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.