ID

13388

Description

Navelbine, Taxol, Herceptin and Neupogen in Stage IV Breast Cancer: A Phase I - II Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00041470

Link

https://clinicaltrials.gov/show/NCT00041470

Keywords

Versions (1)
  1. 2/10/16 2/10/16 -
Uploaded on

February 10, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00041470

English

Eligibility Breast Cancer NCT00041470

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Have stage iv carcinoma of the breast that has been microscopically confirmed
Description

breast carcinoma stage IV

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C0278488
Be age > 18
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Be fully active or ambulatory with symptoms but able to do light work
Description

fully active

Data type

boolean

Alias
UMLS CUI [1]
C1828078
Have a life expectancy of > 16 weeks
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Be > 2 weeks from prior surgery; > 3 weeks from radiation therapy to the pelvis, spine or long bones; > 3 weeks from prior chemotherapy (> 6 weeks for mitomycin c or nitrosureas) and > 2 weeks from prior hormonal therapy
Description

prior cancer theraypy

Data type

boolean

Alias
UMLS CUI [1,1]
C1272706
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0332152
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0279025
Have had one or less prior regimens for metastatic disease
Description

prior regimens for metastatic disease

Data type

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2]
C0392920
Have measurable (bidimensionally) or evaluable disease that is in an area that has not been radiated
Description

evaluable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Have rapidly progressing liver or lung metastases or uncontrolled central nervous system metastases
Description

uncontrolled metastases

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0023884
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0024109
UMLS CUI [3,1]
C0279130
UMLS CUI [3,2]
C0205318
Are medically unstable
Description

medically unstable

Data type

boolean

Alias
UMLS CUI [1]
C0443343
Are pregnant, nursing or unwilling to employ adequate contraception
Description

pregnancy and contraceptive use

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C1999124
Have pre-existing clinically significant peripheral neuropathy except for abnormalities due to cancer
Description

peripheral neuropathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C2985739
Have psychological, familial, sociological or geographical conditions that do not permit weekly medical follow-up and compliance with the study protocol
Description

compliance factors

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [2,1]
C0814423
UMLS CUI [2,2]
C1522577
Have hypersensitivity to e. coli-derived proteins, filgrastim, or any of its components
Description

hypersensitivity to ecoli-derived proteins

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0033684
UMLS CUI [1,3]
C1441547
UMLS CUI [1,4]
C0014834
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0210630
Have had prior therapy with navelbine
Description

prior therapy with navelbine

Data type

boolean

Alias
UMLS CUI [1]
C0131965
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Similar models

Eligibility Breast Cancer NCT00041470

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
breast carcinoma stage IV
Item
Have stage iv carcinoma of the breast that has been microscopically confirmed
boolean
C0027651 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0278488 (UMLS CUI [1,3])
age
Item
Be age > 18
boolean
C0001779 (UMLS CUI [1])
fully active
Item
Be fully active or ambulatory with symptoms but able to do light work
boolean
C1828078 (UMLS CUI [1])
life expectancy
Item
Have a life expectancy of > 16 weeks
boolean
C0023671 (UMLS CUI [1])
prior cancer theraypy
Item
Be > 2 weeks from prior surgery; > 3 weeks from radiation therapy to the pelvis, spine or long bones; > 3 weeks from prior chemotherapy (> 6 weeks for mitomycin c or nitrosureas) and > 2 weeks from prior hormonal therapy
boolean
C1272706 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
prior regimens for metastatic disease
Item
Have had one or less prior regimens for metastatic disease
boolean
C0027627 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
evaluable disease
Item
Have measurable (bidimensionally) or evaluable disease that is in an area that has not been radiated
boolean
C1513041 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
uncontrolled metastases
Item
Have rapidly progressing liver or lung metastases or uncontrolled central nervous system metastases
boolean
C0027627 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0024109 (UMLS CUI [2,2])
C0279130 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
medically unstable
Item
Are medically unstable
boolean
C0443343 (UMLS CUI [1])
pregnancy and contraceptive use
Item
Are pregnant, nursing or unwilling to employ adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C1999124 (UMLS CUI [3])
peripheral neuropathy
Item
Have pre-existing clinically significant peripheral neuropathy except for abnormalities due to cancer
boolean
C0031117 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
compliance factors
Item
Have psychological, familial, sociological or geographical conditions that do not permit weekly medical follow-up and compliance with the study protocol
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0814423 (UMLS CUI [2,1])
C1522577 (UMLS CUI [2,2])
hypersensitivity to ecoli-derived proteins
Item
Have hypersensitivity to e. coli-derived proteins, filgrastim, or any of its components
boolean
C0020517 (UMLS CUI [1,1])
C0033684 (UMLS CUI [1,2])
C1441547 (UMLS CUI [1,3])
C0014834 (UMLS CUI [1,4])
C0020517 (UMLS CUI [2,1])
C0210630 (UMLS CUI [2,2])
prior therapy with navelbine
Item
Have had prior therapy with navelbine
boolean
C0131965 (UMLS CUI [1])
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