ID

21436

Beschrijving

Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00574236

Link

https://clinicaltrials.gov/show/NCT00574236

Trefwoorden

  1. 21-04-17 21-04-17 -
Geüploaded op

21 april 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Metastatic Breast Cancer NCT00574236

Eligibility Metastatic Breast Cancer NCT00574236

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
cytologically or histologically confirmed metastatic breast cancer
Beschrijving

Metastatic breast cancer

Datatype

boolean

Alias
UMLS CUI [1]
C0278488
measurable or evaluable disease
Beschrijving

Measurable or evaluable disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
age > 18, ps 0,1,2
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
muga > 45%
Beschrijving

Ejection fraction percent muga

Datatype

boolean

Alias
UMLS CUI [1]
C0743402
received one or fewer chemotherapies or investigational regimens for metastatic disease, no limit to the number of prior hormonal therapies. may have had single agent herceptin and/or herceptin plus single-agent chemotx.
Beschrijving

Prior therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1514463
must meet designated laboratory criteria within 14 days of enrollment
Beschrijving

Laboratory test result

Datatype

boolean

Alias
UMLS CUI [1]
C2346633
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
doxorubicin for metatstatic disease.
Beschrijving

Doxorubicin

Datatype

boolean

Alias
UMLS CUI [1]
C0013089
pregnant or lactating.
Beschrijving

Gynaecological status

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
active infections, no myocardial infarction within 2 months of enrollment.
Beschrijving

Active infection, myocardial infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0027051
investigational drugs within 14 days of enrollment.
Beschrijving

Experimental drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0304229
chemotherapy, radiotherapy, hormonal therapy or other investigational therapy within 4 weeks of enrollment.
Beschrijving

Chemotherapy, radiotherapy, hormonal therapy or other investigational therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0949266
neuropathy that is > grade 2.
Beschrijving

Neuropathy grade

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C0441800
active brain mets.
Beschrijving

Brain metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
hypersensitivity to bortezomib, boron, or mannitol
Beschrijving

Hypersensitivity to bortezomib, boron, or mannitol

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1176309
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0006030
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0024730

Similar models

Eligibility Metastatic Breast Cancer NCT00574236

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Metastatic breast cancer
Item
cytologically or histologically confirmed metastatic breast cancer
boolean
C0278488 (UMLS CUI [1])
Measurable or evaluable disease
Item
measurable or evaluable disease
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Age
Item
age > 18, ps 0,1,2
boolean
C0001779 (UMLS CUI [1])
Ejection fraction percent muga
Item
muga > 45%
boolean
C0743402 (UMLS CUI [1])
Prior therapy
Item
received one or fewer chemotherapies or investigational regimens for metastatic disease, no limit to the number of prior hormonal therapies. may have had single agent herceptin and/or herceptin plus single-agent chemotx.
boolean
C1514463 (UMLS CUI [1])
Laboratory test result
Item
must meet designated laboratory criteria within 14 days of enrollment
boolean
C2346633 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Doxorubicin
Item
doxorubicin for metatstatic disease.
boolean
C0013089 (UMLS CUI [1])
Gynaecological status
Item
pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Active infection, myocardial infarction
Item
active infections, no myocardial infarction within 2 months of enrollment.
boolean
C0009450 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
Experimental drugs
Item
investigational drugs within 14 days of enrollment.
boolean
C0304229 (UMLS CUI [1])
Chemotherapy, radiotherapy, hormonal therapy or other investigational therapy
Item
chemotherapy, radiotherapy, hormonal therapy or other investigational therapy within 4 weeks of enrollment.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0949266 (UMLS CUI [4])
Neuropathy grade
Item
neuropathy that is > grade 2.
boolean
C0442874 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Brain metastases
Item
active brain mets.
boolean
C0220650 (UMLS CUI [1])
Hypersensitivity to bortezomib, boron, or mannitol
Item
hypersensitivity to bortezomib, boron, or mannitol
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0006030 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0024730 (UMLS CUI [3,2])

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