0 Ratings
ID

16428

Description

A Study of Pertuzumab in Participants With Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02491892

Link

https://clinicaltrials.gov/show/NCT02491892

Keywords

Versions (2)
  1. 7/16/16 7/16/16 -
  2. 9/17/21 9/17/21 -
Uploaded on

July 16, 2016

DOI

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License

Creative Commons BY 4.0
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    Eligibility Breast Cancer NCT02491892

    English

    Eligibility Breast Cancer NCT02491892

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    females at least 18 years of age
    Description

    Gender | Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [2]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    histologically-confirmed metastatic breast cancer with low her2 expression and at least one measurable lesion according to response evaluation criteria in solid tumors (recist)
    Description

    Carcinoma breast stage IV | HER-2 protein overexpression low | Measurable lesion

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0278488 (Carcinoma breast stage IV)
    UMLS CUI [2,1]
    C3888504 (undefined)
    UMLS CUI [2,2]
    C0205251 (low)
    SNOMED
    62482003
    UMLS CUI [3]
    C1513041 (Measurable Disease)
    karnofsky performance status at least 80%
    Description

    Karnofsky Performance Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0206065 (Karnofsky Performance Status)
    SNOMED
    273546003
    LOINC
    LP267177-6
    disease progression on/after up to 2 different chemotherapy regimens, including an anthracycline-containing therapy
    Description

    Chemotherapy Quantity | Anthracycline Antibiotics | Disease Progression

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [1,2]
    C1265611 (Quantity)
    SNOMED
    246205007
    LOINC
    LP202968-6
    UMLS CUI [2]
    C0003234 (Anthracycline Antibiotics)
    SNOMED
    108787006
    UMLS CUI [3]
    C0242656 (Disease Progression)
    SNOMED
    246453008
    LOINC
    LP121764-7
    left ventricular ejection fraction (lvef) at least 50%
    Description

    Left ventricular ejection fraction

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0428772 (Left ventricular ejection fraction)
    SNOMED
    250908004
    adequate liver function
    Description

    Liver function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232741 (Liver function)
    SNOMED
    79036002
    LOINC
    LP31397-0
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    pleural effusions, ascites, or bone lesions as the only manifestation(s) of cancer
    Description

    Malignant Neoplasm Manifestation of | Pleural effusion disorder | Ascites | Bone lesion

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [1,2]
    C1280464 (Manifestation of)
    SNOMED
    251190009
    UMLS CUI [2]
    C0032227 (Pleural effusion disorder)
    UMLS CUI [3]
    C0003962 (Ascites)
    SNOMED
    389026000
    LOINC
    LA17637-2
    UMLS CUI [4]
    C0238792 (Bone lesion)
    SNOMED
    879976004
    pulmonary or central nervous system (cns) metastases
    Description

    Secondary malignant neoplasm of lung | CNS metastases

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0153676 (Secondary malignant neoplasm of lung)
    SNOMED
    94391008
    UMLS CUI [2]
    C0686377 (CNS metastases)
    SNOMED
    94243009
    chemotherapy, radiotherapy, or immunotherapy within 4 weeks; or hormone therapy within 2 weeks of day 1
    Description

    Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Hormone Therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [2]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    UMLS CUI [3]
    C0021083 (Immunotherapy)
    SNOMED
    76334006
    UMLS CUI [4]
    C0279025 (Hormone Therapy)
    SNOMED
    169413002
    previous treatment with any drug that targets the her2 receptor family
    Description

    Pharmaceutical Preparation Targeting erbB-2 Receptor

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C1521840 (Target)
    UMLS CUI [1,3]
    C0069515 (erbB-2 Receptor)
    SNOMED
    44368005
    LOINC
    LP28442-9
    previous treatment with corticosteroids as cancer therapy
    Description

    cancer treatment | Adrenal Cortex Hormones

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0920425 (cancer treatment)
    UMLS CUI [2]
    C0001617 (Adrenal Cortex Hormones)
    SNOMED
    21568003
    LOINC
    LP20687-7
    history of significant cardiac disease
    Description

    Heart Disease Significant

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018799 (Heart Diseases)
    SNOMED
    56265001
    UMLS CUI [1,2]
    C0750502 (Significant)
    SNOMED
    386134007
    LOINC
    LA28474-7
    major surgery or trauma within 4 weeks of day 1
    Description

    major surgery | Major trauma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0679637 (major surgery)
    UMLS CUI [2]
    C0332677 (major injury)
    pregnant or lactating women
    Description

    Pregnancy | Breast Feeding

    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
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    Similar models

    Eligibility Breast Cancer NCT02491892

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Gender | Age
    Item
    females at least 18 years of age
    boolean
    C0079399 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    Carcinoma breast stage IV | HER-2 protein overexpression low | Measurable lesion
    Item
    histologically-confirmed metastatic breast cancer with low her2 expression and at least one measurable lesion according to response evaluation criteria in solid tumors (recist)
    boolean
    C0278488 (UMLS CUI [1])
    C3888504 (UMLS CUI [2,1])
    C0205251 (UMLS CUI [2,2])
    C1513041 (UMLS CUI [3])
    Karnofsky Performance Status
    Item
    karnofsky performance status at least 80%
    boolean
    C0206065 (UMLS CUI [1])
    Chemotherapy Quantity | Anthracycline Antibiotics | Disease Progression
    Item
    disease progression on/after up to 2 different chemotherapy regimens, including an anthracycline-containing therapy
    boolean
    C0392920 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C0003234 (UMLS CUI [2])
    C0242656 (UMLS CUI [3])
    Left ventricular ejection fraction
    Item
    left ventricular ejection fraction (lvef) at least 50%
    boolean
    C0428772 (UMLS CUI [1])
    Liver function
    Item
    adequate liver function
    boolean
    C0232741 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Malignant Neoplasm Manifestation of | Pleural effusion disorder | Ascites | Bone lesion
    Item
    pleural effusions, ascites, or bone lesions as the only manifestation(s) of cancer
    boolean
    C0006826 (UMLS CUI [1,1])
    C1280464 (UMLS CUI [1,2])
    C0032227 (UMLS CUI [2])
    C0003962 (UMLS CUI [3])
    C0238792 (UMLS CUI [4])
    Secondary malignant neoplasm of lung | CNS metastases
    Item
    pulmonary or central nervous system (cns) metastases
    boolean
    C0153676 (UMLS CUI [1])
    C0686377 (UMLS CUI [2])
    Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Hormone Therapy
    Item
    chemotherapy, radiotherapy, or immunotherapy within 4 weeks; or hormone therapy within 2 weeks of day 1
    boolean
    C0392920 (UMLS CUI [1])
    C1522449 (UMLS CUI [2])
    C0021083 (UMLS CUI [3])
    C0279025 (UMLS CUI [4])
    Pharmaceutical Preparation Targeting erbB-2 Receptor
    Item
    previous treatment with any drug that targets the her2 receptor family
    boolean
    C0013227 (UMLS CUI [1,1])
    C1521840 (UMLS CUI [1,2])
    C0069515 (UMLS CUI [1,3])
    cancer treatment | Adrenal Cortex Hormones
    Item
    previous treatment with corticosteroids as cancer therapy
    boolean
    C0920425 (UMLS CUI [1])
    C0001617 (UMLS CUI [2])
    Heart Disease Significant
    Item
    history of significant cardiac disease
    boolean
    C0018799 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    major surgery | Major trauma
    Item
    major surgery or trauma within 4 weeks of day 1
    boolean
    C0679637 (UMLS CUI [1])
    C0332677 (UMLS CUI [2])
    Pregnancy | Breast Feeding
    Item
    pregnant or lactating women
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
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