Table 1.
Baseline patient demographics and disease characteristics (full analysis set)
| Baseline parameters | Full analysis set (N = 281) | |
|---|---|---|
| Patient demographics | ||
| Median age (range), years | 67 (35–85) | |
| Age group, n (%) | <65 years | 127 (45.2) |
| ≥65 years | 154 (54.8) | |
| Race, n (%) | White | 279 (99.3) |
| Asian | 2 (0.7) | |
| ECOG PS, n (%) 1 , 2 | 0 | 170 (60.9) |
| 1 | 98 (35.1) | |
| 2 | 11 (3.9) | |
| Missing | 2 (0.7) | |
| Disease characteristics, n (%) | ||
| Disease status | Metastatic | 270 (96.1) |
| Locally advanced | 5 (1.8) | |
| Metastatic and locally advanced | 6 (2.1) | |
| HR status 3 | ER+, PgR+ | 220 (78.3) |
| ER+, PgR− | 59 (21.0) | |
| ER−, PgR+ | 1 (0.4) | |
| ER−, PgR− | 1 (0.4) | |
| HER2 status 4 | HER2− | 277 (98.6) |
| HER2+ | 2 (0.7) | |
| Unknown/missing | 2 (0.7) | |
| Target lesion (in ≥10 patients) 5 | Liver | 145 (51.6) |
| Lymph nodes | 60 (21.4) | |
| Lung | 46 (16.4) | |
| Bone | 37 (13.2) | |
| Chest wall | 12 (4.3) | |
| Prior therapies, n (%) | ||
| Most recent prior therapy setting | Metastatic | 221 (78.6) |
| Adjuvant | 56 (19.9) | |
| Neoadjuvant | 1 (0.4) | |
| Missing | 3 (1.1) | |
| Prior therapy in the metastatic setting | Chemo‐ or endocrine therapy | 221 (78.6) |
| Chemotherapy | 151 (53.7) | |
| Endocrine therapy | 204 (72.6) | |
| Number of prior lines of therapy for metastatic disease 6 | 0 | 59 (21.0) |
| 1 | 52 (18.5) | |
| 2 | 45 (16.0) | |
| 3 | 34 (12.1) | |
| ≥4 | 87 (31.0) | |
| Unknown | 4 (1.4) | |
| NSAI as most recent therapy | 94 (33.5) | |
| Prior exemestane | 89 (31.7) | |
| Prior fulvestrant | 121 (43.1) | |
At screening.
No patient had an ECOG PS ≥3 at screening; however, one patient had an ECOG PS of 3 at baseline.
Assessed in primary tumor in 70.1% of patients and in metastatic sites in 29.9% of patients.
Assessed in primary tumor in 64.7% of patients, in metastatic sites in 34.8% of patients, and in unknown tumor stage for one patient.
Metastatic sites are not mutually exclusive (i.e. patients may have had metastasis at more than one site). Data on localization of target lesions were missing for 39 patients.
According to assessment by Study Steering Committee.
Abbreviations: ECOG PS: Eastern Cooperative Oncology Group performance status; ER: estrogen receptor; HER2: human epidermal growth factor receptor 2; HR: hormone receptor; NSAI: non‐steroidal aromatase inhibitor; PgR: progesterone receptor.