Table 1.
Characteristics of the Patients at Baseline.*
| Characteristic | Overall Population | Patients with AKT Pathway–Altered Tumors | ||
|---|---|---|---|---|
| Capivasertib–Fulvestrant | Placebo–Fulvestrant | Capivasertib–Fulvestrant | Placebo–Fulvestrant | |
| (N = 355) | (N = 353) | (N = 155) | (N = 134) | |
| Median age (range) — yr | 59 (26–84) | 58 (26–90) | 58 (36–84) | 60 (34–90) |
| Female sex — no. (%) | 352 (99.2) | 349 (98.9) | 153 (98.7) | 134 (100) |
| Race — no. (%)† | ||||
| White | 201 (56.6) | 206 (58.4) | 75 (48.4) | 76 (56.7) |
| Asian | 95 (26.8) | 94 (26.6) | 48 (31.0) | 35 (26.1) |
| Black | 4 (1.1) | 4 (1.1) | 2 (1.3) | 1 (0.7) |
| Other | 55 (15.5) | 49 (13.9) | 30 (19.4) | 22 (16.4) |
| Postmenopausal or menopausal status — no. (%) | 287 (80.8) | 260 (73.7) | 130 (83.9) | 105 (78.4) |
| ECOG performance-status score — no. (%)‡ | ||||
| 0 | 224 (63.1) | 241 (68.3) | 93 (60.0) | 97 (72.4) |
| 1 | 131 (36.9) | 111 (31.4) | 62 (40.0) | 36 (26.9) |
| 2 | 0 | 1 (0.3) | 0 | 1 (0.7) |
| Site of metastases — no. (%) | ||||
| Bone only | 51 (14.4) | 52 (14.7) | 25 (16.1) | 16 (11.9) |
| Liver | 156 (43.9) | 150 (42.5) | 70 (45.2) | 53 (39.6) |
| Viscera | 237 (66.8) | 241 (68.3) | 103 (66.5) | 98 (73.1) |
| No. of previous therapies for advanced breast cancer — no. (%)§ | ||||
| 0 | 37 (10.4) | 52 (14.7) | 12 (7.7) | 20 (14.9) |
| 1 | 235 (66.2) | 208 (58.9) | 107 (69.0) | 79 (59.0) |
| 2 | 73 (20.6) | 77 (21.8) | 31 (20.0) | 29 (21.6) |
| 3 | 10 (2.8) | 16 (4.5) | 5 (3.2) | 6 (4.5) |
| Hormone-receptor status — no. (%)¶ | ||||
| ER-positive, PR-positive | 255 (71.8) | 246 (69.7) | 116 (74.8) | 101 (75.4) |
| ER-positive, PR-negative | 94 (26.5) | 103 (29.2) | 35 (22.6) | 31 (23.1) |
| ER-positive, with unknown PR status | 5 (1.4) | 4 (1.1) | 4 (2.6) | 2 (1.5) |
| Endocrine status — no. (%)‖ | ||||
| Primary resistance | 127 (35.8) | 135 (38.2) | 60 (38.7) | 55 (41.0) |
| Secondary resistance | 228 (64.2) | 218 (61.8) | 95 (61.3) | 79 (59.0) |
| No. of previous endocrine therapies for advanced breast cancer — no. (%) | ||||
| 0 | 39 (11.0) | 54 (15.3) | 13 (8.4) | 20 (14.9) |
| 1 | 287 (80.8) | 252 (71.4) | 131 (84.5) | 96 (71.6) |
| 2 | 29 (8.2) | 47 (13.3) | 11 (7.1) | 18 (13.4) |
| Previous CDK4/6 inhibitor — no. (%) | ||||
| As neoadjuvant or adjuvant therapy | 2 (0.6) | 5 (1.4) | 0 | 2 (1.5) |
| As therapy for advanced breast cancer | 245 (69.0) | 244 (69.1) | 113 (72.9) | 91 (67.9) |
| Previous chemotherapy — no. (%) | ||||
| As neoadjuvant or adjuvant therapy | 180 (50.7) | 170 (48.2) | 79 (51.0) | 67 (50.0) |
| As therapy for advanced breast cancer | 65 (18.3) | 64 (18.1) | 30 (19.4) | 23 (17.2) |
Patients in the AKT pathway–altered population were those with a PIK3CA, AKT1, or PTEN alteration in tumor. Percentages may not total 100 because of rounding. CDK4/6 denotes cyclin-dependent kinases 4 and 6, ER estrogen receptor, and PR progesterone receptor.
Race was determined by the person who filled out the case-report form.
Eastern Cooperative Oncology Group (ECOG) performance-status scores range from 0 (no disability) to 5 (death). A score of 1 indicates that the patient is ambulatory but restricted from strenuous activity. One patient in the placebo–fulvestrant group had a score of 2, which was a protocol deviation.
Endocrine maintenance therapy after chemotherapy was reported as a separate line of therapy.
One patient in the capivasertib–fulvestrant group had ER-negative, PR-negative disease.
Endocrine status was defined in the clinical trial protocol as primary resistance (relapse during the first 2 years of adjuvant endocrine therapy or progressive disease within the first 6 months of first-line endocrine therapy for advanced breast cancer, while receiving endocrine therapy) or secondary resistance (relapse during adjuvant endocrine therapy but after the first 2 years, relapse within 12 months after completing adjuvant endocrine therapy, or progressive disease occurring ≥6 months after initiating endocrine therapy for advanced breast cancer) as previously described in the 4th European School of Oncology–European Society for Medical Oncology International Consensus Guidelines for Advanced Breast Cancer.23 Patients who met any criteria of secondary resistance were classified as such, regardless of whether they met the definition of primary resistance; patients who did not meet any criteria of secondary resistance were classified as having primary resistance.