ID

15780

Description

Effects of Granulocyte Colony-stimulating Factor (G-CSF), Trastuzumab, and Vinorelbine on Immune Cell Function; ODM derived from: https://clinicaltrials.gov/show/NCT00169104

Link

https://clinicaltrials.gov/show/NCT00169104

Keywords

Versions (1)
  1. 6/13/16 6/13/16 -
Uploaded on

June 13, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00169104

English

Eligibility Metastatic Breast Cancer NCT00169104

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients must have pathological confirmation of carcinoma of the breast.
Description

carcinoma of the breast

Data type

boolean

Alias
UMLS CUI [1]
C0678222
patients must have metastatic breast cancer by documented clinical or radiological assessment.
Description

metastatic breast cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0036525
UMLS CUI [1,2]
C0678222
immunohistochemical analysis of her-2/neu expression on paraffin-embedded specimens will be performed. her-2/neu overexpression will be qualitatively scored as 0, 1+, 2+, or 3+, with 3+ indicating the strongest positivity. fluorescence in situ hybridization (fish) analyses will also be performed on these patients. patients with 2+ to 3+ overexpression of her-2/neu (membranous staining) are eligible, regardless of the results of the fish analysis.
Description

immunohistochemical analysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0021044
UMLS CUI [1,2]
C1512413
age ≥18 years.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
karnofsky performance status ≥ 60%.
Description

karnofsky performance status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
adequate hepatic, renal, and hematologic function.
Description

function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0221130
prior treatment with trastuzumab will be allowed.
Description

trastuzumab

Data type

boolean

Alias
UMLS CUI [1]
C0728747
all patients must have adequate cardiac function (defined as left ventricular ejection fraction ≥ 45%) documented by echocardiogram or muga scan.
Description

cardiac function

Data type

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0013516
UMLS CUI [3]
C0521317
premenopausal women will be required to have a negative urine or serum pregnancy test and to use an effective form of contraception.
Description

pregnancy and contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0430060
UMLS CUI [3]
C0700589
patients with a history of brain metastases are permitted as long as it has been at least 30 days since definitive treatment, they are clinically stable and a magnetic resonance imaging scan of the brain demonstrates control of the lesion(s).
Description

brain metastases

Data type

boolean

Alias
UMLS CUI [1]
C0220650
all patients must give written informed consent indicating they are aware of the investigational nature of this treatment, as well as the risks and benefits of this protocol.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
no treatment with chemotherapy or trastuzumab will be allowed within four weeks of study entry.
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0728747
prior therapy with vinorelbine.
Description

vinorelbine

Data type

boolean

Alias
UMLS CUI [1]
C0078257
known history of hypersensitivity to trastuzumab, chinese hamster ovary (cho) cell proteins, or any component of these products.
Description

hypersensitivity to trastuzumab

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0728747
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0085080
history of current unstable angina, symptomatic congestive heart failure, or myocardial infarction within the last 6 months.
Description

unstable angina

Data type

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C0231220
UMLS CUI [3]
C0027051
pregnant women are excluded.
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
history of a known hypersensitivity to e. coli-derived proteins, filgrastim, or any component of the product.
Description

hypersensitivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0950080
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0210630
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Similar models

Eligibility Metastatic Breast Cancer NCT00169104

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
carcinoma of the breast
Item
all patients must have pathological confirmation of carcinoma of the breast.
boolean
C0678222 (UMLS CUI [1])
metastatic breast cancer
Item
patients must have metastatic breast cancer by documented clinical or radiological assessment.
boolean
C0036525 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
immunohistochemical analysis
Item
immunohistochemical analysis of her-2/neu expression on paraffin-embedded specimens will be performed. her-2/neu overexpression will be qualitatively scored as 0, 1+, 2+, or 3+, with 3+ indicating the strongest positivity. fluorescence in situ hybridization (fish) analyses will also be performed on these patients. patients with 2+ to 3+ overexpression of her-2/neu (membranous staining) are eligible, regardless of the results of the fish analysis.
boolean
C0021044 (UMLS CUI [1,1])
C1512413 (UMLS CUI [1,2])
age
Item
age ≥18 years.
boolean
C0001779 (UMLS CUI [1])
karnofsky performance status
Item
karnofsky performance status ≥ 60%.
boolean
C0206065 (UMLS CUI [1])
function
Item
adequate hepatic, renal, and hematologic function.
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0221130 (UMLS CUI [3])
trastuzumab
Item
prior treatment with trastuzumab will be allowed.
boolean
C0728747 (UMLS CUI [1])
cardiac function
Item
all patients must have adequate cardiac function (defined as left ventricular ejection fraction ≥ 45%) documented by echocardiogram or muga scan.
boolean
C0428772 (UMLS CUI [1])
C0013516 (UMLS CUI [2])
C0521317 (UMLS CUI [3])
pregnancy and contraceptive methods
Item
premenopausal women will be required to have a negative urine or serum pregnancy test and to use an effective form of contraception.
boolean
C0032961 (UMLS CUI [1])
C0430060 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
brain metastases
Item
patients with a history of brain metastases are permitted as long as it has been at least 30 days since definitive treatment, they are clinically stable and a magnetic resonance imaging scan of the brain demonstrates control of the lesion(s).
boolean
C0220650 (UMLS CUI [1])
informed consent
Item
all patients must give written informed consent indicating they are aware of the investigational nature of this treatment, as well as the risks and benefits of this protocol.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
chemotherapy
Item
no treatment with chemotherapy or trastuzumab will be allowed within four weeks of study entry.
boolean
C0392920 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
vinorelbine
Item
prior therapy with vinorelbine.
boolean
C0078257 (UMLS CUI [1])
hypersensitivity to trastuzumab
Item
known history of hypersensitivity to trastuzumab, chinese hamster ovary (cho) cell proteins, or any component of these products.
boolean
C0020517 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0085080 (UMLS CUI [2,2])
unstable angina
Item
history of current unstable angina, symptomatic congestive heart failure, or myocardial infarction within the last 6 months.
boolean
C0002965 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
pregnancy
Item
pregnant women are excluded.
boolean
C0032961 (UMLS CUI [1])
hypersensitivity
Item
history of a known hypersensitivity to e. coli-derived proteins, filgrastim, or any component of the product.
boolean
C0020517 (UMLS CUI [1,1])
C0950080 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0210630 (UMLS CUI [2,2])
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