Breast adenocarcinoma metastatic TNM Breast tumor staging
Item
metastatic adenocarcinoma of the breast (stage iv)
boolean
C1697918 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Hormone Therapy | HER2 Targeted Therapy | HER2 Targeted Therapy Absent
Item
actively receiving endocrine therapy for at least 6 weeks (with or without her2 therapy)
boolean
C0279025 (UMLS CUI [1])
C0069515 (UMLS CUI [2,1])
C2985566 (UMLS CUI [2,2])
C0069515 (UMLS CUI [3,1])
C2985566 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Age
Item
minimum age 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
normal organ and marrow function as defined in the protocol
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Investigational New Drugs Other
Item
participants may not be receiving any other study agents
boolean
C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Chemotherapy | Exclusion of Hormone Therapy | Exclusion of HER2 Targeted Therapy
Item
actively receiving chemotherapy (exclusive of hormonal or her2 therapy ) within last 5 weeks
boolean
C0392920 (UMLS CUI [1])
C2828389 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
C2828389 (UMLS CUI [3,1])
C0069515 (UMLS CUI [3,2])
C2985566 (UMLS CUI [3,3])
Statin therapy
Item
any statin therapy within the last 3 weeks
boolean
C1278454 (UMLS CUI [1])
Asians | Filipino | Chinese | Japanese | Korean | Vietnamese | Asian Indian
Item
asian decent (including filipino, chinese, japanese, korean, vietnamese or asian-indian origin)
boolean
C0078988 (UMLS CUI [1])
C1556093 (UMLS CUI [2])
C0152035 (UMLS CUI [3])
C1556094 (UMLS CUI [4])
C1556095 (UMLS CUI [5])
C1561452 (UMLS CUI [6])
C1524069 (UMLS CUI [7])
Cyclosporine | Fibrates | Niacin | Gemfibrozil | Ketoconazole | Spironolactone | Cimetidine | Warfarin | Erythromycin | Protease Inhibitors
Item
concomitant use of the following drugs: cyclosporine, fibrates, niacin, gemfibrozil, ketaconazole, spironolactone, cimetidine, warfarin, erythromycin, or protease inhibitors
boolean
C0010592 (UMLS CUI [1])
C1449704 (UMLS CUI [2])
C0027996 (UMLS CUI [3])
C0017245 (UMLS CUI [4])
C0022625 (UMLS CUI [5])
C0037982 (UMLS CUI [6])
C0008783 (UMLS CUI [7])
C0043031 (UMLS CUI [8])
C0014806 (UMLS CUI [9])
C0033607 (UMLS CUI [10])
Condition predisposed Kidney Failure | Kidney Failure Secondary to Rhabdomyolysis
Item
conditions predisposing to renal failure secondary to rhabdomyolysis
boolean
C0348080 (UMLS CUI [1,1])
C0231203 (UMLS CUI [1,2])
C0035078 (UMLS CUI [1,3])
C0035078 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0035410 (UMLS CUI [2,3])
Heavy alcohol use
Item
recent history of heavy alcohol use as judged by the treating physician
boolean
C0687132 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
known to be pregnant (testing not required) or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Rhabdomyolysis | Statin therapy
Item
history of rhabdomyolysis on statin therapy
boolean
C0035410 (UMLS CUI [1])
C1278454 (UMLS CUI [2])
Hepatitis C | Hepatitis B
Item
known history of hepatitis c or active hepatitis b infection (baseline testing not required)
boolean
C0019196 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
Comorbidity Uncontrolled | Communicable Disease | Hepatitis | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
uncontrolled intercurrent illness including, but not limited to ongoing or active infection, hepatitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0019158 (UMLS CUI [3])
C0742758 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0003811 (UMLS CUI [6])
C0004936 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
C0748872 (UMLS CUI [8,1])
C0439801 (UMLS CUI [8,2])
C0525058 (UMLS CUI [8,3])