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ID

43824

Beschrijving

BEZ235 Trial in Patients With HER2-(Human Epidermal Growth Factor Receptor 2 Negative) /HR+ (Hormonal Receptor Positive) Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01288092

Link

https://clinicaltrials.gov/show/NCT01288092

Trefwoorden

  1. 13-03-16 13-03-16 -
  2. 20-09-21 20-09-21 -
Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY 4.0

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    Eligibility Metastatic Breast Cancer NCT01288092

    Eligibility Metastatic Breast Cancer NCT01288092

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    female ≥ 18 years
    Beschrijving

    female; age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0086287
    UMLS CUI [2]
    C0001779
    ecog performance status ≤ 2
    Beschrijving

    ecog performance status

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    histologically and/or cytologically confirmed diagnosis of breast cancer presenting with metastatic disease (hormone receptor positive and her2 negative)
    Beschrijving

    Neoplasm Metastasis breast cancer; Hormone receptor positive tumor; her2 negative breast cancer

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0027627
    UMLS CUI [1,2]
    C0006142
    UMLS CUI [2]
    C1563119
    UMLS CUI [3]
    C2316304
    known pi3k activation status (defined by pik3ca (phosphoinositide-3-kinase, catalytic, alpha polypeptide) mutation and pten pten (phosphatase and tensin homolog) mutation/expression)
    Beschrijving

    phosphoinositide-3-kinase, catalytic alpha; mutation PTEN gene

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1310696
    UMLS CUI [2,1]
    C0026882
    UMLS CUI [2,2]
    C0694888
    prior treatment with at least one prior line of endocrine therapy and at least two and no more than three prior lines of chemotherapy for metastatic breast cancer
    Beschrijving

    endocrine therapy; chemotherapy metastatic breast cancer

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0279025
    UMLS CUI [2,1]
    C0392920
    UMLS CUI [2,2]
    C0278488
    objective and radiologically confirmed progression of disease after prior treatment and at least one measurable lesion as per recist
    Beschrijving

    Measurable Disease; Cancer Progression

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    UMLS CUI [2]
    C1947901
    adequate bone marrow and organ function
    Beschrijving

    organ function; bone marrow function

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0678852
    UMLS CUI [2]
    C0412480
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    previous treatment with pi3k and/or mtor inhibitors
    Beschrijving

    mtor inhibitors; phosphoinositide-3-kinase

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1515672
    UMLS CUI [2]
    C1310696
    symptomatic central nervous system (cns) metastases
    Beschrijving

    cns metastase

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0686377
    concurrent malignancy or malignancy in the last 5 years prior to start of study treatment
    Beschrijving

    malignancy

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug
    Beschrijving

    field radiotherapy; palliation radiation

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3826993
    UMLS CUI [2]
    C0475092
    active cardiac disease (e.g. left ventricular ejection fraction (lvef) < 50%, qtcf > 480 msec on screening ecgelectrocardiogram (ecg), unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias)
    Beschrijving

    left ventricular ejection fraction; qtcf; electrocardiogram; Angina, Unstable; Cardiac Arrhythmia

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0428772
    UMLS CUI [2]
    C1882513
    UMLS CUI [3]
    C0013798
    UMLS CUI [4]
    C0002965
    UMLS CUI [5]
    C0003811
    inadequately controlled hypertension
    Beschrijving

    hypertension

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0020538
    impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of bez235
    Beschrijving

    gastrointestinal disease; absorption bez235

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0017178
    UMLS CUI [2,1]
    C2698776
    UMLS CUI [2,2]
    C2347425
    treatment at start of study treatment with drugs with a known risk to induce torsades de pointes, moderate and strong inhibitors or inducers of isoenzyme cyp3a4, warfarin and coumadin analogues, lhrh agonists
    Beschrijving

    torsades de pointes; cyp3a4 inhibitor; warfarin; coumadin

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0040479
    UMLS CUI [2]
    C3830624
    UMLS CUI [3]
    C0043031
    UMLS CUI [4]
    C0699129
    history of photosensitivity reactions to other drugs
    Beschrijving

    drug photosensitivity

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0263586
    pregnant or nursing (lactating) woman
    Beschrijving

    pregnancy; lactating

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    other protocol-defined inclusion/exclusion criteria may apply
    Beschrijving

    exclusion criteria

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0680251

    Similar models

    Eligibility Metastatic Breast Cancer NCT01288092

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    female; age
    Item
    female ≥ 18 years
    boolean
    C0086287 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    ecog performance status
    Item
    ecog performance status ≤ 2
    boolean
    C1520224 (UMLS CUI [1])
    Neoplasm Metastasis breast cancer; Hormone receptor positive tumor; her2 negative breast cancer
    Item
    histologically and/or cytologically confirmed diagnosis of breast cancer presenting with metastatic disease (hormone receptor positive and her2 negative)
    boolean
    C0027627 (UMLS CUI [1,1])
    C0006142 (UMLS CUI [1,2])
    C1563119 (UMLS CUI [2])
    C2316304 (UMLS CUI [3])
    phosphoinositide-3-kinase, catalytic alpha; mutation PTEN gene
    Item
    known pi3k activation status (defined by pik3ca (phosphoinositide-3-kinase, catalytic, alpha polypeptide) mutation and pten pten (phosphatase and tensin homolog) mutation/expression)
    boolean
    C1310696 (UMLS CUI [1])
    C0026882 (UMLS CUI [2,1])
    C0694888 (UMLS CUI [2,2])
    endocrine therapy; chemotherapy metastatic breast cancer
    Item
    prior treatment with at least one prior line of endocrine therapy and at least two and no more than three prior lines of chemotherapy for metastatic breast cancer
    boolean
    C0279025 (UMLS CUI [1])
    C0392920 (UMLS CUI [2,1])
    C0278488 (UMLS CUI [2,2])
    Measurable Disease; Cancer Progression
    Item
    objective and radiologically confirmed progression of disease after prior treatment and at least one measurable lesion as per recist
    boolean
    C1513041 (UMLS CUI [1])
    C1947901 (UMLS CUI [2])
    organ function; bone marrow function
    Item
    adequate bone marrow and organ function
    boolean
    C0678852 (UMLS CUI [1])
    C0412480 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    mtor inhibitors; phosphoinositide-3-kinase
    Item
    previous treatment with pi3k and/or mtor inhibitors
    boolean
    C1515672 (UMLS CUI [1])
    C1310696 (UMLS CUI [2])
    cns metastase
    Item
    symptomatic central nervous system (cns) metastases
    boolean
    C0686377 (UMLS CUI [1])
    malignancy
    Item
    concurrent malignancy or malignancy in the last 5 years prior to start of study treatment
    boolean
    C0006826 (UMLS CUI [1])
    field radiotherapy; palliation radiation
    Item
    wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug
    boolean
    C3826993 (UMLS CUI [1])
    C0475092 (UMLS CUI [2])
    left ventricular ejection fraction; qtcf; electrocardiogram; Angina, Unstable; Cardiac Arrhythmia
    Item
    active cardiac disease (e.g. left ventricular ejection fraction (lvef) < 50%, qtcf > 480 msec on screening ecgelectrocardiogram (ecg), unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias)
    boolean
    C0428772 (UMLS CUI [1])
    C1882513 (UMLS CUI [2])
    C0013798 (UMLS CUI [3])
    C0002965 (UMLS CUI [4])
    C0003811 (UMLS CUI [5])
    hypertension
    Item
    inadequately controlled hypertension
    boolean
    C0020538 (UMLS CUI [1])
    gastrointestinal disease; absorption bez235
    Item
    impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of bez235
    boolean
    C0017178 (UMLS CUI [1])
    C2698776 (UMLS CUI [2,1])
    C2347425 (UMLS CUI [2,2])
    torsades de pointes; cyp3a4 inhibitor; warfarin; coumadin
    Item
    treatment at start of study treatment with drugs with a known risk to induce torsades de pointes, moderate and strong inhibitors or inducers of isoenzyme cyp3a4, warfarin and coumadin analogues, lhrh agonists
    boolean
    C0040479 (UMLS CUI [1])
    C3830624 (UMLS CUI [2])
    C0043031 (UMLS CUI [3])
    C0699129 (UMLS CUI [4])
    drug photosensitivity
    Item
    history of photosensitivity reactions to other drugs
    boolean
    C0263586 (UMLS CUI [1])
    pregnancy; lactating
    Item
    pregnant or nursing (lactating) woman
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    exclusion criteria
    Item
    other protocol-defined inclusion/exclusion criteria may apply
    boolean
    C0680251 (UMLS CUI [1])

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