Study of Cipterbin®, Used Alone or With Vinorelbine in Patients With HER2/Neu-overexpressed Metastatic Breast Cancer
2011年9月21日 更新者：Shanghai CP Guojian Pharmaceutical Co., Ltd.
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
109
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Beijing、中国、100021
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：combination agent group
|
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.
其他名称：
Vinorelbine was administered weekly at a dose of 25 mg/m2 on day 1, 8 and 21 every 4 weeks
其他名称：
|
|
实验性的：single agent group
In this arm, patients would be treated with Cipterbin® for 12 or 24 weeks
|
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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall response rate
大体时间：up to 24 weeks
|
according to RECIST 1.0 (Response Evaluation Criteria In Solid Tumors)
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up to 24 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
One-year survival rate
大体时间：1 year
|
1 year
|
|
|
Number of participants with adverse events
大体时间：up to 24 weeks
|
Adverse events was recorded according to NCI CTC 2.0 (National Cancer Institute common toxicity criteria).
|
up to 24 weeks
|
|
Overall control of disease
大体时间：up to 24 weeks
|
defined as overall response rate plus stable disease, by RECIST 1.0
|
up to 24 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Yan Sun, PhD、Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- 研究主任：Yuankai Shi, PhD、Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- 首席研究员：Zefei Jiang, PhD、Hospital Affiliated to Academy Military Medical Science
- 首席研究员：Jun Ren, PhD、Peking University Cancer Hospital & Institute
- 首席研究员：Kai Li, PhD、Tianjin Medical University Cancer Institute and Hospital
- 首席研究员：Dong Wang, PhD、Daping Hospital & Research Institute of Surgery of the Third Military Medical University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2005年7月1日
初级完成 (实际的)
2007年2月1日
研究完成 (实际的)
2007年5月1日
研究注册日期
首次提交
2011年9月21日
首先提交符合 QC 标准的
2011年9月21日
首次发布 (估计)
2011年9月23日
研究记录更新
最后更新发布 (估计)
2011年9月23日
上次提交的符合 QC 标准的更新
2011年9月21日
最后验证
2005年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.