ID

16297

Description

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

Keywords

Versions (1)
  1. 7/10/16 7/10/16 -
Uploaded on

July 10, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00266110

English

Eligibility Breast Cancer NCT00266110

1 forms  
Criteria
Description

Criteria

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

metastatic breast cancer

Data type

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.
Description

Age, contraception

Data type

boolean

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

ecog performance status

Data type

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.
Description

cardiac function

Data type

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.
Description

Liver function

Data type

boolean

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

bilirubin

Data type

boolean

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

hiv

Data type

boolean

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

hepatitis b surface antigen

Data type

boolean

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

informed consent

Data type

boolean

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

HLA genotype

Data type

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
Description

absolute neutrophil count, platelet count, hemoglobin

Data type

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.
Description

her-2/neu

Data type

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.
Description

treatment failure or progress

Data type

boolean

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

Exclusion criteria

Data type

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.
Description

Comorbidity

Data type

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.
Description

CNS metastases, stable disease

Data type

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.
Description

Systemic steroid treatment

Data type

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.
Description

Treatment failure of vinorelbine + trastuzumab

Data type

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.
Description

ID.19

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C0677881
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Similar models

Eligibility Breast Cancer NCT00266110

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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