NCT01198301已完成不适用
Gene Expression Profiling of Metastatic Breast Cancer Predict the Therapeutic Response to Chemotherapy
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 42 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
- 42
- 试验地点
- 1
- 主要终点
- Chemotherapy response
研究概览
简要总结
The investigators want to develop a gene expression profile the for prediction the chemotherapeutic response of patients with metastatic breast cancer.
详细描述
- Metastatic breast cancer tissue is obtained from core needle biopsies pretreatment and is flash frozen and stored at -70℃ until processing.
- After patients received docetaxel combination thiotepa for two cycles, response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines. Degree of response is used to divide the cancers into two groups-sensitive and resistant tumours.
- The gene expression in metastatic breast cancer tissue sample is detected by microarray to screen gene markers that are differently expressed between groups
- Statistical analysis is performed using unsupervised hierarchical cluster.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients should be histologically confirmed with metastatic breast cancer;
- •Patients who had completed the planned chemotherapy regimen with no major protocol violation;
- •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
- •previous history of other malignancies;
- •previous surgery history on the needle biopsy organ;
- •Central nervous system metastases;
- •Serious or uncontrolled concurrent medical illness.
结局指标
主要结局
Chemotherapy response
时间窗: four-months
Response to chemotherapy is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines
次要结局
- clinical benefit response(six months to one year)
- Time to disease progression(six months)
- Overall survival(one year)
研究者
Jun Ren
Director
Peking University Cancer Hospital & Institute
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Gene Expression Profiling of Breast Cancer Cells Predict the Response of Malignant Pleural EffusionBreast NeoplasmsNeoplasm MetastasisGene Expression ProfilingImmunotherapyNCT01256801Peking University Cancer Hospital & Institute36
已完成
不适用
Breast Cancer Molecular Analysis ProtocolMetastatic Breast CancerNCT01855503Yale University121
Unknown
不适用
Determination of the Role of Microarray for Prognosis and Prediction to Chemotherapy Sensitivity in Patients With Operable, Locally Advanced and Metastatic Oesophageal CancerOesophageal CancerNCT00220077Royal Marsden NHS Foundation Trust400
招募中
不适用
Transcriptional and Epimetabolic Profile of Breast Carcinoma With Luminal or HER2+ or Locally Advanced Triple-negative Histotype in Patients With/Without Previous Clinical History of Metabolic SyndromeMetabolic SyndromeBreast CancerNCT06261918Fondazione Policlinico Universitario Agostino Gemelli IRCCS120
撤回
不适用
Molecular Triaging of Newly Diagnosed Breast CancerBreast CancerNCT01159236M.D. Anderson Cancer Center