Conditions: HER2 Positive Early or Locally Advanced Breast Cancer
Keywords: HER2 Positive Breast Cancer Trastuzumab Biosimilar
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 875
Healthy volunteers: no

Brief summary:
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

Detailed description:

Arms:
arm 1: Intravenous administration arm 2: Intravenous administration

Interventions: intervention 1: Herceptin (trastuzuamb) intervention 2: SB3 (proposed trastuzumab biosimilar)
Intervention descriptions: intervention 1: Intravenous administration intervention 2: Intravenous administration

Protocol document: