Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer

This is an interventional treatment trial for Breast Cancer focused on measuring HER2 positive metastatic breast cancer, Inetetamab, Pyrotinib Read More

Inclusion Criteria:

Subjects must meet all of the following conditions:

1. Adult female patients (age 18-70 years) with metastatic breast cancer confirmed by pathology or imaging;
2. Pathological diagnosis of HER-2 was positive (definition: immunohistochemical results were + + + or in situ hybridization results were positive);
3. Received trastuzumab treatment in the past;
4. the patients have received 1-3 treatments for metastatic breast cancer in the past;
5. According to RECIST 1.1, patients with at least one target lesion or simple bone metastasis can be evaluated;
6. ECoG score of physical status was less than 2, and the expected survival time was not less than 3 months;
7. Prior treatment-related toxicity should be reduced to NCI CTCAE (version 5.0) ≤ 1 degree (except for hair loss or other toxicity which is considered as no risk to patient's safety according to the investigator's judgment) 8）LVEF≥50%；

9) Sufficient functional reserve of bone marrow

1. White blood cell count (WBC) ≥ 3.0 × 10 ^ 9 / L,
2. Neutrophil count (ANC) ≥ 1.5 × 10 ^ 9 / L,
3. Platelet count (PLT) ≥ 100 × 10 ^ 9 / L 10) Previous treatment-related toxicity should be relieved as NCI CTCAE (version 5.0) ≤ 1 degree, total bilirubin (TBIL) ≤ 1.5 × upper limit of normal value (ULN), alanine aminotransferase (ALT / AST) ≤ 2.5 × ULN (liver metastasis patients ≤ 5xuln), serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CCR) ≥ 60 ml / min; 11) Be able to understand the research process, volunteer to participate in the study, and sign informed consent.

Exclusion Criteria:

Subjects were not allowed to participate in the study if they had any of the following conditions:

1. No trastuzumab treatment was received;
2. Have received more than 3 therapeutic regimens for metastatic breast cancer;
3. No treatment for metastatic breast cancer was received;
4. Patients who are known to be allergic to active or other components of the study drug.
5. They received radiotherapy, chemotherapy, endocrine therapy within 4 weeks before enrollment, or were participating in any clinical trials of intervention drugs;
6. Pregnant or lactating women, women of childbearing age who refused to take effective contraceptive measures during the study period.
7. Any other situation in which the researcher considers that the patient is not suitable for the study may interfere with the concomitant diseases or conditions involved in the study, or there are any serious medical barriers that may affect the safety of the subjects (e.g., uncontrollable heart disease, hypertension, active or uncontrollable infection, active hepatitis B virus infection)