Evaluation of Sentinel Lymph Node Detection After Neoadjuvant Chemotherapy for Large Operable Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 958
- 试验地点
- 32
- 主要终点
- false-negative (FN) rate for the Sentinel Lymph Node Detection
研究概览
简要总结
Neoadjuvant chemotherapy (NAC) is frequently proposed to patients with large tumours that can be operated in order to increase the chances of breast conservation. After NAC, patients are operated with systematic axillary lymph node dissection (ALND), although more than half of these patients do not have lymph node involvement. These results lead us to consider the indication of the sentinel lymph node (SLN) technique after NAC in order to avoid unnecessary ALND in patients whose SLN is free of involvement.
We need to validate the SLN technique after NAC in patients who have proven lymph node involvement prior to NAC.
GANEA2 is a new trial based on patient treated for a large breast tumor with proven axillary involved nodes. Patients enrolled in this trial will have first an axillary sonography with fine needle punction in case of suspected nodes before NAC. This primary evaluation allow to determine two groups of patients : group 1 (pN+) : patients with proven involved axillary nodes and group 2, patients without proven axillary involved nodes (cN0). Patients of group 1, will undergo SLNB and complete level I-II axillary lymphadenectomy. Patients of group 2 will undergo SLNB and a complete axillary level I-II lymphadenectomy only in the case of detection failure or involved SLN and a SLNB alone in the others cases. Patients of this last group will be followed 5 years in order to evaluate the risk of axillary relapse without lymphadenectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •T2-T3 operable infiltrating breast carcinoma
- •No allergy to Patent Blue
- •Pre-operative diagnosis of unifocal infiltrating breast carcinoma.
- •Patient planned to be treated by NAC.
- •Informed consent.
- •Surgery available 4 to 6 weeks after the last chemotherapy course (radical or conservative surgery)
排除标准
- •pT4d (inflammatory breast cancer)
- •Locally advanced or metastatic breast cancer
- •Any previous chemotherapy of contra-lateral breast cancer.
- •Breast cancer local relapse
- •Previous surgical removal of breast Cancer.
- •Inadequate biopsy for pathological analysis.
- •Dementia or altered mental disorder
- •Pregnant woman or breast feeding or without efficacious contraceptive method.
- •Contra-indication to NAC NAC interrupted due to progressive disease.
- •Neoadjuvant radiotherapy.
结局指标
主要结局
false-negative (FN) rate for the Sentinel Lymph Node Detection
时间窗: after surgery
Ratio of the number of FN cases to the total number of patients with at least one lymph node involved, sentinel or not. a FN case was defined as a patient with a successful mapping, SLN(s) without any metastasis, and a metastasis in at least one node from the ALND
次要结局
- Sataloff score on breast tumour(after surgery)
- Sataloff score on lymph nodes(after surgery)
- Homolateral axillary recurrence rate(5 years post surgery)
- Detection rate(after surgery)