A Clinical Study to Evaluate the Efficacy and Safety of DP303c versus trastuzumab emtansine in patients with HER2-positive Advanced Breast Cancer
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);
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 medical intervention.
4. Known contraindication to the study drugs;
Parallel
DP303c
Drugintravenous injection
trastuzumab emtansine
Drugintravenous injection
Progression-free survival (PFS) by BIRC
PFS is evaluated by a Blinded Independent Review Committee (BIRC) according to the Response Evaluation Criteria for Solid Tumors (RECIST) V1.1.
Progression-free survival (PFS) by investigator
PFS is evaluated by investigator according to the Response Evaluation Criteria for Solid Tumors (RECIST) V1.1.
Overall Survival (OS)
Overall Survival
Objective response rate (ORR)
ORR is evaluated by investigator and BIRC according to the Response Evaluation Criteria for Solid Tumors (RECIST) V1.1.
Duration of response (DoR)
Duration of Response
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