Overview

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

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 the researcher, but the reasons need to be explained
        in the medical record; 4. ECOG score: 0-2 points; 5. Voluntarily sign the informed consent
        form for this study. 6. Contraception during the study period and within 6 months after
        treatment, non lactation.
        Exclusion Criteria:
          1. Pregnant or lactating women;
          2. At the same time or in the past five years, patients with one or more malignant tumors
             with metastatic capacity or potential other than HER2 positive breast cancer, but not
             including cured cervical carcinoma in situ, thyroid cancer, skin basal cell carcinoma
             or squamous cell carcinoma. For other malignant tumors occurring within a period of
             more than 5 years from this treatment, if only cured by surgery, they are allowed to
             be included.
          3. Persons with a known history of allergy to the drug components of this protocol;
          4. Have a history of immunodeficiency, including HIV testing positive, or have other
             acquired or congenital immunodeficiency diseases;
          5. The researcher believes that it is not suitable for inclusion.