Patient population
DISEASE CHARACTERISTIC
This analysis was performed after all patients completed the study at a median follow-up of 37.7 months (Q1-Q3, 37.3–38.1 months). The mFAS comprised 502 randomized and treated patients, among whom 250 (49.8%) were in the HD201 group and 252 (50.2%) were in the referent trastuzumab group and were included between February 19 and September 21, 2018, across 70 centers in 12 countries. A total of 28 patients with mFAS were excluded from the PPS (12 patients in the HD201 treatment group and 16 patients in the referent trastuzumab group). The PPS thus comprised 238 patients in the HD201 treatment group and 236 patients in the referent trastuzumab treatment group. Baseline demographics and disease characteristics were well balanced between the study arms as reported previously [