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talazoparib (n=287) vs. Standard of Care (SoC) (n=144)
randomized controlled trial
talazoparib
talazoparib: 1mg PO once daily continuously
chemotherapy
protocol-specified single-agent chemotherapy (capecitabine, eribulin, gemcitabine, orvinorelbine) in coutinuous 21-day cycle
mBC-Triple negative (TNBC) - 2nd Line (L2)
open-label
145 sites in 16 countries
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
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