0 Ratings

ID

4925

Description

ODM derived from http://clinicaltrials.gov/show/NCT00545077

Link

http://clinicaltrials.gov/show/NCT00545077

Keywords

  1. 12/10/13 12/10/13 - Martin Dugas
  2. 4/14/14 4/14/14 - Julian Varghese
Uploaded on

April 14, 2014

DOI

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License

Creative Commons BY 4.0

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    Eligibility NCT00545077 Breast Cancer

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Description

    Einschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425202
    Alter 18 bis 80 Jahre
    Description

    age 18 Years to 80 Years

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Before starting the specific protocol procedures, the written informed consent must be obtained and documented.
    Description

    Before starting the specific protocol procedures, the written informed consent must be obtained and documented.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0021430
    Women >=18 years.
    Description

    Women >=18 years.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0043210
    SNOMED CT 2011_0131
    224526002
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Capacity to comply with all the protocol requirements.
    Description

    Capacity to comply with all the protocol requirements.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0085732
    SNOMED CT 2011_0131
    371150009
    UMLS CUI 2011AA
    C1321605
    SNOMED CT 2011_0131
    405078008
    UMLS CUI 2011AA
    C1709747
    Functional ECOG status <= 1.
    Description

    Functional ECOG status <= 1.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0598463
    LOINC Version 232
    MTHU027728
    UMLS CUI 2011AA
    C1828127
    SNOMED CT 2011_0131
    424122007
    Life expectancy >= 24 weeks.
    Description

    Life expectancy >= 24 weeks.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0023671
    Histologically confirmed breast adenocarcinoma, with measurable or non-measurable, locally advanced or metastatic (stage IV) disease. In the event that the patient only has locally advanced disease, she will not be able to undergo curative local treatment. Patients with metastasis confined to the bone can be chosen, but the disease must be confirmed by radiology, CT scan or NMR if there is any doubt after a single bone scan.
    Description

    Histologically confirmed breast adenocarcinoma, with measurable or non-measurable, locally advanced or metastatic (stage IV) disease. In the event that the patient only has locally advanced disease, she will not be able to undergo curative local treatment. Patients with metastasis confined to the bone can be chosen, but the disease must be confirmed by radiology, CT scan or NMR if there is any doubt after a single bone scan.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205462
    SNOMED CT 2011_0131
    67151002
    UMLS CUI 2011AA
    C0750484
    UMLS CUI 2011AA
    C0858252
    MedDRA 14.1
    10006173
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C1513041
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C1513040
    UMLS CUI 2011AA
    C0012634
    SNOMED CT 2011_0131
    64572001
    UMLS CUI 2011AA
    C0677984
    UMLS CUI 2011AA
    C0278488
    UMLS CUI 2011AA
    C0153690
    SNOMED CT 2011_0131
    94222008
    MedDRA 14.1
    10055101
    ICD-10-CM Version 2010
    C79.51
    ICD-9-CM Version 2011
    198.5
    UMLS CUI 2011AA
    C0012634
    SNOMED CT 2011_0131
    64572001
    UMLS CUI 2011AA
    C0750484
    UMLS CUI 2011AA
    C1405978
    UMLS CUI 2011AA
    C0040405
    MedDRA 14.1
    10011603
    UMLS CUI 2011AA
    C0028580
    Patients with HER2-negative disease evaluated by IHC and FISH/CISH (IHC 0 or 1+, or 2+ and negative FISH). Patients with 3+ by IHC cannot be chosen regardless of the FISH/CISH status and those with positive FISH/CISH (> 2 amplifications) cannot be chosen either, regardless of the IHC findings.
    Description

    Patients with HER2-negative disease evaluated by IHC and FISH/CISH (IHC 0 or 1+, or 2+ and negative FISH). Patients with 3+ by IHC cannot be chosen regardless of the FISH/CISH status and those with positive FISH/CISH (> 2 amplifications) cannot be chosen either, regardless of the IHC findings.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    CL412283
    UMLS CUI 2011AA
    C0220825
    UMLS CUI 2011AA
    C0021044
    SNOMED CT 2011_0131
    117617002
    MedDRA 14.1
    10059656
    UMLS CUI 2011AA
    C0162789
    SNOMED CT 2011_0131
    426329006
    MedDRA 14.1
    10066931
    UMLS CUI 2011AA
    C1516514
    Positive hormone receptors (estrogen receptor [ER] and/or progesterone receptor [PgR]) evaluated by a local or central laboratory, according to the criteria of the participating institution.
    Description

    Positive hormone receptors (estrogen receptor [ER] and/or progesterone receptor [PgR]) evaluated by a local or central laboratory, according to the criteria of the participating institution.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    CL415097
    UMLS CUI 2011AA
    C0019929
    UMLS CUI 2011AA
    C1521863
    UMLS CUI 2011AA
    C0034833
    SNOMED CT 2011_0131
    61078009
    LOINC Version 232
    MTHU002145
    UMLS CUI 2011AA
    C0220825
    UMLS CUI 2011AA
    C0022877
    SNOMED CT 2011_0131
    261904005
    LOINC Version 232
    MTHU029808
    Patients who are candidates for receiving first-line treatment with letrozole.
    Description

    Patients who are candidates for receiving first-line treatment with letrozole.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0086960
    UMLS CUI 2011AA
    C1708063
    UMLS CUI 2011AA
    C0701348
    SNOMED CT 2011_0131
    386911004
    Patients may have received (neo)adjuvant chemotherapy, provided that the last dose of the latter was received at least 12 months before randomization . Patients must be recovered from toxicity.
    Description

    Patients may have received (neo)adjuvant chemotherapy, provided that the last dose of the latter was received at least 12 months before randomization . Patients must be recovered from toxicity.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0085533
    UMLS CUI 2011AA
    C0600558
    UMLS CUI 2011AA
    C1517741
    UMLS CUI 2011AA
    C0178602
    SNOMED CT 2011_0131
    260911001
    UMLS CUI 2011AA
    C0439234
    SNOMED CT 2011_0131
    258707000
    HL7 V3 2006_05
    Y
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C0034656
    UMLS CUI 2011AA
    C1115804
    LOINC Version 232
    MTHU014522
    UMLS CUI 2011AA
    C0040539
    The patients are allowed to have received adjuvant radiotherapy, provided that it was completed at least 6 weeks before randomization and the patient has recovered from the reversible acute effects of the radiation. The previous administration of radiotherapy to palliate the pain of bone metastases is authorized, provided that:
    Description

    The patients are allowed to have received adjuvant radiotherapy, provided that it was completed at least 6 weeks before randomization and the patient has recovered from the reversible acute effects of the radiation. The previous administration of radiotherapy to palliate the pain of bone metastases is authorized, provided that:

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1524004
    UMLS CUI 2011AA
    C0242939
    UMLS CUI 2011AA
    C0580352
    SNOMED CT 2011_0131
    182992009
    UMLS CUI 2011AA
    C0439231
    SNOMED CT 2011_0131
    258706009
    HL7 V3 2006_05
    MO
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C0034656
    UMLS CUI 2011AA
    C1115804
    LOINC Version 232
    MTHU014522
    UMLS CUI 2011AA
    C0392615
    UMLS CUI 2011AA
    C1524004
    UMLS CUI 2011AA
    C0205156
    SNOMED CT 2011_0131
    9130008
    UMLS CUI 2011AA
    CL421682
    UMLS CUI 2011AA
    C0153690
    SNOMED CT 2011_0131
    94222008
    MedDRA 14.1
    10055101
    ICD-10-CM Version 2010
    C79.51
    ICD-9-CM Version 2011
    198.5
    UMLS CUI 2011AA
    C1709632
    Not more than 30% of bone marrow has been irradiated.
    Description

    Not more than 30% of bone marrow has been irradiated.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0005953
    SNOMED CT 2011_0131
    14016003
    LOINC Version 232
    MTHU016536
    UMLS CUI 2011AA
    CL419326
    UMLS CUI 2011AA
    C1522449
    SNOMED CT 2011_0131
    108290001
    MedDRA 14.1
    10037794
    The patient has recovered from the reversible acute effects of the radiation.
    Description

    The patient has recovered from the reversible acute effects of the radiation.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1115804
    LOINC Version 232
    MTHU014522
    UMLS CUI 2011AA
    C0392615
    The patient has at least one metastatic location which has not been irradiated and which may be evaluated for progression, or a clear progression of the bone disease has been objectified after the end of the palliative radiotherapy.
    Description

    The patient has at least one metastatic location which has not been irradiated and which may be evaluated for progression, or a clear progression of the bone disease has been objectified after the end of the palliative radiotherapy.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0547040
    SNOMED CT 2011_0131
    255605001
    UMLS CUI 2011AA
    C0205447
    SNOMED CT 2011_0131
    38112003
    UMLS CUI 2011AA
    C0036525
    SNOMED CT 2011_0131
    77879006
    MedDRA 14.1
    10027474
    UMLS CUI 2011AA
    C0450429
    SNOMED CT 2011_0131
    246267002
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C1522449
    SNOMED CT 2011_0131
    108290001
    MedDRA 14.1
    10037794
    UMLS CUI 2011AA
    C0220825
    UMLS CUI 2011AA
    C0242656
    SNOMED CT 2011_0131
    246453008
    MedDRA 14.1
    10061818
    UMLS CUI 2011AA
    CL414906
    UMLS CUI 2011AA
    C0242656
    SNOMED CT 2011_0131
    246453008
    MedDRA 14.1
    10061818
    UMLS CUI 2011AA
    C0005940
    SNOMED CT 2011_0131
    76069003
    MedDRA 14.1
    10005956
    ICD-10-CM Version 2010
    M89.9
    UMLS CUI 2011AA
    C0231290
    SNOMED CT 2011_0131
    237679004
    UMLS CUI 2011AA
    CL421682
    Ausschlusskriterien
    Description

    Ausschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425201
    Evolutionary disease requiring an immediate treatment with cytotoxic chemotherapy according to the investigator's judgment.
    Description

    Evolutionary disease requiring an immediate treatment with cytotoxic chemotherapy according to the investigator's judgment.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0015219
    UMLS CUI 2011AA
    C0012634
    SNOMED CT 2011_0131
    64572001
    UMLS CUI 2011AA
    C1514873
    UMLS CUI 2011AA
    C0205253
    SNOMED CT 2011_0131
    88694003
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C0677881
    UMLS CUI 2011AA
    CL102947
    UMLS CUI 2011AA
    C0022423
    SNOMED CT 2011_0131
    61254005
    Patients with locally advanced breast cancer who are expected to undergo surgery or curative radiotherapy.
    Description

    Patients with locally advanced breast cancer who are expected to undergo surgery or curative radiotherapy.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0677984
    UMLS CUI 2011AA
    C0678222
    SNOMED CT 2011_0131
    254838004
    MedDRA 14.1
    10006204
    UMLS CUI 2011AA
    C1517001
    UMLS CUI 2011AA
    C0038895
    UMLS CUI 2011AA
    C1880198
    UMLS CUI 2011AA
    C1522449
    SNOMED CT 2011_0131
    302505005
    Previous chemotherapy or hormonotherapy for the metastatic disease. Patients may have received neoadjuvant chemotherapy or neoadjuvant hormonotherapy with curative intention as a part or as an alternative to an adjuvant treatment. For the previous neoadjuvant hormonotherapy the same premises than for the adjuvant hormonotherapy are valid.
    Description

    Previous chemotherapy or hormonotherapy for the metastatic disease. Patients may have received neoadjuvant chemotherapy or neoadjuvant hormonotherapy with curative intention as a part or as an alternative to an adjuvant treatment. For the previous neoadjuvant hormonotherapy the same premises than for the adjuvant hormonotherapy are valid.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205156
    SNOMED CT 2011_0131
    9130008
    UMLS CUI 2011AA
    C0392920
    SNOMED CT 2011_0131
    150415003
    UMLS CUI 2011AA
    C0279025
    SNOMED CT 2011_0131
    309542002, 169413002
    MedDRA 14.1
    10065646
    UMLS CUI 2011AA
    C0036525
    SNOMED CT 2011_0131
    77879006
    MedDRA 14.1
    10027474
    UMLS CUI 2011AA
    C0012634
    SNOMED CT 2011_0131
    64572001
    UMLS CUI 2011AA
    C0600558
    UMLS CUI 2011AA
    C0392920
    SNOMED CT 2011_0131
    150415003
    UMLS CUI 2011AA
    C0279025
    SNOMED CT 2011_0131
    309542002, 169413002
    MedDRA 14.1
    10065646
    UMLS CUI 2011AA
    C1880198
    UMLS CUI 2011AA
    C0162425
    UMLS CUI 2011AA
    C0677850
    MedDRA 14.1
    10068969
    Previous therapy with anti-VEGF or VEGFR tyrosine-kinase inhibitors.
    Description

    Previous therapy with anti-VEGF or VEGFR tyrosine-kinase inhibitors.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1514463
    UMLS CUI 2011AA
    CL318109
    UMLS CUI 2011AA
    C1268567
    SNOMED CT 2011_0131
    372917005
    UMLS CUI 2011AA
    CL425146
    History of another pathology that may affect the development of the protocol or the interpretation of results. It is considered that patients who have suffered from a skin carcinoma that is not melanoma, cervical carcinoma in situ or another neoplasia treated with a curative intention and with a disease-free interval exceeding 5 years can be chosen.
    Description

    History of another pathology that may affect the development of the protocol or the interpretation of results. It is considered that patients who have suffered from a skin carcinoma that is not melanoma, cervical carcinoma in situ or another neoplasia treated with a curative intention and with a disease-free interval exceeding 5 years can be chosen.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C0677042
    UMLS CUI 2011AA
    C0392760
    SNOMED CT 2011_0131
    247591002
    UMLS CUI 2011AA
    C2348563
    UMLS CUI 2011AA
    C0459471
    SNOMED CT 2011_0131
    280452008
    LOINC Version 232
    MTHU003869
    UMLS CUI 2011AA
    C1274040
    SNOMED CT 2011_0131
    79409006
    UMLS CUI 2011AA
    C0699893
    MedDRA 14.1
    10040810
    UMLS CUI 2011AA
    C0851140
    SNOMED CT 2011_0131
    92564006
    MedDRA 14.1
    10061809
    ICD-10-CM Version 2010
    D06.9
    ICD-9-CM Version 2011
    233.1
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C0006826
    SNOMED CT 2011_0131
    363346000
    MedDRA 14.1
    10028997
    LOINC Version 232
    MTHU010328
    ICD-10-CM Version 2010
    C00-C96
    UMLS CUI 2011AA
    CL415147
    UMLS CUI 2011AA
    C1880198
    UMLS CUI 2011AA
    C0332296
    SNOMED CT 2011_0131
    37837009
    UMLS CUI 2011AA
    C0012634
    SNOMED CT 2011_0131
    64572001
    UMLS CUI 2011AA
    C1272706
    SNOMED CT 2011_0131
    385673002
    UMLS CUI 2011AA
    C0439234
    SNOMED CT 2011_0131
    258707000
    HL7 V3 2006_05
    Y
    Evidence of CNS metastasis. A CT scan or brain NMR must be done within the 4 weeks before the randomization in case of suspecting brain metastasis.
    Description

    Evidence of CNS metastasis. A CT scan or brain NMR must be done within the 4 weeks before the randomization in case of suspecting brain metastasis.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0332120
    SNOMED CT 2011_0131
    18669006
    UMLS CUI 2011AA
    C0279130
    SNOMED CT 2011_0131
    261731003
    UMLS CUI 2011AA
    C0040405
    MedDRA 14.1
    10011603
    UMLS CUI 2011AA
    C1269537
    SNOMED CT 2011_0131
    258335003
    UMLS CUI 2011AA
    C0028580
    UMLS CUI 2011AA
    C0439231
    SNOMED CT 2011_0131
    258706009
    HL7 V3 2006_05
    MO
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C0034656
    UMLS CUI 2011AA
    C0750491
    SNOMED CT 2011_0131
    415684004
    UMLS CUI 2011AA
    C0220650
    MedDRA 14.1
    10006128
    History or evidence in the physical or neurological examination of CNS pathology unrelated to cancer unless it is suitable treated with standard therapy (e.g. uncontrolled convulsions).
    Description

    History or evidence in the physical or neurological examination of CNS pathology unrelated to cancer unless it is suitable treated with standard therapy (e.g. uncontrolled convulsions).

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0332120
    SNOMED CT 2011_0131
    18669006
    UMLS CUI 2011AA
    C1269563
    SNOMED CT 2011_0131
    278199004
    UMLS CUI 2011AA
    C0677042
    UMLS CUI 2011AA
    C1554961
    UMLS CUI 2011AA
    CL415147
    UMLS CUI 2011AA
    CL426127
    UMLS CUI 2011AA
    C0205318
    SNOMED CT 2011_0131
    19032002
    UMLS CUI 2011AA
    C0036572
    SNOMED CT 2011_0131
    91175000
    MedDRA 14.1
    10039910
    ICD-9-CM Version 2011
    780.39
    History of peripheral neuropathy NCI CTCAE grade >2 at the time of randomization.
    Description

    History of peripheral neuropathy NCI CTCAE grade >2 at the time of randomization.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0031117
    MedDRA 14.1
    10029331
    ICD-10-CM Version 2010
    G64
    ICD-9-CM Version 2011
    350-359.99
    UMLS CUI 2011AA
    C1140168
    UMLS CUI 2011AA
    C1516728
    UMLS CUI 2011AA
    C0441800
    SNOMED CT 2011_0131
    258349007
    LOINC Version 232
    MTHU003112
    UMLS CUI 2011AA
    C0439547
    SNOMED CT 2011_0131
    272105005
    UMLS CUI 2011AA
    C0034656
    Patients subjected to major surgical procedures, open biopsies or those having significant trauma injuries within the 28 days prior to randomization, or patients who are expected to undergo a major surgical procedure that must necessarily be performed within the course of the study.
    Description

    Patients subjected to major surgical procedures, open biopsies or those having significant trauma injuries within the 28 days prior to randomization, or patients who are expected to undergo a major surgical procedure that must necessarily be performed within the course of the study.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0679637
    UMLS CUI 2011AA
    C0184922
    SNOMED CT 2011_0131
    119283008
    UMLS CUI 2011AA
    C0750502
    SNOMED CT 2011_0131
    386134007
    UMLS CUI 2011AA
    C0175677
    SNOMED CT 2011_0131
    417746004
    MedDRA 14.1
    10022116
    ICD-10-CM Version 2010
    T14.9
    UMLS CUI 2011AA
    C0439231
    SNOMED CT 2011_0131
    258706009
    HL7 V3 2006_05
    MO
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C0034656
    UMLS CUI 2011AA
    CL414906
    UMLS CUI 2011AA
    C1517001
    UMLS CUI 2011AA
    C0679637
    UMLS CUI 2011AA
    C1514873
    UMLS CUI 2011AA
    C0347984
    SNOMED CT 2011_0131
    371881003
    UMLS CUI 2011AA
    C0750729
    SNOMED CT 2011_0131
    288524001
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008

    Similar models

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Einschlusskriterien
    CL425202 (UMLS CUI 2011AA)
    age 18 Years to 80 Years
    Item
    Alter 18 bis 80 Jahre
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Before starting the specific protocol procedures, the written informed consent must be obtained and documented.
    Item
    Before starting the specific protocol procedures, the written informed consent must be obtained and documented.
    boolean
    C0021430 (UMLS CUI 2011AA)
    Women >=18 years.
    Item
    Women >=18 years.
    boolean
    C0043210 (UMLS CUI 2011AA)
    224526002 (SNOMED CT 2011_0131)
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Capacity to comply with all the protocol requirements.
    Item
    Capacity to comply with all the protocol requirements.
    boolean
    C0085732 (UMLS CUI 2011AA)
    371150009 (SNOMED CT 2011_0131)
    C1321605 (UMLS CUI 2011AA)
    405078008 (SNOMED CT 2011_0131)
    C1709747 (UMLS CUI 2011AA)
    Functional ECOG status <= 1.
    Item
    Functional ECOG status <= 1.
    boolean
    C0598463 (UMLS CUI 2011AA)
    MTHU027728 (LOINC Version 232)
    C1828127 (UMLS CUI 2011AA)
    424122007 (SNOMED CT 2011_0131)
    Life expectancy >= 24 weeks.
    Item
    Life expectancy >= 24 weeks.
    boolean
    C0023671 (UMLS CUI 2011AA)
    Histologically confirmed breast adenocarcinoma, with measurable or non-measurable, locally advanced or metastatic (stage IV) disease. In the event that the patient only has locally advanced disease, she will not be able to undergo curative local treatment. Patients with metastasis confined to the bone can be chosen, but the disease must be confirmed by radiology, CT scan or NMR if there is any doubt after a single bone scan.
    Item
    Histologically confirmed breast adenocarcinoma, with measurable or non-measurable, locally advanced or metastatic (stage IV) disease. In the event that the patient only has locally advanced disease, she will not be able to undergo curative local treatment. Patients with metastasis confined to the bone can be chosen, but the disease must be confirmed by radiology, CT scan or NMR if there is any doubt after a single bone scan.
    boolean
    C0205462 (UMLS CUI 2011AA)
    67151002 (SNOMED CT 2011_0131)
    C0750484 (UMLS CUI 2011AA)
    C0858252 (UMLS CUI 2011AA)
    10006173 (MedDRA 14.1)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C1513041 (UMLS CUI 2011AA)
    C1518422 (UMLS CUI 2011AA)
    C1513040 (UMLS CUI 2011AA)
    C0012634 (UMLS CUI 2011AA)
    64572001 (SNOMED CT 2011_0131)
    C0677984 (UMLS CUI 2011AA)
    C0278488 (UMLS CUI 2011AA)
    C0153690 (UMLS CUI 2011AA)
    94222008 (SNOMED CT 2011_0131)
    10055101 (MedDRA 14.1)
    C79.51 (ICD-10-CM Version 2010)
    198.5 (ICD-9-CM Version 2011)
    C0012634 (UMLS CUI 2011AA)
    64572001 (SNOMED CT 2011_0131)
    C0750484 (UMLS CUI 2011AA)
    C1405978 (UMLS CUI 2011AA)
    C0040405 (UMLS CUI 2011AA)
    10011603 (MedDRA 14.1)
    C0028580 (UMLS CUI 2011AA)
    Patients with HER2-negative disease evaluated by IHC and FISH/CISH (IHC 0 or 1+, or 2+ and negative FISH). Patients with 3+ by IHC cannot be chosen regardless of the FISH/CISH status and those with positive FISH/CISH (> 2 amplifications) cannot be chosen either, regardless of the IHC findings.
    Item
    Patients with HER2-negative disease evaluated by IHC and FISH/CISH (IHC 0 or 1+, or 2+ and negative FISH). Patients with 3+ by IHC cannot be chosen regardless of the FISH/CISH status and those with positive FISH/CISH (> 2 amplifications) cannot be chosen either, regardless of the IHC findings.
    boolean
    CL412283 (UMLS CUI 2011AA)
    C0220825 (UMLS CUI 2011AA)
    C0021044 (UMLS CUI 2011AA)
    117617002 (SNOMED CT 2011_0131)
    10059656 (MedDRA 14.1)
    C0162789 (UMLS CUI 2011AA)
    426329006 (SNOMED CT 2011_0131)
    10066931 (MedDRA 14.1)
    C1516514 (UMLS CUI 2011AA)
    Positive hormone receptors (estrogen receptor [ER] and/or progesterone receptor [PgR]) evaluated by a local or central laboratory, according to the criteria of the participating institution.
    Item
    Positive hormone receptors (estrogen receptor [ER] and/or progesterone receptor [PgR]) evaluated by a local or central laboratory, according to the criteria of the participating institution.
    boolean
    CL415097 (UMLS CUI 2011AA)
    C0019929 (UMLS CUI 2011AA)
    C1521863 (UMLS CUI 2011AA)
    C0034833 (UMLS CUI 2011AA)
    61078009 (SNOMED CT 2011_0131)
    MTHU002145 (LOINC Version 232)
    C0220825 (UMLS CUI 2011AA)
    C0022877 (UMLS CUI 2011AA)
    261904005 (SNOMED CT 2011_0131)
    MTHU029808 (LOINC Version 232)
    Patients who are candidates for receiving first-line treatment with letrozole.
    Item
    Patients who are candidates for receiving first-line treatment with letrozole.
    boolean
    C0086960 (UMLS CUI 2011AA)
    C1708063 (UMLS CUI 2011AA)
    C0701348 (UMLS CUI 2011AA)
    386911004 (SNOMED CT 2011_0131)
    Patients may have received (neo)adjuvant chemotherapy, provided that the last dose of the latter was received at least 12 months before randomization . Patients must be recovered from toxicity.
    Item
    Patients may have received (neo)adjuvant chemotherapy, provided that the last dose of the latter was received at least 12 months before randomization . Patients must be recovered from toxicity.
    boolean
    C0085533 (UMLS CUI 2011AA)
    C0600558 (UMLS CUI 2011AA)
    C1517741 (UMLS CUI 2011AA)
    C0178602 (UMLS CUI 2011AA)
    260911001 (SNOMED CT 2011_0131)
    C0439234 (UMLS CUI 2011AA)
    258707000 (SNOMED CT 2011_0131)
    Y (HL7 V3 2006_05)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C0034656 (UMLS CUI 2011AA)
    C1115804 (UMLS CUI 2011AA)
    MTHU014522 (LOINC Version 232)
    C0040539 (UMLS CUI 2011AA)
    The patients are allowed to have received adjuvant radiotherapy, provided that it was completed at least 6 weeks before randomization and the patient has recovered from the reversible acute effects of the radiation. The previous administration of radiotherapy to palliate the pain of bone metastases is authorized, provided that:
    Item
    The patients are allowed to have received adjuvant radiotherapy, provided that it was completed at least 6 weeks before randomization and the patient has recovered from the reversible acute effects of the radiation. The previous administration of radiotherapy to palliate the pain of bone metastases is authorized, provided that:
    boolean
    C1524004 (UMLS CUI 2011AA)
    C0242939 (UMLS CUI 2011AA)
    C0580352 (UMLS CUI 2011AA)
    182992009 (SNOMED CT 2011_0131)
    C0439231 (UMLS CUI 2011AA)
    258706009 (SNOMED CT 2011_0131)
    MO (HL7 V3 2006_05)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C0034656 (UMLS CUI 2011AA)
    C1115804 (UMLS CUI 2011AA)
    MTHU014522 (LOINC Version 232)
    C0392615 (UMLS CUI 2011AA)
    C1524004 (UMLS CUI 2011AA)
    C0205156 (UMLS CUI 2011AA)
    9130008 (SNOMED CT 2011_0131)
    CL421682 (UMLS CUI 2011AA)
    C0153690 (UMLS CUI 2011AA)
    94222008 (SNOMED CT 2011_0131)
    10055101 (MedDRA 14.1)
    C79.51 (ICD-10-CM Version 2010)
    198.5 (ICD-9-CM Version 2011)
    C1709632 (UMLS CUI 2011AA)
    Not more than 30% of bone marrow has been irradiated.
    Item
    Not more than 30% of bone marrow has been irradiated.
    boolean
    C0005953 (UMLS CUI 2011AA)
    14016003 (SNOMED CT 2011_0131)
    MTHU016536 (LOINC Version 232)
    CL419326 (UMLS CUI 2011AA)
    C1522449 (UMLS CUI 2011AA)
    108290001 (SNOMED CT 2011_0131)
    10037794 (MedDRA 14.1)
    The patient has recovered from the reversible acute effects of the radiation.
    Item
    The patient has recovered from the reversible acute effects of the radiation.
    boolean
    C1115804 (UMLS CUI 2011AA)
    MTHU014522 (LOINC Version 232)
    C0392615 (UMLS CUI 2011AA)
    The patient has at least one metastatic location which has not been irradiated and which may be evaluated for progression, or a clear progression of the bone disease has been objectified after the end of the palliative radiotherapy.
    Item
    The patient has at least one metastatic location which has not been irradiated and which may be evaluated for progression, or a clear progression of the bone disease has been objectified after the end of the palliative radiotherapy.
    boolean
    C0547040 (UMLS CUI 2011AA)
    255605001 (SNOMED CT 2011_0131)
    C0205447 (UMLS CUI 2011AA)
    38112003 (SNOMED CT 2011_0131)
    C0036525 (UMLS CUI 2011AA)
    77879006 (SNOMED CT 2011_0131)
    10027474 (MedDRA 14.1)
    C0450429 (UMLS CUI 2011AA)
    246267002 (SNOMED CT 2011_0131)
    C1518422 (UMLS CUI 2011AA)
    C1522449 (UMLS CUI 2011AA)
    108290001 (SNOMED CT 2011_0131)
    10037794 (MedDRA 14.1)
    C0220825 (UMLS CUI 2011AA)
    C0242656 (UMLS CUI 2011AA)
    246453008 (SNOMED CT 2011_0131)
    10061818 (MedDRA 14.1)
    CL414906 (UMLS CUI 2011AA)
    C0242656 (UMLS CUI 2011AA)
    246453008 (SNOMED CT 2011_0131)
    10061818 (MedDRA 14.1)
    C0005940 (UMLS CUI 2011AA)
    76069003 (SNOMED CT 2011_0131)
    10005956 (MedDRA 14.1)
    M89.9 (ICD-10-CM Version 2010)
    C0231290 (UMLS CUI 2011AA)
    237679004 (SNOMED CT 2011_0131)
    CL421682 (UMLS CUI 2011AA)
    Item Group
    Ausschlusskriterien
    CL425201 (UMLS CUI 2011AA)
    Evolutionary disease requiring an immediate treatment with cytotoxic chemotherapy according to the investigator's judgment.
    Item
    Evolutionary disease requiring an immediate treatment with cytotoxic chemotherapy according to the investigator's judgment.
    boolean
    C0015219 (UMLS CUI 2011AA)
    C0012634 (UMLS CUI 2011AA)
    64572001 (SNOMED CT 2011_0131)
    C1514873 (UMLS CUI 2011AA)
    C0205253 (UMLS CUI 2011AA)
    88694003 (SNOMED CT 2011_0131)
    C0039798 (UMLS CUI 2011AA)
    C0677881 (UMLS CUI 2011AA)
    CL102947 (UMLS CUI 2011AA)
    C0022423 (UMLS CUI 2011AA)
    61254005 (SNOMED CT 2011_0131)
    Patients with locally advanced breast cancer who are expected to undergo surgery or curative radiotherapy.
    Item
    Patients with locally advanced breast cancer who are expected to undergo surgery or curative radiotherapy.
    boolean
    C0677984 (UMLS CUI 2011AA)
    C0678222 (UMLS CUI 2011AA)
    254838004 (SNOMED CT 2011_0131)
    10006204 (MedDRA 14.1)
    C1517001 (UMLS CUI 2011AA)
    C0038895 (UMLS CUI 2011AA)
    C1880198 (UMLS CUI 2011AA)
    C1522449 (UMLS CUI 2011AA)
    302505005 (SNOMED CT 2011_0131)
    Previous chemotherapy or hormonotherapy for the metastatic disease. Patients may have received neoadjuvant chemotherapy or neoadjuvant hormonotherapy with curative intention as a part or as an alternative to an adjuvant treatment. For the previous neoadjuvant hormonotherapy the same premises than for the adjuvant hormonotherapy are valid.
    Item
    Previous chemotherapy or hormonotherapy for the metastatic disease. Patients may have received neoadjuvant chemotherapy or neoadjuvant hormonotherapy with curative intention as a part or as an alternative to an adjuvant treatment. For the previous neoadjuvant hormonotherapy the same premises than for the adjuvant hormonotherapy are valid.
    boolean
    C0205156 (UMLS CUI 2011AA)
    9130008 (SNOMED CT 2011_0131)
    C0392920 (UMLS CUI 2011AA)
    150415003 (SNOMED CT 2011_0131)
    C0279025 (UMLS CUI 2011AA)
    309542002, 169413002 (SNOMED CT 2011_0131)
    10065646 (MedDRA 14.1)
    C0036525 (UMLS CUI 2011AA)
    77879006 (SNOMED CT 2011_0131)
    10027474 (MedDRA 14.1)
    C0012634 (UMLS CUI 2011AA)
    64572001 (SNOMED CT 2011_0131)
    C0600558 (UMLS CUI 2011AA)
    C0392920 (UMLS CUI 2011AA)
    150415003 (SNOMED CT 2011_0131)
    C0279025 (UMLS CUI 2011AA)
    309542002, 169413002 (SNOMED CT 2011_0131)
    10065646 (MedDRA 14.1)
    C1880198 (UMLS CUI 2011AA)
    C0162425 (UMLS CUI 2011AA)
    C0677850 (UMLS CUI 2011AA)
    10068969 (MedDRA 14.1)
    Previous therapy with anti-VEGF or VEGFR tyrosine-kinase inhibitors.
    Item
    Previous therapy with anti-VEGF or VEGFR tyrosine-kinase inhibitors.
    boolean
    C1514463 (UMLS CUI 2011AA)
    CL318109 (UMLS CUI 2011AA)
    C1268567 (UMLS CUI 2011AA)
    372917005 (SNOMED CT 2011_0131)
    CL425146 (UMLS CUI 2011AA)
    History of another pathology that may affect the development of the protocol or the interpretation of results. It is considered that patients who have suffered from a skin carcinoma that is not melanoma, cervical carcinoma in situ or another neoplasia treated with a curative intention and with a disease-free interval exceeding 5 years can be chosen.
    Item
    History of another pathology that may affect the development of the protocol or the interpretation of results. It is considered that patients who have suffered from a skin carcinoma that is not melanoma, cervical carcinoma in situ or another neoplasia treated with a curative intention and with a disease-free interval exceeding 5 years can be chosen.
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C0677042 (UMLS CUI 2011AA)
    C0392760 (UMLS CUI 2011AA)
    247591002 (SNOMED CT 2011_0131)
    C2348563 (UMLS CUI 2011AA)
    C0459471 (UMLS CUI 2011AA)
    280452008 (SNOMED CT 2011_0131)
    MTHU003869 (LOINC Version 232)
    C1274040 (UMLS CUI 2011AA)
    79409006 (SNOMED CT 2011_0131)
    C0699893 (UMLS CUI 2011AA)
    10040810 (MedDRA 14.1)
    C0851140 (UMLS CUI 2011AA)
    92564006 (SNOMED CT 2011_0131)
    10061809 (MedDRA 14.1)
    D06.9 (ICD-10-CM Version 2010)
    233.1 (ICD-9-CM Version 2011)
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C0006826 (UMLS CUI 2011AA)
    363346000 (SNOMED CT 2011_0131)
    10028997 (MedDRA 14.1)
    MTHU010328 (LOINC Version 232)
    C00-C96 (ICD-10-CM Version 2010)
    CL415147 (UMLS CUI 2011AA)
    C1880198 (UMLS CUI 2011AA)
    C0332296 (UMLS CUI 2011AA)
    37837009 (SNOMED CT 2011_0131)
    C0012634 (UMLS CUI 2011AA)
    64572001 (SNOMED CT 2011_0131)
    C1272706 (UMLS CUI 2011AA)
    385673002 (SNOMED CT 2011_0131)
    C0439234 (UMLS CUI 2011AA)
    258707000 (SNOMED CT 2011_0131)
    Y (HL7 V3 2006_05)
    Evidence of CNS metastasis. A CT scan or brain NMR must be done within the 4 weeks before the randomization in case of suspecting brain metastasis.
    Item
    Evidence of CNS metastasis. A CT scan or brain NMR must be done within the 4 weeks before the randomization in case of suspecting brain metastasis.
    boolean
    C0332120 (UMLS CUI 2011AA)
    18669006 (SNOMED CT 2011_0131)
    C0279130 (UMLS CUI 2011AA)
    261731003 (SNOMED CT 2011_0131)
    C0040405 (UMLS CUI 2011AA)
    10011603 (MedDRA 14.1)
    C1269537 (UMLS CUI 2011AA)
    258335003 (SNOMED CT 2011_0131)
    C0028580 (UMLS CUI 2011AA)
    C0439231 (UMLS CUI 2011AA)
    258706009 (SNOMED CT 2011_0131)
    MO (HL7 V3 2006_05)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C0034656 (UMLS CUI 2011AA)
    C0750491 (UMLS CUI 2011AA)
    415684004 (SNOMED CT 2011_0131)
    C0220650 (UMLS CUI 2011AA)
    10006128 (MedDRA 14.1)
    History or evidence in the physical or neurological examination of CNS pathology unrelated to cancer unless it is suitable treated with standard therapy (e.g. uncontrolled convulsions).
    Item
    History or evidence in the physical or neurological examination of CNS pathology unrelated to cancer unless it is suitable treated with standard therapy (e.g. uncontrolled convulsions).
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0332120 (UMLS CUI 2011AA)
    18669006 (SNOMED CT 2011_0131)
    C1269563 (UMLS CUI 2011AA)
    278199004 (SNOMED CT 2011_0131)
    C0677042 (UMLS CUI 2011AA)
    C1554961 (UMLS CUI 2011AA)
    CL415147 (UMLS CUI 2011AA)
    CL426127 (UMLS CUI 2011AA)
    C0205318 (UMLS CUI 2011AA)
    19032002 (SNOMED CT 2011_0131)
    C0036572 (UMLS CUI 2011AA)
    91175000 (SNOMED CT 2011_0131)
    10039910 (MedDRA 14.1)
    780.39 (ICD-9-CM Version 2011)
    History of peripheral neuropathy NCI CTCAE grade >2 at the time of randomization.
    Item
    History of peripheral neuropathy NCI CTCAE grade >2 at the time of randomization.
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0031117 (UMLS CUI 2011AA)
    10029331 (MedDRA 14.1)
    G64 (ICD-10-CM Version 2010)
    350-359.99 (ICD-9-CM Version 2011)
    C1140168 (UMLS CUI 2011AA)
    C1516728 (UMLS CUI 2011AA)
    C0441800 (UMLS CUI 2011AA)
    258349007 (SNOMED CT 2011_0131)
    MTHU003112 (LOINC Version 232)
    C0439547 (UMLS CUI 2011AA)
    272105005 (SNOMED CT 2011_0131)
    C0034656 (UMLS CUI 2011AA)
    Patients subjected to major surgical procedures, open biopsies or those having significant trauma injuries within the 28 days prior to randomization, or patients who are expected to undergo a major surgical procedure that must necessarily be performed within the course of the study.
    Item
    Patients subjected to major surgical procedures, open biopsies or those having significant trauma injuries within the 28 days prior to randomization, or patients who are expected to undergo a major surgical procedure that must necessarily be performed within the course of the study.
    boolean
    C0679637 (UMLS CUI 2011AA)
    C0184922 (UMLS CUI 2011AA)
    119283008 (SNOMED CT 2011_0131)
    C0750502 (UMLS CUI 2011AA)
    386134007 (SNOMED CT 2011_0131)
    C0175677 (UMLS CUI 2011AA)
    417746004 (SNOMED CT 2011_0131)
    10022116 (MedDRA 14.1)
    T14.9 (ICD-10-CM Version 2010)
    C0439231 (UMLS CUI 2011AA)
    258706009 (SNOMED CT 2011_0131)
    MO (HL7 V3 2006_05)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C0034656 (UMLS CUI 2011AA)
    CL414906 (UMLS CUI 2011AA)
    C1517001 (UMLS CUI 2011AA)
    C0679637 (UMLS CUI 2011AA)
    C1514873 (UMLS CUI 2011AA)
    C0347984 (UMLS CUI 2011AA)
    371881003 (SNOMED CT 2011_0131)
    C0750729 (UMLS CUI 2011AA)
    288524001 (SNOMED CT 2011_0131)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)

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