0 Ratings
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

Versions (1)
  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

    English

    Eligibility Metastatic Breast Cancer NCT01423695

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

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

    metastatic breast cancer

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1960398 (HER2-positive carcinoma of breast)
    SNOMED
    427685000
    UMLS CUI [1,2]
    C0027627 (Neoplasm Metastasis)
    LOINC
    LP35033-7
    pretreatment with anthracycline in either the adjuvant or palliative setting.
    Description

    anthracycline

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0003234 (Anthracycline Antibiotics)
    SNOMED
    108787006
    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 (biopsy of breast showed her2 positive carcinoma)
    informed consent
    Description

    informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    more than 1 chemotherapy for advanced disease
    Description

    chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    taxane or trastuzumab pretreatment
    Description

    taxane or trastuzumab

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0215136 (taxane)
    UMLS CUI [2]
    C0728747 (trastuzumab)
    SNOMED
    327397006
    brain metastases
    Description

    brain metastases

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0220650 (Metastatic malignant neoplasm to brain)
    SNOMED
    94225005
    eastern cooperative oncology group (ecog) performance status >1
    Description

    performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    pregnancy or lactation, childbearing potential without reliable contraception
    Description

    pregnancy or lactation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    clinically significant cardiac disease,
    Description

    cardiac disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0018799 (Heart Diseases)
    SNOMED
    56265001
    neutrophils <1500/µl, platelets <75,000/µl
    Description

    neutrophils platelets

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0948762 (Absolute neutrophil count)
    UMLS CUI [2]
    C0005821 (Blood Platelets)
    SNOMED
    16378004
    LOINC
    LP70360-0
    total bilirubin and creatinine >1.5 × the upper limit of normal
    Description

    total bilirubin and creatinine

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201913 (Bilirubin, total measurement)
    SNOMED
    359986008
    UMLS CUI [2]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
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    Similar models

    Eligibility Metastatic Breast Cancer NCT01423695

    1 forms
    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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