TAD: Prospective Evaluation of Targeted Axillary Dissection After Neoadjuvant Systemic Therapy in Patients With Breast Cancer With Advanced Nodal Disease at Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- False Negative Rate
研究概览
简要总结
The purpose of this research is to evaluate how to manage the axillary lymph nodes in patients with breast cancer. The investigators will determine if a sampling of the lymph nodes under the arm will give the information necessary to determine if fewer lymph nodes can be removed.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Women or men greater than or equal to 18 years.
- •Histologically confirmed invasive adenocarcinoma of the breast.
- •Clinical T0-4 N2-3 M0 at diagnosis (American Joint Committee on Cancer, 7th Edition)
- •Assessment for cN2 disease will be performed by clinical exam and imaging. Patients should have pathologic level 1 and/or 2 axillary lymph nodes which are fixed/matted on physical exam.
- •Cross-sectional imaging will be used to identify advanced nodal disease involving the axilla, infraclavicular, supraclavicular, and internal mammary regions, cN3 disease.
- •Patients must have biopsy proven involvement of the axillary lymph nodes.
- •Receipt of standard multiagent chemotherapy +/- targeted therapy based on tumor subtype.
- •Candidate for surgical management of breast cancer.
- •Ability to understand and willingness to sign a written informed consent document.
排除标准
- •History of allergic reactions or hypersensitivity to radioactive lymph node mapping agents or blue dye.
- •Pregnancy.
结局指标
主要结局
False Negative Rate
时间窗: Up to 2 weeks
The false negative rate of targeted axillary dissection after neoadjuvant systemic therapy (NST) in study participants. A false negative event will be defined as a case where the specific node (either the clipped node or the sentinel lymph node, depending on the analysis) does not show metastasis even though residual disease is identified in the other axillary nodes. The false negative rate will be computed as the number of false negative events divided by the total number of pathologically node-positive patients.
次要结局
- Pathologic Complete Response (pCR)(Up to 2 weeks)
- Sentinel Lymph Node Identification Rate(Day 1 (Day of Surgery))
- Incidence of Treatment-Emergent Adverse Events(Up to 3 weeks)
- Clipped Lymph Node Identification Rate(Day 1 (Day of Surgery))
- Accuracy Rate of Imaging Studies(Up to 2 weeks)
研究者
Susan Kesmodel, MD
Associate Professor of Clinical
University of Miami