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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Safety of Inetetamab Combined With Pyrotinib and Vinorelbine in the Treatment of Advanced Breast Cancer

Conditions
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HER2-positive Advanced Breast Cancer

Intervention / Treatment
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* Drug: Inetetamab Combined With Pyrotinib and Vinorelbine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years; 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: Pregnant or lactating women; 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. Persons with a known history of allergy to the drug components of this protocol; Have a history of immunodeficiency, including HIV testing positive, or have other acquired or congenital immunodeficiency diseases; The researcher believes that it is not suitable for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group of ues of inetetamab combined with pyrotinib and vinorelbine<br>Group of ues of inetetamab combined with pyrotinib and vinorelbine | Drug: Inetetamab Combined With Pyrotinib and Vinorelbine<br>* Inetetamab Combined With Pyrotinib and Vinorelbine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progressive 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. | 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 | assessed up to 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | up to 48 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced breast cancer，HER2-positive