histologically/cytologically confirmed breast cancer
Item
histologically/cytologically confirmed breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0332141 (UMLS CUI [1,2])
C0679557 (UMLS CUI [1,3])
Metastatic Neoplasm; Breast Carcinoma; Target Lesion Identification | Secondary malignant neoplasm of bone | Leptomeningeal disease | Ascites | Pericardial effusion | Pleural effusion disorder | Inflammatory disorder of breast | Lymphangitic spread | Cystic Lesion | Conventional manometry | Tomography, Spiral Computed | prior radiation therapy
Item
metastatic breast cancer, having at least one target lesion according to the recist criteria. bone metastases, leptomeningeal disease, ascites, pleural or pericardial effusions, inflammatory breast disease, lymphangitic spread or cystic lesions are not acceptable as target lesions. target lesions must be ≥ 10 mm longest diameter measured in one dimension using spiral ct, or ≥ 20 mm longest diameter measured in one dimension using conventional techniques. in addition to the definitions pertaining to the target lesion(s) from the recist criteria above, the target lesion(s) must not have been previously irradiated (newly arising lesions in previously irradiated areas are acceptable).
boolean
C2939420 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,3])
C0153690 (UMLS CUI [2])
C3160796 (UMLS CUI [3])
C0003962 (UMLS CUI [4])
C0031039 (UMLS CUI [5])
C0032227 (UMLS CUI [6])
C3495439 (UMLS CUI [7])
C3697833 (UMLS CUI [8])
C1511606 (UMLS CUI [9])
C0441679 (UMLS CUI [10])
C0860888 (UMLS CUI [11])
C0279134 (UMLS CUI [12])
age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
signed informed consent obtained prior to initiation of any study-specific procedures or treatment
boolean
C0021430 (UMLS CUI [1])
prior cytotoxic chemotherapy or active/passive immunotherapy for metastatic breast disease
Item
prior cytotoxic chemotherapy or active/passive immunotherapy for metastatic breast disease
boolean
C1514457 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C0021083 (UMLS CUI [2,2])
C2939420 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
prior usage of capecitabine or mitomycin as adjuvant or neoadjuvant treatment
Item
prior usage of capecitabine or mitomycin as adjuvant or neoadjuvant treatment
boolean
C1514463 (UMLS CUI [1,1])
C0671970 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0002475 (UMLS CUI [2,2])
C0600558 (UMLS CUI [3])
C0677850 (UMLS CUI [4])
life expectancy
Item
life expectancy < 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status | Ambulatory Status
Item
not-ambulatory or with an ecog performance status > 1
boolean
C1520224 (UMLS CUI [1])
C1550332 (UMLS CUI [2])
Renal function | Liver function | Hematologic function
Item
insufficient hematological, renal and hepatic functions:
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0221130 (UMLS CUI [3])
hemoglobin
Item
hemoglobin < 8.0 g/dl
boolean
C0019046 (UMLS CUI [1])
anc
Item
absolute neutrophils count (anc) < 1.5 x 109/l
boolean
C0948762 (UMLS CUI [1])
platelet count
Item
platelet count < 100 x 109/l
boolean
C0032181 (UMLS CUI [1])
creatinine
Item
serum creatinine > 1.25 x n*
boolean
C0201976 (UMLS CUI [1])
bilirubin
Item
total bilirubin > 2.0 x n*
boolean
C1278039 (UMLS CUI [1])
asat, alat
Item
asat and/or alat > 2.5 x n* (in case of liver metastases > 5 x n*)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
alkaline phosphatase
Item
alkaline phosphatase > 2.5 x n* (in case of liver metastases > 5 x n*, in case of bone metastases > 10 x n*) *n = upper limit of standard range
boolean
C0201850 (UMLS CUI [1])
creatinine clearance, renal function
Item
severe renal impairment [creatinine clearance < 30 ml/min (calculated according to cockcroft and gault)]
boolean
C0373595 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])