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Table 2 bpCR analyses in the PP and ITT populations

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 Reference pertuzumab Difference (95% Confidence interval)
Breast pCR (PP) 71 (67.62) 73 (71.57) −0.04 (− 0.16, 0.09)
Breast pCR (ITT) 71 (66.36) 74 (69.16) −0.03 (− 0.15, 0.10)
Breast pCR according to ER/PR (ITT)
 ER/PR + (N = 127) 35 (55.55) 38 (59.37) −0.04 (− 0.21, 0.13)
 ER/PR - (N = 87) 36 (81.82) 36 (83.72) −0.02 (− 0.18, 0.14)
  1. For ITT analysis, patients with missing assessments were considered to be nonresponders
  2. Difference = P013- Reference pertuzumab
  3. pCR Pathological complete response, ER/PR Eestrogen/ Progesterone receptor