ID

26576

Description

Clinical Trial of Intravenous Alvespimycin in Patients With Her2 Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00780000

Link

https://clinicaltrials.gov/show/NCT00780000

Keywords

Versions (2)
  1. 10/19/17 10/19/17 -
  2. 10/22/17 10/22/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 19, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Breast Cancer NCT00780000

English

Eligibility Breast Cancer NCT00780000

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
kps performance status of >= 80% ("normal activity with effort")
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
metastatic breast cancer with her2 amplification by fish or 3+ her2 overexpression by immunohistochemistry ("ihc")
Description

Secondary malignant neoplasm of female breast | HER2 gene amplification FISH | HER2 Overexpression Immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1]
C0346993
UMLS CUI [2,1]
C1512127
UMLS CUI [2,2]
C0162789
UMLS CUI [3,1]
C0069515
UMLS CUI [3,2]
C1514559
UMLS CUI [3,3]
C0021044
must have received no more than one prior cytotoxic chemotherapy regimen in the metastatic setting
Description

Cytotoxic Chemotherapy Quantity Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
measurable disease by recist criteria
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
received prior lapatinib, an investigational erbb-2 and/or an investigational egfr dual tyrosine kinase inhibitors
Description

Lapatinib | erbB-2 inhibitors investigational | EGFR tyrosine kinase inhibitor Investigational

Data type

boolean

Alias
UMLS CUI [1]
C1506770
UMLS CUI [2,1]
C0069515
UMLS CUI [2,2]
C0243077
UMLS CUI [2,3]
C1517586
UMLS CUI [3,1]
C1443775
UMLS CUI [3,2]
C1517586
administration of any other chemotherapy, biological, immunotherapy or investigational agent within 14 days prior to receipt of study medication
Description

Chemotherapy | Biological treatment | Immunotherapy | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1531518
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0013230
pregnant or breast-feeding women. known cns metastases, unless treated and without clinically significant neurological deficits
Description

Pregnancy | Breast Feeding | CNS metastases | Exception CNS metastases Treated | Exception Neurologic Deficits Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0686377
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0686377
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0521654
UMLS CUI [5,3]
C0332197
moderately severe dry eye
Description

Dryness of eye Severe Moderately

Data type

boolean

Alias
UMLS CUI [1,1]
C0314719
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205081
congestive heart failure, or a left ventricular ejection fraction
Description

Congestive heart failure | Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0428772
myocardial infarction or active ischemic heart disease within 12 months prior to study drug administration
Description

Myocardial Infarction | Myocardial Ischemia

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0151744
previous malignancies unless free of recurrence for at least 5 years
Description

Malignant Neoplasms | Exception Recurrent disease Free of

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0277556
UMLS CUI [2,3]
C0332296
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Similar models

Eligibility Breast Cancer NCT00780000

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Karnofsky Performance Status
Item
kps performance status of >= 80% ("normal activity with effort")
boolean
C0206065 (UMLS CUI [1])
Secondary malignant neoplasm of female breast | HER2 gene amplification FISH | HER2 Overexpression Immunohistochemistry
Item
metastatic breast cancer with her2 amplification by fish or 3+ her2 overexpression by immunohistochemistry ("ihc")
boolean
C0346993 (UMLS CUI [1])
C1512127 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
C0069515 (UMLS CUI [3,1])
C1514559 (UMLS CUI [3,2])
C0021044 (UMLS CUI [3,3])
Cytotoxic Chemotherapy Quantity Neoplasm Metastasis
Item
must have received no more than one prior cytotoxic chemotherapy regimen in the metastatic setting
boolean
C0677881 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Measurable Disease
Item
measurable disease by recist criteria
boolean
C1513041 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Lapatinib | erbB-2 inhibitors investigational | EGFR tyrosine kinase inhibitor Investigational
Item
received prior lapatinib, an investigational erbb-2 and/or an investigational egfr dual tyrosine kinase inhibitors
boolean
C1506770 (UMLS CUI [1])
C0069515 (UMLS CUI [2,1])
C0243077 (UMLS CUI [2,2])
C1517586 (UMLS CUI [2,3])
C1443775 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
Chemotherapy | Biological treatment | Immunotherapy | Investigational New Drugs
Item
administration of any other chemotherapy, biological, immunotherapy or investigational agent within 14 days prior to receipt of study medication
boolean
C0392920 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
Pregnancy | Breast Feeding | CNS metastases | Exception CNS metastases Treated | Exception Neurologic Deficits Absent
Item
pregnant or breast-feeding women. known cns metastases, unless treated and without clinically significant neurological deficits
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0686377 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0686377 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0521654 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Dryness of eye Severe Moderately
Item
moderately severe dry eye
boolean
C0314719 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205081 (UMLS CUI [1,3])
Congestive heart failure | Left ventricular ejection fraction
Item
congestive heart failure, or a left ventricular ejection fraction
boolean
C0018802 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Myocardial Infarction | Myocardial Ischemia
Item
myocardial infarction or active ischemic heart disease within 12 months prior to study drug administration
boolean
C0027051 (UMLS CUI [1])
C0151744 (UMLS CUI [2])
Malignant Neoplasms | Exception Recurrent disease Free of
Item
previous malignancies unless free of recurrence for at least 5 years
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0277556 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
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