Cipterbin Combined With Vinorelbine in the Treatment of HER2-positive MBC
NCT ID: NCT05131841
Last Updated: 2021-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2021-01-04
2022-12-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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One-week group
Cipterbin combined with Vinorelbine Injection every week in the treatment of patients with HER2-positive metastatic breast cancer
Cipterbin Combined With Vinorelbine
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
Three-week group
Cipterbin combined with Vinorelbine Injection every three weeks in the treatment of patients with HER2-positive metastatic breast cancer
Cipterbin Combined With Vinorelbine
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
Interventions
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Cipterbin Combined With Vinorelbine
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
FEMALE
No
Sponsors
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Proswell Medical Corporation
INDUSTRY
Zhejiang Cancer Hospital
OTHER
Responsible Party
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wangxiaojia
Director
Principal Investigators
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Jian Huang, chief doctor
Role: STUDY_DIRECTOR
Zhejiang Cancer Hospital
Locations
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Xiaojia Wang
Role: primary
Other Identifiers
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SSGJ-302H-mBC-IIT-01
Identifier Type: -
Identifier Source: org_study_id