Sun Yat-sen University Cancer Center
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
Evaluating the Efficacy of Lapatinib in Combination With Chemotherapy in Patients With Trastuzumab-refractory Metastatic HER2-positive Breast Cancer.
详细描述
Some studies has demonstrated that even in trastuzumab pretreated patients with HER-2 positive breast cancer, might benefit from the treatment of trastuzumab. However, there is small benefit for some patients having short disease-free survival after adjuvant trastuzumab or short progression-free survival after first-line trastuzumab-based therapy. In clinical practice, the investigators also found it is fact. And the investigators have a scientific rationale for clinical testing of lapatinib plus chemotherapy in patients with trastuzumab-refractory, metastatic HER2-positive breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Metastatic breast cancer
- •Eastern Cooperative Oncology Group (ECOG) 0 or 1
- •HER2-expressing primary or metastatic tumor
- •Recurrence within 1 year completing adjuvant trastuzumab OR rapid progress following first-line trastuzumab-based care.
- •Measurable disease with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- •Normal organ function, including bone marrow function, renal function, liver function, and cardiac function
- •Signed and dated an informed consent form
- •Life expectancy of at least 12 weeks
排除标准
- •Pregnant or breast feeding
- •left ventricular ejection fraction (LVEF) < 45% by echocardiogram
- •Disease-free interval (DFI) less than 12 months
- •Uncontrolled medical problems
- •Any previous malignancy exceptions for carcinoma of the cervix, squamous carcinoma of the skin, or basal cell carcinoma of the skin
- •Patients were unable or unwilling to comply with program requirements
研究组 & 干预措施
Lapatinib and Capecitabine or Vinorelbine
Lapatinib 1250mg qd and Capecitabine 1000mg/m2 bid or Vinorelbine 25mg/m2 iv (d1,d8)
干预措施: lapatinib and capecitabine or vinorelbine (Drug)
结局指标
主要结局
progression-free survival
时间窗: 36 months
The time from randomization to disease progression or death from any causes
次要结局
未报告次要终点
研究者
Zhong-yu Yuan
Professor
Sun Yat-sen University