Table 1.
Baseline and treatment characteristics of the Asian and non-Asian subsets (full analysis set)
| Characteristic | Asian | Non-Asian | ||
|---|---|---|---|---|
| EVE + TRAS + PAC | PBO + TRAS + PAC | EVE + TRAS + PAC | PBO + TRAS + PAC | |
| n = 198 | n = 105 | n = 282 | n = 134 | |
| Median age, years (range) | 53.0 (23–75) | 51.0 (29–82) | 55.0 (26–86) | 52.0 (19–77) |
| Race, n (%) | ||||
| Asian | 198 (100%) | 105 (100%) | 0 | 0 |
| Black | 0 | 0 | 26 (9.2) | 12 (9.0) |
| White | 0 | 0 | 214 (75.9) | 97 (72.4) |
| Native American | 0 | 0 | 3 (1.1) | 0 |
| Other non-Asian | 0 | 0 | 39 (13.8) | 25 (18.7) |
| Ethnicity, n (%) | ||||
| Chinese | 145 (73.2) | 75 (71.4) | 0 | 0 |
| Indiana | 1 (0.5%) | 0 | 0 | 0 |
| Japanese | 27 (13.6) | 15 (14.3) | 0 | 0 |
| Other Asian | 25 (12.6) | 15 (14.3) | 0 | 0 |
| Hispanic/Latino | 0 | 0 | 78 (27.7) | 34 (25.4) |
| Other non-Asian | 0 | 0 | 204 (72.3) | 100 (74.6) |
| Current disease status, n (%) | ||||
| Locally advanced | 10 (5.1) | 7 (6.7) | 24 (8.5) | 9 (6.7) |
| Metastatic | 188 (94.9) | 98 (93.3) | 258 (91.5) | 125 (93.3) |
| Site of metastasis, n (%) | ||||
| Visceral | 139 (70.2) | 65 (61.9) | 199 (70.6) | 104 (77.6) |
| Lung | 91 (46.0) | 43 (41.0) | 126 (44.7) | 60 (44.8) |
| Liver | 66 (33.3) | 36 (34.3) | 111 (39.4) | 74 (55.2) |
| Lung and liver | 27 (13.6) | 17 (16.2) | 45 (16.0) | 34 (25.4) |
| Bone | 85 (42.9) | 54 (51.4) | 125 (44.3) | 63 (47.0) |
| Bone only | 9 (4.5) | 5 (4.8) | 11 (3.9) | 2 (1.5) |
| Others | 142 (71.7) | 77 (73.3) | 196 (69.5) | 99 (73.9) |
| ECOG PS, n (%) | ||||
| 0 | 121 (61.1) | 64 (61.0) | 157 (55.7) | 84 (62.7) |
| 1 | 77 (38.9) | 41 (39.0) | 125 (44.3) | 50 (37.3) |
| ER and PgR status, n (%) | ||||
| ER and PgR negative (HR–) | 85 (42.9) | 47 (44.8) | 123 (43.6) | 56 (41.8) |
| ER and PgR negative (HR+) | 112 (56.6) | 57 (54.3) | 159 (56.4) | 78 (58.2) |
| Not assessable | 0 | 1 (1.0) | 0 | 0 |
| Missing | 1 (0.5) | 0 | 0 | 0 |
aIndian subcontinent. ECOG PS Eastern Cooperative Oncology Group performance status, ER estrogen receptor, EVE everolimus, HR hormone receptor, PAC paclitaxel, PBO placebo, PgR progesterone receptor, TRAS trastuzumab