ID

16167

Descripción

Trial of Vinflunine Plus Capecitabine in Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01095003

Link

https://clinicaltrials.gov/show/NCT01095003

Palabras clave

  1. 3/7/16 3/7/16 -
Subido en

3 de julio de 2016

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Advanced Breast Cancer NCT01095003

Eligibility Advanced Breast Cancer NCT01095003

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients
Descripción

female patients

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
21 years of age or older
Descripción

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
histologically/cytologically confirmed carcinoma of the breast
Descripción

carcinoma of the breast

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678222
documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy
Descripción

metastatic disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027627
either one, two or three prior chemotherapy regimens
Descripción

chemotherapy regimen

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0392920
prior treatments including both an anthracycline and a taxane and patient no longer candidate for these drugs
Descripción

anthracycline and a taxane

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0282564
UMLS CUI [2]
C0215136
measurable or non-measurable disease according to recist 1.1
Descripción

measurable disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
karnofsky performance score of at least 70 %
Descripción

karnofsky performance score

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206065
adequate haematological, hepatic and renal functions
Descripción

hepatic and renal function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
ecg without clinically relevant abnormality
Descripción

ecg

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1623258
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or clinical evidence of brain metastasis or leptomeningeal involvement
Descripción

brain metastasis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220650
pulmonary lymphangitis or symptomatic pleural effusion
Descripción

lymphangitis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0024225
any serious, concurrent uncontrolled medical disorder
Descripción

medical disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0236748
history of second primary malignancy
Descripción

second primary malignancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0751623
preexisting motor/sensory peripheral neuropathy
Descripción

peripheral neuropathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0031117
known history of hiv infection
Descripción

hiv infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019693
prior therapy with capecitabine and/or vinca-alkaloids
Descripción

capecitabine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0671970
history of severe hypersensitivity to vinca alkaloids and/or to fluoropyrimidine or contra indication to any of these drugs
Descripción

hypersensitivity to vinca alkaloids

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0042672
known or suspected dihydropyrimidine dehydrogenase (dpd) deficiency
Descripción

dihydropyrimidine dehydrogenase (dpd) deficiency

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1959620
pregnancy or breast feeding
Descripción

pregnancy or breast feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Advanced Breast Cancer NCT01095003

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
female patients
Item
female patients
boolean
C0079399 (UMLS CUI [1])
age
Item
21 years of age or older
boolean
C0001779 (UMLS CUI [1])
carcinoma of the breast
Item
histologically/cytologically confirmed carcinoma of the breast
boolean
C0678222 (UMLS CUI [1])
metastatic disease
Item
documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy
boolean
C0027627 (UMLS CUI [1])
chemotherapy regimen
Item
either one, two or three prior chemotherapy regimens
boolean
C0392920 (UMLS CUI [1])
anthracycline and a taxane
Item
prior treatments including both an anthracycline and a taxane and patient no longer candidate for these drugs
boolean
C0282564 (UMLS CUI [1])
C0215136 (UMLS CUI [2])
measurable disease
Item
measurable or non-measurable disease according to recist 1.1
boolean
C1513041 (UMLS CUI [1])
karnofsky performance score
Item
karnofsky performance score of at least 70 %
boolean
C0206065 (UMLS CUI [1])
hepatic and renal function
Item
adequate haematological, hepatic and renal functions
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
ecg
Item
ecg without clinically relevant abnormality
boolean
C1623258 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
brain metastasis
Item
known or clinical evidence of brain metastasis or leptomeningeal involvement
boolean
C0220650 (UMLS CUI [1])
lymphangitis
Item
pulmonary lymphangitis or symptomatic pleural effusion
boolean
C0024225 (UMLS CUI [1])
medical disorder
Item
any serious, concurrent uncontrolled medical disorder
boolean
C0236748 (UMLS CUI [1])
second primary malignancy
Item
history of second primary malignancy
boolean
C0751623 (UMLS CUI [1])
peripheral neuropathy
Item
preexisting motor/sensory peripheral neuropathy
boolean
C0031117 (UMLS CUI [1])
hiv infection
Item
known history of hiv infection
boolean
C0019693 (UMLS CUI [1])
capecitabine
Item
prior therapy with capecitabine and/or vinca-alkaloids
boolean
C0671970 (UMLS CUI [1])
hypersensitivity to vinca alkaloids
Item
history of severe hypersensitivity to vinca alkaloids and/or to fluoropyrimidine or contra indication to any of these drugs
boolean
C0020517 (UMLS CUI [1,1])
C0042672 (UMLS CUI [1,2])
dihydropyrimidine dehydrogenase (dpd) deficiency
Item
known or suspected dihydropyrimidine dehydrogenase (dpd) deficiency
boolean
C1959620 (UMLS CUI [1])
pregnancy or breast feeding
Item
pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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