Table 1.
Patient baseline and disease characteristics of the bone analysis population.
| Baseline parameters | N = 241 |
|---|---|
| Median age (range), years | 67 (35–85) |
| Age group, n (%) | |
| <65 years | 111 (46.1) |
| ≥65 years | 130 (53.9) |
| Race, n (%) | |
| Caucasian | 239 (99.2) |
| Asian | 2 (0.8) |
| ECOG PS, n (%)a,b | |
| 0 | 146 (60.8) |
| 1 | 85 (35.4) |
| 2 | 9 (3.8) |
| Missing | 1 (0.4) |
| Disease status, n (%) | |
| Metastatic | 231 (95.9) |
| Locally advanced | 4 (1.7) |
| Metastatic + locally advanced | 6 (2.5) |
| HR status, n (%)c | |
| ER+, PgR+ | 192 (79.7) |
| ER+, PgR– | 47 (19.5) |
| ER–, PgR+ | 1 (0.4) |
| ER–, PgR– | 1 (0.4) |
| HER2 status, n (%)d | |
| HER2-negative | 240 (99.6) |
| Unknown/missing | 1 (0.4) |
| Baseline bone metastases, n (%) | |
| Yes | 143 (59.3) |
| No | 98 (40.7) |
| Baseline ART, n (%) | |
| Yes | 58 (24.1) |
| No | 183 (75.9) |
| Concomitant ART and study treatment, n (%) | |
| Yes | 152 (63.1) |
| No | 89 (36.9) |
| Prior radiation to bone, n (%) | |
| Yes | 56 (23.2) |
| No | 185 (76.8) |
| Prior fracture, n (%) | |
| Yes | 11 (4.6) |
| No | 230 (95.4) |
| Fracture during study, n (%) | |
| Yes | 4 (1.7) |
| No | 237 (98.3) |
Abbreviations: ART, antiresorptive treatment; ECOG PS, European Cooperative Oncology Group performance status; ER, estrogen receptor; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; PgR, progesterone receptor.
a
At screening.
b
No patient had an ECOG PS ≥ 3 at screening; however, one patient had an ECOG PS = 3 at baseline.
c
Assessed in primary tumor in 70.5% of patients, in metastatic sites in 29.5% of patients.
d
Assessed in primary tumor in 66.7% of patients, in metastatic sites in 33.3% of patients, in unknown tumor stage for one (0.4%) patient.