ID

20416

Description

Trial of Paclitaxel, Bevacizumab, and Enzastaurin Versus Paclitaxel, Bevacizumab and Placebo for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00536939

Link

https://clinicaltrials.gov/show/NCT00536939

Keywords

Versions (1)
  1. 2/22/17 2/22/17 -
Uploaded on

February 22, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00536939

English

Eligibility Breast Cancer NCT00536939

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have signed an inform consent document
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
have histologic or cytologic diagnosis of breast cancer with evidence of unresectable locally recurrent or metastatic disease
Description

Breast Carcinoma; histological diagnosis; Cancer diagnosis based on cytological evidence | Unresectable Malignant Neoplasm | Recurrent disease | Metastatic Neoplasm

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0679557
UMLS CUI [1,3]
C1298647
UMLS CUI [2]
C1336869
UMLS CUI [3]
C0277556
UMLS CUI [4]
C2939420
have not received any prior chemotherapy for locally recurrent or metastatic disease
Description

Prior Chemotherapy | Locally Recurrent Malignant Neoplasm | Metastatic Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C2986682
UMLS CUI [3]
C2939420
have not had adjuvant or neoadjuvant taxane therapy within 12 months prior to assignment to study treatment
Description

adjuvant or neoadjuvant taxane therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C3541958
UMLS CUI [1,2]
C0600558
UMLS CUI [1,3]
C0677850
UMLS CUI [1,4]
C1514457
age 18 years or older at time of informed consent
Description

age, informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have any clinical evidence of central nervous system (cns) metastases
Description

cns metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
have a history of seizure
Description

have a history of seizure

Data type

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0262926
have had a major surgical procedure within 4 weeks prior to assignment to study treatment
Description

surgical procedure

Data type

boolean

Alias
UMLS CUI [1]
C0543467
have had a minor surgical procedure, placement of an access device, or fine needle aspiration within 7 days prior to assignment to study treatment
Description

Minor Surgical Procedures | Vascular Access Device Placement | Fine needle aspiration biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0038904
UMLS CUI [2]
C1519955
UMLS CUI [3]
C1510483
have symptomatic peripheral vascular disease
Description

symptomatic peripheral vascular disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0085096
UMLS CUI [1,2]
C0231220
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Similar models

Eligibility Breast Cancer NCT00536939

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
must have signed an inform consent document
boolean
C0021430 (UMLS CUI [1])
Breast Carcinoma; histological diagnosis; Cancer diagnosis based on cytological evidence | Unresectable Malignant Neoplasm | Recurrent disease | Metastatic Neoplasm
Item
have histologic or cytologic diagnosis of breast cancer with evidence of unresectable locally recurrent or metastatic disease
boolean
C0678222 (UMLS CUI [1,1])
C0679557 (UMLS CUI [1,2])
C1298647 (UMLS CUI [1,3])
C1336869 (UMLS CUI [2])
C0277556 (UMLS CUI [3])
C2939420 (UMLS CUI [4])
Prior Chemotherapy | Locally Recurrent Malignant Neoplasm | Metastatic Neoplasm
Item
have not received any prior chemotherapy for locally recurrent or metastatic disease
boolean
C1514457 (UMLS CUI [1])
C2986682 (UMLS CUI [2])
C2939420 (UMLS CUI [3])
adjuvant or neoadjuvant taxane therapy
Item
have not had adjuvant or neoadjuvant taxane therapy within 12 months prior to assignment to study treatment
boolean
C3541958 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0677850 (UMLS CUI [1,3])
C1514457 (UMLS CUI [1,4])
age, informed consent
Item
age 18 years or older at time of informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
cns metastases
Item
have any clinical evidence of central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1])
have a history of seizure
Item
have a history of seizure
boolean
C0036572 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
surgical procedure
Item
have had a major surgical procedure within 4 weeks prior to assignment to study treatment
boolean
C0543467 (UMLS CUI [1])
Minor Surgical Procedures | Vascular Access Device Placement | Fine needle aspiration biopsy
Item
have had a minor surgical procedure, placement of an access device, or fine needle aspiration within 7 days prior to assignment to study treatment
boolean
C0038904 (UMLS CUI [1])
C1519955 (UMLS CUI [2])
C1510483 (UMLS CUI [3])
symptomatic peripheral vascular disease
Item
have symptomatic peripheral vascular disease
boolean
C0085096 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
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