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Table 2 Randomized trial characteristics by biological subtype of trial population and treatment setting

From: Patterns in target-directed breast cancer research

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      
 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      
 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      
 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      
 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     
 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     
 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     
 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)
  1. DFS disease-free survival, EFS event-free survival, ET endocrine therapy, HER2 human epidermal growth factor receptor 2, HR hormone receptor, mTOR mammalian target of rapamycin, PARP poly(ADP-ribose) polymerase, PI3K phosphoinositide 3-kinase, PFS progression-free survival, RFS relapse-free survival