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

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital
• Collaborator: Proswell Medical Corporation
• Treatments: Vinorelbine

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