A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB3 (proposed trastuzumab biosimilar) and Herceptin® in Women with Newly Diagnosed HER2 Positive Early or Locally Advanced Breast Cancer in Neoadjuvant Setting

This is a randomized phase III, double-blind, parallel group, multicentre study to compare the efficacy, safety, pharmacokinetics and immunogenicity between SB3 and Herceptin® in women with HER2 positive EBC or LABC in neoadjuvant setting. Subjects will be randomised in a 1:1 ratio to either receive SB3 or Herceptin® in neoadjuvant setting for 8 cycles concurrently with 8 cycles of chemotherapy (4 cycles of docetaxel followed by 4 cycles of 5-fluorouracil/epirubicin/ cyclophosphamide). Subjects will then undergo surgery. After surgery**,** subjects will receive further 10 cycles of adjuvant SB3 or Herceptin® as per randomisation to complete one year of therapy. The primary endpoint is the pCR rate of the primary breast tumour and the secondary endpoints are tpCR, Overall clinical response rate, EFS and OS.