T1-T2 Breast Cancer: Comparison Between Removal and Preservation of Axillary Lymph Nodes in the Presence of Sentinel Lymph Node Metastases (SINODAR ONE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 889
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
Italian Multicentric non inferiority two-arm randomized clinical trial to verify that the experimental treatment (omission of axillary lymph node intervention) in the presence of sentinel lymph node metastases does not lead to a significant worsening in survival or in the risk of locoregional recurrence compared to standard treatment (removal of I-II level of axillary lymph nodes).
详细描述
Detailed Description:
The trial is a non-inferiority trial; patients, depending on intra-operative or post-operative sentinel lymph node assessment, are randomly assigned to one of the two intervention groups:
group 1: removal of I-II level of axillary lymph nodes (standard treatment). Removal of at least 10 lymph nodes is recommended.
group 2: no axillary lymph nodes dissection (experimental treatment). Patients for whom sentinel lymph node cannot be found, will undergo complete dissection of the axillary cavity as required by international guidelines.
After surgery, according to their bio-pathological profile and to the international guidelines criteria, patients will be able to receive:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 40 ≤75 years old
- •Breast cancer with infiltrating histology
- •Tumor size ≤50 mm (T1 - T2)
- •Clinically and ultrasound node-negative (cN0) breast cancer
- •No distant metastases (M0)
- •No neoadjuvant therapy
- •Negative history of previous infiltrating neoplasm
- •Maximum number of metastatic sentinel lymph nodes: 2
- •Lymph node macro-metastases > 2mm
排除标准
- •Pregnancy or breastfeeding in progress
- •Inflammatory breast cancer
- •Breast cancer in situ
- •Synchronous contralateral breast cancer
- •Co-morbidities such as to preclude the possible use of adjuvant therapy
- •Conditions that make it impossible to carry out a regular follow-up
- •Other malignancies within the previous 3 years (except carcinoma in situ of the uterine cervix, basalioma or squamous cell ca or non-melanoma skin ca)
- •Breast cancer with non-infiltrating or inflammatory histotype
- •Tumor size> 50 mm
- •No sentinel lymph nodes identified
- •No positive sentinel lymph nodes (pN0)
- •Positive sentinel lymph node number > 2
- •Lymph node micro-metastases <= 2
研究组 & 干预措施
Preservation of axillary lymph nodes
Omission of Axillary dissection in women with sentinel lymph node metastases.
干预措施: Preservation of axillary lymph nodes (Procedure)
Axillary dissection (standard treatment)
Axillary dissection in women with sentinel lymph node metastases.
(removal of at least 10 lymph nodes recommended)
干预措施: Removal of axillary lymph nodes. (Procedure)
结局指标
主要结局
Overall Survival (OS)
时间窗: 5 years of follow up after surgery
Evaluating whether, in women operated for breast cancer (T1-T2) with sentinel lymph node metastases, axillary lymph node conservation is associated with a clinically relevant prognostic worsening (OS). For all the Outcomes Statistical analysis included 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)
- Disease-free distance survival (DDFS)(5 years of follow up after surgery)