Abemaciclib + fulvestrant N = 72 | Placebo + fulvestrant N = 42 | |
---|---|---|
Median age (range) | 46 (32–57) | 47 (32–66) |
Race, n (%) | ||
Asian | 51 (70.8) | 24 (57.1) |
Caucasian | 14 (19.4) | 16 (38.1) |
Other | 7 (9.7) | 2 (4.8) |
Most recent ET, n (%)a | ||
Neoadjuvant or adjuvant | 44 (61.1) | 21 (50.0) |
Metastatic | 26 (36.1) | 20 (47.6) |
Number of lines of ET, n (%) | ||
1 | 60 (83.3) | 30 (71.4) |
2 | 10 (13.9) | 11 (26.2) |
Prior AI, n (%) | ||
Yes | 10 (13.9) | 12 (28.6) |
No | 62 (86.1) | 30 (71.4) |
Sensitivity to ET, n (%)a | ||
Primary resistanceb | 28 (38.9) | 15 (35.7) |
Secondary resistancec | 42 (58.3) | 26 (61.9) |
Progesterone-receptor status, n (%) | ||
Positive | 54 (75.0) | 38 (90.5) |
Negative | 18 (25.0) | 4 (9.5) |
Metastatic site, n (%) | ||
Visceral | 43 (59.7) | 17 (40.5) |
Bone only | 19 (26.4) | 15 (35.7) |
Other | 10 (13.9) | 10 (23.8) |
Measurable disease, n (%) | ||
Yes | 51 (70.8) | 28 (66.7) |
No | 21 (29.2) | 14 (33.3) |
ECOG performance status | ||
0 | 54 (75.0) | 36 (85.7) |
1 | 18 (25.0) | 6 (14.3) |