ID

26634

Beschrijving

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

Trefwoorden

Versies (2)
  1. 19-10-17 19-10-17 -
  2. 22-10-17 22-10-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

22 oktober 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Breast Cancer NCT00780000

Engels

Eligibility Breast Cancer NCT00780000

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Karnofsky Performance Status

Datatype

boolean

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

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

Datatype

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
Beschrijving

Cytotoxic Chemotherapy Quantity Neoplasm Metastasis

Datatype

boolean

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

Measurable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

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

Datatype

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
Beschrijving

Chemotherapy | Biological treatment | Immunotherapy | Investigational New Drugs

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Dryness of eye Severe Moderately

Datatype

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
Beschrijving

Congestive heart failure | Left ventricular ejection fraction

Datatype

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
Beschrijving

Myocardial Infarction | Myocardial Ischemia

Datatype

boolean

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

Malignant Neoplasms | Exception Recurrent disease Free of

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0277556
UMLS CUI [2,3]
C0332296
Terug naar het begin van de pagina

Similar models

Eligibility Breast Cancer NCT00780000

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial