Prediction of Radiotherapy Efficacy in Patients With Triple-negative Breast Cancer : TNBC-RT2023
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Predictive value of recurrence associated with the appearance of inflammatory cytokines
研究概览
简要总结
Recurrence of triple-negative breast cancer (TNBC) occurs in around 30% of patients within 3 years of treatment. For some TNBC patients, recurrence occurs on average 2.6 years after treatment, while for others recurrence does not occur early. TNBC patients can therefore be divided into two groups: those with early recurrence and those who respond well to treatment.
At present, there are no biomarkers to differentiate these two groups. Some studies suggest that radiation-induced inflammatory cytokines may stimulate the development of new metastases. Gene expression profiling or protein signatures have not been able to define such biomarkers.
The aim of this research protocol is to recruit patients to evaluate if the elevation of the cytokines IL-1β, IL-5 and IL-6 in plasma collected during radiotherapy can be used to predict TNBC patients at high risk of recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 with TNBC breast cancer who meet the following criteria:
- •Women aged 18 and over;
- •Any tumor size (pT stage);
- •Regional lymph node pN0 to pN3;
- •Patient with pathologically confirmed TNBC (estrogen and progesterone receptor negative and HER2 negative);
- •Neo- or adjuvant chemotherapy followed by radiotherapy;
- •No evidence of distant metastasis at time of diagnosis;
- •Primary tumor removed by conservative surgery with negative margins;
- •Patient covered by the French social security system (for French patients).
排除标准
- •Distant metastasis at the time of diagnosis;
- •Pregnant or breast-feeding women;
- •Woman deprived of liberty, under guardianship or trusteeship.
- •Patient unable to give consent
- •Patient unable to speak French
- •Patients unable to undergo regular long-term surveillance.
研究组 & 干预措施
Women with TNBC breast cancer
Patients will be recruited before the start of radiotherapy. A blood sample (20 ml) will be taken before radiotherapy and immediately after the 4th radiotherapy session.
They will be followed up annually for 5 years after the end of treatment, to determine whether their cancer has recurred.
干预措施: blood sampling before radiotherapy (Biological)
Women with TNBC breast cancer
Patients will be recruited before the start of radiotherapy. A blood sample (20 ml) will be taken before radiotherapy and immediately after the 4th radiotherapy session.
They will be followed up annually for 5 years after the end of treatment, to determine whether their cancer has recurred.
干预措施: blood sampling after the fourth radiotherapy session (Biological)
Women with TNBC breast cancer
Patients will be recruited before the start of radiotherapy. A blood sample (20 ml) will be taken before radiotherapy and immediately after the 4th radiotherapy session.
They will be followed up annually for 5 years after the end of treatment, to determine whether their cancer has recurred.
干预措施: collection of acute toxicity (radiodermatitis) (Other)
Women with TNBC breast cancer
Patients will be recruited before the start of radiotherapy. A blood sample (20 ml) will be taken before radiotherapy and immediately after the 4th radiotherapy session.
They will be followed up annually for 5 years after the end of treatment, to determine whether their cancer has recurred.
干预措施: collection of late toxicity (Other)
Women with TNBC breast cancer
Patients will be recruited before the start of radiotherapy. A blood sample (20 ml) will be taken before radiotherapy and immediately after the 4th radiotherapy session.
They will be followed up annually for 5 years after the end of treatment, to determine whether their cancer has recurred.
干预措施: collection of disease status (Other)
Women with TNBC breast cancer
Patients will be recruited before the start of radiotherapy. A blood sample (20 ml) will be taken before radiotherapy and immediately after the 4th radiotherapy session.
They will be followed up annually for 5 years after the end of treatment, to determine whether their cancer has recurred.
干预措施: Radiotherapy - Breast +/- lymph node areas (Radiation)
Women with TNBC breast cancer
Patients will be recruited before the start of radiotherapy. A blood sample (20 ml) will be taken before radiotherapy and immediately after the 4th radiotherapy session.
They will be followed up annually for 5 years after the end of treatment, to determine whether their cancer has recurred.
干预措施: Radiotherapy - Boost operating bed (Radiation)
结局指标
主要结局
Predictive value of recurrence associated with the appearance of inflammatory cytokines
时间窗: up to 5 years
Determine whether TNBC patients who respond poorly to radiotherapy can be identified by the appearance of inflammatory cytokines in the blood during radiotherapy.
次要结局
- To determine whether the increased invasive capacity of TNBC cells incubated with plasma collected during radiotherapy will be associated with recurrence.(up to 5 years)
- To determine whether the development of metastases in a mouse model injected with TNBC D2A1 cells pre-incubated with plasma collected during radiotherapy will be associated with recurrence.(up to 5 years)