Novel Breast Cancer Biomarkers and Their Use for Guiding and Monitoring Response to Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 255
- 试验地点
- 7
- 主要终点
- Relationship between changes in a patients circulating miRNA expression levels over the course of their systemic therapy, and their response to that treatment.
研究概览
简要总结
To identify a panel of circulating miRNA markers which could help identify those breast cancer patients who are most likely to respond well to neoadjuvant and adjuvant chemotherapy, and indeed serve as an overall prognostic factor and stratify patients into risk categories which would further guide their management. Similarly, the investigators aim to identify a panel of circulating miRNA markers which could monitor patient's response to chemotherapy and hormonal therapies. Ideally a suitable panel of markers would show significant changes in expression level in good-responders whilst little or no change would be observed in miRNA expression in non-responders.
详细描述
Primary Objectives:
- To identify a panel of miRNAs, detectable in the circulation, which are altered in breast cancer patients
- To identify specific combinations of miRNAs ('signatures') which associate with breast cancer intrinsic subtypes, and thereby could aid in prognostication and treatment planning on an individual patient basis.
Secondary Objective:
- To determine if systemic miRNA analysis can be used as a biomarker for monitoring response to chemotherapy, in the neoadjuvant setting and in patients who present with breast cancer recurrence and are treated with upfront chemotherapy and/or hormonal therapy.
This is a prospective cohort studies, involving three study cohorts:
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Relationship between changes in a patients circulating miRNA expression levels over the course of their systemic therapy, and their response to that treatment.
时间窗: Up to week 66-92
For cohort 1, a patient's response to treatment will be determined using 3 standard parameters: clinical, radiological and pathological responses. For cohort 2 and 3, a patient's response to treatment will be evaluated using RECIST criteria version 1.1." For cohort 1, a patient's response to treatment will be determined using 3 standard parameters: clinical, radiological and pathological responses. For cohort 2 and 3, a patient's response to treatment will be evaluated using RECIST criteria version 1.1."
Correlation of systemic miRNA levels with standard biomarkers of response
时间窗: Up to week 66-92
Standard bio markers of response include serum CEA and Ca15-3 levels
次要结局
- Relationship between miRNA expression levels and other existing clinicopathological parameters.(Up to week 66-92)
- Relationship between circulating miRNA profiles and patients' intrinsic subtype of breast cancer(Up to week 66-92)