A Study Of SIBP-01 Or CN-Trastuzumab Plus Docetaxel And Carboplatin In HER2 Positive Breast Cancer

Authors Shanghai Institute Of Biological Products -More
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2019
Links ClinicalTrials.gov
The study will compare PK, efficacy, safety, and immunogenicity of SIBP‐01 (Trastuzumab Biosimilar) in combination with Docetaxel and Carboplatin versus Herceptin® (CN‐Trastuzumab) approved in the CN in combination with Docetaxel and Carboplatin in patients with operable HER2 positive, with early or locally advanced HER2‐positive breast cancer. The hypothesis to be tested in this study is the tpCR of patients with Cycle 6 of SIBP‐01 is similar to CN‐approved trastuzumab, using a 90% bilateral confidence interval between 0.74 and 1.5.
Epistemonikos ID: 3af558859876961482d9c5e52d4936d37f79afa8
First added on: May 22, 2024