Plasma Circulating Tumor DNA Analyses in ER+ Metastatic Breast Cancer
2021年5月18日 更新者：UNC Lineberger Comprehensive Cancer Center
LCCC 1642: Plasma Circulating Tumor DNA (ctDNA) Analyses in ER+ Metastatic Breast Cancer
The purpose of this study is to evaluate whether increased mutant ESR1 allele fraction in plasma ctDNA 3-6 weeks after initiating salvage endocrine therapy is predictive of progression free survival in patients with ER+ metastatic breast cancer.
研究概览
详细说明
The primary objective of this 110 patient correlative biomarker study is to evaluate whether changes in mutant ESR1 allele fraction in plasma circulating tumor DNA (ctDNA) are predictive of progression-free survival in metastatic ER+ breast cancer patients who are receiving 2nd, 3rd, or 4th line systemic endocrine therapy.
A secondary goal of this study is to explore the prevalence and kinetics of hotspot and non-hotspot ctDNA ESR1 mutations in this patient population, prior to initiating a new line of endocrine therapy as well as upon clinical progression, to identify potential mechanisms of resistance.
Although initially to be opened at UNC Chapel Hill, our goal is to expand enrollment to include Rex Cancer Center in Raleigh, North Carolina, and collaborating institutions through the Translational Breast Cancer Research Consortium.
研究类型
观察性的
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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North Carolina
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Chapel Hill、North Carolina、美国、27599
- University of North Carolina at Chapel Hill Cancer Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 99年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
取样方法
概率样本
研究人群
Females with ER+ metastatic breast cancer receiving 2nd, 3rd, or 4th line systemic endocrine therapy
描述
Inclusion Criteria:
- Age ≥ 18 years of age
- Female gender
- Biopsy proven diagnosis of breast cancer
- Stage IV disease diagnosed either by radiographic studies or biopsy
- ER+ by immunohistochemistry on primary and/or metastatic tissue biopsy (>10%)
- HER2 non-amplified (1+ or below by immunohistochemistry, and/or Her2 FISH <2 HER2-to-CEP17 ratio)
- Progressed on at least one prior line of endocrine therapy for metastatic disease
- Three or fewer prior endocrine-containing therapies for recurrent/metastatic disease
- Two or fewer prior lines of cytotoxic chemotherapy for recurrent/metastatic disease
- Plans to initiate 2nd, 3rd, or 4th line endocrine therapy for metastatic disease
- Recent re-staging scans within 4 weeks of study enrollment, with radiographically identifiable disease
- No concurrent or prior diagnosis of malignancy other than breast cancer for the past 5 years. Patients with a history of in situ cancer or basal or localized squamous cell skin cancer remain eligible
- Intends to pursue treatment as well as clinical and radiographic follow-up at UNC Health Care
- Signed an institutional review board (IRB)-approved informed consent document for this protocol and HIPAA consent form
Exclusion Criteria:
- < 18 years of age
- Tissue biopsies that support the presence of both ER+ and ER- metastatic breast cancer in the same patient
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
- Pregnant or lactating women
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
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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Progression-free Survival Prediction
大体时间：Through study completion, an average of 3-6 weeks
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To evaluate whether increased mutant ESR1 allele fraction in plasma ctDNA 3-6 weeks after initiating salvage endocrine therapy is predictive of progression free survival in patients with ER+ metastatic breast cancer.
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Through study completion, an average of 3-6 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
DNA Analysis of Hotspot Mutation Prevalence
大体时间：Through study completion, an average of 3-6 weeks
|
To evaluate the overall spectrum and prevalence of hotspot and non-hotspot ESR1 mutations in plasma ctDNA prior to initiating 2nd, 3rd, or 4th endocrine therapy and after clinical disease progression.
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Through study completion, an average of 3-6 weeks
|
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DNA Analysis of Mutation and Radiographic Response Correlation
大体时间：Through study completion, an average of 3-6 weeks
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Exploratory analysis of whether changes in mutant ESR1 allele fraction in plasma ctDNA at the time of re-staging scans correlates with radiographic response.
|
Through study completion, an average of 3-6 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Gaorav P Gupta, MD, PhD、University of North Carolina, Chapel Hill
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年1月13日
初级完成 (实际的)
2020年7月9日
研究完成 (实际的)
2020年7月9日
研究注册日期
首次提交
2017年5月15日
首先提交符合 QC 标准的
2017年5月18日
首次发布 (实际的)
2017年5月22日
研究记录更新
最后更新发布 (实际的)
2021年5月21日
上次提交的符合 QC 标准的更新
2021年5月18日
最后验证
2021年5月1日
更多信息
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