Table 2.
Patient baseline demographics
| Arm 1 | Arm 2 | Arm 3 | Arm 4 | Total (safety population) | |
|---|---|---|---|---|---|
| Female gender, n (%) | 34 (100) | 10 (100) | 12 (100) | 13 (100) | 69 (100) |
| Median (range) age | 55·0 (31–75) | 53·5 (45–68) | 48·5 (37–65) | 58·0 (43–71) | 55·0 (31–75) |
| Ethnicity, n (%) | |||||
| Caucasian | 32 (94) | 9 (90) | 10 (83) | 13 (100) | 64 (93) |
| Black | 2 (6) | 0 | 2 (17) | 0 | 4 (6) |
| Asian | 0 | 1 (10) | 0 | 0 | 1 (1) |
| ECOG performance status, n (%) | |||||
| 0 | 16 (47) | 5 (50) | 7 (58) | 5 (39) | 33 (48) |
| 1 | 18 (53) | 5 (50) | 5 (42) | 6 (62) | 36 (52) |
| Median (range) time from first diagnosis, months | 72·8 (7·3–311·0) | 89·7 (8·1–144·5) | 46·3 (10·8–199·6) | 85·4 (11·0–198·6) | 69·1 (7·3–311·0) |
| Median (range) time from first diagnosis of metastatic disease, months | 33·6 (0·1–199·5) | 47·8 (5·0–101·1) | 29·0 (7·6–76·1) | 54·45 (1·2–198·0) | 39·5 (0·1–199·5) |
| Disease status, n (%) | |||||
| Locally advanced | 0 | 0 | 0 | 2 (15) | 2 (3) |
| Distant metastases | 34 (100) | 10 (100) | 12 (100) | 11 (85) | 67 (97) |
| Disease stage at diagnosis, n (%) | |||||
| IA | 5 (15) | 1 (10) | 0 | 3 (23) | 9 (13) |
| IB | 1 (3) | 0 | 0 | 0 | 1 (1) |
| IIA | 6 (18) | 2 (20) | 1 (8) | 2 (15) | 11 (16) |
| IIB | 5 (15) | 2 (20) | 1 (8) | 1 (8) | 9 (13) |
| IIIA | 4 (12) | 2 (20) | 1 (8) | 0 | 7 (10) |
| IIIB | 0 | 0 | 0 | 1 (8) | 1 (1) |
| IIIC | 0 | 0 | 1 (8) | 0 | 1 (1) |
| IV | 4 (12) | 1 (10) | 6 (50) | 3 (23) | 14 (20) |
| Unknown | 9 (27) | 2 (20) | 2 (17) | 3 (23) | 16 (23) |
| ER receptor status, n (%) | |||||
| Positive | 6 (18) | 4 (40) | 1 (8) | 2 (15) | 13 (19) |
| Negative | 1 (3) | 2 (20) | 6 (50) | 3 (23) | 12 (17) |
| Unknown | 27 (79) | 4 (40) | 5 (42) | 8 (62) | 44 (64) |
| PR receptor status, n (%) | |||||
| Positive | 3 (9) | 2 (20) | 2 (16) | 1 (8) | 8 (11) |
| Negative | 4 (12) | 4 (40) | 5 (42) | 4 (31) | 17 (25) |
| Unknown | 27 (79) | 4 (40) | 5 (42) | 8 (61) | 44 (64) |
| Median (range) number of prior anticancer therapies | 5 (1–10) | 4 (1–12) | 4·5 (2–10) | 5 (2–10) | 5 (1–12) |
| Previous exposure to therapy, n (%) | |||||
| Trastuzumab | 34 (100) | 9 (90) | 12 (100) | 13 (100) | 68 (99) |
| Taxane | 33 (97) | 9 (90) | 11 (92) | 11 (85) | 64 (93) |
| Lapatinib | 23 (68) | 6 (60) | 6 (50) | 7 (54) | 42 (61) |
| Anthracycline | 18 (53) | 6 (60) | 5 (42) | 8 (62) | 37 (54) |
| Ado-trastuzumab emtansine | 10 (29) | 4 (40) | 11 (92) | 10 (77) | 35 (51) |
| (T-DM1) | |||||
| Hormonal therapy | 18 (53) | 4 (40) | 3 (25) | 8 (62) | 33 (48) |
| Pertuzumab | 1 (3) | 5 (50) | 8 (67) | 3 (23) | 17 (25) |
| Prior surgery, n (%) | 33 (97) | 9 (90) | 11 (92) | 12 (92) | 65 (94) |
| Prior radiotherapy, n (%) | 23 (68) | 7 (70) | 9 (75) | 8 (62) | 47 (68) |
CISH chromogenic in situ hybridization, ECOG Eastern Cooperative Oncology Group, ER estrogen receptor, FISH fluorescence in situ hybridization, HER2 human epidermal growth factor receptor 2, IHC immunohistochemistry, PR progesterone receptor