ID

21851

Description

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

Keywords

Versions (2)
  1. 5/4/17 5/4/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

May 4, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00367250

English

Eligibility Metastatic Breast Cancer NCT00367250

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of metastatic breast cancer
Description

Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C0346993
presence of at least 1 measurable lesion according to modified recist criteria
Description

Measurable Disease Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
evidence (fluorescence in situ hybridization fish) of
Description

Evidence Fluorescent in Situ Hybridization

Data type

boolean

Alias
UMLS CUI [1,1]
C0332120
UMLS CUI [1,2]
C0162789
her-2 overexpression in tumor tissue:group a: her-2 +++, group b: her-2 + or ++
Description

HER-2 protein overexpression Tumor tissue | HER2 Positive Score

Data type

boolean

Alias
UMLS CUI [1,1]
C3888504
UMLS CUI [1,2]
C0475358
UMLS CUI [2,1]
C3898879
UMLS CUI [2,2]
C0449820
egfr-expressing disease as assessed by immunohistochemistry
Description

Disease Epidermal Growth Factor Receptor expression | Immunohistochemistry Assessment

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0034802
UMLS CUI [1,3]
C0597360
UMLS CUI [2,1]
C0021044
UMLS CUI [2,2]
C1516048
recovered from relevant toxicities from other treatment prior to study entry
Description

Toxicity Due to Therapeutic procedure | Patient recovered

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0087111
UMLS CUI [2]
C1115804
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with trastuzumab for metastatic breast cancer (adjuvant therapy is allowed)
Description

trastuzumab | Adjuvant therapy Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C0728747
UMLS CUI [2,1]
C0677850
UMLS CUI [2,2]
C0346993
prior treatment with cetuximab
Description

cetuximab

Data type

boolean

Alias
UMLS CUI [1]
C0995188
concomitant cytotoxic chemotherapy
Description

Cytotoxic Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0677881
treatment with any investigational agent(s) within 4 weeks prior to study entry
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
known allergic/hypersensitivity reaction to any of the components of study treatments
Description

Hypersensitivity Component Investigational Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C0949266
severe dyspnea
Description

Dyspnea Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0013404
UMLS CUI [1,2]
C0205082
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
Description

Myocardial Infarction | Congestive heart failure Uncontrolled | Cardiovascular Disease New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0007222
UMLS CUI [3,3]
C1275491
history of significant neurologic or psychiatric disorders
Description

nervous system disorder | Mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
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Similar models

Eligibility Metastatic Breast Cancer NCT00367250

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Evidence Fluorescent in Situ Hybridization
Item
evidence (fluorescence in situ hybridization fish) of
boolean
C0332120 (UMLS CUI [1,1])
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
Dyspnea Severe
Item
severe dyspnea
boolean
C0013404 (UMLS CUI [1,1])
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])
nervous system disorder | Mental disorders
Item
history of significant neurologic or psychiatric disorders
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
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