Gender | Invasive Ductal Breast Carcinoma Unilateral | Breast adenocarcinoma Lobular
Item
women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma
boolean
C0079399 (UMLS CUI [1])
C1134719 (UMLS CUI [2,1])
C0205092 (UMLS CUI [2,2])
C0858252 (UMLS CUI [3,1])
C0205417 (UMLS CUI [3,2])
her-2/neu Protein Overexpression | Immunohistochemistry Score | Fluorescent in Situ Hybridization Positive | Chromogenic in situ Hybridization Positive
Item
her2/c-neu over expression should be documented by either immunohistochemistry (score 3+) or fish/cish positivity. a score of 2+ by immunohistochemistry is acceptable only if fish/cish positive
boolean
C0242957 (UMLS CUI [1,1])
C1514559 (UMLS CUI [1,2])
C0021044 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
C0162789 (UMLS CUI [3,1])
C1446409 (UMLS CUI [3,2])
C1516514 (UMLS CUI [4,1])
C1446409 (UMLS CUI [4,2])
Excision primary tumor | Surgical margin uninvolved by tumor | Requirement Excision of axillary lymph nodes Quantity
Item
within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
boolean
C0728940 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0332648 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0193867 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Axillary lymph node Involvement with Neoplasms | Node stage N0 her-2/neu Protein Overexpression
Item
tumor involvement of at least one axillary lymph node (n0 with her2/c-neu over expression are also eligible)
boolean
C0729594 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,3])
C0441959 (UMLS CUI [2,1])
C0242957 (UMLS CUI [2,2])
C1514559 (UMLS CUI [2,3])
Local disease Evidence of | Metastatic Neoplasm Evidence of
Item
absence of any clinical or radiological evidence of local or metastatic disease
boolean
C0277565 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C2939420 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
Premenopausal | Postmenopausal state | Age
Item
premenopausal or postmenopausal women aged 18-75 years old
boolean
C0279752 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin
Item
adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0019046 (UMLS CUI [4])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
adequate liver (bilirubin <1.0 times upper limit of normal and sgot/sgpt <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Cardiac function | Left ventricular ejection fraction | ECG normal | Heart Disease Significant Absent
Item
adequate cardiac function (lvef>50%). normal electrocardiogram and absence of significant heart disease
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
C0522054 (UMLS CUI [3])
C0018799 (UMLS CUI [4,1])
C0750502 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Pregnancy test positive
Item
positive pregnancy test.
boolean
C0240802 (UMLS CUI [1])
Mental disorders Compliance behavior Limited | social situation Compliance behavior Limited
Item
psychiatric illness or social situation that would preclude study compliance.
boolean
C0004936 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Illness Uncontrolled
Item
other concurrent uncontrolled illness.
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Antineoplastic Therapy | Hormone Therapy | Therapeutic radiology procedure | Chemotherapy | Biological Factors
Item
prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents.
boolean
C2346834 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C0005515 (UMLS CUI [5])
invasive cancer | Skin carcinoma
Item
previous history of other invasive malignancy other than non-melanomatous skin cancer.
boolean
C0677898 (UMLS CUI [1])
C0699893 (UMLS CUI [2])