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

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

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

Study Overview

• Status: Recruiting
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: Cipterbin Combined With Vinorelbine

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Xiaojia Wang; Phone Number: +86 13906500190; Email: wxiaojia0803@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Collaborators: Proswell Medical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: November 11, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Metastatic breast cancer; HER2-positive
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Vinorelbine
• Other Study ID Numbers: SSGJ-302H-mBC-IIT-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No