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

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05131841
• Other study ID #: SSGJ-302H-mBC-IIT-01
• Status: Recruiting
• Phase: Phase 4
• Start date: January 4, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: November 2021
• Source: Zhejiang Cancer Hospital
• Contact: Xiaojia Wang, PHD
• Phone: 86 13906500190
• Email: wxiaojia0803[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital	Proswell Medical Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Cmax after the last administration	From enrollment to 21 days after the last dose administrate
Primary	Cmin	Cmin after the last administration	From enrollment to 21 days after the last dose administrate
Primary	AUC0-t	AUC0-t after the last administration	From enrollment to 21 days after the last dose administrate
Primary	AUCtau	AUCtau after the last administration	From enrollment to 21 days after the last dose administrate
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Safety index	Adverse Events during the test	From enrollment to 30 days after the last dose administrate
Secondary	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
Secondary	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
Secondary	OS	Overall Survival of all subjects	From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
Secondary	Immunogenicity index	ADA	From enrollment to 21 days after the last dose administrate