Metastatic Breast CancerPhase 2NCT01439191
Study of Cipterbin®, Used Alone or With Vinorelbine in Patients With HER2/Neu-overexpressed Metastatic Breast Cancer
A Phase 2 study testing humanized anti-HER2 antibody and Vinorelbine in people with Metastatic Breast Cancer, run by Shanghai CP Guojian Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The HER2 gene (also known as HER2/neu and ErbB2 gene) is overexpressed in 20-30% of human breast cancers and leads to a particularly aggressive form of the disease. Trastuzumab,a humanized anti-HER2/neu receptor monoclonal antibody, has been proved a valuable treatment for HER2-positive breast cancer patients.The… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- humanized anti-HER2 antibody and Vinorelbine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteChina
- Study dates
- Jul 2005to May 2007
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathologic diagnosis breast cancer
- HER2+ status defined as IHC3+ Staining or in situ hybridization positive at least 1 measurable lesion as per RECIST criteria
- Adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)
- Adequate liver (bilirubin <1.0 times upper limit of normal and SGOT/SGPT <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)
- Adequate cardiac function (LVEF>50%). Normal electrocardiogram and absence of significant heart disease
- age from 18 to 70y
Show all 10Show fewer
- Karnofsky performance score ≥ 60
- Life expectancy of greater than 3 months
- Negative HCG pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause.
- signed ICF
Who cannot join
- prior exposure vinorelbine for breast cancer
- prior exposure trastuzumab for breast cancer
- Prior chemotherapy and radiation therapy within the last 4 weeks before enrollment
- use of any other investigational agents within the last 4 weeks before enrollment
- symptomatic, central nervous system metastases
- Hypersensitivity to trial medications
- breastfeeding or pregnant
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
About this study
Official title: An Open-Label Randomized Phase II Study of Cipterbin® or Cipterbin® in Combination With Vinorelbine in Patients With HER2/Neu-overexpressed Metastatic Breast Cancer (MBC)
The HER2 gene (also known as HER2/neu and ErbB2 gene) is overexpressed in 20-30% of human breast cancers and leads to a particularly aggressive form of the disease. Trastuzumab,a humanized anti-HER2/neu receptor monoclonal antibody, has been proved a valuable treatment for HER2-positive breast cancer patients.The combination of trastuzumab with chemotherapy has been shown to increase both survival and response rate, in comparison to trastuzumab alone. CMAB302, a biosimilar of trastuzumab, was developed by Shanghai CP Guojian Pharmaceutical Co.Ltd. Efficacy and safety of CMAB302 as a single agent or in combination with vinorelbine were evaluated in patients with HER2-overexpressing metastatic breast cancer.
Read the detailed description
The HER2 gene (also known as HER2/neu and ErbB2 gene) is overexpressed in 20-30% of human breast cancers and leads to a particularly aggressive form of the disease. Trastuzumab,a humanized anti-HER2/neu receptor monoclonal antibody, has been proved valuable treatment for HER2-positive breast cancer patients.The combination of trastuzumab with chemotherapy has been shown to increase both survival and response rate, in comparison to trastuzumab alone. CMAB302, a biosimilar of trastuzumab, was developed by Shanghai CP Guojian Pharmaceutical Co.Ltd. Previous Phase I study showed that CMAB302 was well tolerated as monotherapy and the pharmacokinetic data exhibited a non-linear profile over the dose range of 100 to 500 mg, similar to that of trastuzumab. In this study, efficacy and safety of CMAB302 as a single agent or in combination with vinorelbine were evaluated in patients with HER2-overexpressing metastatic breast cancer.
- Conditions
- Metastatic Breast Cancer
- Being tested
- humanized anti-HER2 antibody, Vinorelbine
- Keywords
- HER2-Overexpressed
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
humanized anti-HER2 antibodyDrug
Also called brand name:Cipterbin®
Initial dose of 4 mg/kg as an intravenous infusion over 90 minutes then at 2 mg/kg as an intravenous infusion over 30 minutes weekly for 12 weeks. For single agent group, patients with complete response, partial response or stable disease could be treated for 24 weeks.
VinorelbineDrug
Also called brand name:NAVELBINE®
Vinorelbine was administered weekly at a dose of 25 mg/m2 on day 1, 8 and 21 every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| combination agent group | Experimental | Not described Receives: Drug: humanized anti-HER2 antibody; Drug: Vinorelbine |
| single agent group | Experimental | In this arm, patients would be treated with Cipterbin® for 12 or 24 weeks Receives: Drug: humanized anti-HER2 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
according to RECIST 1.0 (Response Evaluation Criteria In Solid Tumors)
Measured: up to 24 weeks
Secondary outcomes (3)
One-year survival rate
Measured: 1 year
Number of participants with adverse events
Adverse events was recorded according to NCI CTC 2.0 (National Cancer Institute common toxicity criteria).
Measured: up to 24 weeks
Overall control of disease
defined as overall response rate plus stable disease, by RECIST 1.0
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startJul 2005
- Primary completionFeb 2007
- Study completionMay 2007
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai CP Guojian Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yan Sun, PhD, Study chair, Cancer Institute and Hospital, Chinese Academy of Medical SciencesYuankai Shi, PhD, Study director, Cancer Institute and Hospital, Chinese Academy of Medical SciencesZefei Jiang, PhD, Principal investigator, Hospital Affiliated to Academy Military Medical ScienceJun Ren, PhD, Principal investigator, Peking University Cancer Hospital & InstituteXichun Hu, PhD, Principal investigator, Fudan UniversityKai Li, PhD, Principal investigator, Tianjin Medical University Cancer Institute and HospitalDong Wang, PhD, Principal investigator, Daping Hospital & Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439191
- Sponsor's protocol ID
- C302MBCⅡ
- Status last verified
- Jun 2005
- First submitted
- 21 Sep 2011
- Last updated
- 23 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Randomized Phase II Study of Cipterbin® or Cipterbin® in Combination With Vinorelbine in Patients With HER2/Neu-overexpressed Metastatic Breast Cancer (MBC)
- ClinicalTrials.gov ID
- NCT01439191
- Acronym / sponsor ID
- C302MBCⅡ
- Conditions
- Metastatic Breast Cancer
- Keywords
- HER2-Overexpressed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Shanghai CP Guojian Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 23 Sep 2011 (estimated)
- 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.
The HER2 gene (also known as HER2/neu and ErbB2 gene) is overexpressed in 20-30% of human breast cancers and leads to a particularly aggressive form of the disease. Trastuzumab,a humanized anti-HER2/neu receptor monoclonal antibody, has been proved a valuable treatment for HER2-positive breast cancer patients.The combination of trastuzumab with chemotherapy has been shown to increase both survival and response rate, in comparison to trastuzumab alone. CMAB302, a biosimilar of trastuzumab, was developed by Shanghai CP Guojian Pharmaceutical Co.Ltd. Efficacy and safety of CMAB302 as a single agent or in combination with vinorelbine were evaluated in patients with HER2-overexpressing metastatic breast cancer.
Detailed description
The HER2 gene (also known as HER2/neu and ErbB2 gene) is overexpressed in 20-30% of human breast cancers and leads to a particularly aggressive form of the disease. Trastuzumab,a humanized anti-HER2/neu receptor monoclonal antibody, has been proved valuable treatment for HER2-positive breast cancer patients.The combination of trastuzumab with chemotherapy has been shown to increase both survival and response rate, in comparison to trastuzumab alone. CMAB302, a biosimilar of trastuzumab, was developed by Shanghai CP Guojian Pharmaceutical Co.Ltd. Previous Phase I study showed that CMAB302 was well tolerated as monotherapy and the pharmacokinetic data exhibited a non-linear profile over the dose range of 100 to 500 mg, similar to that of trastuzumab. In this study, efficacy and safety of CMAB302 as a single agent or in combination with vinorelbine were evaluated in patients with HER2-overexpressing metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combination agent group | Experimental | Drug: humanized anti-HER2 antibody, Drug: Vinorelbine |
| single agent group | Experimental | Drug: humanized anti-HER2 antibodyIn this arm, patients would be treated with Cipterbin® for 12 or 24 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- pathologic diagnosis breast cancer
- HER2+ status defined as IHC3+ Staining or in situ hybridization positive at least 1 measurable lesion as per RECIST criteria
- Adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)
- Adequate liver (bilirubin <1.0 times upper limit of normal and SGOT/SGPT <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)
- Adequate cardiac function (LVEF>50%). Normal electrocardiogram and absence of significant heart disease
Key exclusion criteria (7 listed)
- prior exposure vinorelbine for breast cancer
- prior exposure trastuzumab for breast cancer
- Prior chemotherapy and radiation therapy within the last 4 weeks before enrollment
- use of any other investigational agents within the last 4 weeks before enrollment
- symptomatic, central nervous system metastases
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 |
|---|---|---|
| humanized anti-HER2 antibodyAlso: brand name:Cipterbin®Initial dose of 4 mg/kg as an intravenous infusion over 90 minutes then at 2 mg/kg as an intravenous infusion over 30 minutes weekly for 12 weeks. For single agent group, patients with complete response, partial response or stable disease could be treated for 24 weeks. | Drug | combination agent group, single agent group |
| VinorelbineAlso: brand name:NAVELBINE®Vinorelbine was administered weekly at a dose of 25 mg/m2 on day 1, 8 and 21 every 4 weeks | Drug | combination agent group |
Primary outcome
Overall response rate
Time frame: up to 24 weeks
according to RECIST 1.0 (Response Evaluation Criteria In Solid Tumors)
3 secondary outcomes
One-year survival rate
Time frame: 1 year
Number of participants with adverse events
Time frame: up to 24 weeks
Overall control of disease
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2011.
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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.
Yan Sun, PhD study chair
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Yuankai Shi, PhD study director
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Zefei Jiang, PhD principal investigator
Hospital Affiliated to Academy Military Medical Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing humanized anti-HER2 antibody and Vinorelbine in people with Metastatic Breast Cancer, run by Shanghai CP Guojian Pharmaceutical Co., Ltd. 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 10 inclusion and 7 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: finished, as of the sponsor's last update on 23 Sep 2011. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: up to 24 weeks). 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 Sep 2011; AzTrials last refreshed its copy on 7 Nov 2026.