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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Administered intravenously according to protocol.
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Administered according to protocol, as one option for investigator's choice (determined before randomization).
Erwei Song
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGJiong Wu
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGAnyang Cancer Hospital
Anyang, China
NOT_YET_RECRUITINGAffiliated Hospital of Hebei University
Baoding, China
NOT_YET_RECRUITINGProgression 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.
Time frame: up to approximately 3 years after the first enrollment
Overall survival(OS)
OS, defined as the time from randomization to death from any cause;
Time frame: up to approximately 3 years after the first enrollment
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;
Time frame: up to approximately 3 years after the first enrollment
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;
Time frame: up to approximately 3 years after the first enrollment
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Beijing Luhe Hospital
Beijing, China
NOT_YET_RECRUITINGCancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGPeking University Cancer Hospital
Beijing, China
RECRUITINGThe First Affiliated Hospital of China Medical University
Beijing, China
RECRUITINGThe First Medical Center of the General Hospital of the People's Liberation Army Chinese People's Liberation Army
Beijing, China
NOT_YET_RECRUITINGBethune First Hospital of Jilin University
Changchun, China
NOT_YET_RECRUITING...and 77 more locations