Pyrotinib versus placebo in combination with trastuzumab and docetaxel as first line treatment in patients with HER2 positive metastatic breast cancer (PHILA): Randomised, double blind, multicentre, phase 3 trial

Data from a randomized, phase 3 trial of patients with untreated metastatic HER2-positive breast cancer demonstrated that treatment with pyrotinib plus trastuzumab and docetaxel significantly improved PFS, compared with placebo plus trastuzumab and docetaxel (24.3 months [95% CI: 19.1–33.0] vs 10.4 months [95% CI: 9.3–12.3]; HR 0.41 [95% CI: 0.32–0.53]; one sided P<0.001). Grade 3 treatment-related adverse events were reported in 90% of patients in the pyrotinib group and 76% of patients in the placebo group.