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Table 3 Proportion of Clinical Response in the treatment groups

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

Reference trastuzumab

Complete Response (%)

15.22

23.81

Partial Response (%)

73.91

59.52

Progressive Disease (%)

0.00

2.38

Stable Disease (%)

6.52

9.52

Unassessable (%)

4.35

4.76

  1. Valid percent was reported
  2. P-value = 0.59
  3. P-value for ORR (Overall response includes complete and partial response) = 0.72
  4. P-value computed using fisher exact Test