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IPATunity130, 2022 NCT03337724

ipatasertib plus paclitaxel (n=146) vs. paclitaxel (n=76)

randomized controlled trial

Studied treatment

ipatasertib plus paclitaxel
ipatasertib: PO 400mg daily on days 1-21 / paclitaxel: IV 80mg/m² on days 1, 8 and 15

Control treatment

placebo plus paclitaxel
paclitaxel: IV 80mg/m² on days 1, 8 and 15

Patients

la/mBC - HR positive - L1 - PIK3CA mutant

Method

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%

Remark

Adding ipatasertib to paclitaxel did not improve PFS in patients with hr-positive and HER2-negative breast cancer (with PIK3CA altered)