Breast Carcinoma
Item
pathologic diagnosis breast cancer
boolean
C0678222 (UMLS CUI [1])
HER2/Neu Positive | Immunohistochemistry Score | In Situ Hybridization Positive | Measurable Disease Quantity
Item
her2+ status defined as ihc3+ staining or in situ hybridization positive at least 1 measurable lesion as per recist criteria
boolean
C2348909 (UMLS CUI [1])
C0021044 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
C0162788 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C1513041 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
adequate liver (bilirubin <1.0 times upper limit of normal and sgot/sgpt <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Cardiac function | Left ventricular ejection fraction | ECG normal | Heart Disease Absent
Item
adequate cardiac function (lvef>50%). normal electrocardiogram and absence of significant heart disease
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
C0522054 (UMLS CUI [3])
C0018799 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Age
Item
age from 18 to 70y
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky performance score ≥ 60
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of greater than 3 months
boolean
C0023671 (UMLS CUI [1])
Childbearing Potential Hcg pregnancy test Negative | Premenopausal state | Postmenopausal state Duration Hcg pregnancy test Negative
Item
negative hcg pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause.
boolean
C3831118 (UMLS CUI [1,1])
C0546577 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C0232969 (UMLS CUI [2])
C0232970 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C0546577 (UMLS CUI [3,3])
C1513916 (UMLS CUI [3,4])
Informed Consent
Item
signed icf
boolean
C0021430 (UMLS CUI [1])
Vinorelbine Exposure | Breast Carcinoma
Item
prior exposure vinorelbine for breast cancer
boolean
C0078257 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
Trastuzumab Exposure | Breast Carcinoma
Item
prior exposure trastuzumab for breast cancer
boolean
C0728747 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
Chemotherapy | Therapeutic radiology procedure
Item
prior chemotherapy and radiation therapy within the last 4 weeks before enrollment
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Investigational New Drugs
Item
use of any other investigational agents within the last 4 weeks before enrollment
boolean
C0013230 (UMLS CUI [1])
CNS metastases Symptomatic
Item
symptomatic, central nervous system metastases
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Hypersensitivity Investigational New Drugs
Item
hypersensitivity to trial medications
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Breast Feeding | Pregnancy
Item
breastfeeding or pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])