Target Axillary Dissection After Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- TAD validation in locally advanced breast cancer
研究概览
简要总结
This is an observational study to validate target axillary dissection (TAD) in locally advanced tumors (cN2 and/or cT4).
详细描述
The procedure will consist of marking the pathological lymph node with 1 clip before the start of neoadjuvant chemotherapy (NAC) and performing surgery after completing the NAC. The TAD will include the exeresis of the node marked with a clip, and of the sentinels marked with technetium and/or patent blue, seeking to obtain at least 3 lymph nodes. Subsequently, the axillary lymphadenectomy will be completed to identify the false negative rate. An initial analysis will be carried out with the first 30 cases, and if there are more than 2 false negative cases, it will be completed until 81 cases of TAD without associated disease are obtained.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Axillary lymph node metastasis proven by cytology
- •Clinical or radiological N2a (at least 4 suspicious lymph nodes on axillary ultrasound at diagnosis)
- •Extensive T4 subsidiary to axillary lymphadenectomy according to current clinical criteria
- •Neoadjuvant chemotherapy
排除标准
- •cN3 verified by imaging tests
- •N2 due to internal mammary involvement (N2b).
- •Tumors whose surrogate molecular subtype is luminal A.
- •Patients undergoing neoadjuvant endocrine therapy
- •Patients with local recurrences and metastatic tumors.
结局指标
主要结局
TAD validation in locally advanced breast cancer
时间窗: 3 years
False negative rate when performing TAD after NAC
次要结局
- Ultrasound validity to evaluate axillary response after NAC(3 years)
- MRI validity to evaluate axillary response after NAC(3 years)
研究者
Amparo Garcia-Tejedor
Clinical Professor
Hospital Universitari de Bellvitge