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
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
One-week group
Cipterbin combined with Vinorelbine Injection every week in the treatment of patients with HER2-positive metastatic breast cancer
干预措施: Cipterbin Combined With Vinorelbine (Drug)
Three-week group
Cipterbin combined with Vinorelbine Injection every three weeks in the treatment of patients with HER2-positive metastatic breast cancer
干预措施: Cipterbin Combined With Vinorelbine (Drug)
结局指标
主要结局
Cmax
时间窗: From enrollment to 21 days after the last dose administrate
Cmax after the last administration
Cmin
时间窗: From enrollment to 21 days after the last dose administrate
Cmin after the last administration
AUC0-t
时间窗: From enrollment to 21 days after the last dose administrate
AUC0-t after the last administration
AUCtau
时间窗: From enrollment to 21 days after the last dose administrate
AUCtau after the last administration
次要结局
- Multiple sets of Cmax(From enrollment to 21 days after the last dose administrate)
- Multiple sets of Cmin(From enrollment to 21 days after the last dose administrate)
- Multiple sets of AUC0-t(From enrollment to 21 days after the last dose administrate)
- Multiple sets of AUCtau(From enrollment to 21 days after the last dose administrate)
- Multiple sets of Tmax(From enrollment to 21 days after the last dose administrate)
- Safety index(From enrollment to 30 days after the last dose administrate)
- BOR(From enrollment to death(for any reason),Until 24 months after the last subject left the administration group)
- DCR(From enrollment to death(for any reason),Until 24 months after the last subject left the administration group)
- OS(From enrollment to death(for any reason),Until 24 months after the last subject left the administration group)
- Immunogenicity index(From enrollment to 21 days after the last dose administrate)
研究者
wangxiaojia
Director
Zhejiang Cancer Hospital