Early-Stage Breast Carcinoma HER2 Positive Invasive | Node-positive breast cancer | High risk Node-negative breast cancer | Residual Tumor Absent | Recurrent disease Locally Absent | Locally Metastatic Malignant Neoplasm Absent | Breast Carcinoma TNM Breast tumor staging | Eligibility Trastuzumab Adjuvant therapy
Item
histologically confirmed early invasive her2 positive, node positive or high risk node negative breast cancer with no evidence of residual, locally recurrent or metastatic disease and defined as clinical stage i to iiia that is eligible for adjuvant treatment with trastuzumab.
boolean
C2986665 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C0205281 (UMLS CUI [1,3])
C3160887 (UMLS CUI [2])
C4319571 (UMLS CUI [3,1])
C3160889 (UMLS CUI [3,2])
C0543478 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0277556 (UMLS CUI [5,1])
C1517927 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C1334411 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0678222 (UMLS CUI [7,1])
C0474926 (UMLS CUI [7,2])
C1548635 (UMLS CUI [8,1])
C0728747 (UMLS CUI [8,2])
C0677850 (UMLS CUI [8,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0 to 2.
boolean
C1520224 (UMLS CUI [1])
HER2 Overexpression | HER2 gene amplification | Immunohistochemistry Positive | FISH Positive
Item
her2 over-expression/amplification defined as either ihc3+, or ihc2+ and fluorescence in situ hybridization (fish) positive as determined in a central laboratory.
boolean
C0069515 (UMLS CUI [1,1])
C1514559 (UMLS CUI [1,2])
C1512127 (UMLS CUI [2])
C0021044 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C0162789 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
trastuzumab | Left ventricular ejection fraction Echocardiography
Item
at time of starting trastuzumab therapy, left ventricular ejection fraction (lvef) measured by echocardiography.
boolean
C0728747 (UMLS CUI [1])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Left ventricular ejection fraction Screening
Item
screening left ventricular ejection fraction (lvef) =/> 55%.
boolean
C0428772 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
Bone Marrow function | Renal function | Liver function
Item
adequate bone marrow, renal, and hepatic function.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Childbearing Potential Contraceptive methods | Exception Hormonal contraception
Item
agreement to use an adequate, non-hormonal means of contraception by women of childbearing potential.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C2985296 (UMLS CUI [2,2])
Medical contraindication Trastuzumab
Item
any contraindication to trastuzumab.
boolean
C1301624 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
Adjuvant therapy Breast Carcinoma | Anti-HER2 Antibody
Item
previous adjuvant breast cancer treatment with an approved or investigational anti-her2 agent.
boolean
C0677850 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C4329777 (UMLS CUI [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
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 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])
Systemic therapy Ductal carcinoma in situ | Systemic therapy Lobular Carcinoma | Radiotherapy to breast Ipsilateral | Invasive cancer
Item
past history of ductal carcinoma in situ and/or lobular carcinoma that has been treated with any systemic therapy or with radiation therapy to the ipsilateral breast where the invasive cancer subsequently develops.
boolean
C1515119 (UMLS CUI [1,1])
C0007124 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C0206692 (UMLS CUI [2,2])
C0948310 (UMLS CUI [3,1])
C0441989 (UMLS CUI [3,2])
C0677898 (UMLS CUI [4])
Locally Advanced Malignant Neoplasm TNM clinical staging | Neoplasm Metastasis TNM clinical staging
Item
locally advanced (stage iiib and iiic) and metastatic disease (stage iv).
boolean
C0677984 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Cardiovascular Disease
Item
clinically relevant cardiovascular disorder or disease.
boolean
C0007222 (UMLS CUI [1])
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 allergy | Immunologic reaction Severe | Asthma Control Difficult
Item
history of severe allergic or immunological reactions, e.g. difficult to control asthma.
boolean
C2945656 (UMLS CUI [1])
C0301873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0004096 (UMLS CUI [3,1])
C2587213 (UMLS CUI [3,2])
C0332218 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])