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Informações:
Falhas:
ID
21851
Descrição
Safety Study of Combined Immunotherapy With Trastuzumab and Cetuximab in Patients With Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00367250
Link
https://clinicaltrials.gov/show/NCT00367250
Palavras-chave
Versões (2)
- 04/05/2017 04/05/2017 -
- 20/09/2021 20/09/2021 -
Transferido a
4 de maio de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00367250
Eligibility Metastatic Breast Cancer NCT00367250
- StudyEvent: Eligibility
Similar models
Eligibility Metastatic Breast Cancer NCT00367250
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Secondary malignant neoplasm of female breast
Item
diagnosis of metastatic breast cancer
boolean
C0346993 (UMLS CUI [1])
Measurable Disease Quantity
Item
presence of at least 1 measurable lesion according to modified recist criteria
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,2])
Evidence Fluorescent in Situ Hybridization
Item
evidence (fluorescence in situ hybridization fish) of
boolean
C0332120 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,2])
HER-2 protein overexpression Tumor tissue | HER2 Positive Score
Item
her-2 overexpression in tumor tissue:group a: her-2 +++, group b: her-2 + or ++
boolean
C3888504 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C3898879 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
C0475358 (UMLS CUI [1,2])
C3898879 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
Disease Epidermal Growth Factor Receptor expression | Immunohistochemistry Assessment
Item
egfr-expressing disease as assessed by immunohistochemistry
boolean
C0012634 (UMLS CUI [1,1])
C0034802 (UMLS CUI [1,2])
C0597360 (UMLS CUI [1,3])
C0021044 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0034802 (UMLS CUI [1,2])
C0597360 (UMLS CUI [1,3])
C0021044 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
Toxicity Due to Therapeutic procedure | Patient recovered
Item
recovered from relevant toxicities from other treatment prior to study entry
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1115804 (UMLS CUI [2])
C0678226 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1115804 (UMLS CUI [2])
trastuzumab | Adjuvant therapy Secondary malignant neoplasm of female breast
Item
prior treatment with trastuzumab for metastatic breast cancer (adjuvant therapy is allowed)
boolean
C0728747 (UMLS CUI [1])
C0677850 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
C0677850 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
cetuximab
Item
prior treatment with cetuximab
boolean
C0995188 (UMLS CUI [1])
Cytotoxic Chemotherapy
Item
concomitant cytotoxic chemotherapy
boolean
C0677881 (UMLS CUI [1])
Investigational New Drugs
Item
treatment with any investigational agent(s) within 4 weeks prior to study entry
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Component Investigational Therapy
Item
known allergic/hypersensitivity reaction to any of the components of study treatments
boolean
C0020517 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0949266 (UMLS CUI [1,3])
C1705248 (UMLS CUI [1,2])
C0949266 (UMLS CUI [1,3])
Dyspnea Severe
Item
severe dyspnea
boolean
C0013404 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,2])
Myocardial Infarction | Congestive heart failure Uncontrolled | Cardiovascular Disease New York Heart Association Classification
Item
myocardial infarction within 6 months prior to study entry, uncontrolled congestive heart failure; or any current grade 3 or 4 cardio-vascular disorder despite treatment
boolean
C0027051 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0007222 (UMLS CUI [3,2])
C1275491 (UMLS CUI [3,3])
C0018802 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0007222 (UMLS CUI [3,2])
C1275491 (UMLS CUI [3,3])
nervous system disorder | Mental disorders
Item
history of significant neurologic or psychiatric disorders
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0004936 (UMLS CUI [2])