Invasive carcinoma of breast | Curative Surgery Breast Carcinoma Primary
Item
1. histologically diagnosed as invasive breast cancer and received curative operation for primary breast cancer.
boolean
C0853879 (UMLS CUI [1])
C1511562 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0205225 (UMLS CUI [2,3])
TNM Breast tumor staging | Tumor size
Item
2. stage: 1 (tumor size [pt] > 0.5 cm), 2a, 2b or 3a/ m0
boolean
C0474926 (UMLS CUI [1])
C0475440 (UMLS CUI [2])
Gender | Age
Item
3. female between 69 and 81 years old
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
HER2/Neu Positive Overexpression Immunohistochemistry | HER2/Neu Positive FISH
Item
4. primary region is her 2 positive: either 3+ overexpression by ihc or positive by fish
boolean
C2348909 (UMLS CUI [1,1])
C1514559 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C2348909 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan
Item
5. baseline left ventricular ejection fraction (lvef) is ≥55% measured by echocardiography or muga scan within 4 weeks before registration.
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
ECOG performance status
Item
6. ps: 0-1 (ecog)
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
7. sufficient organ function meeting following criteria within 4 weeks before registration:
boolean
C0678852 (UMLS CUI [1])
White Blood Cell Count procedure
Item
leukocyte ≥2500 mm3
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
neutrophil ≥1500 mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet ≥100 000 mm3
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
serum total bilirubin ≤2.0 x upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
alt (gpt) or ast (got) ≤2.5 x uln
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Creatinine measurement, serum
Item
serum creatinine ≤2.0 x uln
boolean
C0201976 (UMLS CUI [1])
Alkaline phosphatase measurement
Item
alp ≤2.5 x uln
boolean
C0201850 (UMLS CUI [1])
Hormone Therapy Absent Breast Carcinoma | Chemotherapy Absent Breast Carcinoma
Item
8. no previous endocrine therapy or chemotherapy for breast cancer
boolean
C0279025 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
Informed Consent
Item
9. signed written informed consent (appendix a)
boolean
C0021430 (UMLS CUI [1])
Multiple cancer, primary | Multiple primary cancer Synchronous | Invasive cancer Organ Other
Item
1. active multiple primary cancer (synchronous multiple primary cancer and invasive cancer of other organs)
boolean
C0865021 (UMLS CUI [1])
C0865021 (UMLS CUI [2,1])
C0439580 (UMLS CUI [2,2])
C0677898 (UMLS CUI [3,1])
C0178784 (UMLS CUI [3,2])
C0205394 (UMLS CUI [3,3])
AXILLARY LYMPH NODE METASTASIS Postoperative
Item
2. postoperative histological axillary lymph node metastasis ≥4
boolean
C0741344 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
Axillary lymph nodes Histology Procedure Lacking
Item
3. axillary lymph node is not histologically evaluated
boolean
C0729594 (UMLS CUI [1,1])
C0344441 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Breast-Conserving Surgery Positive Surgical Margin
Item
4. histologically confirmed positive margin in breast conservation surgery (evaluation of margin status is based on policy of site)
boolean
C0917927 (UMLS CUI [1,1])
C1709603 (UMLS CUI [1,2])
Drug Allergy Preventing Planned Treatment
Item
5. history of drug-related allergy which could hinder planned treatment
boolean
C0013182 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C3641097 (UMLS CUI [1,3])
Heart Diseases | Cardiac complication
Item
6. any history or complication of following cardiac disorders
boolean
C0018799 (UMLS CUI [1])
C0161816 (UMLS CUI [2])
Congestive heart failure | Myocardial Infarction
Item
history of congestive heart failure, cardiac infarction
boolean
C0018802 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
Complication Treatment required for | Myocardial Ischemia | Cardiac Arrhythmia | Heart valve disease
Item
complication requires treatment such as: ischemic cardiac disorder, arrhythmia, valvular heart disease
boolean
C0009566 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0151744 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
C0018824 (UMLS CUI [4])
Hypertensive disease Poorly controlled | Systolic Pressure | Diastolic blood pressure
Item
7. poorly controlled hypertension (ex. systolic arterial pressure ≥180 mmhg or diastolic blood pressure ≥100 mmhg)
boolean
C0020538 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Poorly controlled diabetes mellitus
Item
8. poorly controlled diabetes
boolean
C0554876 (UMLS CUI [1])
Patient Visit Difficult | Deterioration Activities of Daily Living
Item
9. continuous visit to a medial institution is considered difficult due to deterioration of activity of daily living (adl)
boolean
C1512346 (UMLS CUI [1,1])
C0332218 (UMLS CUI [1,2])
C0868945 (UMLS CUI [2,1])
C0001288 (UMLS CUI [2,2])
Mental disorders Study Subject Participation Status Difficult | Psychiatric symptom Study Subject Participation Status Difficult
Item
10. difficult to participate in the trial because of psychiatric disorder or psychiatric symptoms
boolean
C0004936 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332218 (UMLS CUI [1,3])
C0233401 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332218 (UMLS CUI [2,3])
Patient Ineligible
Item
11. ineligible to the trial based on decision of an investigator
boolean
C0030705 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])