Breast adenocarcinoma metastatic Estrogen receptor positive | Breast adenocarcinoma metastatic Progesterone receptor positive
Item
histologically confirmed metastatic adenocarcinoma of the breast (seetnm staging appendix i) that is er and/or pr positive as determined in local laboratories at each investigator site (central verification of er status will be performed after the patient starts treatment
boolean
C1697918 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C1697918 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
Core sample of tissue block Metastatic Neoplasm | Core sample of tissue block primary tumor
Item
a tissue block from either the metastatic or primary tumor site is required.
boolean
C2316369 (UMLS CUI [1,1])
C2939420 (UMLS CUI [1,2])
C2316369 (UMLS CUI [2,1])
C0677930 (UMLS CUI [2,2])
WHO performance status scale
Item
who performance status (ps) 0-2
boolean
C1298650 (UMLS CUI [1])
Pregnancy | Breast Feeding | Premenopausal state Pregnancy test negative | Perimenopausal state Pregnancy test negative | Postmenopausal state
Item
patients must not be pregnant or breast-feeding. a negative pregnancy test is required within 7 days prior to randomization if pre- or peri-menopausal. postmenopausal patients are defined as:
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0232969 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C3839366 (UMLS CUI [4,1])
C0427780 (UMLS CUI [4,2])
C0232970 (UMLS CUI [5])
Natural menopause | Date of last menstrual period
Item
natural menopause with last menses > 1 year ago,
boolean
C0856856 (UMLS CUI [1])
C0425932 (UMLS CUI [2])
Radiation Induced Ovariectomy | Date of last menstrual period
Item
radiation induced oophorectomy with last menses > 1 year ago,
boolean
C1522449 (UMLS CUI [1,1])
C0205263 (UMLS CUI [1,2])
C0029936 (UMLS CUI [1,3])
C0425932 (UMLS CUI [2])
Chemotherapy Induced Menopause | Interval Since Date of last menstrual
Item
chemotherapy induced menopause with 1 year interval since last menses, or
boolean
C0392920 (UMLS CUI [1,1])
C0205263 (UMLS CUI [1,2])
C0025320 (UMLS CUI [1,3])
C1272706 (UMLS CUI [2,1])
C1711239 (UMLS CUI [2,2])
C0425932 (UMLS CUI [2,3])
Serum follicle stimulating hormone measurement Postmenopause | Serum LH measurement Postmenopause | Plasma estradiol measurement Postmenopause
Item
serum fsh and lh and plasma estradiol levels in the postmenopausal range for the institution.
boolean
C0455276 (UMLS CUI [1,1])
C0206159 (UMLS CUI [1,2])
C1304771 (UMLS CUI [2,1])
C0206159 (UMLS CUI [2,2])
C1277973 (UMLS CUI [3,1])
C0206159 (UMLS CUI [3,2])
Bilateral oophorectomy
Item
bilateral oophorectomy
boolean
C0278321 (UMLS CUI [1])
Hormone replacement therapy | Prior Chemotherapy Metastatic Neoplasm
Item
patients cannot be on hormone replacement therapy or received prior chemotherapy for metastatic disease.
boolean
C0282402 (UMLS CUI [1])
C1514457 (UMLS CUI [2,1])
C2939420 (UMLS CUI [2,2])
Protein-tyrosine kinase inhibitor | Interstitial Lung Disease Evidence of
Item
patients previously treated with a tyrosine kinase inhibitor or have evidence of an active interstitial lung disease are not eligible.
boolean
C1268567 (UMLS CUI [1])
C0206062 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
Luteinizing Hormone-releasing Hormone Agonist
Item
treatment with lh-rh analog.
boolean
C1518041 (UMLS CUI [1])
Laboratory Results | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver
Item
laboratory values as follow bilirubin >1.5 times upper limit of normal uln, alanine amino transferase (alt) or aspartate amino transferase (ast) >2.5 times the uln if no demonstrable liver metastases, or >5 times the uln in the presence of liver metastases
boolean
C1254595 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0494165 (UMLS CUI [5])
Bone Marrow function | White Blood Cell Count procedure
Item
bone marrow function: wbc <1500 mm3
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0023508 (UMLS CUI [2])