Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Correlate expression of the defined tumor markers on DTC with clinical outcome of breast cancer patients to identify those markers that are predictive of disease recurrence.
研究概览
简要总结
The main purpose of this study is to compare genetic markers present on tumor cells before and after chemotherapy.
详细描述
In this study, the investigators propose that persistent disseminated tumor cells (DTC) present after systemic therapy represent a unique subpopulation of all DTC, are predictors of a poor response to systemic therapy and correlate with poor clinical outcome. The investigators hypothesize that systemic therapy-resistant DTC can be identified by their expression of a unique constellation of tumor marker proteins which may be similar to those expressed by breast cancer stem cells. In this research, the investigators' specific aims are : 1) to characterize tumor markers expressed by DTC which are present after systemic therapy, 2) to compare the expression of these markers to that on DTC detected prior to systemic therapy, 3) to correlate expression of the defined tumor markers on DTC with clinical outcome of breast cancer patients to identify those markers that are predictive of disease recurrence, 4) to utilize biomarkers identified in Specific Aims 1 and 2 to isolate purified DTC for further molecular analysis.
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
- •Recently diagnosed with clinical stage II, III, or IV breast cancer
- •Planning to undergo neoadjuvant or adjuvant systemic therapy; patients who have already completed neoadjuvant systemic therapy are also eligible
- •Must be >= 18 years of age
- •If female, must not be pregnant
- •Must not have Hepatitis B, C, or HIV
- •Must be willing and able to sign informed consent document
排除标准
- 未提供
结局指标
主要结局
Correlate expression of the defined tumor markers on DTC with clinical outcome of breast cancer patients to identify those markers that are predictive of disease recurrence.
时间窗: Approximately 6 years
Compare the tumor markers present on DTC before and after chemotherapy with the tumor marker expression of the primary tumor and post-treatment tumor.
时间窗: Approximately 6 years.
Characterize tumor markers expressed by DTC which are present after systemic therapy
时间窗: Approximately 6 years
Compare the expression of these markers to that on DTC detected prior to systemic therapy
时间窗: Approximately 6 years
To xenograft tumor cells into mice for further genetic and phenotypic characterization.
时间窗: Approximately 6 years
次要结局
未报告次要终点
