olaparib
olaparib: 300mg twice a day PO (2 tablets of 150mg at the same time each morning and evening of each day with approximately 240mL of water (12 hours appart))
placebo
placebo: PO 2 tablets at the same time each morning and evening of each day with approximately 240mL of water (12 hours appart))
es-BC - TNBC - NA - all population
Exclusion criteria: any previous treatment with a PARP inhibitor
double-blind
in 420 centers across 23 countries
P3 / IDFS at 2-sided 5% (2.5% 1-sided), with 1 IA at 0.005 level. / If IDFS is statistically significant, alpha level will be split for DDFS (4%) and OS (1%), 2 IA dos DDFS and 3 IA for OS. If DDFS is statistically significant, aplha level for DDFS will be recylced to OS and split across the planned analyses (and vice versa if OS is significant, level alpha for OS will be recyled to DDFS) see p-value in protocol.
Results from ESMO virutal plenary
OlympiAD, 2017 NCT02000622
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.