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ID

16259

Beschreibung

Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00193076

Link

https://clinicaltrials.gov/show/NCT00193076

Stichworte

  1. 08.07.16 08.07.16 -
Hochgeladen am

8. Juli 2016

DOI

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Lizenz

Creative Commons BY 4.0

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    Eligibility Breast Cancer NCT00193076

    Eligibility Breast Cancer NCT00193076

    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    to be included in this study, you must meet the following criteria:
    Beschreibung

    ID.1

    Datentyp

    boolean

    locally advanced or metastatic breast cancer
    Beschreibung

    Locally advanced breast cancer | Carcinoma breast stage IV

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3495949
    UMLS CUI [2]
    C0278488
    measurable disease as per recist criteria
    Beschreibung

    Measurable Disease

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    no prior chemotherapy in the metastatic breast setting
    Beschreibung

    Prior Chemotherapy Carcinoma breast stage IV

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457
    UMLS CUI [1,2]
    C0278488
    prior chemotherapy and/or hormonal therapy for early stage breast cancer
    Beschreibung

    Prior Chemotherapy Early-Stage Breast Carcinoma | Hormone Therapy Early-Stage Breast Carcinoma

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457
    UMLS CUI [1,2]
    C2986665
    UMLS CUI [2,1]
    C0279025
    UMLS CUI [2,2]
    C2986665
    adjuvant herceptin is allowed
    Beschreibung

    Herceptin Adjuvant

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0338204
    UMLS CUI [1,2]
    C1522673
    prior radiation therapy in either the metastatic or early stage setting
    Beschreibung

    prior radiation therapy Carcinoma breast stage IV | prior radiation therapy Early-Stage Breast Carcinoma

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0279134
    UMLS CUI [1,2]
    C0278488
    UMLS CUI [2,1]
    C0279134
    UMLS CUI [2,2]
    C2986665
    patients may have received any number of hormonal therapies
    Beschreibung

    Hormone Therapy Quantity

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0279025
    UMLS CUI [1,2]
    C1265611
    age >18 years
    Beschreibung

    Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    only women are eligible for the study
    Beschreibung

    Gender

    Datentyp

    boolean

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

    Performance of activities of daily living Ability | Assistance Minimal

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1821398
    UMLS CUI [1,2]
    C0085732
    UMLS CUI [2,1]
    C0557034
    UMLS CUI [2,2]
    C0547040
    normal organ and bone marrow function
    Beschreibung

    organ function | Bone Marrow function

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0678852
    UMLS CUI [2,1]
    C0005953
    UMLS CUI [2,2]
    C0031843
    patients who will be receiving trastuzumab must have normal heart function
    Beschreibung

    trastuzumab | Cardiac function

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0728747
    UMLS CUI [2]
    C0232164
    sign a written informed consent document
    Beschreibung

    Informed consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    you cannot participate in this study if any of the following apply to you:
    Beschreibung

    Study Subject Participation Status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    received prior chemotherapy for metastatic breast cancer
    Beschreibung

    Prior Chemotherapy Carcinoma breast stage IV

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457
    UMLS CUI [1,2]
    C0278488
    known leptomeningeal carcinomatosis
    Beschreibung

    Leptomeningeal Carcinomatosis

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0220654
    uncontrolled brain metastasis
    Beschreibung

    Metastatic malignant neoplasm to brain Uncontrolled

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0220650
    UMLS CUI [1,2]
    C0205318
    uncontrolled intercurrent illness
    Beschreibung

    Intercurrent disease Uncontrolled

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0277557
    UMLS CUI [1,2]
    C0205318
    pregnant or lactating
    Beschreibung

    Pregnancy | Breast Feeding

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    history of other non-breast cancer malignancy
    Beschreibung

    Malignant Neoplasms | Breast Carcinoma

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2]
    C0678222
    received prior chemotherapy for early stage breast cancer within 6 months
    Beschreibung

    Prior Chemotherapy Early-Stage Breast Carcinoma

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457
    UMLS CUI [1,2]
    C2986665
    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.
    Beschreibung

    criteria Additional | Study Subject Participation Status

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0243161
    UMLS CUI [1,2]
    C1524062
    UMLS CUI [2]
    C2348568

    Ähnliche Modelle

    Eligibility Breast Cancer NCT00193076

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    ID.1
    Item
    to be included in this study, you must meet the following criteria:
    boolean
    Locally advanced breast cancer | Carcinoma breast stage IV
    Item
    locally advanced or metastatic breast cancer
    boolean
    C3495949 (UMLS CUI [1])
    C0278488 (UMLS CUI [2])
    Measurable Disease
    Item
    measurable disease as per recist criteria
    boolean
    C1513041 (UMLS CUI [1])
    Prior Chemotherapy Carcinoma breast stage IV
    Item
    no prior chemotherapy in the metastatic breast setting
    boolean
    C1514457 (UMLS CUI [1,1])
    C0278488 (UMLS CUI [1,2])
    Prior Chemotherapy Early-Stage Breast Carcinoma | Hormone Therapy Early-Stage Breast Carcinoma
    Item
    prior chemotherapy and/or hormonal therapy for early stage breast cancer
    boolean
    C1514457 (UMLS CUI [1,1])
    C2986665 (UMLS CUI [1,2])
    C0279025 (UMLS CUI [2,1])
    C2986665 (UMLS CUI [2,2])
    Herceptin Adjuvant
    Item
    adjuvant herceptin is allowed
    boolean
    C0338204 (UMLS CUI [1,1])
    C1522673 (UMLS CUI [1,2])
    prior radiation therapy Carcinoma breast stage IV | prior radiation therapy Early-Stage Breast Carcinoma
    Item
    prior radiation therapy in either the metastatic or early stage setting
    boolean
    C0279134 (UMLS CUI [1,1])
    C0278488 (UMLS CUI [1,2])
    C0279134 (UMLS CUI [2,1])
    C2986665 (UMLS CUI [2,2])
    Hormone Therapy Quantity
    Item
    patients may have received any number of hormonal therapies
    boolean
    C0279025 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    Age
    Item
    age >18 years
    boolean
    C0001779 (UMLS CUI [1])
    Gender
    Item
    only women are eligible for the study
    boolean
    C0079399 (UMLS CUI [1])
    Performance of activities of daily living Ability | Assistance Minimal
    Item
    able to perform activities of daily living with minimal assistance
    boolean
    C1821398 (UMLS CUI [1,1])
    C0085732 (UMLS CUI [1,2])
    C0557034 (UMLS CUI [2,1])
    C0547040 (UMLS CUI [2,2])
    organ function | Bone Marrow function
    Item
    normal organ and bone marrow function
    boolean
    C0678852 (UMLS CUI [1])
    C0005953 (UMLS CUI [2,1])
    C0031843 (UMLS CUI [2,2])
    trastuzumab | Cardiac function
    Item
    patients who will be receiving trastuzumab must have normal heart function
    boolean
    C0728747 (UMLS CUI [1])
    C0232164 (UMLS CUI [2])
    Informed consent
    Item
    sign a written informed consent document
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Study Subject Participation Status
    Item
    you cannot participate in this study if any of the following apply to you:
    boolean
    C2348568 (UMLS CUI [1])
    Prior Chemotherapy Carcinoma breast stage IV
    Item
    received prior chemotherapy for metastatic breast cancer
    boolean
    C1514457 (UMLS CUI [1,1])
    C0278488 (UMLS CUI [1,2])
    Leptomeningeal Carcinomatosis
    Item
    known leptomeningeal carcinomatosis
    boolean
    C0220654 (UMLS CUI [1])
    Metastatic malignant neoplasm to brain Uncontrolled
    Item
    uncontrolled brain metastasis
    boolean
    C0220650 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    Intercurrent disease Uncontrolled
    Item
    uncontrolled intercurrent illness
    boolean
    C0277557 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    Pregnancy | Breast Feeding
    Item
    pregnant or lactating
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Malignant Neoplasms | Breast Carcinoma
    Item
    history of other non-breast cancer malignancy
    boolean
    C0006826 (UMLS CUI [1])
    C0678222 (UMLS CUI [2])
    Prior Chemotherapy Early-Stage Breast Carcinoma
    Item
    received prior chemotherapy for early stage breast cancer within 6 months
    boolean
    C1514457 (UMLS CUI [1,1])
    C2986665 (UMLS CUI [1,2])
    criteria Additional | Study Subject Participation Status
    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
    C0243161 (UMLS CUI [1,1])
    C1524062 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [2])

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