To compare pharmacokinetics Index of Cipterbin combined with Vinorelbine Injection every week or every three weeks in the treatment of patients with HER2-positive metastatic breast cancer
A multi-center, randomized, open-label study on pharmacokinetics, safety, efficacy, and immunogenicity of Cipterbin combined with Vinorelbine Injection every week or every three weeks in the treatment of patients with HER2-positive metastatic breast cancer. The main purpose was to compare pharmacokinetics Index between two groups, secondly to observe safety, efficacy, and immunogenicity
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
1. Cipterbin combined with Vinorelbine Injection every week in the treatment of patients with HER2-positive metastatic breast cancer 2. Cipterbin combined with Vinorelbine Injection every three weeks in the treatment of patients with HER2-positive metastatic breast cancer
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGCmax
Cmax after the last administration
Time frame: From enrollment to 21 days after the last dose administrate
Cmin
Cmin after the last administration
Time frame: From enrollment to 21 days after the last dose administrate
AUC0-t
AUC0-t after the last administration
Time frame: From enrollment to 21 days after the last dose administrate
AUCtau
AUCtau after the last administration
Time frame: From enrollment to 21 days after the last dose administrate
Multiple sets of Cmax
Cmax after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
Time frame: From enrollment to 21 days after the last dose administrate
Multiple sets of Cmin
Cmin after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
Time frame: From enrollment to 21 days after the last dose administrate
Multiple sets of AUC0-t
AUC0-t after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
Time frame: From enrollment to 21 days after the last dose administrate
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Multiple sets of AUCtau
AUCtau after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
Time frame: From enrollment to 21 days after the last dose administrate
Multiple sets of Tmax
Tmax after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
Time frame: From enrollment to 21 days after the last dose administrate
Safety index
Adverse Events during the test
Time frame: From enrollment to 30 days after the last dose administrate
BOR
Record the proportion of CR and PR in all subjects
Time frame: From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
DCR
CR/PR/SD accounted for the proportion of all subjects
Time frame: From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
OS
Overall Survival of all subjects
Time frame: From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
Immunogenicity index
ADA
Time frame: From enrollment to 21 days after the last dose administrate