Table 1 Demographic and clinical characteristics at baseline
Total (n = 41) | HR + (n = 18) | HR- (n = 23) | |
|---|---|---|---|
Age | |||
Median (range), years | 53.0 (28–68) | 52.5 (30–65) | 53.0 (28–68) |
ECOG performance status, n (%) | |||
0 | 1 (2.4) | 0 (0) | 1 (4.3) |
1 | 40 (97.6) | 18 (100) | 22 (95.7) |
Hormone receptor status, n (%) | |||
HR+ | 18 (43.9) | 18 (100) | — |
ER+ or PR+ | 11 (26.8) | 11 (61.1) | — |
ER+ and PR+ | 7 (17.1) | 7 (38.9) | — |
HR-a | 23 (56.1) | — | 23 (100) |
HER2 status, n (%) | |||
IHC 3+ | 30 (73.2) | 11 (61.1) | 19 (82.6) |
IHC 2+ and FISH + | 10 (24.4) | 7 (38.9) | 3 (13.0) |
IHC 1+ and FISH + | 1 (2.4)b | 0 (0) | 1 (4.3) |
Metastatic sites at screening, n (%) | |||
Visceral | 38 (92.7) | 16 (88.9) | 22 (95.7) |
Brain | 13 (31.7) | 5 (27.8) | 8 (34.8) |
Lung | 23 (56.1) | 9 (50.0) | 14 (60.9) |
Liver | 17 (41.5) | 10 (55.6) | 7 (30.4) |
Non-visceral | 3 (7.3) | 2 (11.1) | 1 (4.3) |
No. of prior systemic treatments, n (%) | |||
0 | 3 (7.3) | 2 (11.1) | 1 (4.3) |
1 | 27 (65.9) | 10 (55.6) | 17 (73.9) |
2 | 11 (26.8) | 6 (33.3) | 5 (21.7) |
Median (range) | 1 (0–2) | 1 (0–2) | 1 (0–2) |
Prior systemic treatment, n (%) | |||
None | 3 (7.3) | 2 (11.1) | 1 (4.3) |
Neoadjuvant/adjuvant | 29 (70.7) | 13 (72.2) | 16 (69.6) |
Metastatic/locally advanced | 21 (51.2) | 10 (55.6) | 11 (47.8) |
Previous HER2-target therapy, n (%) | |||
Trastuzumab | 28 (68.3) | 10 (55.6) | 18 (78.3) |
Pertuzumab | 5 (12.2) | 0 (0) | 5 (21.7) |
None | 13 (31.7) | 8 (44.4) | 5 (21.7) |
Resistance to trastuzumabc, n (%) | |||
Yes | 16 (39.0) | 5 (27.8) | 11 (47.8) |
No | 25 (61.0) | 13 (72.2) | 12 (52.2) |
Previous chemotherapy, n (%) | |||
Yes | 38 (92.7) | 16 (88.9) | 22 (95.7) |
No | 3 (7.3) | 2 (11.1) | 1 (4.3) |
Previous endocrine therapyd, n (%) | |||
Yes | 12 (66.7) | 12 (66.7) | — |
No | 12 (66.7) | 6 (33.3) | — |
