Metastatic Breast CancerPhase 4NCT05131841
Cipterbin Combined With Vinorelbine in the Treatment of HER2-positive MBC
A Phase 4 study testing Cipterbin Combined With Vinorelbine in people with Metastatic Breast Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Cipterbin Combined With Vinorelbine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2021to 30 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Sufficient organ function
- Voluntarily signed an informed consent form.
- Subjects with good compliance
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Xiaojia Wang, +86 13906500190, wxiaojia0803@163.com
About this study
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
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
Read the 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
- Conditions
- Metastatic Breast Cancer
- Being tested
- Cipterbin Combined With Vinorelbine
- Keywords
- Metastatic breast cancer, HER2-positive
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cipterbin Combined With VinorelbineDrug
- 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
| Study group | Role | What they receive |
|---|---|---|
| One-week group | Active comparator | Cipterbin combined with Vinorelbine Injection every week in the treatment of patients with HER2-positive metastatic breast cancer Receives: 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 Receives: Drug: Cipterbin Combined With Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Cmax after the last administration
Measured: From enrollment to 21 days after the last dose administrate
Cmin
Cmin after the last administration
Measured: From enrollment to 21 days after the last dose administrate
AUC0-t
AUC0-t after the last administration
Measured: From enrollment to 21 days after the last dose administrate
AUCtau
AUCtau after the last administration
Measured: From enrollment to 21 days after the last dose administrate
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to 21 days after the last dose administrate
Safety index
Adverse Events during the test
Measured: From enrollment to 30 days after the last dose administrate
BOR
Record the proportion of CR and PR in all subjects
Measured: 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
Measured: From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
OS
Overall Survival of all subjects
Measured: From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
Immunogenicity index
ADA
Measured: From enrollment to 21 days after the last dose administrate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start4 Jan 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Proswell Medical Corporation
- Responsible party
- Principal investigator, wangxiaojia, Zhejiang Cancer Hospital
- Investigators
- Jian Huang, chief doctor, Study director, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131841
- Sponsor's protocol ID
- SSGJ-302H-mBC-IIT-01
- Status last verified
- Nov 2021
- First submitted
- 3 Sep 2021
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared from the trial begin for 10 years
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05131841
- Acronym / sponsor ID
- SSGJ-302H-mBC-IIT-01
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic breast cancer, HER2-positive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Collaborators
- Proswell Medical Corporation
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-week group | Active comparator | Drug: Cipterbin Combined With VinorelbineCipterbin combined with Vinorelbine Injection every week in the treatment of patients with HER2-positive metastatic breast cancer |
| Three-week group | Experimental | Drug: Cipterbin Combined With VinorelbineCipterbin combined with Vinorelbine Injection every three weeks in the treatment of patients with HER2-positive metastatic breast cancer |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cipterbin Combined With Vinorelbine1. 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 | Drug | One-week group, Three-week group |
Primary outcome
Cmax
Time frame: From enrollment to 21 days after the last dose administrate
Cmax after the last administration
Cmin
Time frame: From enrollment to 21 days after the last dose administrate
Cmin after the last administration
AUC0-t
Time frame: From enrollment to 21 days after the last dose administrate
AUC0-t after the last administration
AUCtau
Time frame: From enrollment to 21 days after the last dose administrate
AUCtau after the last administration
10 secondary outcomes
Multiple sets of Cmax
Time frame: From enrollment to 21 days after the last dose administrate
Multiple sets of Cmin
Time frame: From enrollment to 21 days after the last dose administrate
Multiple sets of AUC0-t
Time frame: From enrollment to 21 days after the last dose administrate
Multiple sets of AUCtau
Time frame: From enrollment to 21 days after the last dose administrate
Multiple sets of Tmax
Time frame: From enrollment to 21 days after the last dose administrate
Safety index
Time frame: From enrollment to 30 days after the last dose administrate
BOR
Time frame: From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
DCR
Time frame: From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
OS
Time frame: From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
Immunogenicity index
Time frame: From enrollment to 21 days after the last dose administrate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Individual participant dataSharing planned: Yes. The data will be shared from the trial begin for 10 years
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Huang, chief doctor study director
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cipterbin Combined With Vinorelbine in people with Metastatic Breast Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaojia Wang, PHD (86 13906500190, wxiaojia0803@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: From enrollment to 21 days after the last dose administrate). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.