Secondary malignant neoplasm of female breast | Breast cancer recurrent Locally Inoperable
Item
subject with diagnosis of metastatic (or locally recurrent-inoperable) breast cancer
boolean
C0346993 (UMLS CUI [1])
C0278493 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
C0205187 (UMLS CUI [2,3])
HER2 Positive FISH | HER2 gene amplification Score
Item
subject with histological her2+ status as determined by fish with a gene amplification score of ≥ 2.2
boolean
C2348909 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
C1512127 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
Availability of Biopsy tissue Primary tumor | Availability of Biopsy tissue Metastatic Lesion
Item
subject with availability of archival biopsy tissue from primary tumor or metastatic lesions
boolean
C0470187 (UMLS CUI [1,1])
C3864006 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,3])
C0470187 (UMLS CUI [2,1])
C3864006 (UMLS CUI [2,2])
C1513183 (UMLS CUI [2,3])
Measurable Disease
Item
subject with presence of measurable disease based on recist 1.1
boolean
C1513041 (UMLS CUI [1])
HER2 Targeted Therapy Quantity Advanced breast cancer
Item
subject who has received no more than three prior her2-directed therapeutic regimens for advanced breast cancer
boolean
C0069515 (UMLS CUI [1,1])
C2985566 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3495917 (UMLS CUI [1,4])
Left ventricular ejection fraction decreased
Item
subject with left ventricular ejection fraction (lvef) below institutional normal range
boolean
C1096403 (UMLS CUI [1])
CNS metastases | Exception CNS metastases Asymptomatic Stable
Item
subject with metastasis to the central nervous system unless asymptomatic and clinically stable
boolean
C0686377 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0686377 (UMLS CUI [2,2])
C0231221 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
Malignant Neoplasms | Exception Breast Carcinoma
Item
subject with current active malignancy other than breast cancer
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Cancer Other | Exception Malignant Neoplasm Disease Free
Item
subject with prior history of other malignancy except for cancers from which the patient is currently disease free
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0012634 (UMLS CUI [2,3])
C0332296 (UMLS CUI [2,4])
Renal dysfunction | Liver Dysfunction
Item
subject with significant renal or hepatic dysfunction
boolean
C3279454 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
Venous Thrombosis | Arterial thrombosis | Risk factor Thrombosis | Exception Malignant Neoplasms
Item
subject with history of venous or arterial thrombosis or risk factor for thrombosis other than history of malignancy
boolean
C0042487 (UMLS CUI [1])
C0151942 (UMLS CUI [2])
C0035648 (UMLS CUI [3,1])
C0040053 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
Bone Marrow function Insufficient
Item
subject with insufficient bone marrow function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0231180 (UMLS CUI [1,3])
Medical contraindication Vinorelbine | Medical contraindication Trastuzumab | Medical contraindication Aspirin therapy | Medical contraindication Warfarin therapy
Item
subject with contraindication to vinorelbine, trastuzumab, aspirin and/or warfarin therapy.
boolean
C1301624 (UMLS CUI [1,1])
C0078257 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0728747 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C4303556 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C4303340 (UMLS CUI [4,2])
Bacterial Infections | Hepatitis B | Hepatitis C | HIV Infections
Item
subject with current active bacterial, hepatitis b or c, and/or hiv infections
boolean
C0004623 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0019693 (UMLS CUI [4])