capivasertib plus paclitaxel (n=54) vs. paclitaxel (n=56)
randomized controlled trial
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
placebo plus paclitaxel
paclitaxel: 90 mg/m2 in 4-weekly cycles
la/mBC - HR-positive - 1st line (L1)
double blind
Asia, Canada, Europe, South America
P2 / PFS at 1-sided at 10%
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.