NCT01199393已完成不适用
Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2010年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Response to chemotherapy
研究概览
简要总结
The investigators want to research whether genetic polymorphisms of drug-metabolizing enzymes can be used to predict chemotherapeutic outcomes in patients with metastatic breast cancer.
详细描述
- Patients evaluation On all patients a complete clinical history and physical examination is performed, including routine hematology and biochemistry analyses. Hematology and biochemistry analyses are repeated at the end of each cycle. Toxicity is classified according to WHO criteria at each cycle for each patient. Response is assessed after two cycles of chemotherapy and every two cycles thereafter, using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines.
- Sample collection and SNP genotyping Venous blood (4 ml) is collected from each subject and placed into tubes containing EDTA. Genomic DNA is isolated with a DNA Blood isolation kit.Genotypes are performed by PCR-RFLP, PCR-DHPLC and PCR-direct sequencing, etc.
- Statistical Analysis x2 test is used to summarize the association of response and adverse events to chemotherapy with genetic polymorphisms.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed metastatic breast cancer
- •An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •At least one measurable lesion
- •Normal cardiac, hepatic, renal and bone marrow functions
- •Life expectancy ≥3 months
- •Discontinuity of previous chemotherapy for a minimum of 4 weeks
排除标准
- •Central nervous system metastases
- •Serious or uncontrolled concurrent medical illness
- •History of other malignancies
结局指标
主要结局
Response to chemotherapy
时间窗: 6 months
Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).
次要结局
- Time to disease progression(1 year)
- Toxicity(6 months)
- Overall survival(5 years)
研究者
Jun Ren
Director
Peking University Cancer Hospital & Institute
研究点 (1)
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