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Recruiting NCT05856383

Efficacy and Safety of Inetetamab Combined With Pyrotinib and Vinorelbine in ABC

Trial Parameters

Condition HER2-positive Advanced Breast Cancer
Sponsor Zhejiang Cancer Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-03-16
Completion 2027-12-31
Interventions
Inetetamab Combined With Pyrotinib and Vinorelbine

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: 1. Age ≥ 18 years; 2. The HER2 positive advanced breast cancer confirmed by cytology or histology must meet the following conditions at the same time: (1) HER2 positive is defined as\>10% of immunoreactive cells with an immunohistochemical (IHC) score of 3 or an in situ hybridization (ISH) result of HER2 gene amplification (2) Advanced breast cancer is defined as locally advanced breast cancer or metastatic breast cancer that cannot be removed by radical surgery confirmed by researchers; 3. The functional level of the main organs has been evaluated by the researchers to withstand chemotherapy, anti HER2 monoclonal antibodies, and anti HER2 TKI drugs. The LVEF and QT intervals measured by echocardiography or MUGA are within a clinically acceptable safety range. If the survival benefits of the treatment value are assessed by the researcher to be greater than the risks faced, the admission conditions for the specific organ function level can be appropriately relaxed by

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