ID

12978

Description

Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00193102

Link

https://clinicaltrials.gov/show/NCT00193102

Keywords

  1. 1/9/16 1/9/16 -
Uploaded on

January 9, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00193102

Eligibility Breast Cancer NCT00193102

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
measurable or evaluable disease
Description

measurable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
females > 18 years
Description

age, gender

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
able to perform activities of daily living with minimal assistance
Description

performance status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
life expectancy > 3 months
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
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
all patients must give written informed consent in order to participate.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant or lactating.
Description

pregnancy, lactation

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
received more than 3 prior chemotherapy regimens in the metastatic setting.
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
received continuous infusion 5-fluorouracil lasting > 120 hours.
Description

fluorouracil

Data type

boolean

Alias
UMLS CUI [1]
C0016360
received thalidomide or capecitabine as their last prior regimen.
Description

thalidomide, capecitabine

Data type

boolean

Alias
UMLS CUI [1]
C0039736
UMLS CUI [2]
C0671970
preexisting moderate to severe neuropathy
Description

neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0442874
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 NCT00193102

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])
measurable disease
Item
measurable or evaluable disease
boolean
C1513041 (UMLS CUI [1])
age, gender
Item
females > 18 years
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
performance status
Item
able to perform activities of daily living with minimal assistance
boolean
C1518965 (UMLS CUI [1])
life expectancy
Item
life expectancy > 3 months
boolean
C0023671 (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])
informed consent
Item
all patients must give written informed consent in order to participate.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnancy, lactation
Item
women who are pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
chemotherapy
Item
received more than 3 prior chemotherapy regimens in the metastatic setting.
boolean
C0392920 (UMLS CUI [1])
fluorouracil
Item
received continuous infusion 5-fluorouracil lasting > 120 hours.
boolean
C0016360 (UMLS CUI [1])
thalidomide, capecitabine
Item
received thalidomide or capecitabine as their last prior regimen.
boolean
C0039736 (UMLS CUI [1])
C0671970 (UMLS CUI [2])
neuropathy
Item
preexisting moderate to severe neuropathy
boolean
C0442874 (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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