NCT00107393已完成2 期
Phase II Study of Trastuzumab (Herceptin) and Capecitabine (Xeloda) in Women With Taxanes and Anthracyclines Refractory Metastatic Breast Cancer and HER2 Over-Expression
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 20
- 主要终点
- Median survival and 2-year survival rate as measured by the Kaplan-Meier method 2 years after completion of study treatment
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. 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 trastuzumab together with capecitabine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving trastuzumab together with capecitabine works in treating women with metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the median survival time and 2-year survival rate in women with taxane- and anthracycline-refractory HER2/neu-overexpressing metastatic breast cancer treated with trastuzumab (Herceptin®) and capecitabine.
Secondary
- Determine the progression-free survival of patients treated with this regimen.
- Determine the response rate in patients treated with this regimen.
- Determine the clinical benefit rate of this regimen in these patients.
- Determine the safety profile of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed breast cancer
- •Metastatic disease
- •Patients with only bone metastases are not eligible
- •Refractory disease, defined as disease progression, drug-related adverse reaction, or disease relapse during or within 12 months after completion of paclitaxel or docetaxel AND doxorubicin or epirubicin administered in the neoadjuvant, adjuvant, or metastatic setting
- •Total neoadjuvant or adjuvant taxane dose > 700 mg/m^2 for paclitaxel or > 240 mg/m^2 for docetaxel
- •Total taxane dose > 350 mg/m^2 for paclitaxel or > 120 mg/m^2 for docetaxel in the metastatic setting
- •Total neoadjuvant or adjuvant anthracycline dose > 240 mg/m^2 for doxorubicin or epirubicin
- •Total anthracycline dose > 120 mg/m^2 for doxorubicin or epirubicin in the metastatic setting
- •HER2/neu overexpression
- •3+ by immunohistochemistry or positive by fluorescence in situ hybridization
- •No symptomatic brain metastases
- •No pleural or pericardial effusion or ascites
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status
- •Not specified
- •Performance status
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9.0 g/dL
- •SGOT or SGPT ≤ 2.0 times upper limit of normal (ULN) (< 3.0 times ULN for patients with liver metastases)
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Bilirubin ≤ 1.5 mg/dL
- •Creatinine ≤ 1.2 mg/dL
- •Cardiovascular
- •LVEF > 50%
- •No interstitial pneumonia with pulmonary fibrosis
- •No history of hypersensitivity reactions
- •No serious, uncontrolled infection
- •No other malignancy
- •Not pregnant or nursing
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Prior trastuzumab (Herceptin®) for metastatic disease allowed
- •Chemotherapy
- •See Disease Characteristics
- •No prior capecitabine
- •At least 2 weeks since prior antimetabolites for metastatic disease
- •At least 4 weeks since prior alkylating agents, carcinostatic antibiotics, or other carcinostatic agents
- •Endocrine therapy
- •At least 4 weeks since prior goserelin or leuprolide for metastatic disease
- •At least 2 weeks since prior oral endocrine agents for metastatic disease
- •No concurrent endocrine therapy
- •Radiotherapy
- •No prior radiotherapy to target lesions
- 另有 4 项未显示
排除标准
- 未提供
结局指标
主要结局
Median survival and 2-year survival rate as measured by the Kaplan-Meier method 2 years after completion of study treatment
次要结局
- Progression-free survival
- Response rate
- Clinical benefit rate as measured by Kaplan-Meier method 2 years after completion of study treatment
- Safety profile as measured by the Kaplan-Meier method 2 years after completion of study treatment
研究者
研究点 (20)
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