PHENIX

NCT02973737 📎

Regimen

Experimental
Pyrotinib 400 mg PO daily + capecitabine 1000 mg/m2 PO BID days 1-14, q3w.
Control
Placebo + capecitabine.

Population

HER2-positive metastatic breast cancer previously treated with taxanes, anthracyclines and trastuzumab, Chinese population.

Key finding

PHENIX was the pivotal registration trial that earned pyrotinib its first NMPA conditional approval in 2018. Established the platform for later PHOEBE and PHILA. Magnitude of PFS benefit (HR 0.18) is among the largest observed in HER2+ MBC.

Timeline

    Guideline citations

    • NCCN BREAST