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

NCT05131841 | Unknown Phase 4

• 1 other identifier: SSGJ-302H-mBC-IIT-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Metastatic Breast Cancer

Keywords

Metastatic breast cancer; HER2-positive

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• Multiple sets of Cmax

  From enrollment to 21 days after the last dose administrate

• Multiple sets of Cmin

  From enrollment to 21 days after the last dose administrate

• Multiple sets of AUC0-t

  From enrollment to 21 days after the last dose administrate

• Multiple sets of AUCtau

  From enrollment to 21 days after the last dose administrate

• Multiple sets of Tmax

  From enrollment to 21 days after the last dose administrate

Study Arms (2)

One-week group

ACTIVE COMPARATOR

Cipterbin combined with Vinorelbine Injection every week in the treatment of patients with HER2-positive metastatic breast cancer

Drug: Cipterbin Combined With Vinorelbine

Three-week group

EXPERIMENTAL

Cipterbin combined with Vinorelbine Injection every three weeks in the treatment of patients with HER2-positive metastatic breast cancer

Drug: Cipterbin Combined With Vinorelbine

Interventions

Cipterbin Combined With Vinorelbine DRUG

1. Cipterbin combined with Vinorelbine Injection every week in the treatment of patients with HER2-positive metastatic breast cancer 2. Cipterbin combined with Vinorelbine Injection every three weeks in the treatment of patients with HER2-positive metastatic breast cancer

One-week group; Three-week group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead
• Proswell Medical Corporation: collaborator

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Jian Huang, chief doctor

  Zhejiang Cancer Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiaojia Wang, PHD

CONTACT

86 13906500190; wxiaojia0803@163.com

Jian Huang, chief doctor

CONTACT

86 13588048995; huang_jian22@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: November 23, 2021
• Study Start: January 4, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: November 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: From the trial begin for 10 years
• Access Criteria: Every one

Locations

CN (1)