Informed Consent
Item
1. signed informed consent;
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. age of 18 to 65 years;
boolean
C0001779 (UMLS CUI [1])
Advanced breast cancer
Item
3. documented advanced breast cancer, clinical and pathological confirmed;
boolean
C3495917 (UMLS CUI [1])
Immunohistochemistry | Status of estrogen receptors of neoplasm | Status of progesterone receptors of neoplasm | erbB-2 Receptor | Fluorescent in Situ Hybridization
Item
4. immunohistochemical examination:er<1%+, progestin receptor (pr)<1%+, her-2 -/+ or her-2(++)with negative result of fish;
boolean
C0021044 (UMLS CUI [1])
C2919271 (UMLS CUI [2])
C2919590 (UMLS CUI [3])
C0069515 (UMLS CUI [4])
C0162789 (UMLS CUI [5])
Disease Response First line treatment Chemotherapy Regimen
Item
5. a response after four to eight cycles of first line chemotherapy;
boolean
C1704632 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
Life Expectancy
Item
6. life expectancy longer than six months evaluated by investigator;
boolean
C0023671 (UMLS CUI [1])
WHO performance status finding | Score
Item
7. a performance status of 0 to 2, according to the criteria of the world health organization (with a higher score indicating a poorer performance status)
boolean
C1298651 (UMLS CUI [1])
C0449820 (UMLS CUI [2])
Toxic effect Finding related to participation with treatment Common Terminology Criteria for Adverse Events
Item
8. less than grade 1( common terminology criteria grade version 4.0) of treatment-related toxicities;
boolean
C0600688 (UMLS CUI [1,1])
C1301588 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
body system or organ function
Item
9. adequate baseline organ function.
boolean
C0678852 (UMLS CUI [1])
Malignant Neoplasms
Item
1. history of another malignancy.
boolean
C0006826 (UMLS CUI [1])
Pregnancy
Item
2. pregnancy or gestation
boolean
C0032961 (UMLS CUI [1])
CNS metastases | Metastatic Malignant Neoplasm to the Leptomeninges
Item
3. definite diagnosed of central nervous system (cns)or leptomeningeal metastases
boolean
C0686377 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
Heart Diseases
Item
4. serious cardiac illness or medical condition
boolean
C0018799 (UMLS CUI [1])
CNS disorder | Leptomeningeal disease
Item
5. known history of related central nervous system or leptomeningeal disease
boolean
C0007682 (UMLS CUI [1])
C3160796 (UMLS CUI [2])
Impaired cognition | Mental disorders
Item
6. cognition impairment or suffering from mental illness
boolean
C0338656 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
Psychotropic Drugs Oral Administration Long-term
Item
7. demand a long-term oral administration of psychotropic drugs
boolean
C0033978 (UMLS CUI [1,1])
C0001563 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
Comorbidity Study Subject Participation Status Limited | Disease Affecting patient safety | Disease | Antiviral Therapy | Liver diseases | Gall Bladder Diseases
Item
8. have a concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection, currently active/requiring anti-viral therapy hepatic or biliary disease)
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3])
C0280274 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0016977 (UMLS CUI [6])