Table 2 Randomized trial characteristics by biological subtype of trial population and treatment setting
Categories | HER2-positive [n (%)] | HR-positive [n (%)] | Triple-negative or BRCA-positive [n (%)] | Other or unselected [n (%)] | Total [n (%)] |
|---|---|---|---|---|---|
Total, n (proportion by subtype, %) | 79 (28.2) | 104 (37.1) | 20 (7.1) | 77 (27.5) | 280 (100.0) |
Populations | Â | Â | Â | Â | Â |
 Target-matched | 68 (86.1) | 50 (48.1) | 1 (5.0) | 7 (9.1) | 126 (45.0) |
 Non target-matched | 11 (13.9) | 54 (51.9) | 19 (95.0) | 70 (90.9) | 154 (55.0) |
Investigational target-directed classes | Â | Â | Â | Â | Â |
 HER2-inhibitors | 64 (81.0) | 4 (3.8) | 0 (0) | 5 (6.5) | 73 (26.1) |
 Endocrine agents | 0 (0) | 47 (45.2) | 1 (5.0) | 4 (5.2) | 52 (18.6) |
 Anti-angiogenics | 5 (6.3) | 7 (6.7) | 4 (20.0) | 33 (42.8) | 49 (17.5) |
 mTOR/PI3K/Akt pathway-inhibitors | 4 (5.1) | 14 (13.5) | 3 (15.0) | 7 (9.1) | 28 (10.0) |
 Growth factor-inhibitors | 2 (2.5) | 12 (11.5) | 2 (10.0) | 4 (5.2) | 20 (7.1) |
 Intracellular, non-receptor PK-inhibitors | 0 (0) | 12 (11.5) | 1 (5.0) | 5 (6.5) | 18 (6.4) |
 Immunotherapy/vaccines | 4 (5.1) | 0 (0) | 0 (0) | 6 (7.8) | 10 (3.6) |
 PARP1/2-inhibitors | 0 (0) | 1 (1.0) | 6 (30.0) | 0 (0) | 7 (2.5) |
 Other | 0 (0) | 7 (6.7) | 3 (15.0) | 13 (16.9) | 23 (8.2) |
Types of target-directed therapy | Â | Â | Â | Â | Â |
 Established | 59 (74.7) | 56 (53.8) | 2 (10.0) | 16 (20.8) | 133 (47.5) |
 Emergent | 20 (25.3) | 48 (46.2) | 18 (90.0) | 61 (79.2) | 147 (52.5) |
Therapeutic strategies | Â | Â | Â | Â | Â |
 Chemotherapy-based regimens | 64 (81.0) | 13 (12.5) | 18 (90.0) | 69 (89.6) | 164 (58.6) |
 Non chemotherapy-based regimens | 15 (19.0) | 91 (87.5) | 2 (10.0) | 8 (10.4) | 116 (41.4) |
 ET-based regimens | 6 (7.6) | 95 (91.3) | 1 (5.0) | 11 (14.3) | 113 (40.4) |
 Non ET-based regimens | 73 (92.4) | 9 (8.6) | 19 (95.0) | 66 (85.7) | 167 (59.6) |
 Peptide-drug conjugates | 6 (7.6) | 0 (0) | 1 (5.0) | 1 (1.3) | 8 (2.8) |
 Mono-class regimens | 60 (75.9) | 51 (49.0) | 19 (95.0) | 65 (84.4) | 195 (69.6) |
 Multi-class regimens | 19 (24.0) | 53 (51.0) | 1 (5.0) | 12 (15.6) | 85 (30.4) |
Categories | Neoadjuvant [n (%)] | Adjuvant [n (%)] | Advanced [n (%)] | Total [n (%)] |
|---|---|---|---|---|
Total [n (proportion by setting, %)] | 68 (24.3) | 66 (23.6) | 146 (52.1) | 280 (100.0) |
Subtype | Â | Â | Â | Â |
 HER2-positive | 25 (36.8) | 19 (28.8) | 35 (23.9) | 79 (28.2) |
 HR-positive | 17 (25.0) | 29 (43.9) | 58 (39.7) | 104 (37.1) |
 Triple-negative or BRCA-positive | 7 (10.3) | 3 (4.5) | 10 (6.8) | 20 (7.1) |
 Other or unselected | 19 (27.9) | 15 (22.7) | 43 (29.4) | 77 (27.5) |
Primary endpoint | Â | Â | Â | Â |
 Overall survival | 0 (0) | 1 (1.5) | 6 (4.1) | 7 (2.5) |
 Quality of life | 0 (0) | 2 (3.0) | 1 (0.7) | 3 (1.1) |
 Pathological complete response | 36 (52.9) | 0 (0) | 0 (0) | 36 (12.8) |
 DFS/RFS/PFS/EFS | 3 (4.4) | 51 (77.3) | 106 (72.6) | 160 (57.1) |
 Clinical response | 15 (22.0) | 1 (1.5) | 19 (13.0) | 35 (12.5) |
 Biomarker | 10 (14.7) | 6 (9.1) | 2 (1.4) | 18 (6.4) |
 Safety and tolerability | 4 (5.9) | 3 (4.5) | 8 (5.5) | 15 (5.4) |
 Other | 0 (0) | 2 (3.0) | 4 (2.7) | 6 (2.1) |
Study Phase | Â | Â | Â | Â |
 Phase II (%) | 53 (77.9) | 15 (22.7) | 96 (65.8) | 164 (58.6) |
 Phase III (%) | 15 (22.0) | 51 (77.3) | 50 (34.2) | 116 (41.4) |