It is Possible to Reduce the Performance of Axillary Lymphadenectomies in Patients with HER2-positive Breast Cancer with a Clinically Positive Axilla At Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Location of the marked lymph node and the sentinel lymph node, and assessment after lymphadenectomy of number of true positives and negatives, sensitivity and specificity
研究概览
简要总结
The main objective of the study is to validate the DAT technique in patients with Her2-positive breast cancer who have more than two positive axillary lymph nodes at diagnosis. After receiving adequate oncological treatment and axillary assessment by ultrasound for complete radiological response, DAT and Berg level I and II lymphadenectomy will be performed to assess false negatives and positives, as well as their sensitivity and specificity.
详细描述
This study aims to determine whether axillary treatment can be further de-escalated in patients with HER2-positive breast cancer, as this group has shown good responses to certain targeted therapies. It focuses on reducing the need for extensive axillary surgery (known as axillary lymphadenectomy or AL), which can cause complications, by using a less invasive procedure called Targeted Axillary Dissection (TAD). This method combines the removal of sentinel lymph nodes and previously marked nodes, allowing for an assessment of treatment response without needing to remove all lymph nodes. Currently, this method is used in patients diagnosed with axillary disease involving fewer than two axillary nodes.
Main Objective:
To evaluate whether axillary lymphadenectomy can be avoided in HER2-positive breast cancer patients with more than two affected axillary nodes who respond well to chemotherapy before surgery.
Secondary Objectives:
Analyze the oncological treatment response in these patients. Determine how many affected nodes respond to the treatment. Evaluate whether the number of affected nodes at diagnosis limits the possibility of performing TAD.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •ECOG 0-1 (physical condition: able to walk and live a normal life)
- •Patients with early-stage breast cancer (BC) with histopathological diagnosis of HER2+ and axillary involvement.
- •Patients with either positive or negative hormonal receptor expression will be included.
- •Patients must have marked the pathological axillary lymph node.
- •Any number of affected or suspicious lymph nodes at diagnosis is allowed.
- •Patients will receive appropriate neoadjuvant treatment based on a combination of chemotherapy and anti-HER2 therapy.
- •After neoadjuvant treatment and prior to surgery, radiological response will be assessed.
- •No relevant comorbidities, adequate liver and kidney function, and no contraindications to receive neoadjuvant treatment followed by surgery and radiotherapy.
排除标准
- •Patients with inoperable breast cancer.
- •Patients with a diagnosis of inflammatory breast cancer.
- •Patients without a diagnostic biopsy of the suspicious lymph node or the presence of axillary conglomerate.
结局指标
主要结局
Location of the marked lymph node and the sentinel lymph node, and assessment after lymphadenectomy of number of true positives and negatives, sensitivity and specificity
时间窗: From enrollment to the end of treatment at 12 months
Determining the number of positive and negative nodes in targeted axillary dissection and axillary lymphadenectomy
次要结局
- Detection of the axillary lymph node marked at diagnosis and Detection of the sentinel lymph node and concordance between marked lymph node and sentinel lymph node(From enrollment to the end of treatment at 12 months)
- Number of positive lymph nodes at diagnosis(From enrollment to the end of treatment at 12 months)
研究者
Elvira Buch
Clinical Head of the General Surgery Department
Fundación para la Investigación del Hospital Clínico de Valencia