NCT05115474招募中2 期
Phase II Study of Screening Brain MRIs in Stage IV Breast Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Rate of Brain Metastasis
研究概览
简要总结
The study is a single arm, nonrandomized phase II prospective study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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
- •Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status
- •Radiographic evidence of stage IV extracranial diease having progressed past first line therapy in HR+/HER2- patients
- •Radiographic evidence of stage IV extracranial disease in TN and HER2+ patients
- •Life expectancy ≥ 6 months
- •Eastern Cooperative Oncology Group performance status 0 to 2
- •Patients must be able to understand and the willingness to sign an informed consent for study procedures
- •Stated willingness to comply with all study procedures and availability for the duration of the study
排除标准
- •Prior diagnosis or treatment of brain metastases or leptomeningeal disease
- •Patients with prior history of non-breast cancer malignancies should have no evidence of disease ≥ 2 years
- •Neurologic symptoms warranting standard screening brain MRI in the judgement of the treating physician at time of enrollment
- •Indications warranting brain MRI for other neurologic conditions at time of study entry
- •Contraindication towards MRI imaging with contrast
- •Chronic kidney disease stage IV or V or end stage renal disease
研究组 & 干预措施
Screening MRI
Experimental
Participants will undergo a screening brain MRI. Patients will undergo a second brain MRI at first systemic progression or at 6 months whichever event occurs sooner.
干预措施: Magnetic Resonance Imaging (Diagnostic Test)
结局指标
主要结局
Rate of Brain Metastasis
时间窗: up to 6 months
Rate of brain metastasis by breast cancer subtype at 6 months or first systemic progression using MRI images.
Rate of Brain Metastasis
时间窗: at Baseline
Rate of brain metastasis by breast cancer subtype at baseline using MRI images.
次要结局
- Number of Brain Metastases(Baseline)
- Brain Metastasis Specific Survival(Up to 6 months)
- Rate of Asymptomatic Leptomeningeal Disease(Baseline and at up to 6 months)
- Overall Survival(Up to 6 months)
- Number of Participants Requiring Whole Brain Radiation Therapy vs Stereotactic Radiation(Up to 6 months)
研究者
研究点 (2)
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