Breast Carcinoma
Item
clinical diagnosis of breast cancer
boolean
C0678222 (UMLS CUI [1])
Gender
Item
1. female patients
boolean
C0079399 (UMLS CUI [1])
Invasive carcinoma of breast
Item
2. histologically confirmed invasive breast cancer
boolean
C0853879 (UMLS CUI [1])
Primary tumor Diameter Mammography | Primary tumor Diameter Ultrasonography
Item
1. primary tumor greater than 2cm diameter, measured by mammography and sonography
boolean
C0677930 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0024671 (UMLS CUI [1,3])
C0677930 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0041618 (UMLS CUI [2,3])
Lymph nodes TNM Breast tumor staging
Item
2. any n
boolean
C0024204 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Estrogen receptor negative Immunohistochemistry | Progesterone receptor negative Immunohistochemistry | HER2 Negative Immunohistochemistry | Estrogen receptor negative FISH | Progesterone receptor negative FISH | HER2 Negative FISH
Item
3. er (estrogen receptor)/ pr (progesterone receptor) / her2 (negative/ negative/
boolean
C0279756 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0279766 (UMLS CUI [2,1])
C0021044 (UMLS CUI [2,2])
C2348908 (UMLS CUI [3,1])
C0021044 (UMLS CUI [3,2])
C0279756 (UMLS CUI [4,1])
C0162789 (UMLS CUI [4,2])
C0279766 (UMLS CUI [5,1])
C0162789 (UMLS CUI [5,2])
C2348908 (UMLS CUI [6,1])
C0162789 (UMLS CUI [6,2])
ID.7
Item
negative)(er <1%, pr<1%, ihc 0, 1+ or fish - in case of ihc (immuno-histochemistry) 2+)
boolean
Neoplasm Metastasis Absent
Item
4. no evidence of metastasis (m0)
boolean
C0027627 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Hormone Therapy Absent | Chemotherapy Absent | Therapeutic radiology procedure Absent
Item
5. no prior hormonal, chemotherapy or radiotherapy is allowed.
boolean
C0279025 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Operation on breast Absent | Exception Biopsy of breast
Item
6. no breast operation other than biopsy to make diagnosis is allowed.
boolean
C3714726 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0405352 (UMLS CUI [2,2])
Age | Pregnancy Absent | Postmenopausal state | ECOG performance status
Item
7. age: 20-years and older, not pregnant pre-, and postmenopausal women with good performance status (ecog 0-1)
boolean
C0001779 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3])
C1520224 (UMLS CUI [4])
Hematologic function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
8. adequate hematopoietic function: absolute granulocyte count 1500/mm3, platelet 100,000/mm3, hemoglobin 10 g/mm3
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Renal function | Creatinine measurement, serum
Item
9. adequate renal function: serum creatinine 1.5 mg/dl
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase increased | Alanine aminotransferase increased | Alkaline phosphatase raised
Item
10. adequate hepatic function: total bilirubin: 1.5 mg/dl, ast(aspartate aminotransferase)/alt (alanine transaminase): 2 times normal, alkaline phosphatase:2 times normal
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
C0151849 (UMLS CUI [5])
Informed Consent
Item
11. written informed consent
boolean
C0021430 (UMLS CUI [1])
Cognitive functions Normal
Item
12. normal mental function to understand and sign the consent
boolean
C0392335 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Cardiac function | ECG normal
Item
13. cardiac function: normal or nonspecific ekg taken within 1 mo of enrollment.
boolean
C0232164 (UMLS CUI [1])
C0522054 (UMLS CUI [2])
Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography
Item
14. lvef (left ventricular ejection fraction)50% by muga (multiple gated acquisition scan) or echocardiogram taken within 1 mo of enrollment
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Hormone Therapy Breast Carcinoma | Chemotherapy Breast Carcinoma | Therapeutic radiology procedure Breast Carcinoma
Item
1. patients who received hormonal, chemotherapy or radiotherapy for breast cancer
boolean
C0279025 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
Operative Surgical Procedure Breast Carcinoma
Item
2. patients who underwent surgery for breast cancer
boolean
C0543467 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Congestive heart failure Uncompensated
Item
3. patients with a history of uncompensated congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C0205433 (UMLS CUI [1,2])
Inflammatory Breast Carcinoma TNM Breast tumor staging
Item
4. patients with inflammatory breast cancer (t4d)
boolean
C0278601 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Primary tumor Absent TNM clinical staging
Item
5. patients without primary tumor (t0)
boolean
C0677930 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma
Item
6. patients who have history of cancer other than in situ uterine cervix cancer or non-melanotic skin cancer
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
Hypersensitivity Investigational New Drugs
Item
7. known hypersensitivity to any of the study drugs
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])