NCT05662345进行中（未招募）不适用
ACT-MBC: A Prospective Observational Impact Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- To prospectively evaluate the impact of CellSearch CTCs on treatment decisions and response assessment in MBC patients
研究概览
简要总结
ACT-MBC prospectively assesses the impact of CTCs on treatment decisions, response assessment and prognosis in MBC patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Invasive breast cancer with radiographic and/or clinical evidence of advanced metastatic or unresectable disease
- •ER+/HER2- patients prior to starting 2nd line therapy or beyond OR ER/Progesterone Receptor (PR)/HER2-negative (Triple Negative) patients prior to starting any line of therapy
- •Measurable and/or non-measurable disease is allowed
- •Male or female breast cancer is allowed
- •Age > 18 years
- •Willingness to provide mandatory blood specimens
- •Willing to return to enrolling institution for follow up imaging at least once
排除标准
- •Life expectancy of ≤ 6 months
- •Inability to provide blood samples based on the judgment of the treating provider
结局指标
主要结局
To prospectively evaluate the impact of CellSearch CTCs on treatment decisions and response assessment in MBC patients
时间窗: 3 to 4 months
Assessing proportion of providers that find CellSearch CTCs helpful in determining response to therapy in each unique patient (Questionnaire #2).
次要结局
- Assess barriers and receptiveness of providers in using CTCs in clinical practice(18 months)
- Evaluate if CTC results correlate with response assessment and disease progression defined by standard of care imaging(18 months)
研究者
研究点 (4)
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