0 Ratings
ID

20197

Description

Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00300781

Link

https://clinicaltrials.gov/show/NCT00300781

Keywords

Versions (1)
  1. 2/11/17 2/11/17 -
Uploaded on

February 11, 2017

DOI

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License

Creative Commons BY 4.0
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    Eligibility Breast Neoplasms NCT00300781

    English

    Eligibility Breast Neoplasms NCT00300781

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    pathologic diagnosis of breast cancer and current stage iiib, iiic, or iv
    Description

    Breast cancer stage

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0678222
    UMLS CUI [1,2]
    C0027646
    progression following at least 6 weeks of standard doses of herceptin (arm a only)
    Description

    Herceptin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0338204
    over-expression of her2
    Description

    Over-expression of her2

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3812393
    tumor tissue available and adequate for analysis at screening
    Description

    Tumor tissue sample

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0475358
    at least one measurable lesion
    Description

    Measurable lesion

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    prior treatment with herceptin (arm b only)
    Description

    Prior treatment with herceptin

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0338204
    more than 4 prior cytotoxic chemotherapy regimens
    Description

    Chemotherapy regimen

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    subjects with bone or skin as the only site of measurable disease
    Description

    Bone or skin lesion

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0238792
    UMLS CUI [2]
    C0037284
    inadequate cardiac function
    Description

    Cardiac function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232164
    major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 1 week of treatment day 1
    Description

    Prior treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1514463
    active central nervous system metastases
    Description

    Brain metastasis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0220650
    pregnant or breastfeeding women
    Description

    Gynaecological status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    inability to swallow the hki-272 capsules
    Description

    Swallowing problem

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0392678
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    Similar models

    Eligibility Breast Neoplasms NCT00300781

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Breast cancer stage
    Item
    pathologic diagnosis of breast cancer and current stage iiib, iiic, or iv
    boolean
    C0678222 (UMLS CUI [1,1])
    C0027646 (UMLS CUI [1,2])
    Herceptin
    Item
    progression following at least 6 weeks of standard doses of herceptin (arm a only)
    boolean
    C0338204 (UMLS CUI [1])
    Over-expression of her2
    Item
    over-expression of her2
    boolean
    C3812393 (UMLS CUI [1])
    Tumor tissue sample
    Item
    tumor tissue available and adequate for analysis at screening
    boolean
    C0475358 (UMLS CUI [1])
    Measurable lesion
    Item
    at least one measurable lesion
    boolean
    C1513041 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Prior treatment with herceptin
    Item
    prior treatment with herceptin (arm b only)
    boolean
    C1514463 (UMLS CUI [1,1])
    C0338204 (UMLS CUI [1,2])
    Chemotherapy regimen
    Item
    more than 4 prior cytotoxic chemotherapy regimens
    boolean
    C0392920 (UMLS CUI [1])
    Bone or skin lesion
    Item
    subjects with bone or skin as the only site of measurable disease
    boolean
    C0238792 (UMLS CUI [1])
    C0037284 (UMLS CUI [2])
    Cardiac function
    Item
    inadequate cardiac function
    boolean
    C0232164 (UMLS CUI [1])
    Prior treatment
    Item
    major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 1 week of treatment day 1
    boolean
    C1514463 (UMLS CUI [1])
    Brain metastasis
    Item
    active central nervous system metastases
    boolean
    C0220650 (UMLS CUI [1])
    Gynaecological status
    Item
    pregnant or breastfeeding women
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Swallowing problem
    Item
    inability to swallow the hki-272 capsules
    boolean
    C0392678 (UMLS CUI [1])
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