This study is a randomized controlled, open-label, multicenter phase III clinical study evaluating the efficacy and safety of chemotherapy selected by investigator JSKN003 s in subjects with recurrent or metastatic breast cancer who have previously failed first- or second-line chemotherapy in subjects with recurrent or metastatic breast cancer who have failed prior first- or second-line chemotherapy.
The study planned to enroll 408 subjects in a 1:1 ratio and stratified block randomization method assigned to:
* Experimental group: JSKN003 monotherapy * Control group: investigator's chosen chemotherapy drug (capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin) monotherapy
1. The subject is able to understand the informed consent form, voluntarily participate and sign the informed consent form.
1. Untreated, or unstable brain parenchymal metastases, spinal cord metastases or compression, cancerous meningitis.
Parallel
JSKN003
DrugAdministered intravenously according to protocol.
Capecitabine tablets
DrugAdministered according to protocol, as one option for investigator's choice (determined before randomization).
Gemcitabine hydrochloride for injection
DrugAdministered according to protocol, as one option for investigator's choice (determined before randomization).
Vinorelbine tartrate injection
DrugAdministered according to protocol, as one option for investigator's choice (determined before randomization).
Paclitaxel for injection (albumin-bound type)
DrugAdministered according to protocol, as one option for investigator's choice (determined before randomization).
Docetaxel injection
DrugAdministered according to protocol, as one option for investigator's choice (determined before randomization).
Eribulin mesylate injection
DrugAdministered according to protocol, as one option for investigator's choice (determined before randomization).
Progression Free Survival (PFS)
PFS evaluated by BICR according to RECIST v1.1 criteria is defined as the time from randomization to the first recorded disease progression or death from any cause as a result of BICR evaluation according to RECIST v1.1 criteria.
Overall survival（OS）
OS, defined as the time from randomization to death from any cause;
Objective Response Rate (ORR)
BICR and investigators were judged according to RECIST v1.1 criteria ，objective response rate (ORR), defined as the proportion of participants achieving a complete response (CR) or partial response (PR) according to RECIST v1.1 criteria;
Duration of Response (DOR)
BICR and investigators were judged according to RECIST v1.1 criteria，Duration of response (DoR), defined as the time from the first recorded response (CR/PR) to the first documented disease progression (PD) or death from any cause;
Click on the lead sponsor to view all of their trials.
