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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)

BEECH, 2019 NCT01625286

capivasertib plus paclitaxel (n=54) vs. paclitaxel (n=56)

randomized controlled trial

Studied treatment

capivasertib plus paclitaxel
capivasertib: PO twice daily, each week paclitaxel was received, 2 intermittent dosing schedules of schedule 1 (2 days on then 5 days off treatment, starting at a dose of 560mg) and schedule 2 (4 days on then 3 days off treatment, starting at a dose of 36mg) / paclitaxel: 90 mg/m2 in 4-weekly cycles

Control treatment

placebo plus paclitaxel
paclitaxel: 90 mg/m2 in 4-weekly cycles

Patients

la/mBC - HR-positive - 1st line (L1)

Method

double blind

Asia, Canada, Europe, South America

P2 / PFS at 1-sided at 10%

Remark

Adding capivasertib to weekly paclitaxel seemed to not prolong PFS in the overall population or PIK3CAþ sub-population of ERþ/HER2 advanced/metastatic breast cancer patients.