Table 1 Baseline characteristics: phase II part
Xe1000+Ev10+Ex25 (n = 70) | Ev10+Ex25 (n = 70) | Total (n = 140) | |
|---|---|---|---|
Median age, years (range) | 58.5 (41–86) | 62.0 (42–84) | 60.0 (41–86) |
ECOG PS, n (%) | |||
0 | 45 (64.3) | 38 (54.3) | 83 (59.5) |
1 | 25 (35.7) | 31 (44.3) | 56 (40.0) |
2 | 0 | 1 (1.4) | 1 (0.7) |
Median time since diagnosis, months (range) | 63.4 (12.4–343.5) | 63.3 (8.3–256.6) | 63.3 (8.3–343.5) |
Metastatic sites at screening, n (%) | |||
1 | 18 (25.7) | 16 (22.9) | 34 (24.3) |
2 | 25 (35.7) | 27 (38.6) | 52 (37.1) |
≥ 3 | 27 (38.6) | 27 (38.6) | 54 (38.6) |
Visceral involvement, n (%) | |||
Yes | 53 (75.7) | 54 (77.1) | 107 (76.4) |
No | 17 (24.3) | 16 (22.9) | 33 (23.6) |
Bone metastases, n (%) | 47 (67.1) | 52 (74.3) | 99 (70.7) |
Lymph node metastases, n (%) | 33 (47.1) | 25 (35.7) | 58 (41.4) |
Prior hormone therapy, n (%) | 68 (97.1) | 69 (98.6) | 137 (97.9) |
Prior chemotherapy in metastatic setting, n (%) | 17 (24.3) | 18 (25.7) | 35 (25.0) |
Prior CDK 4/6 inhibitor treatment, n (%) | 0 | 2 (2.9) | 2 (1.4) |