ID

12961

Beschrijving

Epirubicin and Docetaxel in the Treatment of Patients With Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00193024

Link

https://clinicaltrials.gov/show/NCT00193024

Trefwoorden

  1. 07-01-16 07-01-16 -
Geüploaded op

7 januari 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00193024

Eligibility Breast Cancer NCT00193024

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
metastatic breast cancer confirmed by biopsy.
Beschrijving

biopsy metastasis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0027627
received no previous chemotherapy for metastatic breast cancer.
Beschrijving

chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
prior hormonal therapy is acceptable.
Beschrijving

hormone therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0279025
measurable or evaluable disease.
Beschrijving

measurement, evaluation

Datatype

boolean

Alias
UMLS CUI [1]
C0242485
UMLS CUI [2]
C0220825
able to perform activities of daily living without considerable assistance
Beschrijving

performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1518965
adequate bone marrow, liver and kidney function
Beschrijving

organ function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0005953
UMLS CUI [3]
C0232804
must be able to understand the nature of this study and give written informed consent.
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
age < 18 years.
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
cardiac ejection fraction < 45%.
Beschrijving

cardiac ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0232174
women who are pregnant or lactating.
Beschrijving

pregnancy, lactating

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C2828358
patients with meningeal metastases are ineligible.
Beschrijving

meningeal metastasis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0025284
moderate peripheral neuropathy
Beschrijving

peripheral neuropathy

Datatype

boolean

Alias
UMLS CUI [1]
C0031117
history of hypersensitivity reaction to taxotere
Beschrijving

hypersensitivity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0699967
males with metastatic breast cancer
Beschrijving

gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
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.
Beschrijving

additional inclusion/exclusion criteria

Datatype

boolean

Similar models

Eligibility Breast Cancer NCT00193024

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
chemotherapy
Item
received no previous chemotherapy for metastatic breast cancer.
boolean
C0392920 (UMLS CUI [1])
hormone therapy
Item
prior hormonal therapy is acceptable.
boolean
C0279025 (UMLS CUI [1])
measurement, evaluation
Item
measurable or evaluable disease.
boolean
C0242485 (UMLS CUI [1])
C0220825 (UMLS CUI [2])
performance status
Item
able to perform activities of daily living without considerable assistance
boolean
C1518965 (UMLS CUI [1])
organ function
Item
adequate bone marrow, liver and kidney function
boolean
C0232741 (UMLS CUI [1])
C0005953 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
informed consent
Item
must be able to understand the nature of this study and give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
age
Item
age < 18 years.
boolean
C0001779 (UMLS CUI [1])
cardiac ejection fraction
Item
cardiac ejection fraction < 45%.
boolean
C0232174 (UMLS CUI [1])
pregnancy, lactating
Item
women who are pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
meningeal metastasis
Item
patients with meningeal metastases are ineligible.
boolean
C0027627 (UMLS CUI [1,1])
C0025284 (UMLS CUI [1,2])
peripheral neuropathy
Item
moderate peripheral neuropathy
boolean
C0031117 (UMLS CUI [1])
hypersensitivity
Item
history of hypersensitivity reaction to taxotere
boolean
C0020517 (UMLS CUI [1,1])
C0699967 (UMLS CUI [1,2])
gender
Item
males with metastatic breast cancer
boolean
C0079399 (UMLS CUI [1])
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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