0 Bedömningar
ID

16431

Beskrivning

Study in Women With Metastatic Breast Cancer Whose Cancer Has Gotten Worse After Anthracycline and Taxane Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00067314

Länk

https://clinicaltrials.gov/show/NCT00067314

Nyckelord

Versioner (1)
  1. 2016-07-16 2016-07-16 -
Uppladdad den

16 juli 2016

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Breast Neoplasms NCT00067314

    Engelsk

    Eligibility Breast Neoplasms NCT00067314

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    locally advanced or metastatic breast cancer not amenable to surgery or radiation with curative intent
    Beskrivning

    Locally advanced breast cancer Amenable Operative Surgical Procedures | Carcinoma breast stage IV Amenable Operative Surgical Procedures | Locally advanced breast cancer Amenable Therapeutic radiology procedure Curative | Carcinoma breast stage IV Amenable Therapeutic radiology procedure Curative

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3495949
    UMLS CUI [1,2]
    C3900053
    UMLS CUI [1,3]
    C0543467
    UMLS CUI [2,1]
    C0278488
    UMLS CUI [2,2]
    C3900053
    UMLS CUI [2,3]
    C0543467
    UMLS CUI [3,1]
    C3495949
    UMLS CUI [3,2]
    C3900053
    UMLS CUI [3,3]
    C1522449
    UMLS CUI [3,4]
    C1276305
    UMLS CUI [4,1]
    C0278488
    UMLS CUI [4,2]
    C3900053
    UMLS CUI [4,3]
    C1522449
    UMLS CUI [4,4]
    C1276305
    must have received any chemotherapy regimen in the past
    Beskrivning

    Prior Chemotherapy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1514457
    evidence of tumor resistance to last chemotherapy defined as progression after 6 months of previous chemotherapy for advanced disease
    Beskrivning

    Chemotherapy Refractory cancer Evidence of | Disease Progression Status post Prior Chemotherapy Advanced cancer

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C0677936
    UMLS CUI [1,3]
    C0332120
    UMLS CUI [2,1]
    C0242656
    UMLS CUI [2,2]
    C0231290
    UMLS CUI [2,3]
    C1514457
    UMLS CUI [2,4]
    C0877373
    must have measurable (by imaging techniques) disease
    Beskrivning

    Measurable Disease Imaging Techniques

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C0079595
    adequate bone marrow, liver and renal function
    Beskrivning

    Bone Marrow function | Liver function | Renal function

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005953
    UMLS CUI [1,2]
    C0031843
    UMLS CUI [2]
    C0232741
    UMLS CUI [3]
    C0232804
    must provide evidence of informed consent and willingness and ability to comply with scheduled visits, treatment plan and study procedures.
    Beskrivning

    Informed Consent | Compliance behavior Study Protocol

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2,1]
    C1321605
    UMLS CUI [2,2]
    C2348563
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    received more than 2 prior chemotherapy regimens for metastatic disease
    Beskrivning

    Prior Chemotherapy Quantity Carcinoma breast stage IV

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457
    UMLS CUI [1,2]
    C1265611
    UMLS CUI [1,3]
    C0278488
    received in the past another drug of the same class as the investigational drug, i.e. topoisomerase i inhibitor
    Beskrivning

    Pharmaceutical Preparation Class of Trial Agent Same | Topoisomerase I Inhibitors

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C2983595
    UMLS CUI [1,3]
    C0445247
    UMLS CUI [2]
    C0594374
    enrolled in another clinical intervention study
    Beskrivning

    Study Subject Participation Status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    pregnancy, breast feeding, fertile women refusing to use reliable contraceptive methods
    Beskrivning

    Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Refused

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0700589
    UMLS CUI [3,3]
    C1705116
    cardiac or thrombotic event in the last 12 months
    Beskrivning

    cardiac event | Thrombotic disorder

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0741923
    UMLS CUI [2]
    C0040053
    brain metastases
    Beskrivning

    Metastatic malignant neoplasm to brain

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0220650
    Tillbaka till toppen

    Similar models

    Eligibility Breast Neoplasms NCT00067314

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Locally advanced breast cancer Amenable Operative Surgical Procedures | Carcinoma breast stage IV Amenable Operative Surgical Procedures | Locally advanced breast cancer Amenable Therapeutic radiology procedure Curative | Carcinoma breast stage IV Amenable Therapeutic radiology procedure Curative
    Item
    locally advanced or metastatic breast cancer not amenable to surgery or radiation with curative intent
    boolean
    C3495949 (UMLS CUI [1,1])
    C3900053 (UMLS CUI [1,2])
    C0543467 (UMLS CUI [1,3])
    C0278488 (UMLS CUI [2,1])
    C3900053 (UMLS CUI [2,2])
    C0543467 (UMLS CUI [2,3])
    C3495949 (UMLS CUI [3,1])
    C3900053 (UMLS CUI [3,2])
    C1522449 (UMLS CUI [3,3])
    C1276305 (UMLS CUI [3,4])
    C0278488 (UMLS CUI [4,1])
    C3900053 (UMLS CUI [4,2])
    C1522449 (UMLS CUI [4,3])
    C1276305 (UMLS CUI [4,4])
    Prior Chemotherapy
    Item
    must have received any chemotherapy regimen in the past
    boolean
    C1514457 (UMLS CUI [1])
    Chemotherapy Refractory cancer Evidence of | Disease Progression Status post Prior Chemotherapy Advanced cancer
    Item
    evidence of tumor resistance to last chemotherapy defined as progression after 6 months of previous chemotherapy for advanced disease
    boolean
    C0392920 (UMLS CUI [1,1])
    C0677936 (UMLS CUI [1,2])
    C0332120 (UMLS CUI [1,3])
    C0242656 (UMLS CUI [2,1])
    C0231290 (UMLS CUI [2,2])
    C1514457 (UMLS CUI [2,3])
    C0877373 (UMLS CUI [2,4])
    Measurable Disease Imaging Techniques
    Item
    must have measurable (by imaging techniques) disease
    boolean
    C1513041 (UMLS CUI [1,1])
    C0079595 (UMLS CUI [1,2])
    Bone Marrow function | Liver function | Renal function
    Item
    adequate bone marrow, liver and renal function
    boolean
    C0005953 (UMLS CUI [1,1])
    C0031843 (UMLS CUI [1,2])
    C0232741 (UMLS CUI [2])
    C0232804 (UMLS CUI [3])
    Informed Consent | Compliance behavior Study Protocol
    Item
    must provide evidence of informed consent and willingness and ability to comply with scheduled visits, treatment plan and study procedures.
    boolean
    C0021430 (UMLS CUI [1])
    C1321605 (UMLS CUI [2,1])
    C2348563 (UMLS CUI [2,2])
    Item Group
    C0680251 (UMLS CUI)
    Prior Chemotherapy Quantity Carcinoma breast stage IV
    Item
    received more than 2 prior chemotherapy regimens for metastatic disease
    boolean
    C1514457 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C0278488 (UMLS CUI [1,3])
    Pharmaceutical Preparation Class of Trial Agent Same | Topoisomerase I Inhibitors
    Item
    received in the past another drug of the same class as the investigational drug, i.e. topoisomerase i inhibitor
    boolean
    C0013227 (UMLS CUI [1,1])
    C2983595 (UMLS CUI [1,2])
    C0445247 (UMLS CUI [1,3])
    C0594374 (UMLS CUI [2])
    Study Subject Participation Status
    Item
    enrolled in another clinical intervention study
    boolean
    C2348568 (UMLS CUI [1])
    Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Refused
    Item
    pregnancy, breast feeding, fertile women refusing to use reliable contraceptive methods
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C3831118 (UMLS CUI [3,1])
    C0700589 (UMLS CUI [3,2])
    C1705116 (UMLS CUI [3,3])
    cardiac event | Thrombotic disorder
    Item
    cardiac or thrombotic event in the last 12 months
    boolean
    C0741923 (UMLS CUI [1])
    C0040053 (UMLS CUI [2])
    Metastatic malignant neoplasm to brain
    Item
    brain metastases
    boolean
    C0220650 (UMLS CUI [1])
    Tillbaka till toppen 

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