NCT01291667已完成不适用
A Phase III Randomized Study for HER2-Overexpressed Metastatic Breast Cancer Patients Treated by Trastuzumab( Cipterbin®) Plus vinorelbinE Simultaneously or Sequencely
Shanghai CP Guojian Pharmaceutical Co., Ltd.0 个研究点目标入组 330 人开始时间: 2009年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 主要终点
- progress-free survival
研究概览
简要总结
Breast cancer is the most common malignant disease and the most frequent causes of cancer mortality in females worldwide. The situation is same as the world in China. Trastuzumab has been proved valuable treatment for HER2-positive breast cancer patients. Cipterbin® is developing by Shanghai CP Guojian Pharmaceutical Co.Ltd.Now we carried on the phase III trial in order to prove Cipterbin® 's efficacy and safety.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed ICF
- •pathologic diagnosis breast cancer
- •HER2+ status defined as IHC3+ Staining or in situ hybridization positive at least 1 measurable lesion as per RECIST criteria age from 18y to 70y KPS>=70
排除标准
- •More than three prior chemotherapy lines for advanced disease LVEF<50%
- •prior exposure vinorebine for breast cancer
- •prior exposure Trastuzumab for breast cancer
- •uncontrolled brain metastasis
- •breastfeeding or pregnant
结局指标
主要结局
progress-free survival
次要结局
- overall response rate,safety
研究者
相似试验
已完成
不适用
Are Text Message Reminders an Effective Intervention for Improving the Uptake of Breast Screening?Breast ScreeningNCT01977599Imperial College Healthcare NHS Trust2,240
Unknown
不适用
Evaluation of Clinical Significance of Circulating Markers in Breast Cancer Patients Undergoing Herceptin TherapyBreast CancerNCT00530569Alberta Health services60
招募中
不适用
Clinical Study of High-intensity Focused Ultrasound Tumor Treatment System(Super Knife) in the Treatment of Breast CancerBreast CancerNCT06210529Shengjing Hospital12
终止
1 期
A Study of Allogenic Natural Killer Cells in Combination With Trastuzumab and Pertuzumab in Adult Patients With Refractory Metastatic Her2 Positive Breast Cancer. NK-ACT-BC_2020Breast NeoplasmsNCT05385705Vall d'Hebron Institute of Oncology2
已完成
2 期
Abraxane With or Without Tigatuzumab in Patients With Metastatic, Triple Negative Breast CancerBreast CancerTriple Negative Breast CancerStage IV Breast CancerMetastatic Breast CancerNCT01307891University of Alabama at Birmingham64