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ID

15287

Beschreibung

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

Stichworte

Versionen (1)
  1. 25.05.16 25.05.16 -
Hochgeladen am

25. Mai 2016

DOI

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

    Englisch

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

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

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

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2,1]
    C3495949
    UMLS CUI [2,2]
    C2945760
    UMLS CUI [3,1]
    C3495917
    UMLS CUI [3,2]
    C1522484
    UMLS CUI [4]
    C1273390
    UMLS CUI [5]
    C1511562
    UMLS CUI [6]
    C1522449
    patient is postmenopausal.
    Beschreibung

    Postmenopausal state

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0232970
    patient has a histologically and/or cytologically confirmed diagnosis of estrogen receptor positive and/or progesterone receptor positive breast cancer
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2367479
    UMLS CUI [2]
    C0344441
    UMLS CUI [3]
    C1305671
    patient has her2-negative breast cancer
    Beschreibung

    Human epidermal growth factor 2 negative carcinoma of breast

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2316304
    patient has adequate bone marrow and organ function
    Beschreibung

    Bone Marrow physiological aspects | organ function

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005953
    UMLS CUI [1,2]
    C0031843
    UMLS CUI [2]
    C0678852
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patient who received any cdk4/6 inhibitor.
    Beschreibung

    CDK4/6 Inhibition

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3899807
    patient has a known hypersensitivity to any of the excipients of lee011 or letrozole
    Beschreibung

    Hypersensitivity LEE011 Excipient | Hypersensitivity letrozole Excipient

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C2987342
    UMLS CUI [1,3]
    C0015237
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0246421
    UMLS CUI [2,3]
    C0015237
    patients with inflammatory breast cancer.
    Beschreibung

    Inflammatory Breast Carcinoma

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0278601
    patient who received any prior systemic anti-cancer therapy (including hormonal therapy and chemotherapy) for advanced breast cancer
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3495917
    UMLS CUI [2,1]
    C0920425
    UMLS CUI [2,2]
    C0205373
    UMLS CUI [3]
    C0279025
    UMLS CUI [4]
    C0392920
    patient is currently using other anti-cancer therapy
    Beschreibung

    Cancer treatment Other

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0920425
    UMLS CUI [1,2]
    C0205394
    patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
    Beschreibung

    major surgery | Investigational New Drugs | adverse effects Major

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0679637
    UMLS CUI [2]
    C0013230
    UMLS CUI [3,1]
    C0001688
    UMLS CUI [3,2]
    C0205164
    patient who has received radiotherapy ≤ 4 weeks
    Beschreibung

    Therapeutic radiology procedure

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1522449
    patient has a concurrent malignancy or malignancy within 3 years
    Beschreibung

    Malignant Neoplasms

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    patient has metastases to the central nervous system (cns).
    Beschreibung

    CNS metastases

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0686377
    patient has a known history of hiv infection
    Beschreibung

    HIV Infections

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    other protocol-defined inclusion/exclusion criteria may apply
    Beschreibung

    Inclusion Other | Exclusion Criteria Other

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2,1]
    C0680251
    UMLS CUI [2,2]
    C0205394
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

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

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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])
    Zum Seitenanfang zurückkehren 

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