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Table 1 Baseline Characteristics of the participants in the Intention-to-Treat Population

From: A randomized, double-blind, phase III, non-inferiority clinical trial comparing the efficacy and safety of TA4415V (a proposed Trastuzumab biosimilar) and Herceptin (Trastuzumab reference product) in HER2-positive early-stage breast Cancer patients

  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)
  1. There is no imputation for missing values
  2. IHC Immunohistochemistry, FISH Fluorescence in situ hybridization, CISH Chromogenic in situ hybridization, ER Estrogen receptor, PR Progesterone receptor