Breast Carcinoma T1-T2-T3 / cN +: Axillary Conservation of Lymph Nodes in the Presence of Micro Metastases in Sentinel Lymph Node, in cN- After Neoadjuvant Chemotherapy - Studio NEONOD 2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 850
- 试验地点
- 2
- 主要终点
- Disease-free or death-free survival for any reason (DFS)
研究概览
简要总结
Italian multicentric non inferiority clinical study to verify whether the omission of axillary lymph node intervention in patients with SLN (Sentinel Lymph Nodes) ypN1mi after NAC (Neo Adiuvant Chemotherapy) does not lead to a significant deterioration in survival or in the risk of regional or distant recurrence, compared to patients with negative SLN (SLN ypN0) after NAC ,where the omission of axillary treatment is currently the standard treatment.
详细描述
The study includes patients with cN+ positive axillary lymph nodes at initial diagnosis and who also have negative clinical and instrumental evaluation after NAC. Based on the sentinel lymph nodes definitive histological evaluation patients are allocated in one of the 2 comparison groups (Group 1 experimental or Group 2 standard) or in Group 3 internal control group. Group 3 is not used in statistical comparison with the other two groups but it's aim is to evaluate the appropriateness of the cases.
Referring to bio-pathologic characteristics after surgery patients will receive:
- no further treatment
- complementary radiotherapy
- adjuvant medical therapy (hormonal therapy and/or biological therapy)
Irradiation:
Group 1 (experimental) and Group 2 (standard): irradiation won't be performed neither in the axillary region nor in the other lymph node stations
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18 ≤75 years
- •Breast carcinoma with infiltrating histotype
- •Tumor size: cT1 - cT2 - cT3
- •Positive axillary lymph nodes (cN +) at the initial diagnosis by clinical, ultrasound and cyto-microhistology evaluation
- •Neoadjuvant chemotherapy performed
- •Negative axillary lymph nodes (cN-) from the NAC by clinical and ultrasound assessment
- •Absence of distant metastases (M0)
- •Negative medical history for previous infiltrating breast cancer
排除标准
- •Current pregnancy or lactation status
- •Inflammatory breast cancer
- •In situ breast cancer
- •Synchronous contralateral breast cancer
- •Co-morbidity and/or medical disorder precluding any adjuvant therapy
- •Co-morbidity and/or medical/mental disorder making impossible making a regular follow-up
- •Other cancers in the previous 3 years (except forcarcinoma in situ of the uterine cervix, basalioma, squamous cell carcinoma or non-melanoma skin cancer)
结局指标
主要结局
Disease-free or death-free survival for any reason (DFS)
时间窗: 5 years of follow up after surgery
Evaluating whether in patients operated for breast cancer (cT1-T2-T3) with sentinel node micrometastases (SLNypN1mi) after neoadjuvant chemotherapy (NAC), the preservation of axillary lymph nodes is not associated with a clinically relevant prognostic deterioration using Kaplan-Meier Product Limit Estimator and the log-rank test
次要结局
- Regional Disease Free Survival (RDFS)(5 years of follow up after surgery)
- Global Survival (OS)(5 years of follow up after surgery)
- Disease-free distance survival (DDFS)(5 years of follow up after surgery)