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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
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
Details
| Lead sponsor | Samsung Bioepis Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 875 |
| Start date | 2014-04 |
| Completion | 2017-02 |
Conditions
- HER2 Positive Early or Locally Advanced Breast Cancer
Interventions
- Herceptin (trastuzuamb)
- SB3 (proposed trastuzumab biosimilar)
Primary outcomes
- The Pathologic Complete Response (pCR) Rate of the Primary Breast Tumour — Week 24
Countries
Czechia