Table 1.
Baseline Characteristics of the participants in the Intention-to-Treat Population
| TA4415V (N = 54) | Reference trastuzumab (N = 54) | |
|---|---|---|
| Age (Years) | ||
| Median (range) | 47.5 (28, 63) | 46 (26, 69) |
| Weight (Kg) | ||
| Median (range) | 70 (46, 110) | 70 (44, 100) |
| Tumor Size (mm) | ||
| Median (range) | 33(22,44) | 33(21,41) |
| IHC 2+, No. (%) | 9 (16.67) | 11 (20.37) |
| FISH+, No. (% of IHC 2+) | 3 (33.33) | 2 (18.18) |
| CISH+, No. (% of IHC 2+) | 6 (66.67) | 9 (81.82) |
| IHC 3+, No. (%) | 45 (83.33) | 43 (79.63) |
| ER/PR | ||
| ER and/or PR positive | 36 (66.67) | 30 (55.56) |
| ER and PR negative | 18 (33.33) | 24 (44.44) |
There is no imputation for missing values
IHC Immunohistochemistry, FISH Fluorescence in situ hybridization, CISH Chromogenic in situ hybridization, ER Estrogen receptor, PR Progesterone receptor