Table 1 Demographic and baseline characteristics
Characteristic | Phase 1b | Phase 2a | ||
|---|---|---|---|---|
All patients (N = 60) | Group A (n = 22) | Group B (n = 22) | All patients (N = 44) | |
Median age, years (range) | 53.5 (23–77) | 50.0 (35–81) | 54.0 (43–72) | 52.5 (35–81) |
Gender, n (%) | ||||
Female | 58 (97) | 21 (95.5) | 22 (100) | 43 (97.7) |
Male | 2 (3) | 1 (4.5) | 0 | 1 (2.3) |
Race, n (%) | ||||
White | 55 (92) | 16 (72.7) | 20 (90.9) | 36 (81.8) |
Asian | 3 (5) | 2 (9.1) | 0 | 2 (4.5) |
Black | 1 (2) | 3 (13.6) | 1 (4.5) | 4 (9.1) |
Not available | 1 (2) | 1 (4.5) | 1 (4.5) | 2 (4.5) |
ECOG performance status, n (%) | ||||
0 | 28 (47) | 12 (54.5) | 14 (63.6) | 26 (59.1) |
1 | 29 (48) | 8 (36.4) | 7 (31.8) | 15 (34.1) |
2 | 3 (5) | 2 (9.1) | 1 (4.5) | 3 (6.8) |
Hormone status, n (%) | ||||
ER+ and/or PR+ | 43 (61) | 10 (45.5) | 13 (59.1) | 23 (52.3) |
ER- and PR– | 16 (27) | 12 (54.5)a | 9 (40.9) | 21 (47.7) |
Unknown | 1 (2) | 0 | 0 | 0 |
Prior radiotherapy, n (%) | 47 (78) | 17 (77.3) | 17 (77.3) | 34 (77.3) |
Prior surgery, n (%) | 60 (100) | 22 (100) | 22 (100) | 44 (100) |
Prior systemic therapies, n (%) | 60 (100) | 22 (100) | 22 (100) | 44 (100) |
Trastuzumab | 60 (100) | 22 (100) | 21 (95.5) | 43 (97.7) |
Chemotherapy | 60 (100) | 22 (100) | 22 (100) | 44 (100) |
Anthracycline | 47 (78) | 13 (59.1) | 17 (77.3) | 30 (68.2) |
Taxane | 54 (90) | 20 (90.9) | 16 (72.7) | 36 (81.8) |
Lapatinib | 48 (80) | 15 (68.2) | 14 (63.6) | 29 (65.9) |
Hormonal | 39 (65) | 12 (54.5)a | 13 (59.1) | 25 (56.8)a |
Experimental | 7 (31.8) | 5 (22.7) | 12 (27.3) | |
Other biologic | 3 (13.6) | 1 (4.5) | 4 (9.1) | |
Number of prior systemic agents, median (range)b | 8.5 (2–21) | 7.5 (2–12) | 6.5 (3–14) | 7.0 (2–14) |
Number of prior systemic agents in the metastatic setting, median (range)b | 6.5 (0–18) | 6.0 (1–9) | 5.0 (0–10) | 5.0 (0–10)c |
Median time since metastatic diagnosis, months (range) | 37.9 (4–111) | 46.9 (11–199) | 48.1 (1–170) | 46.9 (1–199) |