Table 1.
Baseline characteristics of trial participants
| 12-month group (n=2045) | 6-month group (n=2043) | |
|---|---|---|
| Oestrogen receptor status* | ||
| Negative | 633 (31%) | 632 (31%) |
| Positive | 1412 (69%) | 1411 (69%) |
| Chemotherapy type* | ||
| Anthracycline-based | 854 (42%) | 846 (41%) |
| Taxane-based | 200 (10%) | 203 (10%) |
| Anthracycline-based and taxane-based | 989 (48%) | 991 (49%) |
| No taxane and no anthracycline | 2 (<1%) | 3 (<1%) |
| Chemotherapy timing* | ||
| Adjuvant | 1737 (85%) | 1731 (85%) |
| Neoadjuvant | 308 (15%) | 312 (15%) |
| Trastuzumab timing* | ||
| Concurrent | 951 (47%) | 952 (47%) |
| Sequential | 1094 (53%) | 1091 (53%) |
| Age at randomisation, years | ||
| Median (range) | 56 (23–82) | 56 (23–83) |
| <35 | 50 (2%) | 45 (2%) |
| 35–49 | 552 (27%) | 557 (27%) |
| 50–59 | 608 (30%) | 656 (32%) |
| ≥60 | 835 (41%) | 785 (38%) |
| Nodal status at surgery (patients who received adjuvant therapy) | ||
| Negative | 1003/1737 (58%) | 1019/1731 (59%) |
| 1–3 nodes positive | 479/1737 (28%) | 486/1731 (28%) |
| 4+ nodes positive | 244/1737 (14%) | 211/1731 (12%) |
| Unknown | 11/1737 (<1%) | 15/1731 (<1%) |
| Tumour size (patients who received adjuvant therapy)† | ||
| ≤2 cm | 824/1737 (47%) | 807/1731 (47%) |
| >2 and ≤5 cm | 778/1737 (45%) | 786/1731 (45%) |
| >5 cm | 87/1737 (5%) | 83/1731 (5%) |
| Unknown | 48/1737 (3%) | 55/1731 (3%) |
| Tumour grade‡ | ||
| I (well differentiated) | 29 (1%) | 34 (2%) |
| II (moderately differentiated) | 628 (31%) | 642 (31%) |
| III (poorly differentiated) | 1322 (65%) | 1297 (63%) |
| Unknown | 66 (3%) | 70 (3%) |
| Ethnicity | ||
| White | 1658 (81%) | 1648 (81%) |
| Asian | 57 (3%) | 52 (3%) |
| Black | 52 (3%) | 45 (2%) |
| Other | 17 (1%) | 21 (1%) |
| Unknown | 261 (13%) | 277 (14%) |
| Menopausal status before chemotherapy | ||
| Premenopausal | 567 (28%) | 580 (28%) |
| Perimenopausal | 110 (5%) | 150 (7%) |
| Postmenopausal | 1144 (56%) | 1070 (52%) |
| Not assessable or not available | 224 (11%) | 243 (12%) |
| Reported previous use of cardiac medication | ||
| Yes | 44 (2%) | 55 (3%) |
| No | 2001 (98%) | 1988 (97%) |
| HER2 immunohistochemistry score and FISH positivity | ||
| 3+ | 1460 (71%) | 1487 (73%) |
| 2+ and FISH positive | 540 (26%) | 497 (24%) |
| Not available | 45 (2%) | 59 (3%) |
Data are n (%), unless otherwise specified. Six men are included in the 4088 patients, four in the 12-month group and two in the 6-month group. FISH=fluorescence in-situ hybridisation.
*
Stratification variable.
†
Size of the largest invasive tumour at diagnosis.
‡
Grade of the largest invasive tumour at diagnosis.