Molecular Profiling in Young (<50 Years of Age) Patients With Metastatic Breast Cancer
Molecular Profiling Using FoundationOne CDx in Young (<50 Years of Age) Patients With Metastatic Breast Cancer (ML41263)
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.
研究概览
详细说明
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).
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Seoul、大韩民国、110-744
- Seoul National University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：FMI
FoundationOne CDx will be performed using archival tumor tissue
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FoundationOne CDx will be performed using archival tumor tissue
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Genetic characteristic of young (<50 years of age) Korean patients with metastatic breast cancer.
大体时间：After the end of patient enrollment
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Genetic characteristics will be evaluated using FoundationOne CDx.
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After the end of patient enrollment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evaluate the prognostic and predictive role of tumor mutation burden
大体时间：After the end of patient enrollment
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Tumor mutation burden will be analysed using FoundationOne CDx.
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After the end of patient enrollment
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Reveal the correlation between genetic characteristics and immunohistochemical expression of selected proteins.
大体时间：After the end of patient enrollment
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FoundationOne CDx results and immunohistochemical expression will be analysed.
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After the end of patient enrollment
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Compare molecular characteristics of breast cancer according to age groups.
大体时间：After the end of patient enrollment
|
Genetic characteristics will be analysed 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).
大体时间：After the end of patient enrollment
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The result of FoundationOne CDx will be used in patient treatment
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After the end of patient enrollment
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合作者和调查者
调查人员
- 首席研究员：Seock-Ah Im, MD PhD、Seoul National University Hospital
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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