Invasive carcinoma of breast Appropriate Neoadjuvant Therapy
Item
1. histologically proven primary invasive breast cancer which is thought to be suitable for neo-adjuvant treatment
boolean
C0853879 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0600558 (UMLS CUI [1,3])
Neoplasm Lymph node positive Fine needle aspiration biopsy | Neoplasm Lymph node positive Core needle biopsy
Item
2. pathologically proven lymph node positive tumor(fnab or core biopsy)
boolean
C0027651 (UMLS CUI [1,1])
C0746319 (UMLS CUI [1,2])
C1510483 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C0746319 (UMLS CUI [2,2])
C1318309 (UMLS CUI [2,3])
Neoplasm Estrogen receptor positive Allred score | Neoplasm HER2 Negative Immunohistochemistry | Neoplasm HER2 Negative Fluorescent in Situ Hybridization | Other Coding
Item
3. tumor must be er positive(eligible patients include allred score 5 and more, modified allred 4 and more) and her-2 negative(ihc score is 0-1+; if ihc score is 2+, the result of fish or sish is negative)
boolean
C0027651 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C2919519 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C2348908 (UMLS CUI [2,2])
C0021044 (UMLS CUI [2,3])
C0027651 (UMLS CUI [3,1])
C2348908 (UMLS CUI [3,2])
C0162789 (UMLS CUI [3,3])
C3846158 (UMLS CUI [4])
Gender | Premenopausal state
Item
4. premenopausal women
boolean
C0079399 (UMLS CUI [1])
C0232969 (UMLS CUI [2])
Premenopausal state Definition
Item
premenopausal status as defined by :
boolean
C0232969 (UMLS CUI [1,1])
C1704788 (UMLS CUI [1,2])
Menstruation Last Recently
Item
last menses within 6 month of randomization or
boolean
C0025344 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Unilateral oophorectomy | Estradiol measurement | Follicle stimulating hormone measurement
Item
for patients who have had a unilateral oophorectomy, e2 ≥ 20pg/ml and fsh < 30miu/ml within 4 weeks of randomization
boolean
C0041687 (UMLS CUI [1])
C0337434 (UMLS CUI [2])
C0202022 (UMLS CUI [3])
Age
Item
5. over 20 years old
boolean
C0001779 (UMLS CUI [1])
pre treatment Hematology | pre treatment Biochemistry
Item
6. pre-treatment haematology and biochemistry values within acceptable limits :
boolean
C2709094 (UMLS CUI [1,1])
C0200627 (UMLS CUI [1,2])
C2709094 (UMLS CUI [2,1])
C0428132 (UMLS CUI [2,2])
Absolute neutrophil count
Item
anc ≥ 1.5 × 109/l
boolean
C0948762 (UMLS CUI [1])
Hemoglobin measurement
Item
hb > 9g/dl
boolean
C0518015 (UMLS CUI [1])
Platelet Count measurement
Item
platelets ≥ 100 × 109/l
boolean
C0032181 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast/alt ≤ 1.5 × uln(upper limit of normal)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Alkaline phosphatase measurement
Item
alp ≤ 1.5 × uln
boolean
C0201850 (UMLS CUI [1])
Serum total bilirubin measurement
Item
serum bilirubin ≤ 1.5 × uln
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine ≤ 1.5 × uln
boolean
C0201976 (UMLS CUI [1])
ECOG performance status
Item
7. ecog ps of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Exclusion Criteria | Comorbidity Preventing Treatment completion | Comorbidity Preventing Follow-up | Mental problem Preventing Treatment completion | Mental problem Preventing Follow-up | Geographic Factors Preventing Treatment completion | Geographic Factors Preventing Follow-up
Item
8. no concomitant medical, psychiatric or geographic problems that might prevent completion of treatment or follow-up
boolean
C0680251 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0580352 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C3274571 (UMLS CUI [3,3])
C0848067 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0580352 (UMLS CUI [4,3])
C0848067 (UMLS CUI [5,1])
C1292733 (UMLS CUI [5,2])
C3274571 (UMLS CUI [5,3])
C0017444 (UMLS CUI [6,1])
C1292733 (UMLS CUI [6,2])
C0580352 (UMLS CUI [6,3])
C0017444 (UMLS CUI [7,1])
C1292733 (UMLS CUI [7,2])
C3274571 (UMLS CUI [7,3])
Informed Consent
Item
9. before any study-specific procedures, the appropriate written informed consent must be obtained
boolean
C0021430 (UMLS CUI [1])
Inflammatory Breast Carcinoma
Item
1. inflammatory breast cancer
boolean
C0278601 (UMLS CUI [1])
Disease Inoperable
Item
2. inoperable disease that is judged very unlikely to be rendered operable by neo-adjuvant treatment
boolean
C0012634 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
Severe allergy GNRH-A
Item
3. known severe hypersensitivity to gnrha treatment
boolean
C2945656 (UMLS CUI [1,1])
C2012324 (UMLS CUI [1,2])
Invasive carcinoma of breast Bilateral
Item
4. bilateral invasive breast cancer
boolean
C0853879 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
Illness Serious | Other medical condition Serious
Item
5. other serious illness or medical condition:
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Congestive heart failure | Angina, Unstable | Myocardial Infarction | Uncontrolled hypertension | High risk of Cardiac Arrhythmia Uncontrolled
Item
congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias
boolean
C0018802 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C1868885 (UMLS CUI [4])
C0332167 (UMLS CUI [5,1])
C0003811 (UMLS CUI [5,2])
C0205318 (UMLS CUI [5,3])
Nervous system disorder Preventing Informed Consent | Mental disorders Preventing Informed Consent | Psychotic Disorders | Dementia | Seizures
Item
history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
boolean
C0027765 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0033975 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
C0036572 (UMLS CUI [5])
Communicable Disease Uncontrolled
Item
active uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Hormone replacement therapy
Item
6. hrt within 4 weeks of starting treatment
boolean
C0282402 (UMLS CUI [1])
Medical contraindication Adrenal Cortex Hormones
Item
7. definite contra-indications for the use of corticosteroids.
boolean
C1301624 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Excision only
Item
8. last 10 years with a history of other malignant tumor (except in the case of basal cell carcinoma or cervical carcinoma in situ, and where treatment consisted solely of resection)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0728940 (UMLS CUI [4,2])
C0205171 (UMLS CUI [4,3])
Neoplasm Metastasis Systemic
Item
9. systemic metastatic (tests for the diagnosis of systemic metastatic comply with the guideline in each institution)
boolean
C0027627 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
10. pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Adrenal Cortex Hormones Oral chronic | Exception Low-Dose Treatment | Exception Methylprednisolone Dose | Exception Equivalent
Item
11. chronic oral treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (≤ 20 mg methylprednisolone or equivalent).
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1708745 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0025815 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0205163 (UMLS CUI [4,2])