The value of completion axillary treatment in sentinel node positive breast cancer patients undergoing a mastectomy: a Dutch multicentre cohort study l - BOOG 2013-07

Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 878 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•- Aged 18 years or older
•- Pathologically confirmed invasive unilateral breast carcinoma
•- A clinical T1-2 tumour (* 5cm) (including multifocal or multicentric breast cancer)
•- Will be or is treated by mastectomy
•- Clinically node negative: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
•- SLN 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

•- Clinically node positive pre-operative
•- Sentinel lymph nodes only containing isolated tumour cells (<0.2mm)
•- Solitary parasternal sentinel lymph node metastasis (pN1b(sn))
•- Bilateral breast cancer
•- Irradical resection of primary tumour at time of inclusion (applicable in case the mastectomy is performed before inclusion)
•- Evidence of metastatic disease
•- History of invasive breast cancer
•- Previous treatment of the axilla by 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 history of unsuccessfully treated malignancies
•- Unable or unwilling to give informed consent

发起方

Medisch Universitair Ziekenhuis Maastricht