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LOTUS, 2017 NCT02162719

ipatasertib plus paclitaxel (n=62) vs. Standard of Care (SoC) (n=62)

randomized controlled trial

Studied treatment

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

Control treatment

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

Patients

mBC - TNBC - L1 - all population

Exclusion criteria: patients with known brain or spinal cord metastasis.

Method

double-blind

44 hospitals in South Korea, USA, France, Spain, Taiwan, SIngapore, Italy and Belgium

P2 / exploratory results, no SAP

Remark