Optimizing Treatment of Metastatic Breast Cancer Through Real-Time Disease Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- Mayo Clinic
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Detection of treatment failure
研究概览
简要总结
This study evaluates if blood tests can detect changes in disease status during treatment for stage IV breast cancer. Information from this study may help researchers learn more about metastatic breast cancer and how to optimize treatment.
详细描述
PRIMARY OBJECTIVES:
I. To identify subtype-specific signatures for breast cancer using genomic positioning of plasma deoxyribonucleic acid (DNA) fragments.
II. To validate changes in circulating tumor-derived DNA (ctDNA) levels as a biomarker for treatment monitoring in patients with metastatic breast cancer.
OUTLINE:
Patients undergo collection of blood samples at baseline, 2 weeks after the start of treatment, and at the beginning of each new treatment cycle.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Adults > 18 years of age
- •Stage IV breast cancer undergoing cancer treatment
排除标准
- •Stage I-III breast cancer
- •Unwilling or unable to give consent
- •Patients with a prior or concurrent malignancy, excluding non-melanoma skin cancers and non-invasive cancers whose natural history or treatment does not have the potential to interfere with the assessment of the investigational marker
研究组 & 干预措施
Ancillary-Correlative (biospecimen collection)
Patients undergo collection of blood samples at baseline, 2 weeks after the start of treatment, and at the beginning of each new treatment cycle.
干预措施: Biospecimen Collection (Procedure)
结局指标
主要结局
Detection of treatment failure
时间窗: Up to 1 year
Defined as progression of disease on imaging studies.
Identification of patients with high circulating tumor-derived deoxyribonucleic acid (ctDNA) fractions (> 50%)
时间窗: Up to 1 year
Will analyze across all three subtypes: Estrogen receptor positive (ER+), human epidermal growth factor receptor 2 positive (HER2+), and triple-negative breast cancer (TNBC). Will perform 30x whole genome sequencing (WGS) and generate subtype-specific pooled nucleosome occupancy maps. By comparing these maps with healthy volunteers, we will identify a set of loci across the genome most informative of cancer contribution in cell-free DNA (cfDNA).
次要结局
- Correlation of shallow whole genome sequencing circulating tumor-derived DNA analysis results with available serologic tumor biomarkers used as a standard in clinical practice(Up to 1 year)