ID

21436

Description

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

Keywords

Versions (1)
  1. 4/21/17 4/21/17 -
Uploaded on

April 21, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00574236

English

Eligibility Metastatic Breast Cancer NCT00574236

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Metastatic breast cancer

Data type

boolean

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

Measurable or evaluable disease

Data type

boolean

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

Age

Data type

boolean

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

Ejection fraction percent muga

Data type

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.
Description

Prior therapy

Data type

boolean

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

Laboratory test result

Data type

boolean

Alias
UMLS CUI [1]
C2346633
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
doxorubicin for metatstatic disease.
Description

Doxorubicin

Data type

boolean

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

Gynaecological status

Data type

boolean

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

Active infection, myocardial infarction

Data type

boolean

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

Experimental drugs

Data type

boolean

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

Chemotherapy, radiotherapy, hormonal therapy or other investigational therapy

Data type

boolean

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

Neuropathy grade

Data type

boolean

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

Brain metastases

Data type

boolean

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

Hypersensitivity to bortezomib, boron, or mannitol

Data type

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
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Similar models

Eligibility Metastatic Breast Cancer NCT00574236

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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