Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Age
Item
aged 18 years or older
boolean
C0001779 (UMLS CUI [1])
Invasive carcinoma of breast Unilateral
Item
pathologically confirmed invasive unilateral breast carcinoma
boolean
C0853879 (UMLS CUI [1,1])
C0205092 (UMLS CUI [1,2])
Neoplasm TNM clinical staging | Multifocal breast carcinoma | Multicentric Breast Carcinoma
Item
a clinical t1-2 tumour (including multifocal or multicentric breast cancer)
boolean
C0027651 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C2986662 (UMLS CUI [2])
C2986664 (UMLS CUI [3])
Mastectomy Planned | Mastectomy
Item
will be or is treated with mastectomy
boolean
C0024881 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0024881 (UMLS CUI [2])
Negative Lymph Node | Axillary lymph nodes Free of Neoplasm Metastasis | Physical Examination | Axillary Lymph Node Ultrasound Preoperative | Cytopathology finding Negative | Histopathology finding Negative
Item
clinically node negative: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
boolean
C0678034 (UMLS CUI [1])
C0729594 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
C0031809 (UMLS CUI [3])
C4527288 (UMLS CUI [4,1])
C0445204 (UMLS CUI [4,2])
C0456521 (UMLS CUI [5,1])
C1513916 (UMLS CUI [5,2])
C0428093 (UMLS CUI [6,1])
C1513916 (UMLS CUI [6,2])
Sentinel Lymph Node Biopsy Evaluation
Item
sentinel lymph node procedure and its pathologic evaluation should be performed according to the dutch breast cancer guideline
boolean
C0796693 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
Sentinel Lymph Node TNM clinical staging | Number of lymph nodes with micrometastases Sentinel Lymph Node Axillary | Number of lymph nodes with macrometastases Sentinel Lymph Node Axillary
Item
pn1mi(sn) or pn1(sn): at least one and a maximum of three axillary sentinel lymph nodes containing micro- and/or macrometastases
boolean
C1522495 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C2733510 (UMLS CUI [2,1])
C1522495 (UMLS CUI [2,2])
C0004454 (UMLS CUI [2,3])
C2733106 (UMLS CUI [3,1])
C1522495 (UMLS CUI [3,2])
C0004454 (UMLS CUI [3,3])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Lymph node positive Preoperative
Item
clinically node positive pre-operative
boolean
C0746319 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
Sentinel Lymph Nodes Containing Neoplastic Cells Isolated
Item
sentinel lymph nodes only containing isolated tumour cells (<0.2 mm)
boolean
C1522495 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0597032 (UMLS CUI [1,3])
C0205409 (UMLS CUI [1,4])
Sentinel Lymph Node TNM clinical staging | Sentinel Lymph Node Parasternal Neoplasm Metastasis
Item
solitary parasternal sentinel lymph node metastasis (pn1b)
boolean
C1522495 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1522495 (UMLS CUI [2,1])
C0442146 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
Bilateral breast cancer
Item
bilateral breast cancer
boolean
C0281267 (UMLS CUI [1])
Excision Primary tumor
Item
irradical resection of primary tumour at time of randomization (applicable in case the mastectomy is performed before randomization)
boolean
C0728940 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
Neoplasm Metastasis
Item
evidence of metastatic disease
boolean
C0027627 (UMLS CUI [1])
Medical History Invasive carcinoma of breast
Item
history of invasive breast cancer
boolean
C0262926 (UMLS CUI [1,1])
C0853879 (UMLS CUI [1,2])
Prior surgery Axilla | Radiotherapy to axilla | Exception Operative Surgical Procedure Hidradenitis Suppurativa | Exception Operative Surgical Procedure Nevus
Item
previous treatment of the axilla with surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi)
boolean
C0455610 (UMLS CUI [1,1])
C0004454 (UMLS CUI [1,2])
C1997064 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0162836 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0543467 (UMLS CUI [4,2])
C0027960 (UMLS CUI [4,3])
Pregnancy | Breast Feeding
Item
pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Breast Carcinoma Ipsilateral Treated | Exception Contralateral breast cancer Treated | Cancer treatment Unsuccessful
Item
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
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0678222 (UMLS CUI [5,2])
C0441989 (UMLS CUI [5,3])
C1522326 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C1096616 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
C0920425 (UMLS CUI [7,1])
C1272705 (UMLS CUI [7,2])
Informed Consent Unable | Informed Consent Unwilling
Item
unable or unwilling to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])