Adult | Age
Item
adult male or female patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Invasive carcinoma of breast HER2 Positive Early | Residual disease Absent | Recurrent disease Locally Absent | Neoplasm Metastasis Absent | Disease TNM Breast tumor staging | Eligibility Trastuzumab Adjuvant therapy
Item
histologically confirmed early invasive her2-positive carcinoma of the breast with no evidence of residual, locally recurrent or metastatic disease and defined as clinical stage i to iiic that is eligible for adjuvant treatment with trastuzumab
boolean
C0853879 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C1279919 (UMLS CUI [1,3])
C0543478 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0277556 (UMLS CUI [3,1])
C1517927 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0027627 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0012634 (UMLS CUI [5,1])
C0474926 (UMLS CUI [5,2])
C1548635 (UMLS CUI [6,1])
C0728747 (UMLS CUI [6,2])
C0677850 (UMLS CUI [6,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction
Item
screening left ventricular ejection fraction (lvef) >/= 55%
boolean
C0428772 (UMLS CUI [1])
Neoadjuvant Therapy Breast Carcinoma | Adjuvant therapy Breast Carcinoma | HER2 Receptor Antagonist | HER2 Receptor Antagonist Investigational
Item
previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-her2 agent
boolean
C0600558 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0677850 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C2267079 (UMLS CUI [3])
C2267079 (UMLS CUI [4,1])
C1517586 (UMLS CUI [4,2])
Cancer Other | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Cancer Other | Exception Disease Free Duration | Exception Breast Carcinoma
Item
history of other malignancy, except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma and patients with other curatively treated malignancies, other than breast cancer, who have been disease-free for at least 5 years
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0851140 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0007117 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C1707251 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0678222 (UMLS CUI [6,2])
DCIS | Systemic therapy | Radiotherapy to breast Ipsilateral | Invasive cancer Progressing
Item
past history of ductal carcinoma in situ that has been treated with any systemic therapy or with radiation therapy to the ipsilateral breast where the invasive cancer subsequently develops
boolean
C0007124 (UMLS CUI [1])
C1515119 (UMLS CUI [2])
C0948310 (UMLS CUI [3,1])
C0441989 (UMLS CUI [3,2])
C0677898 (UMLS CUI [4,1])
C0205329 (UMLS CUI [4,2])
Neoplasm Metastasis
Item
metastatic disease
boolean
C0027627 (UMLS CUI [1])
Bone Marrow function Inadequate | Liver function Inadequate | Renal function Inadequate
Item
inadequate bone marrow, hepatic or renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0232741 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0232804 (UMLS CUI [3,1])
C0205412 (UMLS CUI [3,2])
Heart Disease Serious | Cardiovascular Disease Serious
Item
serious cardiac or cardiovascular disease
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Uncontrolled hypertension | Hypertensive crisis | Hypertensive Encephalopathy
Item
uncontrolled hypertension, or history of hypertensive crisis or hypertensive encephalopathy
boolean
C1868885 (UMLS CUI [1])
C0020546 (UMLS CUI [2])
C0151620 (UMLS CUI [3])
Severe allergic reaction | Immunologic reaction Severe | Difficulty with Asthma Control
Item
history of severe allergic or immunological reactions, e.g. difficult to control asthma
boolean
C2220378 (UMLS CUI [1])
C0301873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332218 (UMLS CUI [3,1])
C0004096 (UMLS CUI [3,2])
C2587213 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])