Eligibility Breast Cancer NCT00427427

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StudyEvent: Eligibility
1. Eligibility Breast Cancer NCT00427427

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

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])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

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])

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Eligibility Breast Cancer NCT00427427