Table 1.
Patient demographic and baseline characteristics
| Xe1000 + Ev10 + Ex25 n = 52 |
Plc + Ev10 + Ex25 n = 51 |
Total N = 103 |
|
|---|---|---|---|
| Median age, years (range) | 60.5 (29–84) | 59.0 (41–78) | 60.0 (29–84) |
| Race, n (%) | |||
| Black or African American | 0 | 1 (2.0) | 1 (1.0) |
| Asian | 1 (1.9) | 0 | 1 (1.0) |
| Native Hawaiian or other Pacific Islander | 1 (1.9) | 0 | 1 (1.0) |
| White | 44 (84.6) | 41 (80.4) | 85 (82.5) |
| Missing | 6 (11.5) | 9 (17.6) | 15 (14.6) |
| ECOG PS, n (%) | |||
| 0 | 38 (73.1) | 30 (58.8) | 68 (66.0) |
| 1 | 14 (26.9) | 21 (41.2) | 35 (34.0) |
| Menopausal status, n (%) | |||
| Premenopausal | 1 (1.9) | 4 (7.8) | 5 (4.9) |
| Postmenopausal | 50 (96.2) | 47 (92.2) | 97 (94.2) |
| Missing | 1 (1.9)a | 0 | 1 (1.0)a |
| Bone-only metastases at screening, n (%) | |||
| No | 13 (25.0) | 19 (37.3) | 32 (31.1) |
| Yes | 38 (73.1) | 32 (62.7) | 70 (68.0) |
| Missing | 1 (1.9)a | 0 | 1 (1.0)a |
| Previous systemic chemotherapy in metastatic setting, n (%) | 6 (11.5) | 3 (5.9) | 9 (8.7) |
| Previous fulvestrant treatment,b n (%) | 26 (50.0) | 19 (37.3) | 45 (43.7) |
| Previous CDK4/6 inhibitor,b n (%) | 39 (75.0) | 39 (76.5) | 78 (75.7) |
| Endocrine resistance,c n (%) | |||
| Primary | 15 (28.8) | 12 (23.5) | 27 (26.2) |
| Secondary | 37 (71.2) | 39 (76.5) | 76 (73.8) |
CDK4/6, cyclin-dependent kinase 4/6; ECOG PS, Eastern Cooperative Oncology Group performance status; Ev, everolimus; Ex, exemestane; Plc, placebo; Xe, xentuzumab
aMissing data relates to one patient who was randomised but not treated; bIn the adjuvant, neoadjuvant or metastatic setting; cPrimary resistance defined as relapse within 24 months of starting neoadjuvant or adjuvant treatment or progressive disease within 6 months of starting metastatic treatment. Secondary resistance defined as relapse ≥ 24 months on neoadjuvant or adjuvant treatment, or < 12 months after completion, or progressive disease ≥ 6 months after starting metastatic treatment