0 Evaluaciones
ID

15287

Descripción

Phase Ib Dose-escalation, Phase II Study of LEE011 and Letrozole for Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02333370

Link

https://clinicaltrials.gov/show/NCT02333370

Palabras clave

Versiones (1)
  1. 25/5/16 25/5/16 -
Subido en

25 de mayo de 2016

DOI

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Licencia

Creative Commons BY 4.0
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    Eligibility Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer NCT02333370

    Inglés

    Eligibility Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer NCT02333370

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    women with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy (surgery and/or radiotherapy).
    Descripción

    Gender | Locally advanced breast cancer Recurrent | Advanced breast cancer metastatic | curative treatment | Curative Surgery | Therapeutic radiology procedure

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [2,1]
    C3495949 (Locally advanced breast cancer)
    SNOMED
    1082701000112100
    UMLS CUI [2,2]
    C2945760 (Recurrent)
    SNOMED
    255227004
    UMLS CUI [3,1]
    C3495917 (Advanced breast cancer)
    UMLS CUI [3,2]
    C1522484 (metastatic qualifier)
    UMLS CUI [4]
    C1273390 (curative treatment)
    UMLS CUI [5]
    C1511562 (Curative Surgery)
    UMLS CUI [6]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    patient is postmenopausal.
    Descripción

    Postmenopausal state

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0232970 (Postmenopausal state)
    SNOMED
    76498008
    patient has a histologically and/or cytologically confirmed diagnosis of estrogen receptor positive and/or progesterone receptor positive breast cancer
    Descripción

    estrogen or progesterone receptor positive for breast cancer | Histology | Cytology

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2367479 (estrogen or progesterone receptor positive for breast cancer)
    UMLS CUI [2]
    C0344441 (Histology Procedure)
    SNOMED
    714797009
    LOINC
    LP72693-2
    UMLS CUI [3]
    C1305671 (Cytology procedure)
    LOINC
    LP7789-3
    patient has her2-negative breast cancer
    Descripción

    Human epidermal growth factor 2 negative carcinoma of breast

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2316304 (Human epidermal growth factor 2 negative carcinoma of breast)
    SNOMED
    431396003
    patient has adequate bone marrow and organ function
    Descripción

    Bone Marrow physiological aspects | organ function

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0005953 (Bone Marrow)
    SNOMED
    279729006
    LOINC
    LP7410-6
    UMLS CUI [1,2]
    C0031843 (physiological aspects)
    UMLS CUI [2]
    C0678852 (body system or organ function)
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    patient who received any cdk4/6 inhibitor.
    Descripción

    CDK4/6 Inhibition

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C3899807 (CDK4/6 Inhibition)
    patient has a known hypersensitivity to any of the excipients of lee011 or letrozole
    Descripción

    Hypersensitivity LEE011 Excipient | Hypersensitivity letrozole Excipient

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C2987342 (LEE011)
    UMLS CUI [1,3]
    C0015237 (Pharmaceutical Excipient)
    SNOMED
    43747001
    UMLS CUI [2,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [2,2]
    C0246421 (letrozole)
    SNOMED
    108777007
    UMLS CUI [2,3]
    C0015237 (Pharmaceutical Excipient)
    SNOMED
    43747001
    patients with inflammatory breast cancer.
    Descripción

    Inflammatory Breast Carcinoma

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0278601 (Inflammatory Breast Carcinoma)
    SNOMED
    254840009
    patient who received any prior systemic anti-cancer therapy (including hormonal therapy and chemotherapy) for advanced breast cancer
    Descripción

    Advanced breast cancer | Cancer treatment Systemic | Hormone Therapy | Chemotherapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C3495917 (Advanced breast cancer)
    UMLS CUI [2,1]
    C0920425 (cancer treatment)
    UMLS CUI [2,2]
    C0205373 (Systemic)
    SNOMED
    31099001
    UMLS CUI [3]
    C0279025 (Hormone Therapy)
    SNOMED
    169413002
    UMLS CUI [4]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    patient is currently using other anti-cancer therapy
    Descripción

    Cancer treatment Other

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0920425 (cancer treatment)
    UMLS CUI [1,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
    Descripción

    major surgery | Investigational New Drugs | adverse effects Major

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0679637 (major surgery)
    UMLS CUI [2]
    C0013230 (Investigational New Drugs)
    UMLS CUI [3,1]
    C0001688 (aspects of adverse effects)
    UMLS CUI [3,2]
    C0205164 (Major)
    SNOMED
    255603008
    LOINC
    LA29634-5
    patient who has received radiotherapy ≤ 4 weeks
    Descripción

    Therapeutic radiology procedure

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    patient has a concurrent malignancy or malignancy within 3 years
    Descripción

    Malignant Neoplasms

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    patient has metastases to the central nervous system (cns).
    Descripción

    CNS metastases

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0686377 (CNS metastases)
    SNOMED
    94243009
    patient has a known history of hiv infection
    Descripción

    HIV Infections

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0019693 (HIV Infections)
    SNOMED
    86406008
    other protocol-defined inclusion/exclusion criteria may apply
    Descripción

    Inclusion Other | Exclusion Criteria Other

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1512693 (Inclusion)
    UMLS CUI [1,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [2,1]
    C0680251 (Exclusion Criteria)
    UMLS CUI [2,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
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    Similar models

    Eligibility Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer NCT02333370

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Gender | Locally advanced breast cancer Recurrent | Advanced breast cancer metastatic | curative treatment | Curative Surgery | Therapeutic radiology procedure
    Item
    women with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy (surgery and/or radiotherapy).
    boolean
    C0079399 (UMLS CUI [1])
    C3495949 (UMLS CUI [2,1])
    C2945760 (UMLS CUI [2,2])
    C3495917 (UMLS CUI [3,1])
    C1522484 (UMLS CUI [3,2])
    C1273390 (UMLS CUI [4])
    C1511562 (UMLS CUI [5])
    C1522449 (UMLS CUI [6])
    Postmenopausal state
    Item
    patient is postmenopausal.
    boolean
    C0232970 (UMLS CUI [1])
    estrogen or progesterone receptor positive for breast cancer | Histology | Cytology
    Item
    patient has a histologically and/or cytologically confirmed diagnosis of estrogen receptor positive and/or progesterone receptor positive breast cancer
    boolean
    C2367479 (UMLS CUI [1])
    C0344441 (UMLS CUI [2])
    C1305671 (UMLS CUI [3])
    Human epidermal growth factor 2 negative carcinoma of breast
    Item
    patient has her2-negative breast cancer
    boolean
    C2316304 (UMLS CUI [1])
    Bone Marrow physiological aspects | organ function
    Item
    patient has adequate bone marrow and organ function
    boolean
    C0005953 (UMLS CUI [1,1])
    C0031843 (UMLS CUI [1,2])
    C0678852 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    CDK4/6 Inhibition
    Item
    patient who received any cdk4/6 inhibitor.
    boolean
    C3899807 (UMLS CUI [1])
    Hypersensitivity LEE011 Excipient | Hypersensitivity letrozole Excipient
    Item
    patient has a known hypersensitivity to any of the excipients of lee011 or letrozole
    boolean
    C0020517 (UMLS CUI [1,1])
    C2987342 (UMLS CUI [1,2])
    C0015237 (UMLS CUI [1,3])
    C0020517 (UMLS CUI [2,1])
    C0246421 (UMLS CUI [2,2])
    C0015237 (UMLS CUI [2,3])
    Inflammatory Breast Carcinoma
    Item
    patients with inflammatory breast cancer.
    boolean
    C0278601 (UMLS CUI [1])
    Advanced breast cancer | Cancer treatment Systemic | Hormone Therapy | Chemotherapy
    Item
    patient who received any prior systemic anti-cancer therapy (including hormonal therapy and chemotherapy) for advanced breast cancer
    boolean
    C3495917 (UMLS CUI [1])
    C0920425 (UMLS CUI [2,1])
    C0205373 (UMLS CUI [2,2])
    C0279025 (UMLS CUI [3])
    C0392920 (UMLS CUI [4])
    Cancer treatment Other
    Item
    patient is currently using other anti-cancer therapy
    boolean
    C0920425 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    major surgery | Investigational New Drugs | adverse effects Major
    Item
    patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
    boolean
    C0679637 (UMLS CUI [1])
    C0013230 (UMLS CUI [2])
    C0001688 (UMLS CUI [3,1])
    C0205164 (UMLS CUI [3,2])
    Therapeutic radiology procedure
    Item
    patient who has received radiotherapy ≤ 4 weeks
    boolean
    C1522449 (UMLS CUI [1])
    Malignant Neoplasms
    Item
    patient has a concurrent malignancy or malignancy within 3 years
    boolean
    C0006826 (UMLS CUI [1])
    CNS metastases
    Item
    patient has metastases to the central nervous system (cns).
    boolean
    C0686377 (UMLS CUI [1])
    HIV Infections
    Item
    patient has a known history of hiv infection
    boolean
    C0019693 (UMLS CUI [1])
    Inclusion Other | Exclusion Criteria Other
    Item
    other protocol-defined inclusion/exclusion criteria may apply
    boolean
    C1512693 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0680251 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
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