Back to resultsCipterbin Combined With Vinorelbine in the Treatment of HER2-positive MBC
Primary Purpose
Metastatic Breast Cancer
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Cipterbin Combined With Vinorelbine
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Metastatic breast cancer, HER2-positive
Eligibility 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
Sites / Locations
- Zhejiang Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
One-week group
Three-week group
Arm Description
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
Outcomes
Primary Outcome Measures
Cmax
Cmax after the last administration
Cmin
Cmin after the last administration
AUC0-t
AUC0-t after the last administration
AUCtau
AUCtau after the last administration
Secondary Outcome Measures
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.
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.
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.
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.
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.
Safety index
Adverse Events during the test
BOR
Record the proportion of CR and PR in all subjects
DCR
CR/PR/SD accounted for the proportion of all subjects
OS
Overall Survival of all subjects
Immunogenicity index
ADA
Full Information
NCT ID
NCT05131841
First Posted
September 3, 2021
Last Updated
November 11, 2021
Sponsor
Zhejiang Cancer Hospital
Collaborators
Proswell Medical Corporation
1. Study Identification
Unique Protocol Identification Number
NCT05131841
Brief Title
Cipterbin Combined With Vinorelbine in the Treatment of HER2-positive MBC
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Cancer Hospital
Collaborators
Proswell Medical Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
Metastatic breast cancer, HER2-positive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
One-week group
Arm Type
Active Comparator
Arm Description
Cipterbin combined with Vinorelbine Injection every week in the treatment of patients with HER2-positive metastatic breast cancer
Arm Title
Three-week group
Arm Type
Experimental
Arm Description
Cipterbin combined with Vinorelbine Injection every three weeks in the treatment of patients with HER2-positive metastatic breast cancer
Intervention Type
Drug
Intervention Name(s)
Cipterbin Combined With Vinorelbine
Intervention Description
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
Primary Outcome Measure Information:
Title
Cmax
Description
Cmax after the last administration
Time Frame
From enrollment to 21 days after the last dose administrate
Title
Cmin
Description
Cmin after the last administration
Time Frame
From enrollment to 21 days after the last dose administrate
Title
AUC0-t
Description
AUC0-t after the last administration
Time Frame
From enrollment to 21 days after the last dose administrate
Title
AUCtau
Description
AUCtau after the last administration
Time Frame
From enrollment to 21 days after the last dose administrate
Secondary Outcome Measure Information:
Title
Multiple sets of Cmax
Description
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.
Time Frame
From enrollment to 21 days after the last dose administrate
Title
Multiple sets of Cmin
Description
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.
Time Frame
From enrollment to 21 days after the last dose administrate
Title
Multiple sets of AUC0-t
Description
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.
Time Frame
From enrollment to 21 days after the last dose administrate
Title
Multiple sets of AUCtau
Description
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.
Time Frame
From enrollment to 21 days after the last dose administrate
Title
Multiple sets of Tmax
Description
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.
Time Frame
From enrollment to 21 days after the last dose administrate
Title
Safety index
Description
Adverse Events during the test
Time Frame
From enrollment to 30 days after the last dose administrate
Title
BOR
Description
Record the proportion of CR and PR in all subjects
Time Frame
From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
Title
DCR
Description
CR/PR/SD accounted for the proportion of all subjects
Time Frame
From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
Title
OS
Description
Overall Survival of all subjects
Time Frame
From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
Title
Immunogenicity index
Description
ADA
Time Frame
From enrollment to 21 days after the last dose administrate
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaojia Wang, PHD
Phone
86 13906500190
Email
wxiaojia0803@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Huang, chief doctor
Phone
86 13588048995
Email
huang_jian22@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Huang, chief doctor
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojia Wang
Phone
+86 13906500190
Email
wxiaojia0803@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be shared from the trial begin for 10 years
IPD Sharing Time Frame
From the trial begin for 10 years
IPD Sharing Access Criteria
Every one
Learn more about this trial
Cipterbin Combined With Vinorelbine in the Treatment of HER2-positive MBC
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