ID

15496

Description

Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01423695

Link

https://clinicaltrials.gov/show/NCT01423695

Keywords

  1. 6/1/16 6/1/16 -
Uploaded on

June 1, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Metastatic Breast Cancer NCT01423695

Eligibility Metastatic Breast Cancer NCT01423695

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed metastatic breast cancer overexpressing her2
Description

metastatic breast cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C0027627
pretreatment with anthracycline in either the adjuvant or palliative setting.
Description

anthracycline

Data type

boolean

Alias
UMLS CUI [1]
C0003234
her2 positivity was defined as 2+ or 3+ overexpression using the dako herceptest, confirmed by fluorescence in-situ hybridization (fish) if 2+.
Description

her2 positivity

Data type

boolean

Alias
UMLS CUI [1]
C4031572
informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than 1 chemotherapy for advanced disease
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
taxane or trastuzumab pretreatment
Description

taxane or trastuzumab

Data type

boolean

Alias
UMLS CUI [1]
C0215136
UMLS CUI [2]
C0728747
brain metastases
Description

brain metastases

Data type

boolean

Alias
UMLS CUI [1]
C0220650
eastern cooperative oncology group (ecog) performance status >1
Description

performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
pregnancy or lactation, childbearing potential without reliable contraception
Description

pregnancy or lactation

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
clinically significant cardiac disease,
Description

cardiac disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
neutrophils <1500/µl, platelets <75,000/µl
Description

neutrophils platelets

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0005821
total bilirubin and creatinine >1.5 × the upper limit of normal
Description

total bilirubin and creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201913
UMLS CUI [2]
C0201976

Similar models

Eligibility Metastatic Breast Cancer NCT01423695

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
metastatic breast cancer
Item
histologically confirmed metastatic breast cancer overexpressing her2
boolean
C1960398 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
anthracycline
Item
pretreatment with anthracycline in either the adjuvant or palliative setting.
boolean
C0003234 (UMLS CUI [1])
her2 positivity
Item
her2 positivity was defined as 2+ or 3+ overexpression using the dako herceptest, confirmed by fluorescence in-situ hybridization (fish) if 2+.
boolean
C4031572 (UMLS CUI [1])
informed consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
chemotherapy
Item
more than 1 chemotherapy for advanced disease
boolean
C0392920 (UMLS CUI [1])
taxane or trastuzumab
Item
taxane or trastuzumab pretreatment
boolean
C0215136 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
brain metastases
Item
brain metastases
boolean
C0220650 (UMLS CUI [1])
performance status
Item
eastern cooperative oncology group (ecog) performance status >1
boolean
C1520224 (UMLS CUI [1])
pregnancy or lactation
Item
pregnancy or lactation, childbearing potential without reliable contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
cardiac disease
Item
clinically significant cardiac disease,
boolean
C0018799 (UMLS CUI [1])
neutrophils platelets
Item
neutrophils <1500/µl, platelets <75,000/µl
boolean
C0948762 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
total bilirubin and creatinine
Item
total bilirubin and creatinine >1.5 × the upper limit of normal
boolean
C0201913 (UMLS CUI [1])
C0201976 (UMLS CUI [2])

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