Infiltrating carcinoma of breast Without Neoplasm Metastasis
Item
1. confirmed non-metastatic infiltrating carcinoma of the breast.
boolean
C0853879 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
HER2 gene amplification FISH Positive
Item
2. her-2 amplified (fish +) determination in 2004 or thereafter.
boolean
C1512127 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
ECOG performance status
Item
3. ecog performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
Age
Item
4. patients 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
HER2/Neu Status FISH test
Item
5. her-2 status is determined by fish test.
boolean
C1512413 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
Criteria Trastuzumab Group
Item
6. the following criteria are applicable to the trastuzumab treatment group:
boolean
C0243161 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
C0441833 (UMLS CUI [1,3])
LVEF Normal Echocardiography | LVEF Normal MUGA | Baseline LVEF
Item
normal lvef as determined by echo or muga. if baseline lvef > 75%, then lvef shall be repeated to determine if falsely elevated.
boolean
C0428772 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,3])
C0428772 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0521317 (UMLS CUI [2,3])
C1442488 (UMLS CUI [3,1])
C0428772 (UMLS CUI [3,2])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
adequate bone marrow function as indicated by the following: anc >1500/ml, platelets >/=100,000/ml, hemoglobin >9 g/dl
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Renal function | Creatinine measurement, serum
Item
adequate renal function,as indicated by serum creatinine </= 1.5 x uln
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver function | Serum total bilirubin measurement
Item
adequate liver function, as indicated by total bilirubin </= 1.5 x uln
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Exception Relationship Primary disease
Item
ast and alt < 2 x uln unless related to primary disease.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0277554 (UMLS CUI [3,3])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods
Item
if female of childbearing potential, pregnancy test (blood or urine) is negative and she agrees to use effective birth control method for the duration of the study.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Informed Consent
Item
7. signed informed consent has been obtained.
boolean
C0021430 (UMLS CUI [1])
Infiltrating carcinoma of breast | FISH HER2/Neu Positive Lacking
Item
1. non-confirmed her-2 positive by fish infiltrating carcinoma of the breast.
boolean
C0853879 (UMLS CUI [1])
C0162789 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Neoplasm Metastasis
Item
2. evidence of metastatic disease.
boolean
C0027627 (UMLS CUI [1])
Trastuzumab
Item
3. previous trastuzumab treatment.
boolean
C0728747 (UMLS CUI [1])
Cancer treatment | Exception Hormonal Agents | Exception Tamoxifen | Exception Aromatase Inhibitors | Therapeutic radiology procedure
Item
4. concurrent anticancer treatment other than hormonal agents (tamoxifen, aromatase inhibitors) or radiotherapy.
boolean
C0920425 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0282559 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0039286 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0593802 (UMLS CUI [4,2])
C1522449 (UMLS CUI [5])
Heart Disease | Cardiomyopathy | Congestive heart failure | Myocardial Infarction | Cardiac Arrhythmia
Item
5. patient with history of or active cardiac disease, including cardiomyopathy, congestive heart failure, prior myocardial infarction, or arrhythmia.
boolean
C0018799 (UMLS CUI [1])
C0878544 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
Lung disease Intrinsic Symptomatic | Resting Dyspnea
Item
6. symptomatic intrinsic lung disease resulting in dyspnea at rest.
boolean
C0024115 (UMLS CUI [1,1])
C0205102 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
C0743330 (UMLS CUI [2])
Disease Life Limiting | Life Expectancy
Item
7. concurrent life-limiting disease with a life expectancy of less than one year.
boolean
C0012634 (UMLS CUI [1,1])
C0376558 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0023671 (UMLS CUI [2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking
Item
8. pregnancy, nursing women, and fertile women who do not practice birth control.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
Informed Consent Unable
Item
9. inability to give informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])