Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement: the UTAD Study of the Italian National Association of Breast Surgeons (ANISC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 14
- 主要终点
- Successful rate of the retrieval of the deflector.
研究概览
简要总结
The present study aims to avoid axillary lymph node dissection (ALND) in patients with an Ultrasound (US) detected positive preoperative lymph node involvement (1 or 2 suspicious lymph-nodes) and a needle histology/cytology placing a marker in the most suspicious node undergoing upfront surgery if neoadjuvant treatment is not indicated. The marked lymph node will be retrieved along with sentinel lymphnode(SLN)(s) to minimize the false-negative rate and only in case of ≥3 positive SLNs ALND will be performed, in order to minimize surgical overtreatment among women with preoperatively confirmed axillary nodal metastasis.
详细描述
The patients that will avoid axillary lymph node dissection (ALND) meet all the criteria listed in the latest NCCN guidelines version.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of T0-T1-T2 ER+/PR+ HER2- breast cancer with limited nodal involvement (1 or 2 suspicious lymph node on US, with at least 1 nodal positive cytology/histology)
- •Conservative surgery or mastectomy
- •Neoadjuvant treatment not recommended after a multidisciplinary discussion
- •Patients between 18 and 90 years old
- •Patients willing and able to follow the study procedures and available for follow-up over the entire duration of the study
排除标准
- •Psychiatric, addictive or any disorder, which compromises ability to give informed consent for participation in the study
- •Personal history of invasive breast cancer
- •Other invasive malignancies diagnosed in the last five years
- •Any condition that may expose the individual to a higher risk or preclude the study from achieving full compliance or completion
- •Contraindications to radiation therapy
结局指标
主要结局
Successful rate of the retrieval of the deflector.
时间窗: Perioperative/Periprocedural
Number of successful retrieval of the deflector on the total number of surgeries.
Prevention of Axillary Lymph Node Dissection
时间窗: Perioperative/Periprocedural
Total number of patient that did not received but were elegible for Axillary Lymph Node Dissection by the current guidelines on the total number of surgeries.
次要结局
- Axillary recurrence rate(5 years from surgery.)