Molecular Profiling Using FoundationOne CDx in Young (<50 Years of Age) Patients With Metastatic Breast Cancer (ML41263)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Genetic characteristic of young (<50 years of age) Korean patients with metastatic breast cancer.
研究概览
简要总结
Breast cancer is the most common cancer in women worldwide, especially in developed countries. In developing countries, including South Korea, the incidence and mortality rate of breast cancer is rapidly increasing. One of the most important characteristics of breast cancer in South Korea, as well as in other Asian countries, is the younger onset of disease compared to Western.
Medical treatment of breast cancer is evolving rapidly, incorporating immune checkpoint blockades and molecularly targeted agents. However, data and knowledge are still limited in terms of molecular characteristics of Asian breast cancer, compared to that of Western countries, and this remains a major hurdle for drug development in Asian breast cancer patients.
The primary objective of this study is to elucidate the genetic characteristic of young (<50 years of age) Korean patients with metastatic breast cancer using FoundationOne CDx.
详细描述
Secondary Objective(s):
- To evaluate the prognostic and predictive role of tumor mutation burden.
- To reveal the correlation between genetic characteristics and immunohistochemical expression of selected proteins (including DNA damage repair (DDR) molecules and various immune modulating molecules including PD-L1, PD-1, IDO, and OX40).
- Compare molecular characteristics of breast cancer according to age groups (<35 years vs. 35-50 years).
- To offer genomic profiling guided therapy to patients as early as possible (preferably, 1st- or 2nd-line of treatment). In addition, to explore how genomic profiling guided therapy could improve patient outcome as an ad-hoc if sufficient number of patients can be followed up (compared to historic data).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients between 19 - 50 years of age on the day of signing informed consent.
- •Able to provide written informed consent for voluntary participation in the trial.
- •With metastatic breast cancer
- •Willing to provide biopsies from the primary tumor or lymph nodes at screening to the central laboratory. (with at least 10 unstained slides and 1 H&E slide)
排除标准
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
研究组 & 干预措施
FMI
FoundationOne CDx will be performed using archival tumor tissue
干预措施: FoundationOne CDx (Genetic)
结局指标
主要结局
Genetic characteristic of young (<50 years of age) Korean patients with metastatic breast cancer.
时间窗: After the end of patient enrollment
Genetic characteristics will be evaluated using FoundationOne CDx.
次要结局
- Evaluate the prognostic and predictive role of tumor mutation burden(After the end of patient enrollment)
- Reveal the correlation between genetic characteristics and immunohistochemical expression of selected proteins.(After the end of patient enrollment)
- Compare molecular characteristics of breast cancer according to age groups.(After the end of patient enrollment)
- To offer genomic profiling guided therapy to patients To explore how genomic profiling guided therapy could improve patient outcome as an ad-hoc if sufficient number of patients can be followed up (compared to historic data).(After the end of patient enrollment)
研究者
Seock-Ah Im
Professor
Seoul National University Hospital