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)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •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
排除标准
- •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
研究组 & 干预措施
combination agent group
干预措施: humanized anti-HER2 antibody (Drug)
combination agent group
干预措施: Vinorelbine (Drug)
single agent group
In this arm, patients would be treated with Cipterbin® for 12 or 24 weeks
干预措施: humanized anti-HER2 antibody (Drug)
结局指标
主要结局
Overall response rate
时间窗: up to 24 weeks
according to RECIST 1.0 (Response Evaluation Criteria In Solid Tumors)
次要结局
- One-year survival rate(1 year)
- Number of participants with adverse events(up to 24 weeks)
- Overall control of disease(up to 24 weeks)