Cipterbin Combined With Vinorelbine in the Treatment of HER2-positive MBC

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

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

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