NCT02830282已完成不适用
Surveillance Markers of Utility for Recurrence After Neoadjuvant Chemotherapy for Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Number of circulating tumor cells (CTCs)
研究概览
简要总结
This is a nested multicenter, prospective cohort study within the I-SPY 2 TRIAL for women undergoing neoadjuvant chemotherapy for primary breast cancer who are also undergoing definitive surgical resection and have clinical or radiographic evidence of residual tumor at the completion of chemotherapy.
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
- •Enrollment on the treatment phase of the I-SPY 2 TRIAL
- •Completed a standard neoadjuvant chemotherapy regimen or assigned treatment on I-SPY 2 and planning definitive surgical resection. Participants who have discontinued assigned treatment on I-SPY 2, switched to standard of care, and have completed a standard neoadjuvant chemotherapy regimen are still considered eligible.
- •Pre-surgical imaging or clinical examination demonstrating residual disease in the breast. Participants with any extent of enhancement attributable to tumor on the pre-surgical MRI are eligible. No minimum extent of palpable tumor pre-surgery is required.
- •Willing to undergo bone marrow aspiration and blood specimen collection per protocol specifications
- •No clinical evidence of distant metastatic disease. Pre-chemotherapy staging scans are sufficient in the absence of any symptoms or subsequent clinical evidence suggesting distant metastases
- •Age 18 or over and are able to give informed consent
排除标准
- •Individuals under the age of 18
- •Individuals who cannot understand and give informed consent. We will not be assessing decisional capacity; determination of ability to give informed consent will be at the discretion of the treating physician.
- •Pregnancy. Participants in the parent I-SPY 2 TRIAL are screened for pregnancy at enrollment and pregnancy is an exclusion criteria. No additional screening for pregnancy is required for participants enrolling on SURMOUNT. However if a study participant does become pregnant while on study or during the course of the 10 year follow-up, the study participant will remain on the study protocol and will not be withdrawn. Because this is an observational study and does not have a therapeutic component, there will be no increased risk to following a study participant through annual blood draws and medical information abstraction from the medical chart who may or may not become pregnant during the course of the follow-up period.
结局指标
主要结局
Number of circulating tumor cells (CTCs)
时间窗: 2 years
Number of other circulating tumor biomarkers (CBMs)
时间窗: 2 years
Number of disseminated tumor cells (DTCs),
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
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