ID

16297

Descripción

Vaccine Therapy, Trastuzumab, and Vinorelbine in Treating Patients With Locally Recurrent or Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00266110

Link

https://clinicaltrials.gov/show/NCT00266110

Palabras clave

Versiones (1)
  1. 10/7/16 10/7/16 -
Subido en

10 de julio de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Breast Cancer NCT00266110

Inglés

Eligibility Breast Cancer NCT00266110

1 formularios  
Criteria
Descripción

Criteria

4.1 inclusion criteria 4.1.1 histologically proven metastatic breast cancer with measurable or evaluable disease per investigator discretion.
Descripción

metastatic breast cancer

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0278488
4.1.2 patients must be 18 years of age or older. women of child bearing potential must be practicing barrier or oral contraception for the duration of the study, or documented as surgically sterile or one year post-menopausal.
Descripción

Age, contraception

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0700589
4.1.3 ecog performance status 0-2 (see appendix a).
Descripción

ecog performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
4.1.5 cardiac function by muga with an ef > 45% or an echocardiogram that shows normal lv function.
Descripción

cardiac function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232164
4.1.6 serum creatinine < 2.0 mg/dl. 4.1.7 hepatic transaminases (alanine aminotransferase (alt) and aspartate aminotransferase (ast)) ≤3.0 times the upper limit of normal if no liver metastases or ≤5 times the upper limit of normal if liver metastases are present.
Descripción

Liver function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0600061
UMLS CUI [3]
C0002594
4.1.8 bilirubin no more than 2x normal.
Descripción

bilirubin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
4.1.9 seronegative for hiv.
Descripción

hiv

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019682
4.1.10 negative for hepatitis b surface antigen.
Descripción

hepatitis b surface antigen

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019168
4.1.11 signed and dated informed consent.
Descripción

informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
4.1.12 hla a0201+ by dna genotyping.
Descripción

HLA genotype

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019721
4.1.13 absolute neutrophil count greater than 1,500/mm3. platelet count greater 100,000/mm3 and hemoglobin greater than or equal to 10
Descripción

absolute neutrophil count, platelet count, hemoglobin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C1287267
UMLS CUI [3]
C0019046
4.1.14. 3+ expression of her-2/neu from original pathology (diagnostic) tumor sample by ihc or 2+ expression by ihc with gene amplification by fish.
Descripción

her-2/neu

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242957
4.1.15. patients will be eligible even if they have failed treatment for metastatic breast cancer with trastuzumab and a chemotherapy agent other than vinorelbine or if they have progressed within 12 months of receiving adjuvant chemotherapy using trastuzumab and a taxane.
Descripción

treatment failure or progress

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0162643
UMLS CUI [2]
C0178874
4.2 exclusion criteria
Descripción

Exclusion criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0680251
4.2.1 patients with any serious medical, cardiac, or psychiatric condition which, in the opinion of the investigator, would make the patient unsuitable for study participation or would impede probable compliance with the protocol.
Descripción

Comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0004936
4.2.2 patients with central nervous system metastases must have stable disease for at least 3 months prior to study entry.
Descripción

CNS metastases, stable disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0279130
UMLS CUI [1,2]
C0677946
4.2.3 patient is currently taking steroid medications. systemic steroid treatment is not allowed.
Descripción

Systemic steroid treatment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0205373
4.2.4 patients that have failed prior therapy with vinorelbine + trastuzumab will not be eligible for therapy.
Descripción

Treatment failure of vinorelbine + trastuzumab

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0162643
UMLS CUI [1,2]
C0935819
4.2.5 patient has received hormonal or cytotoxic chemotherapy within 14 days of apheresis and within 28-30 days prior to study treatment.
Descripción

ID.19

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C0677881
Volver a la parte superior de la página

Similar models

Eligibility Breast Cancer NCT00266110

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
metastatic breast cancer
Item
4.1 inclusion criteria 4.1.1 histologically proven metastatic breast cancer with measurable or evaluable disease per investigator discretion.
boolean
C0278488 (UMLS CUI [1])
Age, contraception
Item
4.1.2 patients must be 18 years of age or older. women of child bearing potential must be practicing barrier or oral contraception for the duration of the study, or documented as surgically sterile or one year post-menopausal.
boolean
C0001779 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
ecog performance status
Item
4.1.3 ecog performance status 0-2 (see appendix a).
boolean
C1520224 (UMLS CUI [1])
cardiac function
Item
4.1.5 cardiac function by muga with an ef > 45% or an echocardiogram that shows normal lv function.
boolean
C0232164 (UMLS CUI [1])
Liver function
Item
4.1.6 serum creatinine < 2.0 mg/dl. 4.1.7 hepatic transaminases (alanine aminotransferase (alt) and aspartate aminotransferase (ast)) ≤3.0 times the upper limit of normal if no liver metastases or ≤5 times the upper limit of normal if liver metastases are present.
boolean
C0232741 (UMLS CUI [1])
C0600061 (UMLS CUI [2])
C0002594 (UMLS CUI [3])
bilirubin
Item
4.1.8 bilirubin no more than 2x normal.
boolean
C1278039 (UMLS CUI [1])
hiv
Item
4.1.9 seronegative for hiv.
boolean
C0019682 (UMLS CUI [1])
hepatitis b surface antigen
Item
4.1.10 negative for hepatitis b surface antigen.
boolean
C0019168 (UMLS CUI [1])
informed consent
Item
4.1.11 signed and dated informed consent.
boolean
C0021430 (UMLS CUI [1])
HLA genotype
Item
4.1.12 hla a0201+ by dna genotyping.
boolean
C0019721 (UMLS CUI [1])
absolute neutrophil count, platelet count, hemoglobin
Item
4.1.13 absolute neutrophil count greater than 1,500/mm3. platelet count greater 100,000/mm3 and hemoglobin greater than or equal to 10
boolean
C0200633 (UMLS CUI [1])
C1287267 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
her-2/neu
Item
4.1.14. 3+ expression of her-2/neu from original pathology (diagnostic) tumor sample by ihc or 2+ expression by ihc with gene amplification by fish.
boolean
C0242957 (UMLS CUI [1])
treatment failure or progress
Item
4.1.15. patients will be eligible even if they have failed treatment for metastatic breast cancer with trastuzumab and a chemotherapy agent other than vinorelbine or if they have progressed within 12 months of receiving adjuvant chemotherapy using trastuzumab and a taxane.
boolean
C0162643 (UMLS CUI [1])
C0178874 (UMLS CUI [2])
Exclusion criteria
Item
4.2 exclusion criteria
boolean
C0680251 (UMLS CUI [1])
Comorbidity
Item
4.2.1 patients with any serious medical, cardiac, or psychiatric condition which, in the opinion of the investigator, would make the patient unsuitable for study participation or would impede probable compliance with the protocol.
boolean
C0009488 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
CNS metastases, stable disease
Item
4.2.2 patients with central nervous system metastases must have stable disease for at least 3 months prior to study entry.
boolean
C0279130 (UMLS CUI [1,1])
C0677946 (UMLS CUI [1,2])
Systemic steroid treatment
Item
4.2.3 patient is currently taking steroid medications. systemic steroid treatment is not allowed.
boolean
C0149783 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Treatment failure of vinorelbine + trastuzumab
Item
4.2.4 patients that have failed prior therapy with vinorelbine + trastuzumab will not be eligible for therapy.
boolean
C0162643 (UMLS CUI [1,1])
C0935819 (UMLS CUI [1,2])
ID.19
Item
4.2.5 patient has received hormonal or cytotoxic chemotherapy within 14 days of apheresis and within 28-30 days prior to study treatment.
boolean
C0279025 (UMLS CUI [1])
C0677881 (UMLS CUI [2])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial