Table 1.
Patient population enrolled in the BIG 02-98 trial (N = 2887) (intention-to-treat)
| Treatment arm | Control arms (no T) |
Experimental arms (T) |
||
| Treatment | A or AC |
A–T or AT |
||
| n | % | n | % | |
| Patients | 968 | 100 | 1919 | 100 |
| Age | ||||
| <50 years | 520 | 54 | 1022 | 53 |
| ≥50 years | 448 | 46 | 897 | 47 |
| Menopausal status | ||||
| Pre | 518 | 53 | 1034 | 54 |
| Post | 393 | 41 | 780 | 41 |
| Unknown | 57 | 6 | 105 | 5 |
| Nodal status | ||||
| 1–3 LNs | 527 | 54 | 1045 | 54 |
| 4 or more | 441 | 46 | 874 | 46 |
| Tumour grade | ||||
| Grade 1 | 90 | 9 | 161 | 8 |
| Grade 2 | 403 | 42 | 855 | 45 |
| Grade 3 | 432 | 45 | 832 | 43 |
| Unknown | 43 | 4 | 71 | 4 |
| Tumour size | ||||
| pT1 | 367 | 38 | 776 | 40 |
| pT2 | 529 | 55 | 994 | 52 |
| pT3 | 66 | 7 | 141 | 7 |
| pTX | 6 | 0.6 | 8 | 0.4 |
| Hormone receptors | ||||
| ER+/PgR+ | 488 | 50 | 994 | 52 |
| ER+/PgR− | 112 | 12 | 230 | 12 |
| ER−/PgR+ | 44 | 4 | 73 | 4 |
| ER−/PgR− | 238 | 25 | 447 | 23 |
| ER+/PgR unknown | 80 | 8 | 158 | 8 |
| ER−/PgR unknown | 5 | 0.5 | 14 | 0.7 |
| ER unknown | 1 | 0.1 | 3 | 0.2 |
| HER2 available | 374 | 38.6 | 731 | 38.1 |
| HER2+ | 95 | 25.4 | 189 | 25.9 |
| HER2− | 279 | 74.6 | 542 | 74.1 |
A, doxorubicin; AC, doxorubicin/cyclophosphamide; A–T, doxorubicin followed by docetaxel; AT, doxorubicin combined with docetaxel; ER, oestrogen receptor; PgR, progesterone receptor; HER2, human epithelial (growth factor) receptor 2; LNs, lymph nodes; T, docetaxel.