A Proportion of ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC (ARES)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- ctDNA detection
研究概览
简要总结
This translational biomarker study will collect blood in patients Stage I triple negative breast cancer at diagnosis prior to either neoadjuvant treatment or surgery and then during treatment.
详细描述
A highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors has been developed. Plasma will be assayed for ctDNA using the SaferSeqS tumor-informed assay employing DNA sequences derived from breast biopsies and/ or surgery specimens. The abundance and molecular characteristics of ctDNA will be evaluated in 77 patients using optimum Simon Stage II statistical design.
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
- •Patients must be ≥18 years of age
- •Cytologically or histologically confirmed and previously untreated invasive breast cancer that is:
- •Clinical stage I
- •≤2 cm on imaging
- •Grade 2 or Grade 3
- •Locally assessed ER+ in 0% of cells.
- •Locally assessed HER2-negative (IHC 2+/FISH-negative or IHC 0 or 1+ /either FISH-negative or untested).
- •No prior chemotherapy
- •Fit for chemotherapy and surgery
- •Must have the ability to understand and the willingness to sign a written informed consent document.
- •Must be willing to provide serial blood samples for the study.
排除标准
- •History of other invasive malignancy in the past 2 years
- •Synchronous breast cancers and multifocal/multicentric breast cancers
- •Medical condition or social situation that may preclude adherence to the protocol.
结局指标
主要结局
ctDNA detection
时间窗: Up to 2 years
Detection of ctDNA by assay in blood collected prior to radical prostatectomy using the Vogelstein lab assay. This assay is a highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors. This assay has shown prognostic value for recurrence and predictive for benefit of adjuvant chemotherapy.
次要结局
- ctDNA clearing(Up to 2 years)
- pCR rate(Up to 2 years)
- ctDNA after surgery treatment(Up to 2 years)
- Event free survival (EFS)(Up to 2 years)
- Invasive disease-free survival (IDFS)(Up to 2 years)
研究者
Marija Balic, MD PhD
Professor of Medicine, Hematology Oncology
University of Pittsburgh