ID

43651

Description

Predicting Response to Capecitabine in Women With Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00953537

Link

https://clinicaltrials.gov/show/NCT00953537

Keywords

Versions (2)
  1. 10/27/17 10/27/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00953537

English

Eligibility Breast Cancer NCT00953537

1 forms  
Criteria
Description

Criteria

radiologically (by scintography) or histologically confirmed metastatic breast cancer
Description

Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C0346993
at least 1 measurable or evaluable target lesion
Description

Target Lesion Measurable Quantity | Target Lesion Evaluable Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1513040
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C1516986
UMLS CUI [2,3]
C1265611
receiving capecitabine as monotherapy or with targeted antiangiogenic therapies (e.g., bevacizumab or trastuzumab)
Description

Capecitabine | Antiangiogenic therapy Targeted | bevacizumab | trastuzumab

Data type

boolean

Alias
UMLS CUI [1]
C0671970
UMLS CUI [2,1]
C2363719
UMLS CUI [2,2]
C1521840
UMLS CUI [3]
C0796392
UMLS CUI [4]
C0728747
no uncontrolled brain metastases
Description

Exclusion | Metastatic malignant neoplasm to brain Uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0205318
hormone receptor status not specified
Description

Hormone Receptor Status Unspecified

Data type

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0205370
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
menopausal status not specified
Description

Menopausal Status Unspecified

Data type

boolean

Alias
UMLS CUI [1,1]
C3829127
UMLS CUI [1,2]
C0205370
life expectancy ≥ 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
fertile patients must use effective contraception
Description

Fertility Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
no chronic uncontrolled illness
Description

Exclusion | Chronic disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0205318
no congestive heart failure
Description

Exclusion | Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C0018802
no peripheral venous disease
Description

Exclusion | Peripheral venous disease

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C0750166
no severe uncontrolled infection
Description

Exclusion | Communicable Disease Uncontrolled Severe

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0205082
no hypoxemic respiratory failure
Description

Exclusion | Hypoxemic respiratory failure

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C0340194
no prior primary cancer except for basal cell carcinoma of the skin
Description

Exclusion | Primary malignant neoplasm | Exception Basal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C1306459
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
no psychologic disorder
Description

Exclusion | Mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C0004936
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Description

ID.18

Data type

boolean

no capecitabine co-administered with chemotherapy
Description

Exclusion | Capecitabine Associated with Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0671970
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0392920
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Similar models

Eligibility Breast Cancer NCT00953537

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Secondary malignant neoplasm of female breast
Item
radiologically (by scintography) or histologically confirmed metastatic breast cancer
boolean
C0346993 (UMLS CUI [1])
Target Lesion Measurable Quantity | Target Lesion Evaluable Quantity
Item
at least 1 measurable or evaluable target lesion
boolean
C2986546 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C1516986 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Capecitabine | Antiangiogenic therapy Targeted | bevacizumab | trastuzumab
Item
receiving capecitabine as monotherapy or with targeted antiangiogenic therapies (e.g., bevacizumab or trastuzumab)
boolean
C0671970 (UMLS CUI [1])
C2363719 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0796392 (UMLS CUI [3])
C0728747 (UMLS CUI [4])
Exclusion | Metastatic malignant neoplasm to brain Uncontrolled
Item
no uncontrolled brain metastases
boolean
C2828389 (UMLS CUI [1])
C0220650 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Hormone Receptor Status Unspecified
Item
hormone receptor status not specified
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0205370 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Menopausal Status Unspecified
Item
menopausal status not specified
boolean
C3829127 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy ≥ 3 months
boolean
C0023671 (UMLS CUI [1])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Exclusion | Chronic disease Uncontrolled
Item
no chronic uncontrolled illness
boolean
C2828389 (UMLS CUI [1])
C0008679 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Exclusion | Congestive heart failure
Item
no congestive heart failure
boolean
C2828389 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
Exclusion | Peripheral venous disease
Item
no peripheral venous disease
boolean
C2828389 (UMLS CUI [1])
C0750166 (UMLS CUI [2])
Exclusion | Communicable Disease Uncontrolled Severe
Item
no severe uncontrolled infection
boolean
C2828389 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
Exclusion | Hypoxemic respiratory failure
Item
no hypoxemic respiratory failure
boolean
C2828389 (UMLS CUI [1])
C0340194 (UMLS CUI [2])
Exclusion | Primary malignant neoplasm | Exception Basal cell carcinoma
Item
no prior primary cancer except for basal cell carcinoma of the skin
boolean
C2828389 (UMLS CUI [1])
C1306459 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
Exclusion | Mental disorders
Item
no psychologic disorder
boolean
C2828389 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.18
Item
see disease characteristics
boolean
Exclusion | Capecitabine Associated with Chemotherapy
Item
no capecitabine co-administered with chemotherapy
boolean
C2828389 (UMLS CUI [1])
C0671970 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
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