Table 1.
Baseline Characteristics (ITT Population).
| TALA (N = 287) | Overall PCT (N = 144) | |
|---|---|---|
| Age, median (range), y | 45 (27.0–84.0) | 50 (24.0–88.0) |
| <50 y, No. % | 182 (63.4) | 67 (46.5) |
| Female, % | 98.6 | 97.9 |
| ECOG PS 0 / 1 / 2, % | 53.3 / 44.3 / 2.1 | 58.3 / 39.6 / 1.4 |
| Stage of breast cancer | ||
| Locally advanced, No. % | 15 (5.2) | 9 (6.3) |
| Metastatic, No. % | 271 (94.4) | 135 (93.8) |
| Measurable disease by investigator, No. (%) | 219 (76.3) | 114 (79.2) |
| History of CNS metastases, No. (%) | 43 (15.0) | 20 (13.9) |
| Visceral disease, No. (%) | 200 (69.7) | 103 (71.5) |
| Hormone receptor status, No. (%) | ||
| TNBC | 130 (45.3) | 60 (41.7) |
| HR+ | 157 (54.7) | 84 (58.3) |
| BRCA status, No. (%)a | ||
| BRCA1+ | 133 (46.3) | 63 (43.8) |
| BRCA2+ | 154 (53.7) | 81 (56.3) |
| Disease-free interval (initial diagnosis to aBC) <12 months, No. (%) | 108 (37.6) | 42 (29.2) |
| Prior adjuvant/neoadjuvant therapy, No. (%) | 238 (82.9) | 121 (84.0) |
| No. of prior hormonal therapy-based regimens (for patients with HR+ BC), median (range) | 2.0 (0–6) (n = 157) |
2.0 (0–6) (n = 84) |
| Prior platinum therapy, No. (%) | 46 (16.0) | 30 (20.8) |
| Prior cytotoxic regimens for aBC, No. (%) | ||
| 0 | 111 (38.7) | 54 (37.5) |
| 1 | 107 (37.3) | 54 (37.5) |
| 2 | 57 (19.9) | 28 (19.4) |
| ≥3 | 12 (4.2) | 8 (5.6) |
Abbreviations: aBC = advanced breast cancer; BRCA = breast cancer susceptibility gene; CNS = central nervous system; ECOG PS = Eastern Cooperative Oncology Group performance status; ITT = intent-to-treat; HR = hormone receptor; PCT = physician’s choice of therapy; TALA = talazoparib; TNBC = triple-negative breast cancer.
a
Only 10 patients (6 and 4 patients in the talazoparib and control arms, respectively) were identified as having a suspected deleterious mutation. The remainder who underwent MYRIAD assessment carried a known pathogenic variation.