Triple Negative Breast Cancer: Study of Molecular and Genetic Factors
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- incidence of BRCA1/2, PALB2, PTEN, PALB2 mutations
研究概览
简要总结
Breast cancer triples negatives (TN; 15 % of the cases) are characterized by a high histoprognostic grade, a strong proliferation, a strong metastatic power, and a worse prognosis than the other forms of breast cancer. It is however a heterogenous group for histological and molecular level, but also for evolution. Most of the TN is part of the basal breast cancer subcategory. Until now, the medical treatment is based on chemotherapy.
Breast cancers by constitutional mutation of BRCA1 / BRCA2 (5 % of breast cancers) are mostly of basal type and their prognostic seems better that what could be expected from high grade tumours and without hormonal receptors. They would be much more frequent in the TN group. However, at this day, no prospective study was led to estimate this incidence, or to study the intervention of other genes of predisposition, as well to analyse the links between this phenotype and their consequences at the germinal or somatic level, in terms of associated molecular changes and prognosis.
The purpose of this study is, on a prospective study, to lead a joined analysis at the germinal level, in search of mutations of the main genes of breast cancer predisposition (BRCA1/2, PALB2, PTEN, PALB2), and at the tumour level (tissue micro-array and transcriptome), by correlating these results to the main clinical parameters.
The 5 years relapse-free survival will also be estimated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •women > 18
- •non metastatic breast cancer
- •triple negative
- •5 years follow-up
- •signed informed consent
排除标准
- •other cancer (except in situ)
- •metastases at diagnosis
- •impossibility of follow-up
结局指标
主要结局
incidence of BRCA1/2, PALB2, PTEN, PALB2 mutations
时间窗: up to 1 month
1) Determine the incidence of the BRCA1/2, PALB2, PTEN, PALB2 mutations in patients having at diagnosis a non metastatic triple negative breast cancer
次要结局
- molecular profiles(up to 1 month)
- years relapse-free survival(at 5 years)
