Table 1.
Baseline patient and tumor characteristics
| Safety Run-in | Study Cohort | |||||
|---|---|---|---|---|---|---|
| (n=8) | Arm A (n=19) | Arm B (n=36) | ||||
| N | % | N | % | N | % | |
| Age at registration (years) | ||||||
| <50 | 2 | 25.0 | 6 | 31.6 | 16 | 44.4 |
| 50-60 | 4 | 50.0 | 4 | 21.0 | 11 | 30.6 |
| 60+ | 2 | 25.0 | 9 | 47.4 | 9 | 25.0 |
| Race | ||||||
| White | 8 | 100.0 | 15 | 78.9 | 30 | 83.3 |
| Black or African American | 3 | 15.8 | 4 | 11.1 | ||
| Other | 1 | 5.3 | 2 | 5.6 | ||
| Ethnicity | ||||||
| Hispanic or LatinX | 0 | 0 | 0 | 0 | 3 | 8.3 |
| Non-Hispanic | 6 | 75.0 | 18 | 94.7 | 32 | 88.9 |
| Not Reported | 2 | 25.0 | 1 | 5.3 | 1 | 2.8 |
| Performance Score | ||||||
| 0 | 4 | 50.0 | 10 | 52.6 | 21 | 58.3 |
| 1 | 3 | 37.5 | 8 | 42.1 | 14 | 38.9 |
| 2 | 1 | 12.5 | 1 | 5.3 | 1 | 2.8 |
| ER/PR status | ||||||
| ER+/PR+ | 3 | 15.8 | 13 | 36.1 | ||
| ER+/PR- | 1 | 12.5 | 7 | 36.8 | 3 | 8.3 |
| ER-/PR+ | 1 | 12.5 | ||||
| ER-/PR- | 6 | 75.0 | 9 | 47.4 | 20 | 55.6 |
| Common sites of metastases | ||||||
| Bone (Yes) | 1 | 12.5 | 6 | 31.6 | 15 | 41.7 |
| Liver (Yes) | 3 | 37.5 | 9 | 47.4 | 11 | 30.6 |
| Lung (Yes) | 3 | 37.5 | 10 | 52.6 | 16 | 44.4 |
| Nodal (Yes) | 4 | 50.0 | 11 | 57.9 | 24 | 66.7 |
| Skin (Yes) | 3 | 15.8 | 7 | 19.4 | ||
| Neoadjuvant/Adjuvant Chemotherapy (Yes) | 7 | 87.5 | 14 | 73.7 | 24 | 66.7 |
| Prior hormonal therapy for metastases (Yes) | 1 | 12.5 | 3 | 15.8 | 8 | 22.2 |
| Previous radiation therapy (Yes) | 6 | 75 | 14 | 73.7 | 23 | 63.9 |