A Study Of SIBP-01 Or CN-Trastuzumab Plus Docetaxel And Carboplatin In HER2 Positive Breast Cancer
Status:
Unknown status
Trial end date:
2021-07-30
Target enrollment:
Participant gender:
Summary
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.