Table 1. Patient demographic and baseline disease characteristics.
| |
Part 1 |
Part 2 |
|
||
|---|---|---|---|---|---|
| Characteristic | Neratinib 160 mg+paclitaxel (n=3) | Neratinib 240 mg+paclitaxel (n=5) | Group Aa (n=71) | Group Bb (n=31) | Total (N=110) |
| Median age (range), years | 61 (40–68) | 44 (37–64) | 49 (20–76) | 51 (36–63) | 50.5 (20–76) |
| <65 Years, n (%) | 2 (67) | 5 (100) | 67 (94) | 31 (100) | 105 (95) |
| ⩾65 Years, n (%) | 1 (33) | 0 | 4 (6) | 0 | 5 (5) |
| Female sex, n (%) |
1 (33) |
2 (40) |
71 (100) |
31 (100) |
105 (95) |
|
Ethnicity, n (%) | |||||
| Asian | 2 (67) | 2 (40) | 48 (68) | 25 (81) | 77 (70) |
| White | 0 | 3 (60) | 22 (31) | 5 (16) | 30 (27) |
| Other |
1 (33) |
0 |
1 (1) |
1 (3) |
3 (3) |
| Stage III/IV disease at diagnosis, n (%) | 2 (67) | 3 (60) | 36 (51) | 12 (39) | 53 (48) |
| ER/PR-positive disease, n (%) |
1 (33) |
0 |
36 (51) |
20 (65) |
57 (52) |
|
ECOG performance status, n (%) | |||||
| 0 | 2 (67) | 3 (60) | 31 (44) | 22 (71) | 58 (53) |
| 1 |
1 (33) |
2 (40) |
40 (56) |
9 (29) |
52 (47) |
|
No. of prior chemotherapy regimens,c
n
(%) | |||||
| 0 | 0 | 0 | 15 (21) | 0 | 15 (14) |
| 1 | 2 (67) | 2 (40) | 30 (42) | 0 | 34 (31) |
| 2 | 1 (33) | 0 | 20 (28) | 9 (29) | 30 (27) |
| 3 | 0 | 1 (20) | 4 (6) | 15 (48) | 20 (18) |
| >3 |
0 |
2 (40) |
2 (3) |
7 (23) |
11 (10) |
| Prior radiotherapy, n (%) | 2 (67) | 3 (60) | 40 (56) | 20 (65) | 65 (59) |
| Prior trastuzumab therapy,c n (%) | 0 | 1 (20) | 18 (25) | 12 (39) | 31 (28) |
| Prior lapatinib therapy,c n (%) | 0 | 1 (20) | 0 | 14 (45) | 15 (14) |
| Prior endocrine therapy,c n (%) | 0 | 0 | 24 (34) | 16 (52) | 40 (36) |
| Prior taxane therapy,c n (%) | 1 (33) | 2 (40) | 34 (48) | 30 (97) | 67 (61) |
Abbreviations: ECOG=Eastern Cooperative Oncology Group; ER=estrogen receptor; PR=progesterone receptor.
a
Group A allowed ⩽1 prior cytotoxic chemotherapy regimen for metastatic disease.
b
Group B allowed ⩽3 prior cytotoxic chemotherapy regimens for metastatic disease, with prior lapatinib permitted.
c
Includes treatment regimens used in the neoadjuvant, adjuvant, or metastatic setting.