Table 1.
Baseline patient characteristics
| Characteristic | Patients with de novo advanced HR+, HER2− breast cancer n = 227 |
|
|---|---|---|
| Ribociclib + letrozole (n = 114) |
Placebo + letrozole (n = 113) |
|
| Age, median (range), years | 62.5 (37.0–82.0) | 63.0 (29.0–88.0) |
| Race, n (%) | ||
| Caucasian | 90 (79) | 91 (81) |
| Asian | 10 (9) | 11 (10) |
| Black | 6 (5) | 4 (4) |
| Other/unknown | 8 (7) | 7 (6) |
| ECOG performance status, n (%) | ||
| 0 | 75 (66) | 61 (54) |
| 1 | 39 (34) | 52 (46) |
| Disease stage at study entry, n (%) | ||
| III | 1 (1) | 1 (1) |
| IV | 113 (99) | 112 (99) |
| Number of metastatic sites, n (%) | ||
| 0 | 1 (1) | 0 |
| 1 | 33 (29) | 36 (32) |
| 2 | 37 (32) | 38 (34) |
| ≥ 3 | 43 (38) | 39 (35) |
| Site of metastases, n (%) | ||
| Breast | 7 (6) | 9 (8) |
| Bone | 88 (77) | 85 (75) |
| Bone only | 28 (25) | 24 (21) |
| Viscerala | 53 (46) | 55 (49) |
| Lymph nodes | 61 (54) | 56 (50) |
| Other | 15 (13) | 8 (7) |
ECOG Eastern Cooperative Oncology Group, HER2− human epidermal growth factor receptor 2-negative, HR+ hormone receptor-positive
aIncludes liver, lung, and other visceral metastases