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Table 2 pCR analyses in the PP and ITT populations

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)

Difference (95% CI)

Per-Protocol Populationa

 pCR

18 (37.50)

15 (34.09)

−0.03 (− 0.23, 0.16)

Intention-to-treat Population

 pCRb

19 (37.25)

16 (34.78)

−0.02 (− 0.22, 0.17)

 pCRc (Imputed analysis)

19 (35.19)

16 (29.63)

−0.05 (− 0.23, 0.12)

  1. Data are n (%), unless otherwise indicated
  2. Difference = proportion (reference trastuzumab) – proportion (TA4415V)
  3. an = 48 for TA4415V and n = 44 for reference trastuzumab
  4. bn = 51 for TA4415V and 46 for reference trastuzumab
  5. cn = 54 for TA4415V and 54 for reference trastuzumab
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BMC Pharmacology and Toxicology

ISSN: 2050-6511

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