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

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: Cipterbin Combined With Vinorelbine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: One-week group<br>Cipterbin combined with Vinorelbine Injection every week in the treatment of patients with HER2-positive metastatic breast cancer | Drug: Cipterbin Combined With Vinorelbine<br>* 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<br>|
| Experimental: Three-week group<br>Cipterbin combined with Vinorelbine Injection every three weeks in the treatment of patients with HER2-positive metastatic breast cancer | Drug: Cipterbin Combined With Vinorelbine<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Cmax after the last administration | From enrollment to 21 days after the last dose administrate | 
| Cmin | Cmin after the last administration | From enrollment to 21 days after the last dose administrate | 
| AUC0-t | AUC0-t after the last administration | From enrollment to 21 days after the last dose administrate | 
| AUCtau | AUCtau after the last administration | From enrollment to 21 days after the last dose administrate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple sets of Cmax | 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. | From enrollment to 21 days after the last dose administrate | 
| Multiple sets of Cmin | 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. | From enrollment to 21 days after the last dose administrate | 
| Multiple sets of AUC0-t | 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. | From enrollment to 21 days after the last dose administrate | 
| Multiple sets of AUCtau | 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. | From enrollment to 21 days after the last dose administrate | 
| Multiple sets of Tmax | 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. | From enrollment to 21 days after the last dose administrate | 
| Safety index | Adverse Events during the test | From enrollment to 30 days after the last dose administrate | 
| BOR | Record the proportion of CR and PR in all subjects | From enrollment to death(for any reason),Until 24 months after the last subject left the administration group | 
| DCR | CR/PR/SD accounted for the proportion of all subjects | From enrollment to death(for any reason),Until 24 months after the last subject left the administration group | 
| OS | Overall Survival of all subjects | From enrollment to death(for any reason),Until 24 months after the last subject left the administration group | 
| Immunogenicity index | ADA | From enrollment to 21 days after the last dose administrate | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic breast cancer, HER2-positive