NCT03255577进行中（未招募）不适用
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients Presenting With Locally Advanced Breast Cancer: A Prospective Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 162
- 试验地点
- 8
- 主要终点
- The false negative rate of sentinel lymph node biopsy in patients with locally advanced breast cancer
研究概览
简要总结
This study is being done to help the investigators determine how accurate the sentinel lymph node biopsy (SLNB) procedure is in identifying residual cancer cells after neoadjuvant chemotherapy in patients presenting with locally advanced 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
- Treatment
- 盲法
- None
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
- •Female patients over 18 years of age with biopsy-proven breast cancer
- •Patients presenting with locally advanced disease in the breast (cT4) and/or in the nodes (cN2/N3) as assessed by clinical exam and imaging
- •Patients presenting to surgery clinic after receipt of NAC at outside hospital with documentation of cT4 or cN2/3 disease on initial outside physical exam and imaging studies
- •Patients receiving NAC and having a nodal complete clinical response as assessed by physical exam
排除标准
- •Patients with a prior history of ipsilateral breast cancer
- •Pregnant patients
- •Patients with persistent palpable axillary nodes after NAC, as assessed by physical exam
- •Patients not consenting to ALND
研究组 & 干预措施
Sentinel Lymph Node Biopsy (SLNB)
Experimental
The patients will undergo SLNB with dual tracer mapping using technetium-99m sulfur colloid and isosulfan blue dye, as is standard practice at our institution for cN1 patients. Than the SLNB procedure will be performed
干预措施: Sentinel Lymph Node Biopsy (SLNB) (Procedure)
结局指标
主要结局
The false negative rate of sentinel lymph node biopsy in patients with locally advanced breast cancer
时间窗: 3 years
次要结局
未报告次要终点
研究者
研究点 (8)
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