DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer
Trial Parameters
Brief Summary
A Clinical Study to Evaluate the Efficacy and Safety of DP303c versus trastuzumab emtansine in patients with HER2-positive Advanced Breast Cancer
Eligibility Criteria
Inclusion Criteria: * 1．Voluntarily agree to participate in the study and sign the informed consent; * 2．Age≥18 years old; * 3．Patients with unresectable locally advanced or metastatic breast cancer confirmed by histology; * 4．Confirmed to be HER2 positive (HER2-positive is defined as IHC 3+ or IHC 2+ with ISH positive); * 5．Previously received regimens containing trastuzumab and taxanes at the advanced stage of disease. * 6．The Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2; * 7．Patients with adequate organ functions; * 8．Life expectancy ≥ 3 months; * 9．Female and male patients of childbearing age must agree to take adequate contraceptive measures during the entire study period. Exclusion Criteria: * 1\. Patients who have previously received tubulin inhibitor-loaded HER2 ADC therapy * 2\. History of any other malignant tumors within three years * 3\. With uncontrollable serous effusion within 14 days before randomization, which required frequent drainage or medi