Parameter | Group 1: BCD-022 (n = 113) | Group 2: Reference Trastuzumab (n = 110) | p-value | ||
---|---|---|---|---|---|
N | % (95% CI) | n | % (95% CI) | ||
Primary outcome measure | |||||
ORR | 56 | 49.6 (40.08–59.07) | 48 | 43.6 (34.31–53.41) | 0.452a |
Secondary outcome measure | |||||
CR | 4 | 3.5 (1.14–9.35) | 2 | 1.8 (0.32–7.06) | 0.683b |
PR | 52 | 46.0 (36.69–55.62) | 46 | 41.8 (32.6–51.61) | 0.619a |
ST | 28 | 24.8 (17.35–33.95) | 21 | 19.1 (12.46–27.93) | 0.388a |
PD | 25 | 22.1 (15.08–31.10) | 28 | 25.5 (17.84–34.81) | 0.670a |