Table 1.
Patient characteristics at baseline
| Characteristics | Dose group | Total (n = 97) | ||
|---|---|---|---|---|
| 40 mg (n = 33) | 80 mg (n = 32) | 120 mg (n = 32) | ||
| Median age, years (range) | 63.0 (44–80) | 63.0 (50–74) | 58.5 (48–78) | 62.0 (44–80) |
| Performance status, n (%) | ||||
| 0 | 28 (85) | 27 (84) | 28 (88) | 83 (86) |
| 1 | 5 (15) | 5 (16) | 4 (13) | 14 (14) |
| 2 | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Body mass index (median), kg/m2 | 23.2 | 23.0 | 22.1 | 22.7 |
| Prior treatment, n (%)a | ||||
| Endocrine therapy regimens | ||||
| 1 | 19 (58) | 13 (41) | 21 (66) | 53 (55) |
| 2 | 14 (42) | 19 (59) | 11 (34) | 44 (45) |
| Chemotherapy regimens | ||||
| 0 | 21 (64) | 28 (88) | 23 (72) | 72 (74) |
| 1 | 12 (36) | 4 (13) | 9 (28) | 25 (26) |
| Sites of metastasis, n (%) | ||||
| Soft tissue | 20 (61) | 23 (72) | 19 (59) | 62 (64) |
| Bone | 12 (36) | 15 (47) | 17 (53) | 44 (45) |
| Visceral | 23 (70) | 23 (72) | 23 (72) | 69 (71) |
| Other | 2 (6) | 0 (0) | 4 (13) | 6 (6) |
| Receptor status, n (%)b | ||||
| ER+/PgR+ | 22 (67) | 20 (63) | 19 (59) | 61 (63) |
| ER+/PgR− | 11 (33) | 9 (28) | 11 (34) | 31 (32) |
| ER−/PgR+ | 0 (0) | 2 (6) | 1 (3) | 3 (3) |
| ER−/PgR− | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| HER2+ | 4 (12) | 4 (13) | 7 (22) | 15 (15) |
| HER2− | 24 (73) | 23 (72) | 23 (72) | 70 (72) |
| HER2 unknown | 5 (15) | 5 (16) | 2 (6) | 12 (12) |
| Disease‐free interval, n (%) | ||||
| <2 years | 5 (15) | 5 (16) | 5 (16) | 15 (15) |
| ≥2 years | 21 (64) | 22 (69) | 17 (53) | 60 (62) |
a
Counting a case treated with adjuvant endocrine therapy/chemotherapy as one regimen, if it had relapsed either during therapy or within 6 months of completion of therapy.
b
Hormone receptor status (estrogen receptor [ER]/progesterone receptor [PgR]) was determined by each study site.