olaparib (n=205) vs. Standard of Care (SoC) (n=97)
randomized controlled trial
olaparib
olaparib: tablets 300mg twice daily
standard chemotherapy
capecitabine PO 2500 mg per square meter of body-surface area daily (divided into two doses) for 14 days, repeated every 21 days / eribulin mesylate IV 1.4 mg per square meter on day 1 and day 8, repeated every 21 days / or vinorelbine IV 30 mg per square meter on day 1 and day 8, repeated every 21 days.
mBC - TNBC - L2 - all population
Patients with hormone-receptor positive breast cancer had received at least one endocrine therapy.
open-label
169 centers in 18 countries (Asia, Europe, Mexico, Peru, USA)
P3 / PFS, PFS2 (time to 2nd progression) and OS will be tested at a 2-sided significance level of 5% in this order. No interim analysis for the PE (PFS). PFS2 and OS will be split between the initial and final analysis : A 2-sided significance level of 0.025 will be assigned to the initial analysis of PFS2 and OS
this study showed an improvement statistically significant for the PFS with the olaparib, however the OS was not different between groups.
EMBRACA, 2018 NCT01945775
talazoparib (n=287) vs. Standard of Care (SoC) (n=144)
randomized controlled trial
talazoparib
talazoparib: 1mg PO once daily continuously
P3 / PFS at 2-sided with a 0.05 level of significance. ORR then OS were tested after, hirearchically at a level of 0.05, if PFS was significant. Control of the type I error rate by employing a fixed-sequence testing procedure at 0.05 / An interim analysis for OS at the time of the unblinding PFS (if PFS and ORR are significant)
the overall survival was not significantly improved in the talazoprib group compared to chemotherapy group