The Value of Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy. A Dutch Randomized Controlled Multicentre Trial.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 36
- 主要终点
- Regional recurrence rate
研究概览
简要总结
STUDY AIM To decrease the number of breast cancer patients receiving overtreatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life.
PRIMARY OBJECTIVE To determine whether omitting completion axillary treatment is not inferior to the current axillary treatment regimen in sentinel node positive breast cancer patients undergoing a mastectomy, in terms of regional recurrence rate.
HYPOTHESIS Completion axillary treatment can be safely omitted in sentinel node positive breast cancer patients undergoing a mastectomy. This will lead to a decreased axillary morbidity rate and to an increased quality of life, with non-inferior regional control, distant-disease free- and overall survival rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Aged 18 years or older
- •Pathologically confirmed invasive unilateral breast carcinoma
- •A clinical T1-2 tumour (including multifocal or multicentric breast cancer)
- •Will be or is treated with mastectomy
- •Clinically node negative: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
- •Sentinel lymph node procedure and its pathologic evaluation should be performed according to the Dutch breast cancer guideline
- •pN1mi(sn) or pN1(sn): at least one and a maximum of three axillary sentinel lymph nodes containing micro- and/or macrometastases
- •Written informed consent
排除标准
- •Clinically node positive pre-operative
- •Sentinel lymph nodes only containing isolated tumour cells (<0.2 mm)
- •Solitary parasternal sentinel lymph node metastasis (pN1b)
- •Bilateral breast cancer
- •Irradical resection of primary tumour at time of randomization (applicable in case the mastectomy is performed before randomization)
- •Evidence of metastatic disease
- •History of invasive breast cancer
- •Previous treatment of the axilla with surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi)
- •Pregnant or nursing
- •Other prior malignancies within the past 5 years (except successfully treated basal cell and squamous cell skin cancer, carcinoma in situ of the cervix or carcinoma in situ of the ipsilateral or contralateral breast) or unsuccessfully treated malignancies > 5 years before randomization
- •Unable or unwilling to give informed consent
结局指标
主要结局
Regional recurrence rate
时间窗: up to ten years
Regional recurrence is defined as tumour recurrence and as residual tumour that became clinically apparent in ipsilateral axillary, infraclavicular and supraclavicular lymph nodes (pathologically proven).
次要结局
未报告次要终点