ID

12965

Description

Docetaxel, Vinorelbine and Trastuzumab in the Treatment of Patients With Metastatic Her-2 Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00193089

Link

https://clinicaltrials.gov/show/NCT00193089

Keywords

  1. 1/7/16 1/7/16 -
Uploaded on

January 7, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00193089

Eligibility Breast Cancer NCT00193089

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
metastatic breast cancer confirmed by biopsy
Description

biopsy metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0027627
overexpression of the her-2 oncogene
Description

her2 overexpression

Data type

boolean

Alias
UMLS CUI [1]
C1960398
age > 18 years
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
measurable disease
Description

measurable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
able to perform activities of daily living with minimal assistance
Description

performance status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
no previous chemotherapy for metastatic disease
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
one or more previous hormonal therapies for metastatic disease.
Description

hormone therapy

Data type

boolean

Alias
UMLS CUI [1]
C0279025
adequate bone marrow, liver and kidney function
Description

bone marrow, liver and kidney function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0005953
UMLS CUI [3]
C0232804
patients with < grade 1 peripheral neuropathy are eligible.
Description

peripheral neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0031117
must give written informed consent prior to entering this study.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
abnormal heart function
Description

cardiac function

Data type

boolean

Alias
UMLS CUI [1]
C0232164
previous treatment with trastuzumab
Description

trastuzumab

Data type

boolean

Alias
UMLS CUI [1]
C0338204
brain metastases untreated
Description

brain metastases

Data type

boolean

Alias
UMLS CUI [1]
C0220650
pre-existing symptomatic peripheral neuropathy
Description

peripheral neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0031117
serious underlying medical conditions
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Description

additional inclusion/exclusion criteria

Data type

boolean

Similar models

Eligibility Breast Cancer NCT00193089

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
biopsy metastasis
Item
metastatic breast cancer confirmed by biopsy
boolean
C0005558 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
her2 overexpression
Item
overexpression of the her-2 oncogene
boolean
C1960398 (UMLS CUI [1])
age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
measurable disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
performance status
Item
able to perform activities of daily living with minimal assistance
boolean
C1518965 (UMLS CUI [1])
chemotherapy
Item
no previous chemotherapy for metastatic disease
boolean
C0392920 (UMLS CUI [1])
hormone therapy
Item
one or more previous hormonal therapies for metastatic disease.
boolean
C0279025 (UMLS CUI [1])
bone marrow, liver and kidney function
Item
adequate bone marrow, liver and kidney function
boolean
C0232741 (UMLS CUI [1])
C0005953 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
peripheral neuropathy
Item
patients with < grade 1 peripheral neuropathy are eligible.
boolean
C0031117 (UMLS CUI [1])
informed consent
Item
must give written informed consent prior to entering this study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
cardiac function
Item
abnormal heart function
boolean
C0232164 (UMLS CUI [1])
trastuzumab
Item
previous treatment with trastuzumab
boolean
C0338204 (UMLS CUI [1])
brain metastases
Item
brain metastases untreated
boolean
C0220650 (UMLS CUI [1])
peripheral neuropathy
Item
pre-existing symptomatic peripheral neuropathy
boolean
C0031117 (UMLS CUI [1])
comorbidity
Item
serious underlying medical conditions
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
additional inclusion/exclusion criteria
Item
please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
boolean

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