Table 1 Baseline characteristics, intent-to-treat population
Characteristic | Cohort 1: pertuzumab, trastuzumab, and vinorelbine N = 106 |
|---|---|
Median age, years (range) | 56 (30–82) |
Female gender | 106 (100%) |
Geographical region | |
Europe | 91 (85.8%) |
North America | 15 (14.2%) |
ECOG performance status | |
0 | 74 (69.8%) |
1 | 32 (30.2%) |
Disease type at screening | |
Visceral | 78 (73.6%) |
Non-visceral | 28 (26.4%) |
Disease stage at initial diagnosis | |
I | 12 (11.3%) |
II | 31 (29.2%) |
III | 29 (27.4%) |
IV | 34 (32.1%) |
Disease stage at advanced breast cancer diagnosis | |
Locally advanced | 11 (10.4%) |
Metastatic | 95 (89.6%) |
Hormone receptor status | |
Estrogen and/or progesterone receptor-positive | 70 (66.0%) |
Estrogen and progesterone receptor-negative | 36 (34.0%) |
HER2 status, local assessment | |
Immunohistochemistry | |
0 or 1+ | 0 |
2+ | 14 (13.2%) |
3+ | 85 (80.2%) |
Not performed | 7 (6.6%) |
In situ hybridization | |
Positive | 26 (24.5%) |
Negative | 0 |
Not performed | 80 (75.5%) |
HER2 status, central assessment | |
HER2-positive | 88 (83.0%) |
HER2-negative | 12 (11.3%) |
Not done | 2 (1.9%) |
Missing | 4 (3.8%) |
Immunohistochemistry | |
0 or 1+ | 8 (7.5%) |
2+ | 17 (16.0%) |
3+ | 75 (70.8%) |
Not performed | 2 (1.9%) |
Missing | 4 (3.8%) |
In situ hybridization | |
Positive | 80 (75.5%) |
Negative | 8 (7.5%) |
Not performed | 3 (2.8%) |
Not evaluable | 11 (10.4%) |
Missing | 4 (3.8%) |
Prior systemic cancer therapy | 65 (61.3%) |
Taxanea | 40 (37.7%) |
Anthracyclineb | 41 (38.7%) |
Trastuzumab | 44 (41.5%) |
Bevacizumab | 1 (0.9%) |