Table 1. Patient Characteristics at Baseline.
| Characteristic | Alpelisib Dose Level Plus Fulvestrant, 500 mg | |||
|---|---|---|---|---|
| 300 mg Once Daily (n = 9) | 350 mg Once Daily (n = 8) | 400 mg Once Daily (n = 70) | All Patients (N = 87) | |
| Age, median (range), y | 56 (39-73) | 55 (43-65) | 59 (37-79) | 58 (37-79) |
| ECOG performance status, No. (%) | ||||
| 0 | 4 (44) | 3 (38) | 32 (46) | 39 (45) |
| 1 | 5 (56) | 5 (63) | 36 (51) | 46 (53) |
| 2 | 0 | 0 | 1 (1) | 1 (1) |
| Missing | 0 | 0 | 1 (1) | 1 (1) |
| Breast cancer stage at initial diagnosis, No. (%) | ||||
| 0 | 0 | 0 | 1 (1) | 1 (1) |
| I/Ia | 2 (22) | 2 (25) | 7 (10) | 11 (13) |
| II/IIa/IIb/IIc | 2 (22) | 1 (13) | 29 (41) | 32 (37) |
| III/IIIa/IIIb/IIIc | 0 | 1 (13) | 11 (16) | 12 (14) |
| IV | 4 (44) | 1 (13) | 18 (26) | 23 (26) |
| Missing | 1 (11) | 3 (38) | 4 (6) | 8 (9) |
| No. of metastatic sites, median (range) | 3 (1-5) | 3 (1-5) | 3 (1-8) | 3 (1-8) |
| Time between initial diagnosis and study treatment initiation, median (range), mo | 62 (9-176) | 106 (20-292) | 94 (12-349) | 93 (9-349) |
| No. of prior antineoplastic therapies, median (range) | 6 (1-11) | 5 (2-7) | 5 (1-16) | 5 (1-16) |
| Prior mTOR inhibitor, No. (%) | 1 (11) | 2 (25) | 18 (26) | 21 (24) |
| Prior fulvestrant, No. (%) | 5 (56) | 6 (75) | 28 (40) | 39 (45) |
| Prior chemotherapy, No. (%) | 7 (78) | 6 (75) | 66 (94) | 79 (91) |
| Locally assessed PIK3CA status, No. (%) | ||||
| Altered (mutation/amplification) | 9 (100) | 8 (100) | 35 (50) | 52 (60) |
| Wild type | 0 | 0 | 33 (47) | 33 (38) |
| Unknown | 0 | 0 | 2 (3) | 2 (2) |
Abbreviations: ECOG, Eastern Cooperative Oncology Group; mTOR, mammalian target of rapamycin.