Breast Carcinoma Operable TNM Breast tumor staging
Item
confirmed stage ii or iii (operable) primary breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0205188 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
Lesion Evaluable Radiology | Measurable lesion Radiology | Primary tumor
Item
having radiologically evaluable and measurable lesion(s) of the primary tumor
boolean
C0221198 (UMLS CUI [1,1])
C1516986 (UMLS CUI [1,2])
C0043299 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C0043299 (UMLS CUI [2,2])
C0677930 (UMLS CUI [3])
Karnofsky Performance Status
Item
karnofsky performance status 80 %
boolean
C0206065 (UMLS CUI [1])
Cardiac function | Left ventricular ejection fraction
Item
normal cardiac function: lvef > 50 %
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Hematologic function | Hemoglobin measurement | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement
Item
adequate hematological function: hb ≥ 10.0 g/dl, wbc ≥ 3,000/mm3, anc ≥ 1,500 /mm3, platelet count ≥ 100,000/mm3
boolean
C0221130 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
Liver function | Alanine aminotransferase measurement | Serum total bilirubin measurement
Item
adequate liver function: alt ≤ 2.5 times upper limit of normal, total bilirubin level
boolean
C0232741 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
ID.7
Item
≤ 1.5 times upper limit of normal
boolean
Renal function | Creatinine measurement, serum
Item
adequate renal function: serum creatinine ≤ 1.5 times upper limit of normal
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Able to swallow Oral medication
Item
able to take oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding subjects
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Breast Carcinoma Previous | Breast cancer recurrent
Item
history of previous breast cancer (recurrent breast cancer)
boolean
C0678222 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0278493 (UMLS CUI [2])
Cancer Other
Item
history of other cancer within the past 5 years
boolean
C1707251 (UMLS CUI [1])
Systemic therapy Previous Breast Carcinoma
Item
prior systemic treatment for the current breast cancer
boolean
C1515119 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Neoadjuvant Therapy Topical Breast Carcinoma
Item
prior preoperative topical treatments for the current breast cancer
boolean
C0600558 (UMLS CUI [1,1])
C0332237 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease Serious
Item
uncontrolled or serious cvd
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Hypersensitivity Chemotherapeutic agent Clinical Trial | Hypersensitivity Suspected Chemotherapeutic agent Clinical Trial
Item
known or suspected hypersensitivity to any of the chemotherapeutic agents used in the study
boolean
C0020517 (UMLS CUI [1,1])
C0729502 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0729502 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
Disease Serious Interferes with Study Subject Participation Status | Medical condition Serious Interferes with Study Subject Participation Status | Disease Serious Interferes with Evaluation | Medical condition Serious Interferes with Evaluation
Item
any other serious disease state or medical condition which judged by investigator could interfere with trial participation or trial evaluation
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0012634 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C1261322 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C1261322 (UMLS CUI [4,4])
Herbal medicine Effect Breast Carcinoma | Dietary Supplements Effect Breast Carcinoma
Item
concurrent herbal (alternative) medicines or food supplements suspected to have effect on breast cancer disease within 14 days prior to screening
boolean
C2240391 (UMLS CUI [1,1])
C1280500 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0242295 (UMLS CUI [2,1])
C1280500 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
Severe Mental Disorders Exclude Informed Consent | Nervous system disorder Excludes Informed Consent | Dementia Excludes Informed Consent
Item
severe psychological or neurological disorder or dementia that would preclude understanding of the informed consent
boolean
C4046029 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0027765 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0497327 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
Study Subject Participation Status
Item
participation in any other clinical studies within 30 days prior to screening
boolean
C2348568 (UMLS CUI [1])