This is a prospective, no interventional, single arm cohort study, which aims to study the efficacy and safety of inetetamab combined with pyrotinib and vinorelbine in the Treatment of HER2 positive advanced breast cancer in the real world. The study will be conducted by signing an informed consent form for study enrollment, collecting patient case information, and conducting observation and follow-up.
This is a prospective, no interventional, single arm cohort study, which aims to study the efficacy and safety of inetetamab combined with pyrotinib and vinorelbine in the Treatment of HER2 positive advanced breast cancer in the real world. The study will be conducted by signing an informed consent form for study enrollment, collecting patient case information, and conducting observation and follow-up.The research process is divided into screening period, treatment period, and survival and follow-up periods.
Study Type
OBSERVATIONAL
Enrollment
100
Inetetamab Combined With Pyrotinib and Vinorelbine
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGProgressive free survival(PFS)
The time between the date of treatment of inetetamab combined with pyrotinib and vinorelbine and the progression of the tumor or death from any cause.
Time frame: From date of treatment of inetetamab combined with pyrotinib and vinorelbine until the date of the progression of the tumor or death from any cause, whichever came first, assessed up to about 48 months
Adverse events
The duration of adverse reaction data collection should be from the date the patient started medication to 30 days after the end of the last medication
Time frame: assessed up to 48 months
Overall Survival(OS)
Refers to the time between the date when the patient starts treatment of inetetamab combined with pyrotinib and vinorelbine and vinorelbine and death from any cause.
Time frame: From date of the patient starts treatment of inetetamab combined with pyrotinib and vinorelbine and vinorelbine and death from any cause,assessed up to about 48 months.
Objective response rate(ORR)
Refers to the proportion of patients whose tumors have shrunk to a certain amount and remained for a certain period of time. The percentage of cases that include CR and PR in the number of evaluable cases.
Time frame: up to 48 months.
Disease Control Rate (DCR)
Refers to the percentage of confirmed cases of complete remission (CR), partial remission (PR), and disease stabilization (SD) (≥ 4 weeks) among patients with evaluable efficacy.
Time frame: up to 48 months.
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