LOTUS

NCT02162719 📎

Regimen

Experimental
Ipatasertib 400 mg once daily D1-21 + paclitaxel 80 mg/m2 D1,8,15 of 28-day cycles.
Control
Placebo + paclitaxel on same schedule.

Population

Locally advanced or metastatic triple-negative breast cancer without prior systemic therapy for advanced disease; biomarker-enriched analysis in PTEN-low and PIK3CA/AKT1/PTEN-altered subgroups.

Key finding

LOTUS showed PFS signal for AKT inhibitor ipatasertib + paclitaxel in 1L metastatic TNBC, enriched in PIK3CA/AKT1/PTEN-altered tumors. Phase 3 IPATunity130 later failed to confirm.

Source: PMID 28800861

Timeline

  • Publication: 2017 Oct

Guideline citations

  • NCCN BREAST