A Clinical Study to Evaluate the Efficacy and Safety of DP303c versus trastuzumab emtansine in patients with HER2-positive Advanced Breast Cancer
This is a multi-centre, randomized, open-label, controlled phase Ш clinical study to evaluate the efficacy and safety of DP303c injection versus trastuzumab emtansine in in patients with HER2-positive advanced breast cancer. Patients will be treated with DP303c injection at 3.0 mg/kg or trastuzumab emtansine at 3.6 mg/kg every 3 weeks. Patients will continue to receive treatment until disease progression, intolerable toxicity, withdrawal of informed consent, death, or any other reasons for treatment discontinuation, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
442
intravenous injection
intravenous injection
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGProgression-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.
Time frame: Up to approximately 4 years
Progression-free survival (PFS) by investigator
PFS is evaluated by investigator according to the Response Evaluation Criteria for Solid Tumors (RECIST) V1.1.
Time frame: Up to approximately 4 years
Overall Survival (OS)
Overall Survival
Time frame: Up to approximately 4 years
Objective response rate (ORR)
ORR is evaluated by investigator and BIRC according to the Response Evaluation Criteria for Solid Tumors (RECIST) V1.1.
Time frame: Up to approximately 4 years
Duration of response (DoR)
Duration of Response
Time frame: Up to approximately 4 years
Incidence and severity of adverse events (AEs)
Incidence and severity of adverse events
Time frame: Up to approximately 4 years
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