Informed Consent
Item
1. signed informed consent obtained prior to inclusion in study
boolean
C0021430 (UMLS CUI [1])
Breast Carcinoma | Complete Blood Count | White Blood Cell Count procedure | Absolute neutrophil count | Chemotherapy cycle
Item
2. pathologically confirmed breast cancer, whose cbc has shown ever dropped unto 1,000 to 3,000/mm3 in wbc count, or unto 500 to 1,500/mm3 in anc count, on day 8 or day 15, whilst on cycle 1 of current chemotherapy.
boolean
C0678222 (UMLS CUI [1])
C0009555 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C1302181 (UMLS CUI [5])
Age
Item
3. age 20 - 70 years
boolean
C0001779 (UMLS CUI [1])
TNM clinical staging
Item
4. stage t 1-3, n 0-2, m0.
boolean
C3258246 (UMLS CUI [1])
ECOG performance status
Item
5. ecog performance status of < 2
boolean
C1520224 (UMLS CUI [1])
Chemotherapy Regimen Restricted
Item
6. chemotherapy regimen is restricted to one of the followings:
boolean
C0392920 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
Doxorubicin | Cyclophosphamide | Adriamycin | Fluorouracil | Laboratory Results
Item
(1)doxorubicin 60 mg/m2 + cyclophosphamide 600 mg/m2(ac x 4cycles) or (2)cyclophosphamide 500 mg/m2 + doxorubicin 50 mg/m2 + 5-fu 500 mg/m2 (caf x 6 cycles) 7.laboratory test results within 30 days prior to study entry:
boolean
C0013089 (UMLS CUI [1])
C0010583 (UMLS CUI [2])
C0085752 (UMLS CUI [3])
C0013089 (UMLS CUI [4])
C0016360 (UMLS CUI [5])
C1254595 (UMLS CUI [6])
Hemoglobin measurement | Gender | Platelet Count measurement | Erythropoietin Continuous Redundant | Transfusion Continuous Redundant
Item
1. hemoglobin 9.0 g/dl for men and 8.7 g/dl for women and platelet> 100,000/mm³ without the need for current, on-going use of erythropoietin or transfusion
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0014822 (UMLS CUI [4,1])
C0549178 (UMLS CUI [4,2])
C1313915 (UMLS CUI [4,3])
C0005841 (UMLS CUI [5,1])
C0549178 (UMLS CUI [5,2])
C1313915 (UMLS CUI [5,3])
Liver function | Aspartate aminotransferase measurement
Item
2. normal liver function (got < 1.5 x uln)
boolean
C0232741 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Renal function | Creatinine measurement, serum | Dialysis procedure Absent | Gender Pregnancy test negative
Item
3. normal kidney function (creatinine < 1.5 x uln) and no dialysis. 8.negative of mandatory pregnancy test for women subjects.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0011946 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0427780 (UMLS CUI [4,2])
Pregnancy | Pregnancy test positive | Breast Feeding | Childbearing Potential Contraceptive methods
Item
1. women under pregnancy or with positive result from mandatory pregnancy test or in lactating; women of child-bearing potential must use adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Systemic therapy Breast Carcinoma | Therapeutic radiology procedure Breast Carcinoma
Item
2. prior systemic therapy or radiotherapy for breast cancer
boolean
C1515119 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Allergy to bean
Item
3. known hypersensitivity to bean products
boolean
C2227748 (UMLS CUI [1])
Illness Serious Interferes with Protocol Compliance | Mental disorder Serious Interferes with Protocol Compliance
Item
4. serious medical or psychiatric illness that, in the opinion of the principal investigator, would interfere with the ability to adhere to study requirements.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
Myocardial Infarction | Angina Pectoris
Item
5. history of myocardial infraction or angina.
boolean
C0027051 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
Disease Uncontrolled | Chronic disease Uncontrolled | Uncontrolled hypertension | Diabetic - poor control
Item
6. uncontrollable acute or chronic diseases, including hypertension or diabetes.
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1868885 (UMLS CUI [3])
C0421258 (UMLS CUI [4])
Neoplasms, Second Primary | Neoplasm Metastasis
Item
7. second malignancy or cancer metastasis
boolean
C0085183 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
carrier of type B viral hepatitis | Hepatitis C carrier
Item
8. hbv or hcv carrier
boolean
C2025297 (UMLS CUI [1])
C0400920 (UMLS CUI [2])
White Blood Cell Count procedure | Absolute neutrophil count | Chemotherapy cycle
Item
9. wbc below 4000 or anc below 2000 on d1 of cycle 1
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C1302181 (UMLS CUI [3])
Study Subject Participation Status | Investigational New Drugs
Item
10. participation in investigational drug study within the past 30 days
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])