Table 1.
Patient demographics and baseline characteristics in the safety analysis set
| TNBC cohort (n = 62) |
HR+/HER2− cohort (n = 26) |
Total (N = 88) |
|
|---|---|---|---|
| Median age, years (range) | 45.0 (27–65) | 47.5 (29–67) | 45.5 (27–67) |
| Age group, n (%) | |||
| < 50 years | 43 (69.4) | 16 (61.5) | 59 (67.0) |
| 50–65 years | 19 (30.6) | 9 (34.6) | 28 (31.8) |
| > 65 years | 0 (0.0) | 1 (3.8) | 1 (1.1) |
| Sex, n (%) | |||
| Female | 62 (100.0) | 26 (100.0) | 88 (100.0) |
| Race, n (%) | |||
| Asian: Chinese | 62 (100.0) | 26 (100.0) | 88 (100.0) |
| ECOG performance status, n (%) | |||
| 0 | 31 (50.0) | 17 (65.4) | 48 (54.5) |
| 1 | 31 (50.0) | 9 (34.6) | 40 (45.5) |
| Number of metastatic sites, n (%) | |||
| 1 | 18 (29.0) | 4 (15.4) | 22 (25.0) |
| 2 | 17 (27.4) | 9 (34.6) | 26 (29.5) |
| ≥ 3 | 27 (43.5) | 13 (50.0) | 40 (45.5) |
| History of brain metastasis, n (%) | 6 (9.7) | 0 (0.0) | 6 (6.8) |
| Visceral metastasis, n (%)a | 42 (67.7) | 20 (76.9) | 62 (70.5) |
| Germline BRCA mutation status, n (%) | |||
| BRCA1 mutation | 47 (75.8) | 9 (34.6) | 56 (63.6) |
| BRCA2 mutation | 15 (24.2) | 17 (65.4) | 32 (36.4) |
| Hormone receptor status, n (%)b | |||
| ER positive | 0 (0.0) | 23 (88.5) | 23 (26.1) |
| PR positive | 0 (0.0) | 19 (73.1) | 19 (21.6) |
| Prior lines of chemotherapy, n (%) | |||
| 0 | 17 (27.4) | 11 (42.3) | 28 (31.8) |
| 1 | 32 (51.6) | 10 (38.5) | 42 (47.7) |
| 2 | 13 (21.0) | 5 (19.2) | 18 (20.5) |
| Prior platinum therapy, n (%) | 31 (50.0) | 11 (42.3) | 42 (47.7) |
| Prior hormonal therapy, n (%) | 8 (12.9) | 22 (84.6) | 30 (34.1) |
| Prior anthracycline, n (%) | 59 (95.2) | 25 (96.2) | 84 (95.5) |
| Prior taxane, n (%) | 60 (96.8) | 26 (100.0) | 86 (97.7) |
| Median time from initial diagnosis to study entry, years (range) | 2.62 (0.3–19.9) | 4.11 (1.4–11.6) | 2.95 (0.3–19.9) |
Data cutoff: October 9, 2020
BRCA breast cancer susceptibility gene, ECOG Eastern Cooperative Oncology Group, ER estrogen receptor, HER2- human epidermal growth factor receptor 2-negative, HR + hormone receptor-positive, PR progesterone receptor, TNBC triple-negative breast cancer
aVisceral metastasis included patients who had metastatic lesions located on the lung, liver, pleura, pleural effusion, brain, or peritoneum
bER status and PR status were based on most recent biopsy