Prospective Trial to Evaluate MUltimodal Targeted Axillary Surgery (MUTAS) Approaches in Breast Cancer Patients With Positive Lymph Nodes.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Number of patients correctly identified as low axillary tumor load carriers by a pre-defined systematic axillary ultrasound imaging workflow
研究概览
简要总结
The present trial will prospectively evaluate the accuracy of both a systematic predefined axillary ultrasound imaging together with tumor load quantification of suspicious and sentinel axillary lymph nodes to predict overall tumor load in the axilla.
详细描述
Axillary node clearance (ANC) is a controversial intervention in the surgical treatment of breast cancer. Different studies have shown that in some patients with infiltrated axillary lymph nodes but low tumor burden, ANC can be safely omitted. However, indications for ANC persist in nowadays for patients with positive axillary lymph nodes and upfront surgery and patients with positive lymph nodes after neoadjuvant treatment. The present prospective study will evaluate the ability to establish an axillary tumor load with two steps. The first step will be a preoperative predefined systematic axillary ultrasound imaging workflow. The second step will be the tumor load evaluation of suspicious and sentinel axillary lymph nodes. We will also evaluate which patients have infiltrated nodes only beneath the second intercostobrachial nerve. The trial intends to identify patients for who a complete axillary node clearance could be spared.
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
- •Node-positive breast cancer patients confirmed by biopsy or cytology
- •Positivity confirmed before the surgical treatment
排除标准
- •Inability to confirm positive lymph nodes by biopsy or cytology
- •Inability to understand the protocol design
- •Poor understanding of the Spanish language
研究组 & 干预措施
Node-positive breast cancer patients
All patients with positive lymph nodes for who an axillary node clearance is proposed as part of the surgical treatment
干预措施: Systematic axillary ultrasound imaging (Diagnostic Test)
Node-positive breast cancer patients
All patients with positive lymph nodes for who an axillary node clearance is proposed as part of the surgical treatment
干预措施: Sentinel node (Diagnostic Test)
Node-positive breast cancer patients
All patients with positive lymph nodes for who an axillary node clearance is proposed as part of the surgical treatment
干预措施: Excision of suspicious lymph nodes (Procedure)
Node-positive breast cancer patients
All patients with positive lymph nodes for who an axillary node clearance is proposed as part of the surgical treatment
干预措施: Two steps axillary node clearance (Procedure)
结局指标
主要结局
Number of patients correctly identified as low axillary tumor load carriers by a pre-defined systematic axillary ultrasound imaging workflow
时间窗: 24 months
The accuracy (in terms of sensibility, specificity, positive predictive value and negative predictive value) of the pre-defined systematic ultrasound imaging workflow for identifying patients wih low axillary tumor load will be reported. Low axillary tumor load is defined as two or less infiltrated axillary lymph nodes.
Number of patients correctly identified as low axillary tumor load carriers by the information on tumor load of suspicious and sentinel axillary lymph nodes.
时间窗: 24 months
The accuracy (in terms of sensibility, specificity, positive predictive value and negative predictive value) of different tumor load cut-off points of the suspicious and sentinel axillary lymph nodes for identifying patients with low axillary tumor load will be reported.Low axillary tumor load is defined as two or less infiltrated axillary lymph nodes.
Number of patients correctly identified as low axillary tumor load carriers combining both the pre-defined axillary ultrasound imaging workflow with the information on tumor load of suspicious and sentinel axillary nodes
时间窗: 24 months
The accuracy (in terms of sensibility, specificity, positive predictive value and negative predictive value) of both the pre-defined systematic axillary ultrasound imaging workflow combined with tumor load information of suspicious and sentinel axillary lymph nodes for identifying patients with low axillary tumor load will be reported.Low axillary tumor load is defined as two or less infiltrated axillary lymph nodes.
次要结局
- Number of infiltrated axillary lymph nodes detected by physical exploration(24 months)
- Number of infiltrated lymph nodes detected by computed tomography(24 months)
- Number of patients with low axillary tumor load among menopause status categories(24 months)
- Number of patients with low axillary tumor load among each breast cancer pathology subtype.(24 months)
- Number of patients with low axillary tumor load among each breast cancer immunophenotype.(24 months)
- Number of patients with infiltrated nodes exclusively in the inferior axillary node clearance.(24 months)
- Number of infiltrated lymph nodes detected by magnetic resonance(24 months)