Table 1.
Baseline demographic and other characteristics (ITT population)
| PF-05280014 plus paclitaxel (n = 352) | Trastuzumab-EU plus paclitaxel (n = 355) | Total (N = 707) | |
|---|---|---|---|
| Age, years | |||
| Mean (SD) | 54.0 (10.8) | 54.1 (10.9) | 54.1 (10.8) |
| Median (range) | 55.0 (19–80) | 54.0 (25–85) | 54.0 (19–85) |
| Weight, kg | |||
| Mean (SD) | 69.1 (17.1) | 68.1 (16.1) | 68.6 (16.6) |
| Median (range) | 68.2 (29–147) | 66.0 (36–139) | 67.0 (29–147) |
| Race, n (%) | |||
| White | 232 (65.9) | 244 (68.7) | 476 (67.3) |
| Black | 5 (1.4) | 8 (2.3) | 13 (1.8) |
| Asian | 104 (29.5) | 84 (23.7) | 188 (26.6) |
| Other | 11 (3.1) | 19 (5.4) | 30 (4.2) |
| Time since initial diagnosis of breast cancera | |||
| Mean (SD), months | 24.8 (37.81) | 22.4 (29.83) | 23.6 (34.02) |
| Missing, n | 9 | 7 | 16 |
| Histopathological classification, n (%) | |||
| Ductal | 278 (79.0) | 277 (78.0) | 555 (78.5) |
| Lobular | 14 (4.0) | 17 (4.8) | 31 (4.4) |
| Unknown | 4 (1.1) | 3 ( < 1.0) | 7 ( < 1.0) |
| Other | 56 (15.9) | 58 (16.3) | 114 (16.1) |
| Disease site,b n (%) | |||
| Lung | 186 (52.8) | 185 (52.1) | 371 (52.5) |
| Liver | 146 (41.5) | 166 (46.8) | 312 (44.1) |
| Lymph node | 259 (73.6) | 252 (71.0) | 511 (72.3) |
| Skin | 45 (12.8) | 33 (9.3) | 78 (11.0) |
| Bone | 183 (52.0) | 177 (49.9) | 360 (50.9) |
| Brain | 4 (1.1) | 4 (1.1) | 8 (1.1) |
| Breast | 192 (54.5) | 191 (53.8) | 383 (54.2) |
| Other | 68 (19.3) | 82 (23.1) | 150 (21.2) |
| Oestrogen receptor status, n (%) | |||
| Positive | 184 (52.3) | 184 (51.8) | 368 (52.1) |
| Negative | 168 (47.7) | 171 (48.2) | 339 (47.9) |
| Prior trastuzumab exposure, n (%) | |||
| Yes | 33 (9.4) | 39 (11.0) | 72 (10.2) |
| No | 319 (90.6) | 316 (89.0) | 635 (89.8) |
| ECOG score, n (%) | |||
| 0 | 186 (52.8) | 194 (54.6) | 380 (53.7) |
| 1 | 150 (42.6) | 146 (41.1) | 296 (41.9) |
| 2 | 16 (4.5) | 15 (4.2) | 31 (4.4) |
| LVEF result, % | |||
| Mean (SD) | 65.4 (5.84) | 65.3 (6.20) | 65.3 (6.02) |
ECOG Eastern Cooperative Oncology Group, ITT intent-to-treat, LVEF left ventricular ejection fraction, SD standard deviation, trastuzumab-EU reference trastuzumab sourced from the European Union
aDefined as time from initial diagnosis to first dose on Cycle 1 Day 1
bData for disease sites recorded as “No” or “Not Assessed” are not presented