ID

19561

Descripción

Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00258960

Link

https://clinicaltrials.gov/show/NCT00258960

Palabras clave

  1. 10/1/17 10/1/17 -
Subido en

10 de enero de 2017

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00258960

Eligibility Breast Cancer NCT00258960

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must sign an informed consent before of especific procedures of clinical trial.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
patients with histologically confirmed breast cancer and overexpression of her2neu.
Descripción

Breast Carcinoma | erbB-2 Receptor Overexpression

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C0069515
UMLS CUI [2,2]
C1514559
age> 18 years.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
ecog equal or < 2.
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
patients have not been treated previously with chemotherapy for metastatic disease.
Descripción

Chemotherapy Neoplasm Metastasis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0027627
patients must have at least one measurable lesion according to recist criteria.
Descripción

Measurable lesion Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
patients should have an adequate organ function to tolerate chemotherapy.
Descripción

Organ function Adequate Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0205411
UMLS CUI [1,3]
C0392920
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with hypersensitivity reactions to any of the medications of the clinical trial.
Descripción

Hypersensitivity Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
patients who are pregnant or lactating are not eligible.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
hepatic disease.
Descripción

Liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023895
not controlled active infection
Descripción

Communicable Disease Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
symptomatic metastatic brain cancer
Descripción

Metastatic malignant neoplasm to brain Symptomatic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
previous adyuvant treatment with antrhacyclines with a total accumulated dose > 300 mg/m2 (doxorubicin) or > 600 mg/m2 (epirubicin)
Descripción

Adjuvant therapy Anthracyclines | Doxorubicin Dose Accumulation | Epirubicin Dose Accumulation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0677850
UMLS CUI [1,2]
C0282564
UMLS CUI [2,1]
C0013089
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C4055506
UMLS CUI [3,1]
C0014582
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C4055506

Similar models

Eligibility Breast Cancer NCT00258960

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
patients must sign an informed consent before of especific procedures of clinical trial.
boolean
C0021430 (UMLS CUI [1])
Breast Carcinoma | erbB-2 Receptor Overexpression
Item
patients with histologically confirmed breast cancer and overexpression of her2neu.
boolean
C0678222 (UMLS CUI [1])
C0069515 (UMLS CUI [2,1])
C1514559 (UMLS CUI [2,2])
Age
Item
age> 18 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog equal or < 2.
boolean
C1520224 (UMLS CUI [1])
Chemotherapy Neoplasm Metastasis
Item
patients have not been treated previously with chemotherapy for metastatic disease.
boolean
C0392920 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Measurable lesion Quantity
Item
patients must have at least one measurable lesion according to recist criteria.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Organ function Adequate Chemotherapy
Item
patients should have an adequate organ function to tolerate chemotherapy.
boolean
C0678852 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs
Item
patients with hypersensitivity reactions to any of the medications of the clinical trial.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
patients who are pregnant or lactating are not eligible.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Liver disease
Item
hepatic disease.
boolean
C0023895 (UMLS CUI [1])
Communicable Disease Uncontrolled
Item
not controlled active infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain Symptomatic
Item
symptomatic metastatic brain cancer
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Adjuvant therapy Anthracyclines | Doxorubicin Dose Accumulation | Epirubicin Dose Accumulation
Item
previous adyuvant treatment with antrhacyclines with a total accumulated dose > 300 mg/m2 (doxorubicin) or > 600 mg/m2 (epirubicin)
boolean
C0677850 (UMLS CUI [1,1])
C0282564 (UMLS CUI [1,2])
C0013089 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C4055506 (UMLS CUI [2,3])
C0014582 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C4055506 (UMLS CUI [3,3])

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