (NA)
Enrollment in the buparlisib arm was discontinued on December 22, 2015, due to the nontolerable toxicity profile associated with buparlisib; patients randomized after this date were assigned 1:1 to either alpelisib plus letrozole or placebo plus letrozole.
double blind
at 87 centers in 17 countries
P2 / Bayesian methods
Exploratory results
buparlisib plus letrozole (n=-9) vs. letrozole (n=-9)
randomized controlled trial
buparlisib plus letrozole
buparlisib: PO 100mg/per day / letrozole: PO 2.5mg/per day (all trt were self-administered)
letrozole
letrozole: PO 2.5mg/per day (all trt were self-administered)
la/mBC - HR positive - (neo)adjuvant (NA)
Enrollment in the buparlisib arm was discontinued on December 22, 2015, due to the nontolerable toxicity profile associated with buparlisib; patients randomized after this date were assigned 1:1 to either alpelisib plus letrozole or placebo plus letrozole.
double blind
at 87 centers in 17 countries
P2 / ORR at
Enrollment in the buparlisib arm was discontinued on December 22, 2015, due to the nontolerable toxicity profile associated with buparlisib (24); patients randomized after this datewere assigned 1:1 to either alpelisib plus letrozole or placebo plus letrozole.
buparlisib plus fulvestrant (n=576) vs. fulvestrant (n=571)
randomized controlled trial
buparlisib plus fulvestrant
buparlisib: PO 100mg/day starting on day 15 of cycle 1 to receive / fulvestrant: IM 500mg on days 1 and 15 of cycle 1 and on day 1 of subsequent 28-day cycles.
placebo plus fulvestrant
fulvestrant: IM 500mg on days 1 and 15 of cycle 1 and on day 1 of subsequent 28-day cycles.
la/mBC - HR positive - L2 - all population
double blind
from 267 centres in 29 countries (Asia, Australia, Europe, North and South America, South Africa)
P3 / alpha at 1-sided at 0.025 -> split between PFS (main): p=0.02, then only if PFS (main) is significant, test of the PFS (full pop) p=0.014. For PFS (PI3K activated) p=0.005 but if PFS (main) is significant: p=0.01). / For OS (main): p=0.001 if PFS main is significant and OS (full pop) is not significant or p=0.015 if PFS (main), PFS (full pop) and OS (full pop) are all significant. For OS with PI3K activated, p=0.01 if PFS (main) and PFS (PI3K activated) are significant or p=0.005 if only PFS (PI3K activated) is significant. For OS (full pop), p=0.014 if only PFS (main) is sifnificant, or p=0.015 if PFS (main), PFS (full pop) and OS (main) are significant
buparlisib plus fulvestrant (n=188) vs. fulvestrant (n=184)
randomized controlled trial
buparlisib plus fulvestrant
buparlisib: PO 100mg/day starting on day 15 of cycle 1 to receive / fulvestrant: IM 500mg on days 1 and 15 of cycle 1 and on day 1 of subsequent 28-day cycles.
placebo plus fulvestrant
fulvestrant: IM 500mg on days 1 and 15 of cycle 1 and on day 1 of subsequent 28-day cycles.
la/mBC - HR positive - L2 - PIK3CA mutant
double blind
from 267 centres in 29 countries (Asia, Australia, Europe, North and South America, South Africa)
P3 / alpha at 1-sided at 0.025 -> split between PFS (main): p=0.02, then only if PFS (main) is significant, test of the PFS (full pop) p=0.014. For PFS (PI3K activated) p=0.005 but if PFS (main) is significant: p=0.01). / For OS (main): p=0.001 if PFS main is significant and OS (full pop) is not significant or p=0.015 if PFS (main), PFS (full pop) and OS (full pop) are all significant. For OS with PI3K activated, p=0.01 if PFS (main) and PFS (PI3K activated) are significant or p=0.005 if only PFS (PI3K activated) is significant. For OS (full pop), p=0.014 if only PFS (main) is sifnificant, or p=0.015 if PFS (main), PFS (full pop) and OS (main) are significant
buparlisib did not improve PFS in patients with a PI3K pathway activated. Therefore, OS was not tested
alpelisib plus fulvestrant (n=169) vs. fulvestrant (n=172)
randomized controlled trial
alpelisib plus fulvestrant
alpelisib: PO 300 mg to be taken with food every day / fulvestrant: IM 500mg on days 1 and 15 of cycle 1 and on day 1 of subsequent 28-day cycles
placebo plus fulvestrant
fulvestrant: IM 500mg on days 1 and 15 of cycle 1 and on day 1 of subsequent 28-day cycles
la/mBC - HR-positive - 2nd line (L2)
double blind
in 198 trial centers in 34 countries
P3 /overall type I error at 1-sided at 2.5% level, with PFS in patients with PIK3CA mutant (1-sided at 2.0%) and PFS in patients with PIK3CA non-mutant (1-sided at 0.5%). / 1IA for efficacy for the first PFS, p = 0.0001 (and 0.0199 for the final analysis) / The type I error probability was controlled using an O’Briene-Fleming spending function independent of the Haybittlee-Peto spending function used for PFS; final OS would be statistically significant if P=< 0.0161.
alpelisib plus fulvestrant (n=115) vs. fulvestrant (n=116)
randomized controlled trial
alpelisib plus fulvestrant
alpelisib: PO 300 mg to be taken with food every day / fulvestrant: IM 500mg on days 1 and 15 of cycle 1 and on day 1 of subsequent 28-day cycles
placebo plus fulvestrant
fulvestrant: IM 500mg on days 1 and 15 of cycle 1 and on day 1 of subsequent 28-day cycles
la/mBC - HR-positive - 2nd line (L2)
double blind
in 198 trial centers in 34 countries
P3 / overall type I error at 1-sided at 2.5% level, with PFS in patients with PIK3CA mutant (1-sided at 2.0%) and PFS in patients with PIK3CA non-mutant (1-sided at 0.5%). / 1IA for efficacy for the first PFS, p = 0.0001 (and 0.0199 for the final analysis) / hierarchical testing approach for OS, at 2-sided at 2%
buparlisib plus fulvestrant (n=289) vs. fulvestrant (n=143)
randomized controlled trial
buparlisib plus fulvestrant
buparlisib: PO 100mg/day starting on day 1 of cycle 1 / fulvestrant: IM 500mg on days 1 and 15 of cycle 1 and on day 1 of each 28-day cycles.
placebo plus fulvestrant
fulvestrant: IM 500mg on days 1 and 15 of cycle 1 and on day 1 of each 28-day cycles.
la/mBC - HR-positive - 2nd line (L2)
double blind
200 trial centres in 22 countries
P3 / at 1-sided at 2.5%: fisrts PFS, if significant then OS (IA for OS)
Adding buparlisib to fulvestant increased significantly PFS in postmenopausal women with HR-positive BC
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