Table 1.
Characteristics of the patients (overall and per randomization arm).
| All patients | Trastuzumab + lapatinib | Trastuzumab alone | Trastuzumab followed by lapatinib | |
|---|---|---|---|---|
| N (%) | 2794 (100.0) | 925 (100.0) | 936 (100.0) | 933 (100.0) |
| Age at randomization | ||||
| ≤40 | 495 (17.7) | 161 (17.4) | 160 (17.1) | 174 (18.7) |
| 41–64 | 1989 (71.2) | 667 (72.1) | 667 (71.3) | 655 (70.2) |
| ≥65 | 310 (11.1) | 97 (10.5) | 109 (11.7) | 104 (11.2) |
| Ethnicity | ||||
| Asian | 606 (21.7) | 201 (21.7) | 200 (21.4) | 205 (22.0) |
| Black | 59 (2.1) | 28 (3.0) | 14 (1.5) | 17 (1.8) |
| White | 2001 (71.6) | 657 (71.0) | 677 (72.3) | 667 (71.5) |
| Other/missing | 128 (4.6) | 39 (4.2) | 45 (4.8) | 44 (4.7) |
| Histology | ||||
| Ductal | 2605 (93.2) | 868 (93.8) | 867 (92.6) | 870 (93.2) |
| Lobular | 101 (3.6) | 34 (3.7) | 38 (4.1) | 29 (3.1) |
| Others | 119 (4.3) | 35 (3.8) | 43 (4.6) | 41 (4.4) |
| Central HR status | ||||
| Negative | 1185 (42.4) | 393 (42.5) | 398 (42.5) | 394 (42.2) |
| Positive | 1609 (57.6) | 532 (57.5) | 538 (57.5) | 539 (57.8) |
| Number of positive lymph nodes | ||||
| 0 | 567 (25.5) | 180 (24.7) | 200 (26.5) | 187 (25.3) |
| 1–3 | 945 (42.6) | 319 (43.8) | 314 (41.6) | 312 (42.3) |
| ≥4 | 709 (31.9) | 230 (31.6) | 240 (31.8) | 239 (32.4) |
| Tumor size (mm) | ||||
| ≤20 mm | 1248 (44.7) | 397 (42.9) | 436 (46.6) | 415 (44.5) |
| 21–50 mm | 1356 (48.5) | 466 (50.4) | 439 (46.9) | 451 (48.3) |
| >50 mm | 190 (6.8) | 62 (6.7) | 61 (6.5) | 67 (7.2) |
| Tumor grade | ||||
| 1 | 79 (2.8) | 26 (2.8) | 22 (2.4) | 31 (3.3) |
| 2 | 936 (33.6) | 310 (33.6) | 295 (31.6) | 331 (35.6) |
| 3 | 1698 (60.9) | 561 (60.9) | 589 (63.0) | 548 (58.9) |
| X (differentiation cannot be assessed) | 75 (2.7) | 25 (2.7) | 29 (3.1) | 21 (2.3) |
| Surgery | ||||
| BCS | 1226 (43.9) | 399 (43.1) | 408 (43.6) | 419 (44.9) |
| Mastecomy | 1538 (56.1) | 526 (56.9) | 529 (56.4) | 514 (55.1) |
| Type of CT | ||||
| Non-anthracycline based | 322 (11.5) | 103 (11.1) | 109 (11.7) | 110 (11.8) |
| Anthracycline-based | 2472 (88.5) | 822 (88.9) | 827 (88.4) | 823 (88.2) |
| Type of endocrine therapy | ||||
| AI | 581 (39.4) | 192 (39.4) | 197 (40.3) | 192 (38.5) |
| AI & SERM | 212 (14.4) | 68 (14.0) | 77 (15.8) | 67 (13.4) |
| LHRH | 11 (0.8) | 4 (0.8) | 5 (1.0) | 2 (0.4) |
| SERM | 671 (45.5) | 223 (45.8) | 210 (42.9) | 238 (47.7) |
HR hormone receptors, BCS breast conserving surgery, CT chemotherapy, AI aromatase inhibitors, SERM selective estrogen receptor modulators, LHRH luteinizing hormone-releasing hormone.