ID.1
Item
female, non-pregnant, non-lactating, and, if of child-bearing potential, have a negative serum pregnancy test, and use approved contraception
boolean
C0086287 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0015895 (UMLS CUI [4])
C0700589 (UMLS CUI [5])
ID.2
Item
sixteen years of age or older
boolean
C0001779 (UMLS CUI [1])
ID.3
Item
histologically or cytologically confirmed breast cancer (stage iii or iv) with evidence of inoperable local recurrence or metastasis, with measurable disease
boolean
C0678222 (UMLS CUI [1,1])
C0019638 (UMLS CUI [1,2])
C1300072 (UMLS CUI [1,3])
C0205187 (UMLS CUI [2])
C1513041 (UMLS CUI [3])
ID.4
Item
if patient has received taxane therapy as an adjuvant he/she has not relapsed within one year of completing adjuvant taxane
boolean
C3541958 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
ID.5
Item
no other malignancy present within the past 5 years, except non-melanoma skin cancer, cervical intraepithelial neoplasia or in-situ cervical cancer
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
ID.6
Item
suitable candidate for paclitaxel therapy
boolean
C0144576 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
ID.7
Item
hematology levels at baseline of: absolute neutrophil count of at least 1500 cells/mm3; platelet count of at least 100,000 cells/mm3; hemoglobin of at least 9 g/dl
boolean
C0948762 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
ID.8
Item
chemistry levels at baseline of: ast and alt of less than or equal to 2.5 x the upper limit of normal, if no evidence of liver metastasis; total bilirubin of less than or equal to 1.5 mg/dl; creatinine of less than or equal to 2 mg/dl; alkaline phosphatase of less than or equal to 5 x the upper limit of normal, unless there is bone metastasis but not liver metastasis
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
ID.9
Item
expected survival of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
ID.10
Item
patient or his/her representative has signed an informed consent form
boolean
C0021430 (UMLS CUI [1])