Table 2.
Baseline characteristics of patients in the expanded PI3K/AKT/PTEN pathway-altered and pathway non-altered subgroups
|
Expanded pathway-altered subgroup |
Expanded pathway non-altered subgroup |
||||
|---|---|---|---|---|---|
| Fulvestrant plus capivasertib (n=39) | Fulvestrant plus placebo (n=37) | Fulvestrant plus capivasertib (n=30) | Fulvestrant plus placebo (n=34) | ||
| Median age, years (IQR); range | 60 (55–69); 46–81 | 62 (56–68); 47–73 | 62 (57–68); 42–79 | 60 (52–67); 40–82 | |
| ECOG performance status (physical examination) | |||||
| 0 | 25 (64%) | 25 (68%) | 17 (57%) | 24 (71%) | |
| 1 | 14 (36%) | 9 (24%) | 11 (37%) | 8 (24%) | |
| 2 | 0 | 1 (3%) | 1 (3%) | 1 (3%) | |
| Missing data | 0 | 2 (5%) | 1 (3%) | 1 (3%) | |
| Histopathological subtype | |||||
| Invasive ductal carcinoma | 33 (85%) | 31 (84%) | 24 (80%) | 27 (79%) | |
| Invasive lobular cancer | 2 (5%) | 5 (14%) | 2 (7%) | 7 (21%) | |
| Mixed invasive ductal carcinoma and invasive lobular cancer | 3 (8%) | 0 | 2 (7%) | 0 | |
| Other | 1 (3%) | 1 (3%) | 2 (7%) | 0 | |
| Stage | |||||
| III inoperable | 0 | 1 (3%) | 0 | 0 | |
| IV | 38 (97%) | 35 (95%) | 30 (100%) | 33 (97%) | |
| Missing | 1 (3%) | 1 (3%) | 0 | 1 (3%) | |
| Number of disease sites | |||||
| Median (IQR); range | 2 (2–3); 1–5 | 2 (1–3); 1–5 | 2 (2–3); 1–5 | 2 (2–3); 1–5 | |
| 1 | 8 (21%) | 11 (30%) | 5 (17%) | 8 (24%) | |
| 2 | 31 (79%) | 26 (70%) | 25 (83%) | 26 (76%) | |
| Metastatic sites* | |||||
| Brain | 1 (3%) | 1 (3%) | 0 | 0 | |
| Liver | 22 (56%) | 12 (32%) | 10 (33%) | 17 (50%) | |
| Lung | 17 (44%) | 17 (46%) | 13 (43%) | 11 (32%) | |
| Bone | 34 (87%) | 28 (76%) | 25 (83%) | 27 (79%) | |
| Lymph | 14 (36%) | 19 (51%) | 14 (47%) | 12 (35%) | |
| Pericardial or pleural | 2 (5%) | 0 | 3 (10%) | 3 (9%) | |
| Chest wall or skin | 0 | 2 (5%) | 1 (3%) | 1 (3%) | |
| Other visceral | 2 (5%) | 0 | 0 | 0 | |
| Visceral disease | 30 (77%) | 24 (65%) | 19 (63%) | 23 (68%) | |
| Measurable disease† | 27 (69%) | 26 (70%) | 22 (73%) | 24 (71%) | |
| Primary or secondary aromatase inhibitor resistance† | |||||
| Primary | 15 (38%) | 10 (27%) | 10 (33%) | 16 (47%) | |
| Secondary | 24 (62%) | 27 (73%) | 20 (67%) | 18 (53%) | |
| Previous breast surgery | 34 (87%) | 32 (86%) | 25 (83%) | 30 (88%) | |
| Previous adjuvant endocrine therapy | 34 (87%) | 35 (95%) | 26 (87%) | 30 (88%) | |
| Any tamoxifen | 23 (59%) | 23 (62%) | 18 (60%) | 22 (65%) | |
| Any aromatase inhibitor | 22 (56%) | 21 (57%) | 18 (60%) | 17 (50%) | |
| Any gonadotropin-releasing hormone | 2 (5%) | 0 | 1 (3%) | 1 (3%) | |
| Other | 1 (3%) | 0 | 0 | 1 (3%) | |
| Missing | 0 | 0 | 0 | 1 (3%) | |
| Previous adjuvant chemotherapy | 20 (51%) | 21 (57%) | 16 (53%) | 21 (62%) | |
| Anthracycline based | 7 (18%) | 10 (27%) | 4 (13%) | 3 (9%) | |
| Taxane based | 1 (3%) | 4 (11%) | 4 (13%) | 1 (3%) | |
| Anthracycline plus taxane | 8 (21%) | 2 (5%) | 3 (10%) | 7 (21%) | |
| Cyclophosphamide, methotrexate, and fluorouracil or capecitabine | 2 (5%) | 4 (11%) | 5 (17%) | 10 (29%) | |
| Other | 1 (3%) | 1 (3%) | 0 | 0 | |
| Missing | 1 (3%) | 0 | 0 | 0 | |
| Previous endocrine treatment (metastatic or locally advanced setting) | |||||
| 0 lines | 6 (15%) | 2 (5%) | 3 (10%) | 4 (12%) | |
| 1 line | 22 (56%) | 26 (70%) | 17 (57%) | 19 (56%) | |
| ≥2 lines | 11 (28%) | 9 (24%) | 9 (30%) | 11 (32%) | |
| Missing | 0 | 0 | 1 (3%) | 0 | |
| Metastatic chemotherapy for advanced breast cancer | 9 (23%) | 9 (24%) | 8 (27%) | 11 (32%) | |
| Capecitabine based | 0 | 1 (3%) | 3 (10%) | 5 (15%) | |
| Taxane based | 5 (13%) | 5 (14%) | 3 (10%) | 3 (9%) | |
| Anthracycline based | 2 (5%) | 3 (8%) | 0 | 3 (9%) | |
| Combined anthracycline and taxane | 1 (3%) | 0 | 2 (7%) | 0 | |
| Other | 1 (3%) | 0 | 0 | 0 | |
Data are n (%) unless otherwise stated. The displayed percentages include missing values. ECOG=Eastern Cooperative Oncology Group.
*
Sites are not mutually exclusive.
†
Randomisation minimisation factor.