Table 1.
Patient demographics and baseline characteristics in the intention-to-treat population
| Characteristic | Patients (N = 132) |
|---|---|
| Female, n (%) | 132 (100) |
| Median age, years (range) | 56.5 (34–81) |
| ECOG performance status, n (%) | |
| 0 | 115 (87.1) |
| 1 | 17 (12.9) |
| Stage of disease at initial diagnosis, n (%) | |
| Stage I | 8 (6.1) |
| Stage II | 31 (23.5) |
| Stage IIIA | 7 (5.3) |
| Stage IIIB | 7 (5.3) |
| Stage IIIC | 8 (6.1) |
| Stage IV | 71 (53.8) |
| Site of disease, n (%) | |
| Non-visceral | 51 (38.6) |
| Visceral | 81 (61.4) |
| Hormone-receptor status, n (%) | |
| ER- and/or PgR-positive | 72 (54.5) |
| ER- and PgR-negative | 60 (45.5) |
| HER2 status by IHC/ISH, n (%) | |
| IHC 2 + and ISH-positive | 17 (12.9) |
|
IHC 3 + and ISH-positive IHC 3 + and ISH unknown |
4 (3.0) 107 (81.1) |
| IHC unknown and ISH-positive | 4 (3.0) |
| Recurrence | |
| De novo metastatic disease | 83 (62.9) |
| Recurrent metastatic diseasea | 49 (37.1) |
| Disease-free interval (month)b,c | |
| n | 49 |
| Mean (SD) | 55.7 (41.7) |
| Median | 44.3 |
| Min–max | 0.6–179.4 |
| Prior therapies, n (%) | |
| No | 94 (71.2) |
| Yes | 38 (28.8) |
| Anthracycline | 25 (18.9) |
| Taxanes | 22 (16.7) |
| Trastuzumab | 30 (22.7) |
ECOG Eastern Cooperative Oncology Group, ER estrogen receptor, HER2 human epidermal growth factor receptor 2, IHC immunohistochemistry, ISH in situ hybridization, PgR progesterone receptor
aPatients with non-recurrence were classified as having "de novo metastatic disease”
bDisease-free interval is the time from completion of systemic treatment (chemotherapy) and/or surgery to the diagnosis of metastatic/recurrence disease
cPatients with a disease-free interval of < 1 month were not assumed to have “de novo metastatic disease”