cipterbin combined with vinorelbine in the treatment of her2-positive mbc

Conditions: Metastatic Breast Cancer

Summary: to compare pharmacokinetics index of cipterbin combined with vinorelbine injection every week or every three weeks in the treatment of patients with her2-positive metastatic breast cancer

a multi-center, randomized, open-label study on pharmacokinetics, safety, efficacy, and immunogenicity of cipterbin combined with vinorelbine injection every week or every three weeks in the treatment of patients with her2-positive metastatic breast cancer. the main purpose was to compare pharmacokinetics index between two groups, secondly to observe safety, efficacy, and immunogenicity

Eligibility criteria:
inclusion criteria: * age ≥18 and ≤70 years old, female. * bmi index in the range of 19.0\~28.0 * ecog≤1, and the expected os ≥3 months * unresectable metastatic breast cancer diagnosed by histology or pathology that has received one or more chemotherapy regimens. * her2 overexpression is +++ by immunohistochemistry (ihc) or + by fluorescence hybridization fish. * at least one measurable lesion. * sufficient organ function * voluntarily signed an informed consent form. * subjects with good compliance exclusion criteria: * rapid disease progression or threaten important organs and require urgent replacement therapy. * undergone surgery within 28 days before treatment (except for biopsy) * received radiotherapy within 21 days before the first study drug treatment or the side effects of radiotherapy have not recovered to 0 or 1 * suffer from other serious uncontrolled diseases (such as epilepsy, liver failure, kidney failure, etc.) * suffered from other malignant tumors within 5 years before receiving the first study drug treatment or at the same time. * severely infected * clear history of mental illness, or have a history of alcoholism or drug abuse. * central nervous system metastasis or meningeal metastasis with clinical symptoms * cardiac function left ventricular ejection fraction \< 50% * obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency, severe heart valve membrane disease patients * poorly controlled hypertension * patients with coagulopathy: inr or aptt ≥1.5×uln * allergic to the test drug or its excipients in the study treatment, or have a severe allergic reaction to other monoclonal antibody drugs in the past * pregnant or breastfeeding, or cannot take reliable contraceptive measures during the trial and within 6 months after the end of the medication giver * have received a certain test drug in other interventional clinical trials, the interval is less than 28 days or less than 5 half lives of the drug (whichever is longer) * have used a monoclonal antibody within 6 months before receiving the first study drug treatment * have received other drugs that may affect the pharmacokinetic results of the study drug, the interval is less than 28 days or less than 5 half lives of the drug (whichever is longer) * have received organ transplants (including autologous/allologous stem cell transplants) in the past * other conditions judged by the investigator to be inappropriate for participating in this trial

Keywords: metastatic breast cancer her2-positive