Exosomal and Free Extracellular RNAs and Proteins as Predictive Biomarkers for HER2 Therapies in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 11
- 主要终点
- Identification of Extra Cellular RNAs/proteins in sera from cancer patients
研究概览
简要总结
Primary Objective:
(i) To identify panels of RNAs and proteins predictive of response to HER2 targeted agents, considering clinical responses. (ii) To investigate associations between presence vs. absence (or relative levels) of identified extracellular (EC) RNAs/proteins and patients' clinicopathological characteristics, including age at diagnosis, time to progression and overall survival, as well as correlations with serum protein biomarkers routinely analysed for these patients. (iii) To compare HER2 positive samples versus HER2 negative samples for the existence of RNAs/proteins identified in (i) and (ii).
Secondary Objective:
To develop a predictive model for use in the HER2 positive population based on the most accurate and sensitive combination of the identified biomarkers.
详细描述
This is a translational pilot study, involving two patient cohorts, designed to identify predictive biomarkers for HER2 targeted therapy, which will be validated in a larger future study.
Cohort 1: 300 newly diagnosed (including metastatic) HER2 positive breast cancer patients. Cohort 2: 30 newly diagnosed HER2 negative breast cancer patients.
Blood specimens will be taken:
- before starting treatment (cohort 1 and 2)
- after receiving chemotherapy and before starting HER2 targeted treatment (if applicable) (cohort 1)
- within one month following 1st treatment of HER2 targeted treatment (cohort 1)
- approximately every 3 months (coinciding with formal disease assessment) while on HER2 targeted treatment for a maximum of 5 years (cohort 1)
Blood will be processed to serum, which will be analysed for RNA and protein biomarkers.
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
- •Patient with a newly diagnosed (including metastatic) HER2 positive breast cancer, who is to commence HER2 targeted treatment.
- •Patient with a newly diagnosed HER2 negative breast cancer, who is to commence any type of treatment.
- •Patient must be female and aged 18 years or over.
- •Patient must provide written informed consent.
排除标准
- •Patients who do not fulfil the inclusion criteria mentioned above
结局指标
主要结局
Identification of Extra Cellular RNAs/proteins in sera from cancer patients
时间窗: 7 years
Identification of EC RNAs/proteins in sera from cancer patients, which correlate with their response to treatment
次要结局
未报告次要终点