Prognosis and Targeted Therapy Related Molecular Screening Program for Patients of Breast Cancer in China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change from baseline targeted mutation analysis of ctDNA
研究概览
简要总结
The anticipated objectives of this study are: 1) to understand the pathogenesis and molecular typing of breast cancer patients in China (mainly HER2 overexpression, triple negative and hormone receptor-positive patients) by detecting DNA and RNA in tumor tissue (fresh tissue or paraffin section), and to compare the similarities and differences between the western population and Chinese population; 2) plasma samples of patients with HER2 overexpression , hormone receptor-positive and triple negative (ER, PR, HER2 expression negative) were sequenced for ctDNA and ctRNA, to find out whether there are genes or gene sets related to therapeutic effect; 3) to study the specific changes of liquid molecular detection results according to the previous research results, and establish mathematical models to predict and monitor the effects of targeted therapy and endocrine therapy; 4) to compare liquid biopsy and imaging and clinical features in monitoring clinical therapeutic effect, and to elaborate the advantages and disadvantages of liquid biopsy and conventional imaging; 5) to provide molecular detection basis for follow-up clinical research and screening for targets of new drugs.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with first treated or recurrent metastatic breast cancer, according to RECIST version 1.1 standard, confirmed by CT or MRI, have at least one measurable lesion.
- •HER2 positive or triple negative patients; (IHC++, fish amplification)
- •Patients with anti-HER2 treatment as first-line or not, and patients with HER2 positive can be treated with adjuvant therapy containing trastuzumab.
排除标准
- 未提供
结局指标
主要结局
Change from baseline targeted mutation analysis of ctDNA
时间窗: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
ctDNA sequenced with Illumina Sequencer and analyzing SNV and Indel in ctDNA by software.
ctDNA copy number loss related with progress free survival(PFS)
时间窗: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
ctDNA sequenced with Illumina Sequencer and analyzing SNV and Indel in ctDNA by software.
ctDNA copy number loss related with Overall survival(OS)
时间窗: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
ctDNA sequenced with Illumina Sequencer and analyzing SNV and Indel in ctDNA by software.
次要结局
未报告次要终点
研究者
Li Huiping
Head of the department of breast oncology
Peking University Cancer Hospital & Institute