Gender | Breast Carcinoma TNM Breast tumor staging
Item
female or male patient diagnosed with stage i-iv breast cancer
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0474926 (UMLS CUI [2,2])
HER2-positive carcinoma of breast | Specimen from breast HER2 protein Immunohistochemistry | Specimen from breast HER2 gene amplification Fluorescent in Situ Hybridization | Metastatic cancer site Biopsy
Item
her2 positive breast cancer, defined by immunohistochemical staining for her2 protein of 3+ intensity and/or amplification of the her2 gene on fluorescence in situ hybridization (fish) ≥ 2.0 on breast specimen or biopsy of a metastatic site
boolean
C1960398 (UMLS CUI [1])
C0586519 (UMLS CUI [2,1])
C1702024 (UMLS CUI [2,2])
C0021044 (UMLS CUI [2,3])
C0586519 (UMLS CUI [3,1])
C1512127 (UMLS CUI [3,2])
C0162789 (UMLS CUI [3,3])
C0280457 (UMLS CUI [4,1])
C0005558 (UMLS CUI [4,2])
Left ventricular ejection fraction Echocardiography
Item
lvef < 50% and ≥ 40% documented in echocardiogram done within the last 30 days
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Therapy naive HER2 gene | Targeted Therapy HER2 gene | Exception Lapatinib
Item
her2 therapy naïve or currently receiving non-lapatinib her2 targeted therapy
boolean
C0919936 (UMLS CUI [1,1])
C0242957 (UMLS CUI [1,2])
C2985566 (UMLS CUI [2,1])
C0242957 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1506770 (UMLS CUI [3,2])
trastuzumab | Trastuzumab Planned | Pertuzumab/Trastuzumab Regimen | Pertuzumab/Trastuzumab Regimen Planned | Ado-trastuzumab emtansine | Ado-trastuzumab emtansine Planned | Combined Modality Therapy | Systemic therapy | Therapeutic radiology procedure
Item
patient receiving or planning to receive trastuzumab, trastuzumab with pertuzumab or ado-trastuzumab emtansine, for at least 3 months, alone or in combination with other systemic treatment or radiation
boolean
C0728747 (UMLS CUI [1])
C0728747 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C4527348 (UMLS CUI [3])
C4527348 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C2935436 (UMLS CUI [5])
C2935436 (UMLS CUI [6,1])
C1301732 (UMLS CUI [6,2])
C0009429 (UMLS CUI [7])
C1515119 (UMLS CUI [8])
C1522449 (UMLS CUI [9])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance
Item
patient is willing and able to comply with protocol required assessments and procedures
boolean
C0525058 (UMLS CUI [1])
Hospitalization Due to Heart Failure Previous
Item
previous hospitalization due to documented heart failure in the last 12 months
boolean
C3898876 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Sign or Symptom Heart failure | Sign or Symptom Ischemia
Item
current signs or symptoms of heart failure or ischemia
boolean
C3540840 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C3540840 (UMLS CUI [2,1])
C0022116 (UMLS CUI [2,2])
Cardiac Arrhythmia Requirement Pharmacotherapy | Cardiac Arrhythmia Requirement Electric Countershock
Item
history of arrhythmia requiring pharmacological or electrical treatment
boolean
C0003811 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
C0003811 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0013778 (UMLS CUI [2,3])
Anthracyclines
Item
concomitant use of anthracyclines or use of anthracyclines in the last 50 days
boolean
C0282564 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative
Item
pregnant or lactating patients. patients of childbearing potential must implement contraceptive measures during study treatment and for 7 months after last dose of treatment drug and must have negative urine or serum pregnancy test within 7 days prior to registration.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0430057 (UMLS CUI [4,2])
C3831118 (UMLS CUI [5,1])
C0430061 (UMLS CUI [5,2])
Nervous system disorder Preventing Informed Consent | Mental disorders Preventing Informed Consent | Psychotic Disorders | Dementia
Item
history of significant neurologic or psychiatric disorders including psychotic disorders or dementia that would prohibit the understanding and giving of informed consent.
boolean
C0027765 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0033975 (UMLS CUI [3])
C0497327 (UMLS CUI [4])