NCT00896376已完成不适用
Prospective Multicenter Study of Genetic Factors Predictive of the Pharmacodynamics of Trastuzumab in Patients With Metastatic Breast Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Toxicity, including cardiotoxicity and immuno-allergic reactions
研究概览
简要总结
RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This clinical trial is studying the side effects of trastuzumab in treating women with metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- To evaluate the predictive value of genetic factors on the toxicity and efficacy of a trastuzumab-based therapy in women with metastatic breast cancer.
Secondary
- To analyze tumor factors potentially related to the efficacy of trastuzumab (i.e., expression of proteins involved in cell proliferation and survival).
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 —（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, defined by the existence of a secondary tumor localization radiologically (i.e., by radiography, CT scan, MRI scan, or ultrasound) or scintigraphically confrimed
- •Evaluable disease
- •Beginning first-line metastatic treatment with trastuzumab (Herceptin®) with or without chemotherapy
- •Primary tumor must overexpress HER2 (IHC 3+ OR IHC 2+ and FISH+ OR FISH+)
- •Hormone receptor status not specified
- •No brain metastasis
- •PATIENT CHARACTERISTICS:
- •Menopausal status not specified
- •Life expectancy > 3 months
- •Able to undergo cardiotoxicity evaluation every 4 months by measuring LVEF via an isotopic method or ultrasound with systematic registration
- •No chronic uncontrolled disease
- •No heart failure
- •No respiratory failure or hypoxemia
- •No history of another primary cancer except for basal cell carcinoma of the skin
- •No severe uncontrolled infection
- •No psychological incapacity
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
研究组 & 干预措施
trastuzumab
Experimental
干预措施: laboratory biomarker analysis (Other)
trastuzumab
Experimental
干预措施: pharmacological study (Other)
trastuzumab
Experimental
干预措施: trastuzumab (Biological)
结局指标
主要结局
Toxicity, including cardiotoxicity and immuno-allergic reactions
时间窗: 1 year
Clinical response as assessed by RECIST criteria
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (2)
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