Table 1.
Summary of pharmacokinetic parameters
| Drug substance (treatment arm) |
C
max
Cycle 1 (μg/mL) |
C
min
Cycle 1 (μg/mL) |
C
min
Cycle 3 (μg/mL) |
C
max
Cycle 4 (μg/mL) |
C
min
Cycle 5 (μg/mL) |
C
min
Cycle 7 (μg/mL) |
C
max
Cycle 8 (μg/mL) |
|---|---|---|---|---|---|---|---|
| Pertuzumab (pertuzumab arm) | |||||||
| n | 374 | 349 | 305 | 302 | 274 | 114 | 106 |
| Mean (SD) | 258 (90.3) | 42.4 (24.8) | 90.4 (42.4) | 341(111) | 114 (51.8) | 142 (67.9) | 371 (127) |
| Trastuzumab (pertuzumab arm) | |||||||
| n | 372 | 345 | 305 | 304 | 274 | 114 | 115 |
| Mean (SD) | 142 (86.8) | 15.4 (11.3) | 22.9 (12.7) | 127 (50.9) | 26.3 (14.8) | 32.7 (15.0) | 130 (50.8) |
| Trastuzumab (placebo arm) | |||||||
| n | 375 | 354 | 300 | 299 | 254 | 92 | 90 |
| Mean (SD) | 139 (58.6) | 17.2 (15.4) | 24.1 (19.0) | 129 (58.1) | 29.8 (21.9) | 37.4 (20.3) | 147 (90.2) |
Cmax peak (maximum) serum concentration, Cmin serum trough (minimum) concentration, SD standard deviation