A Multicenter Phase II Clinical Trial Assessing the Efficacy of the Combination of Lapatinib and Capecitabine in Patients With Non Pretreated Brain Metastasis From HER2 Positive Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
RATIONALE: Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib ditosylate together with capecitabine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving lapatinib ditosylate together with capecitabine works in treating patients with stage IV breast cancer and brain metastases.
详细描述
OBJECTIVES:
Primary
- To assess the objective response rate by volumetric analysis of brain metastasis as assessed by MRI in patients with HER2-positive stage IV breast cancer treated with lapatinib ditosylate and capecitabine.
Secondary
- To document any toxicity evaluated by NCI CTC v3.0.
- To assess the time to radiotherapy.
- To document the time to disease progression in the central nervous system (CNS) of these patients.
- To evaluate the overall response rate for extra-CNS disease.
- To assess the clinical benefit (complete response, partial response, and stable disease for ≥ 6 months) for both CNS and extra-CNS disease in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lapatinib + capecitabine
lapatinib 1250mg/day + capecitabine 2000mg/m2/day
干预措施: capecitabine (Drug)
Lapatinib + capecitabine
lapatinib 1250mg/day + capecitabine 2000mg/m2/day
干预措施: lapatinib ditosylate (Drug)
Lapatinib + capecitabine
lapatinib 1250mg/day + capecitabine 2000mg/m2/day
干预措施: circulating tumor cell analysis (Other)
Lapatinib + capecitabine
lapatinib 1250mg/day + capecitabine 2000mg/m2/day
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Objective response rate
时间窗: february 2012
次要结局
- Toxicity as assessed by NCI CTC v3.0(february 2012)
- Time to radiotherapy(february 2012)
- Time to disease progression(february 2012)
- Overall response rate(february 2012)
- Clinical benefit (complete response, partial response, and stable disease for at least 6 months)(february 2012)
- Evaluation of serum proteomics and metabonomics markers as predictors of response(may 2012)
- Evaluation of the predictive value of circulating tumor cells on response(february 2012)