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ipatasertib plus paclitaxel (n=146) vs. paclitaxel (n=76)
randomized controlled trial
ipatasertib plus paclitaxel
ipatasertib: PO 400mg daily on days 1-21 / paclitaxel: IV 80mg/m² on days 1, 8 and 15
placebo plus paclitaxel
paclitaxel: IV 80mg/m² on days 1, 8 and 15
la/mBC - HR positive - L1 - PIK3CA mutant
double blind
180 sites in worldwide (Asia, Australia, Europe, North America, South-Africa and South America)
P3 / PFS at 2-sided at 5% / OS with hierachically testing at 2-sided at 5%
Adding ipatasertib to paclitaxel did not improve PFS in patients with hr-positive and HER2-negative breast cancer (with PIK3CA altered)
ipatasertib plus paclitaxel (n=62) vs. Standard of Care (SoC) (n=62)
randomized controlled trial
ipatasertib plus paclitaxel
ipatasertib: 400mg/day PO on days1-21 of each 28-day cycle / paclitaxel: 80mg/m² on days 1, 8 and 15 of each 28-day cycle
placebo plus paclitaxel
placebo matching ipatasertib: PO on days1-21 of each 28-day cycle / paclitaxel: 80mg/m² on days 1, 8 and 15 of each 28-day cycle
mBC - TNBC - L1 - all population
Exclusion criteria: patients with known brain or spinal cord metastasis.
double-blind
44 hospitals in South Korea, USA, France, Spain, Taiwan, SIngapore, Italy and Belgium
P2 / exploratory results, no SAP
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