|  | Included |  |  | Excluded |  |  |
---|---|---|---|---|---|---|---|
Characteristics | No. | Â | (%) | No. | Â | (%) | Pd |
No. of patients | 264 | Â | Â | 73 | Â | Â | Â |
Regimen | Â | Â | Â | Â | Â | Â | 0.36 |
   Docetaxel and Gemcitabine | 137 |  | (51.9) | 33 |  | (45.2) |  |
   Docetaxel | 127 |  | (48.1) | 40 |  | (54.8) |  |
Median age at randomization, years | Â | 59 | Â | Â | 57 | Â | 0.57e |
   Range |  | 30-75 |  |  | 36-73 |  |  |
ECOG performance status | Â | Â | Â | Â | Â | Â | 0.84 |
   0-1 | 223 |  | (84.5) | 65 |  | (89.0) |  |
   2 | 32 |  | (12.1) | 8a |  | (11.0) |  |
   Unknown | 9 |  | (3.4) | 0 |  | (0.0) |  |
Stage of disease | Â | Â | Â | Â | Â | Â | 0.049 |
   Locally advanced | 22 |  | (8.3) | 12 |  | (16.4) |  |
   Metastatic | 242 |  | (91.7) | 61 |  | (83.6) |  |
No. of metastatic sites | Â | Â | Â | Â | Â | Â | 0.74 |
   1 | 78 |  | (29.5) | 18 |  | (24.7) |  |
   2 | 93 |  | (35.2) | 27 |  | (37.0) |  |
   ≥ 3 | 93 |  | (35.2) | 28 |  | (38.4) |  |
Type of metastatic site | Â | Â | Â | Â | Â | Â | Â |
   Visceral | 150 |  | (56.8) | 43 |  | (58.9) | 0.79 |
   Lung | 78 |  | (29.5) | 25 |  | (34.2) |  |
   Liver | 99 |  | (37.5) | 27 |  | (37.0) |  |
   Non-visceral | 114 |  | (43.2) | 30 |  | (41.1) |  |
   Bone | 175 |  | (66.3) | 41 |  | (56.2) |  |
Hormone receptor status | Â | Â | Â | Â | Â | Â | 0.76 |
   Positive | 190 |  | (72.0) | 49 |  | (67.1) |  |
   Negative | 70 |  | (26.5) | 20 |  | (27.4) |  |
   Unknown | 4 |  | (1.5) | 4 |  | (5.5) |  |
HER2 statusb | Â | Â | Â | Â | Â | Â | 0.77 |
   Normal/deletion | 212 |  | (80.3) | 20 |  | (27.4) |  |
   Amplification | 37 |  | (14.0) | 4 |  | (5.5) |  |
   Unknown | 15 |  | (5.7) | 49 |  | (67.1) |  |
PAM50 subtype | Â | Â | Â | Â | Â | Â | 0.18 |
   Luminal A | 78 |  | (29.5) | 6 |  | (8.2) |  |
   Luminal B | 94 |  | (35.6) | 3 |  | (4.1) |  |
   Basal-like | 40 |  | (15.2) | 3 |  | (4.1) |  |
   HER2-enriched | 46 |  | (17.4) | 0 |  | (0.0) |  |
   Unknown | 6 |  | (2.3) | 61 |  | (83.6) |  |
Prior chemotherapy | Â | Â | Â | Â | Â | Â | Â |
   Total | 188 |  | (71.2) | 45 |  | (61.6) | 0.15 |
   (Neo)adjuvant | 127 |  | (48.1) | 17 |  | (23.3) | 0.0002 |
    Anthracycline | 71 |  | (26.9) | 11 |  | (15.1) |  |
    Non-anthracycline | 56 |  | (21.2) | 6 |  | (8.2) |  |
   Locally advanced/metastatic | 102 |  | (38.6) | 31 |  | (42.5) | 0.20 |
    Anthracycline | 86 |  | (32.6) | 30 |  | (41.1) |  |
    Non-anthracycline | 16 |  | (6.1) | 1 |  | (1.4) |  |
Hormonal therapy | Â | Â | Â | Â | Â | Â | Â |
   Total | 173 |  | (65.5) | 41 |  | (56.2) | 0.17 |
   Adjuvant | 119 |  | (45.1) | 19 |  | (26.0) | 0.006 |
   Locally advanced/metastatic | 120 |  | (45.5) | 37 |  | (50.7) | 0.43 |
Radiation therapy | 157 | Â | (59.5) | 22 | Â | (30.1) | <0.0001 |
Disease-free interval, monthsc | Â | Â | Â | Â | Â | Â | Â |
   Median |  | 31 |  |  | 22 |  | 0.12e |
   Range |  | 0-250 |  |  | 0-231 |  |  |