Cipterbin Combined With Vinorelbine in the Treatment of HER2-positive MBC
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: One-week group Cipterbin combined with Vinorelbine Injection every week in the treatment of patients with HER2-positive metastatic breast cancer |
Drug: Cipterbin Combined With Vinorelbine
Cipterbin combined with Vinorelbine Injection every week in the treatment of patients with HER2-positive metastatic breast cancer
Cipterbin combined with Vinorelbine Injection every three weeks in the treatment of patients with HER2-positive metastatic breast cancer
|
| Experimental: Three-week group Cipterbin combined with Vinorelbine Injection every three weeks in the treatment of patients with HER2-positive metastatic breast cancer |
Drug: Cipterbin Combined With Vinorelbine
Cipterbin combined with Vinorelbine Injection every week in the treatment of patients with HER2-positive metastatic breast cancer
Cipterbin combined with Vinorelbine Injection every three weeks in the treatment of patients with HER2-positive metastatic breast cancer
|
Outcome Measures
Primary Outcome Measures
- Cmax [From enrollment to 21 days after the last dose administrate]
Cmax after the last administration
- Cmin [From enrollment to 21 days after the last dose administrate]
Cmin after the last administration
- AUC0-t [From enrollment to 21 days after the last dose administrate]
AUC0-t after the last administration
- AUCtau [From enrollment to 21 days after the last dose administrate]
AUCtau after the last administration
Secondary Outcome Measures
- Multiple sets of Cmax [From enrollment to 21 days after the last dose administrate]
Cmax after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
- Multiple sets of Cmin [From enrollment to 21 days after the last dose administrate]
Cmin after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
- Multiple sets of AUC0-t [From enrollment to 21 days after the last dose administrate]
AUC0-t after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
- Multiple sets of AUCtau [From enrollment to 21 days after the last dose administrate]
AUCtau after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
- Multiple sets of Tmax [From enrollment to 21 days after the last dose administrate]
Tmax after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
- Safety index [From enrollment to 30 days after the last dose administrate]
Adverse Events during the test
- BOR [From enrollment to death(for any reason),Until 24 months after the last subject left the administration group]
Record the proportion of CR and PR in all subjects
- DCR [From enrollment to death(for any reason),Until 24 months after the last subject left the administration group]
CR/PR/SD accounted for the proportion of all subjects
- OS [From enrollment to death(for any reason),Until 24 months after the last subject left the administration group]
Overall Survival of all subjects
- Immunogenicity index [From enrollment to 21 days after the last dose administrate]
ADA
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥18 and ≤70 years old, female.
-
BMI index in the range of 19.0~28.0
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ECOG≤1, and the expected os ≥3 months
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Unresectable metastatic breast cancer diagnosed by histology or pathology that has received one or more chemotherapy regimens.
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HER2 overexpression is +++ by immunohistochemistry (IHC) or + by fluorescence hybridization FISH.
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At least one measurable lesion.
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Sufficient organ function
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Voluntarily signed an informed consent form.
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Subjects with good compliance
Exclusion Criteria:
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Rapid disease progression or threaten important organs and require urgent replacement therapy.
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Undergone surgery within 28 days before treatment (except for biopsy)
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Received radiotherapy within 21 days before the first study drug treatment or the side effects of radiotherapy have not recovered to 0 or 1
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Suffer from other serious uncontrolled diseases (such as epilepsy, liver failure, kidney failure, etc.)
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Suffered from other malignant tumors within 5 years before receiving the first study drug treatment or at the same time.
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Severely infected
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Clear history of mental illness, or have a history of alcoholism or drug abuse.
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Central nervous system metastasis or meningeal metastasis with clinical symptoms
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Cardiac function left ventricular ejection fraction < 50%
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Obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency, severe heart valve Membrane disease patients
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Poorly controlled hypertension
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Patients with coagulopathy: INR or APTT ≥1.5×ULN
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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
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Pregnant or breastfeeding, or cannot take reliable contraceptive measures during the trial and within 6 months after the end of the medication Giver
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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)
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Have used a monoclonal antibody within 6 months before receiving the first study drug treatment
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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)
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Have received organ transplants (including autologous/allologous stem cell transplants) in the past
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Other conditions judged by the investigator to be inappropriate for participating in this trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhejiang Cancer Hospital | Hangzhou | Zhejiang | China | 310000 |
Sponsors and Collaborators
- Zhejiang Cancer Hospital
- Proswell Medical Corporation
Investigators
- Study Director: Jian Huang, chief doctor, Zhejiang Cancer Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SSGJ-302H-mBC-IIT-01