ID

16327

Descripción

BREAST-10: Three-weekly Versus Weekly First-line Chemotherapy for Metastatic or Locally Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00540800

Link

https://clinicaltrials.gov/show/NCT00540800

Palabras clave

  1. 11/7/16 11/7/16 -
Subido en

11 de julio de 2016

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00540800

Eligibility Breast Cancer NCT00540800

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological diagnosis of breast cancer
Descripción

diagnosis of breast cancer

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0678222
inoperable locally advanced or metastatic disease not yet treated with first-line chemotherapy
Descripción

inoperable locally advanced or metastatic disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3495949
UMLS CUI [1,2]
C0205187
UMLS CUI [2]
C0278488
age < 70 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status < 2
Descripción

ecog performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
written informed consent
Descripción

written informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous or concomitant malignant neoplasm (excluding adequately treated baso or spinocellular skin carcinoma or carcinoma in situ of the cervix)
Descripción

previous or concomitant malignant neoplasm

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
previous treatment with docetaxel
Descripción

docetaxel

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0246415
symptomatic brain metastases
Descripción

symptomatic brain metastases

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
neutrophil < 2000/mm3, platelets < 100,000/mm3, haemoglobin < 10 g/dl
Descripción

Neutrophil, platelets, haemoglobin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
creatinine > 1.25 x the upper normal limits
Descripción

creatinine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
got and/or gpt > 1.25 x the upper normal limits in absence of hepatic metastases
Descripción

transaminases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002594
got and/or gpt > 2.5 x the upper normal limits in presence of hepatic metastases
Descripción

transaminases in presence of hepatic metastases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002594
UMLS CUI [2]
C0494165
bilirubin > 1.5 x the upper normal limit
Descripción

bilirubin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study
Descripción

Comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
inability to provide informed consent
Descripción

Unable Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0021430
inability to comply with follow-up
Descripción

inability to comply with follow-up

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1299582

Similar models

Eligibility Breast Cancer NCT00540800

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
diagnosis of breast cancer
Item
histological diagnosis of breast cancer
boolean
C0019638 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
inoperable locally advanced or metastatic disease
Item
inoperable locally advanced or metastatic disease not yet treated with first-line chemotherapy
boolean
C3495949 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C0278488 (UMLS CUI [2])
Age
Item
age < 70 years
boolean
C0001779 (UMLS CUI [1])
ecog performance status
Item
ecog performance status < 2
boolean
C1520224 (UMLS CUI [1])
written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
previous or concomitant malignant neoplasm
Item
previous or concomitant malignant neoplasm (excluding adequately treated baso or spinocellular skin carcinoma or carcinoma in situ of the cervix)
boolean
C0006826 (UMLS CUI [1])
docetaxel
Item
previous treatment with docetaxel
boolean
C0246415 (UMLS CUI [1])
symptomatic brain metastases
Item
symptomatic brain metastases
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Neutrophil, platelets, haemoglobin
Item
neutrophil < 2000/mm3, platelets < 100,000/mm3, haemoglobin < 10 g/dl
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
creatinine
Item
creatinine > 1.25 x the upper normal limits
boolean
C0201976 (UMLS CUI [1])
transaminases
Item
got and/or gpt > 1.25 x the upper normal limits in absence of hepatic metastases
boolean
C0002594 (UMLS CUI [1])
transaminases in presence of hepatic metastases
Item
got and/or gpt > 2.5 x the upper normal limits in presence of hepatic metastases
boolean
C0002594 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
bilirubin
Item
bilirubin > 1.5 x the upper normal limit
boolean
C1278039 (UMLS CUI [1])
Comorbidity
Item
any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study
boolean
C0009488 (UMLS CUI [1])
Unable Informed Consent
Item
inability to provide informed consent
boolean
C1299582 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
inability to comply with follow-up
Item
inability to comply with follow-up
boolean
C3274571 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])

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