Table 1.
Baseline demographics and disease characteristics
| All patients | Patients with PIK3CA/AKT1/PTEN-altered tumors | |||||||
|---|---|---|---|---|---|---|---|---|
| Japan subgroup | Global CAPItello-291 population | Japan subgroup | Global CAPItello-291 population | |||||
| Capivasertib–fulvestrant (n = 37) | Placebo–fulvestrant (n = 41) | Capivasertib–fulvestrant (n = 355) | Placebo–fulvestrant (n = 353) | Capivasertib–fulvestrant (n = 19) | Placebo–fulvestrant (n = 19) | Capivasertib–fulvestrant (n = 155) | Placebo–fulvestrant (n = 134) | |
| Demographics | ||||||||
| Median age (range), years | 61 (42–84) | 61 (37–83) | 59 (26–84) | 58 (26–90) | 61 (48–84) | 62 (39–80) | 58 (36–84) | 60 (34–90) |
| Female sex, n (%) | 37 (100) | 41 (100) | 352 (99.2) | 349 (98.9) | 19 (100) | 19 (100) | 153 (98.7) | 134 (100) |
| Postmenopausal, n (%) | 29 (78.4) | 29 (70.7) | 287 (80.8) | 260 (73.7) | 15 (78.9) | 14 (73.7) | 130 (83.9) | 105 (78.4) |
| Asian, n (%) | 37 (100) | 41 (100) | 95 (26.8) | 94 (26.6) | 19 (100) | 19 (100) | 48 (31.0) | 35 (26.1) |
| ECOG performance status score, n (%) | ||||||||
| 0 | 35 (94.6) | 35 (85.4) | 224 (63.1) | 241 (68.3) | 19 (100) | 18 (94.7) | 93 (60.0) | 97 (72.4) |
| 1 | 2 (5.4) | 6 (14.6) | 131 (36.9) | 111 (31.4) | 0 | 1 (5.3) | 62 (40.0) | 36 (26.9) |
| 2 | 0 | 0 | 0 | 1 (0.3) | 0 | 0 | 0 | 1 (0.7) |
| Disease characteristics | ||||||||
| Liver metastasis,a n (%) | 11 (29.7) | 13 (31.8) | 156 (43.9) | 150 (42.5) | 4 (21.1) | 6 (31.6) | 70 (45.2) | 53 (39.6) |
| Number of previous therapies for advanced breast cancer, n (%) | ||||||||
| 0 | 11 (29.7) | 16 (39.0) | 37 (10.4) | 52 (14.7) | 5 (26.3) | 7 (36.8) | 12 (7.7) | 20 (14.9) |
| 1 | 17 (45.9) | 16 (39.0) | 235 (66.2) | 208 (58.9) | 10 (52.6) | 6 (31.6) | 107 (69.0) | 79 (59.0) |
| 2 | 8 (21.6) | 7 (17.1) | 73 (20.6) | 77 (21.8) | 4 (21.1) | 4 (21.1) | 31 (20.0) | 29 (21.6) |
| 3 | 1 (2.7) | 2 (4.9) | 10 (2.8) | 16 (4.5) | 0 | 2 (10.5) | 5 (3.2) | 6 (4.5) |
| Hormone-receptor status,b n (%) | ||||||||
| ER-positive, PgR-positive | 30 (81.1) | 33 (80.5) | 255 (71.8) | 246 (69.7) | 16 (84.2) | 14 (73.7) | 116 (74.8) | 101 (75.4) |
| ER-positive, PgR-negative | 7 (18.9) | 8 (19.5) | 94 (26.5) | 103 (29.2) | 3 (15.8) | 5 (26.3) | 35 (22.6) | 31 (23.1) |
| ER-positive, with unknown PgR status | 0 | 0 | 5 (1.4) | 4 (1.1) | 0 | 0 | 4 (2.6) | 2 (1.5) |
| Endocrine status,c n (%) | ||||||||
| Primary resistance | 15 (40.5) | 14 (34.1) | 127 (35.8) | 135 (38.2) | 10 (52.6) | 6 (31.6) | 60 (38.7) | 55 (41.0) |
| Secondary resistance | 22 (59.5) | 27 (65.9) | 228 (64.2) | 218 (61.8) | 9 (47.4) | 13 (68.4) | 95 (61.3) | 79 (59.0) |
| Number of previous endocrine therapies for advanced breast cancer, n (%) | ||||||||
| 0 | 11 (29.7) | 16 (39.0) | 39 (11.0) | 54 (15.3) | 5 (26.3) | 7 (36.8) | 13 (8.4) | 20 (14.9) |
| 1 | 19 (51.4) | 18 (43.9) | 287 (80.8) | 252 (71.4) | 11 (57.9) | 8 (42.1) | 131 (84.5) | 96 (71.6) |
| 2 | 7 (18.9) | 7 (17.1) | 29 (8.2) | 47 (13.3) | 3 (15.8) | 4 (21.1) | 11 (7.1) | 18 (13.4) |
| Previous CDK4/6 inhibitor, n (%) | ||||||||
| As neoadjuvant or adjuvant therapy | 0 | 0 | 2 (0.6) | 5 (1.4) | 0 | 0 | 0 | 2 (1.5) |
| As therapy for advanced breast cancer | 5 (13.5) | 8 (19.5) | 245 (69.0) | 244 (69.1) | 4 (21.1) | 3 (15.8) | 113 (72.9) | 91 (67.9) |
| Previous chemotherapy, n (%) | ||||||||
| As neoadjuvant or adjuvant therapy | 15 (40.5) | 19 (46.3) | 180 (50.7) | 170 (48.2) | 6 (31.6) | 8 (42.1) | 79 (51.0) | 67 (50.0) |
| As therapy for advanced breast cancer | 3 (8.1) | 4 (9.8) | 65 (18.3) | 64 (18.1) | 1 (5.3) | 4 (21.1) | 30 (19.4) | 23 (17.2) |
AKT1 Akt serine/threonine kinase 1, CDK 4/6 cyclin-dependent kinases 4/6, ECOG Eastern Cooperative Oncology Group, ER estrogen receptor, PIK3CA catalytic subunit of phosphatidylinositol-3-kinase, PgR progesterone receptor, PTEN phosphatase and tensin homolog
aBaseline stratification factor
bOne patient in the global CAPItello-291 population treated with capivasertib–fulvestrant was ER-negative
cPrimary and secondary resistance were defined using the 4th European School of Oncology-European Society for Medical Oncology International Consensus Guidelines for advanced breast cancer