Locoregional Control With Radiotherapy of cT1-2N0 Invasive Breast Cancer Patients With MACrometastases in the Sentinel Node Treated With MAstectomy: a Multi-center Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 82
- 试验地点
- 7
- 主要终点
- Axillary recurrence rate
研究概览
简要总结
Sentinel lymph node biopsy (SLNB) is the standard procedure to stage the axilla in clinically node-negative invasive breast cancer (IBC) patients undergoing upfront surgery.
The ACOSOG-Z0011 and the AMAROS trial demonstrated that SLNB with or without radiotherapy provided equivalent local control and survival to axillary lymph node dissection (ALND) in early-stage breast cancer patients with 1 or 2 positive SLNs. However, the ACOSOG-Z0011 trial did not included patients treated with mastectomy, and the AMAROS trial only included 17% of mastectomy patients.
The investigators conduct an observational cohort study of early stage breast cancer patients receiving upfront mastectomy with 1 or 2 macrometastases after SLNB. The study aim to demonstrate a 5-year disease-free survival of not less than 80% when ALND is omitted and replaced by axillary radiotherapy, and determine the axillary recurrence rate.
详细描述
This is a multi-center, prospective study with an estimated sample size of 60 early-stage IBC patients.
Clinically node-negative T1-2 IBC patients undergoing mastectomy with up to 2 macrometases after SLNB will be informed about this study.
Patients will be checked with annual mammography and clinical examination. The axilla will be checked with ultrasound at 3 and 5 years of the surgery.
After surgery, patients will receive axillary radiotherapy, but no ALND, and adjuvant systemic treatment based on international guidelines.
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 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with T1-2 primary invasive breast cancer
- •No suspicion of lymph node involvement prior to sentinel lymph node biopsy
- •Patients undergoing upfront mastectomy
- •Macrometastasis in not more than 2 lymph nodes at sentinel lymph node biopsy
- •Patients treated with adjuvant axillary radiotherapy
排除标准
- •Prior history of invasive breast cancer
- •Medical contraindication for radiotherapy
- •Medical contraindication for adjuvant systemic treatment
- •Planned neoadjuvant systemic treatment
- •Distant metastasis at initial diagnosis
- •Inability to absorb or understand the meaning of the study information
结局指标
主要结局
Axillary recurrence rate
时间窗: 3 and 5 years
recurrence rate in the ipsilateral axillary lymph nodes
Disease-free survival
时间窗: 3 and 5 years
recurrence in the ipsilateral breast/thoracic wall, regional recurrence, distant recurrence or death
次要结局
- Overall survival(5 years)
研究者
Alberto Bouzon
Principal Investigator, M.D., Ph.D.
University Hospital A Coruña