Table 1 Baseline demographics and disease characteristics
| Â | Pyrotinib, trastuzumab, and docetaxel (n=178) | Placebo, trastuzumab, and docetaxel (n=177) |
|---|---|---|
Age, years | ||
 Median (IQR) | 50 (43 to 55) | 50 (44 to 55) |
 ≤40 | 37 (20.8%) | 32 (18.1%) |
 41 to 64 | 130 (73.0%) | 140 (79.1%) |
 ≥65 | 11 (6.2%) | 5 (2.8%) |
ECOG performance status | ||
 0 | 172 (97.2%) | 172 (96.6%) |
 1 | 5 (2.8%) | 6 (3.4%) |
Clinical status of lymph nodes | ||
 N0 | 41 (23.0%) | 48 (27.1%) |
 N1 | 101 (56.7%) | 93 (52.5%) |
 N2 | 27 (15.2%) | 22 (12.4%) |
 N3 | 9 (5.1%) | 14 (7.9%) |
Clinical stage | ||
 II | 128 (71.9%) | 125 (70.6%) |
 III | 50 (28.1%) | 52 (29.4%) |
Hormone receptor status | ||
 ER and/or PR positive | 97 (54.5%) | 98 (55.4%) |
 ER and PR negative | 81 (45.5%) | 79 (44.6%) |
Primary tumor size | ||
 >2 cm and ≤5 cm | 156 (87.6%) | 155 (87.6%) |
 >5 cm | 22 (12.4%) | 22 (12.4%) |