A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer
Phase 3
Completed
NCT02149524
| Condition | HER2 Positive Early or Locally Advanced Breast Cancer |
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| Phase | Phase 3 |
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| Sponsor | Samsung Bioepis Co., Ltd. |
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| Status | Completed |
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| Enrollment | 875 participants |
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| Interventions | Herceptin (trastuzuamb), SB3 (proposed trastuzumab biosimilar) |
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| Start date | Apr, 2014 |
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| Completion date | Mar, 2016 |
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| Results posted | Oct 24, 2018 |
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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
The Pathologic Complete Response (pCR) Rate of the Primary Breast Tumour
Week 24 · percentage of responders
| Herceptin (Trastuzumab) | 42.0 percentage of responders |
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| SB3 (Proposed Trastuzumab Biosimilar) | 51.7 percentage of responders |
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Open in BENITIONS
View on ClinicalTrials.gov
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