Clinical trial NCT05131841: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Metastatic Breast Cancer
Keywords: Metastatic breast cancer
HER2-positive
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Proswell Medical Corporation
First posted: 2021-11-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Cmax
timeFrame: From enrollment to 21 days after the last dose administrate
measure: Cmin
timeFrame: From enrollment to 21 days after the last dose administrate
measure: AUC0-t
timeFrame: From enrollment to 21 days after the last dose administrate
measure: AUCtau
timeFrame: From enrollment to 21 days after the last dose administrate
Secondary outcomes:
measure: Multiple sets of Cmax
timeFrame: From enrollment to 21 days after the last dose administrate
measure: Multiple sets of Cmin
timeFrame: From enrollment to 21 days after the last dose administrate
measure: Multiple sets of AUC0-t
timeFrame: From enrollment to 21 days after the last dose administrate
measure: Multiple sets of AUCtau
timeFrame: From enrollment to 21 days after the last dose administrate
measure: Multiple sets of Tmax
timeFrame: From enrollment to 21 days after the last dose administrate
measure: Safety index
timeFrame: From enrollment to 30 days after the last dose administrate
measure: BOR
timeFrame: From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
measure: DCR
timeFrame: From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
measure: OS
timeFrame: From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
measure: Immunogenicity index
timeFrame: From enrollment to 21 days after the last dose administrate
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Jian Huang, chief doctor
role: STUDY_DIRECTOR
References: