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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.
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