Skip to main content

Table 1 Demographics and baseline characteristics of the participants

From: Comparing efficacy and safety of P013, a proposed pertuzumab biosimilar, with the reference product in HER2-positive breast cancer patients: a randomized, phase III, equivalency clinical trial

  P013 (N = 107) Reference pertuzumab (N = 107)
Age (years), Mean ± SD 47.56 ± 10.31 44.35 ± 9.81
BMI (kg/m2), Mean ± SD 28.27 ± 5.30 27.27 ± 4.38
BSA (m2), Mean ± SD 1.79 ± 0.18 1.79 ± 0.18
IHC 2+, No. (%)
 FISH+ 3 (2.80) 3 (2.80)
 CISH+ 6 (5.61) 3 (2.80)
IHC 3+, No. (%) 98 (91.59) 101 (94.39)
ER/PR, No. (%)
 ER and/or PR positive 63 (58.88) 64 (59.81)
 ER and PR negative 44 (41.12) 43 (40.19)
Type of breast cancer, No. (%)
 Inflammatory 6 (5.61) 6 (5.61)
 Locally advanced 49 (45.79) 48 (44.86)
 Operable 52 (48.60) 53 (49.53)
The largest dimension of the tumor size, median (Q1, Q3) 45 (34, 65) 45 (35, 63)
  1. There is no imputation for missing values
  2. BMI Body Mass Index, BSA Body Surface Area, IHC Immunohistochemistry, FISH Fluorescence in situ hybridization, CISH Chromogenic in situ hybridization, ER/PR Eestrogen/ Progesterone receptor