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ID

11655

Description

Registration Breast Cancer CALGB 40503 NCT00601900 Registration Breast Cancer CALGB 40503 REGISTRATION WORKSHEET - 2551888v1.0 NCT00601900 CALGB 40503 REGISTRATION WORKSHEET Tamoxifen or Letrozole With or Without Bevacizumab in Treating Women With Stage III or Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=24089B14-3CCA-485C-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=24089B14-3CCA-485C-E044-0003BA3F9857

Keywords

Versions (3)
  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 7/25/15 7/25/15 - Martin Dugas
Uploaded on

July 25, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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    Registration Breast Cancer CALGB 40503 NCT00601900

    English

    Endocrine Therapy in Combination with Anti-VEGF Therapy: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy plus for Women with Hormone Receptor-Positive Advanced Breast Cancer

    1 forms  
    Header Module
    Description

    Header Module

    Lead Institution
    Description

    Lead Institution

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C21541
    NCI Thesaurus ObjectClass-2
    C25552
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ValueDomain
    C25191
    NCI Thesaurus ValueDomain-2
    C21541
    UMLS CUI-1
    C1522538
    UMLS CUI-2
    C0565990
    Inst/Affiliate
    Description

    Combined Institution Name

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25454
    NCI Thesaurus ObjectClass-2
    C21541
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ValueDomain
    C25191
    NCI Thesaurus ValueDomain-2
    C21541
    UMLS CUI-1
    C0565990
    CALGB Patient ID
    Description

    Patient CALGB Identifier Number

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25442
    UMLS CUI-1
    C1549740
    UMLS CUI-2
    C1516238
    Physician of Record
    Description

    Registered Investigator Name

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ObjectClass
    C17089
    NCI Thesaurus ObjectClass-2
    C25644
    UMLS CUI-1
    C2826892
    Participating Group
    Description

    Participating Group

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    NCI Thesaurus ObjectClass
    C25608
    NCI Thesaurus ObjectClass-2
    C17005
    NCI Thesaurus Property
    C25364
    Protocol Administration
    Description

    Protocol Administration

    IRB Approval Date
    Description

    Protocol IRB Approved Date

    Data type

    date

    Measurement units
    • MM DD YYYY
    Alias
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ObjectClass
    C25320
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus Property
    C16741
    NCI Thesaurus Property-2
    C25425
    UMLS CUI-1
    C2346846
    UMLS CUI-2
    C0011008
    MM DD YYYY
    Date Informed Consent Signed
    Description

    Informed Consent Date

    Data type

    date

    Measurement units
    • MM DD YYYY
    Alias
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C16468
    NCI Thesaurus Property
    C25679
    UMLS CUI-1
    C2985782
    MM DD YYYY
    Projected Start Date of Treatment (MM DD YYYY)
    Description

    Treatment Projected Begin Date

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C25631
    NCI Thesaurus Property
    C25431
    NCI Thesaurus Property-2
    C25275
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25431
    UMLS CUI-1
    C0439659
    UMLS CUI-2
    C2745955
    UMLS CUI-3
    C0011008
    UMLS CUI-4
    C0439659
    HIPAA Authorization Date (MM DD YYYY)
    Description

    Patient Signed Discharge Medical Record Date

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25679
    NCI Metathesaurus Property
    C0012621
    NCI Thesaurus Property-2
    C45258
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0030705
    UMLS CUI-2
    C0025102
    UMLS CUI-3
    C0011008
    Contact Person at Institution
    Description

    InstitutionContactPersonName

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C21541
    UMLS 2011AA ObjectClass
    C0018704
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass-2
    C25461
    UMLS 2011AA ObjectClass-2
    C0337611
    Phone
    Description

    Person Completing Form Phone

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1550483
    NCI Thesaurus ObjectClass
    C25190
    UMLS CUI-2
    C1515258
    NCI Thesaurus ObjectClass-2
    C25657
    NCI Thesaurus Property
    C25395
    Fax
    Description

    ResponsiblePersonFaxNumber

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ObjectClass-2
    C25657
    UMLS 2011AA ObjectClass-2
    C1273518
    NCI Thesaurus Property
    C25210
    UMLS 2011AA Property
    C0085205
    Patient Demographics/pre-treatment Characteristics
    Description

    Patient Demographics/pre-treatment Characteristics

    Patient Initials (Last, First Middle)
    Description

    Patient Initials

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    UMLS CUI-1
    C2986440
    Patient Date of Birth
    Description

    Patient Birth Date

    Data type

    date

    Measurement units
    • MM.DD.YYYY
    Alias
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus Property
    C25155
    UMLS CUI-1
    C0421451
    MM.DD.YYYY
    Patient Social Security Number
    Description

    Social Security Number

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    NCI Thesaurus ObjectClass
    C25190
    NCI Thesaurus Property
    C25686
    UMLS CUI-1
    C1301821
    Patient Hospital No.
    Description

    Patient Medical Record Number

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25261
    NCI Thesaurus Property-2
    C25198
    UMLS CUI-1
    C1301894
    Gender
    Description

    Gender

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C17357
    UMLS CUI-1
    C0079399
    Race (Mark all that apply)
    Description

    Race

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C17049
    UMLS CUI-1
    C0034510
    Ethnicity (Mark one)
    Description

    Ethnicity

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C16564
    UMLS CUI-1
    C0015031
    Patient Demographics/pre-treatment Characteristics2
    Description

    Patient Demographics/pre-treatment Characteristics2

    Performance Status (ECOG/Zubrod scale)
    Description

    ECOG

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    NCI Thesaurus Property
    C25367
    NCI Thesaurus ValueDomain-2
    C25491
    NCI Thesaurus ObjectClass
    C20641
    UMLS CUI-1
    C1520224
    Height
    Description

    Patient Height

    Data type

    integer

    Measurement units
    • cm
    Alias
    NCI Thesaurus ValueDomain
    C25209
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25347
    UMLS CUI-1
    C0489786
    cm
    Body weight
    Description

    Body weight

    Data type

    float

    Measurement units
    • kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25208
    UMLS CUI-1
    C0005910
    kg
    Body surface area
    Description

    Body surface area

    Data type

    float

    Measurement units
    • m²
    Alias
    NCI Thesaurus ValueDomain
    C25209
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25157
    UMLS CUI-1
    C0005902
    m²
    Disease (Advanced Breast Cancer)
    Description

    DiseaseDescriptionText

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Stage (IIIB IV)
    Description

    DiseaseDescriptionStage

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus ValueDomain
    C16899
    UMLS 2011AA ValueDomain
    C1300072
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Method of Payment (Adminstration USA only Mark one)
    Description

    Payment method

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25371
    UMLS CUI-1
    C0680264
    Patient Zip Code
    Description

    Zip code

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25407
    UMLS CUI-1
    C1521842
    Country of Residence (if not USA)
    Description

    Country of Residence

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus ValueDomain
    C25464
    NCI Thesaurus Property
    C25407
    NCI Thesaurus ValueDomain-2
    C42614
    UMLS CUI-1
    C1562954
    Certification Of Eligibility And Protocol Design
    Description

    Certification Of Eligibility And Protocol Design

    In the opinion of the investigator, is the patient eligible?
    Description

    Eligibility for trial

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C1302261
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25171
    Stratification Factors
    Description

    StudyStratificationText

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C15206
    UMLS 2011AA ObjectClass
    C0008972
    NCI Thesaurus Property
    C25689
    UMLS 2011AA Property
    C1514983
    Planned endocrine therapy
    Description

    HormoneTherapyPlannedType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C15445
    UMLS 2011AA ObjectClass
    C0279025
    NCI Thesaurus Property
    C25619
    UMLS 2011AA Property
    C1301732
    Disease Free Interval (months from initial diagnosis to first progression)
    Description

    FirstPostDiagnosisProgressionPresentDuration

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25331
    NCI Thesaurus ObjectClass-2
    C38008
    UMLS 2011AA ObjectClass
    C0687676
    NCI Thesaurus ObjectClass-3
    C25509
    UMLS 2011AA ObjectClass-2
    C1279901
    NCI Thesaurus ObjectClass-4
    C15220
    UMLS 2011AA ObjectClass-3
    C0011900
    NCI Thesaurus Property
    C25626
    UMLS 2011AA Property
    C0150312
    NCI Thesaurus ValueDomain
    C25330
    UMLS 2011AA ValueDomain
    C0449238
    Is measurable disease present?
    Description

    Measurable Disease

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    NCI Thesaurus Property
    C25626
    NCI Thesaurus ObjectClass
    C2991
    NCI Thesaurus ObjectClass-2
    C37894
    Assigned Treatment Arm
    Description

    Protocol Treatment Arm

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1522541
    NCI Thesaurus Property
    C32141
    NCI Thesaurus ObjectClass
    C15368
    Kit number
    Description

    BlindedProtocolAgentIdentifierNumber

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C41161
    UMLS 2011AA ObjectClass
    C1521826
    NCI Thesaurus ObjectClass-2
    C49068
    UMLS 2011AA ObjectClass-2
    C0150108
    Initial Patient Consent For Specimen Use
    Description

    Initial Patient Consent For Specimen Use

    Patient's Initial Consent given for specimen use for research on the patient's cancer?
    Description

    SpecimenResearchConsentRelatedInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    NCI Thesaurus Property
    C15319
    NCI Thesaurus ObjectClass
    C19157
    NCI Thesaurus Property-2
    C25460
    UMLS CUI-1
    C1512699
    UMLS CUI-2
    C0370003
    UMLS CUI-3
    C1511481
    Patient's initial consent given for specimen use for genetic research relating to the study treatment
    Description

    SpecimenRelatedGeneticResearchConsentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C19157
    NCI Thesaurus Property
    C15319
    NCI Thesaurus Property-2
    C25648
    NCI Thesaurus Property-3
    C17938
    NCI Thesaurus Property-4
    C25460
    NCI Thesaurus ValueDomain
    C38147
    UMLS CUI-1
    C0370003
    UMLS CUI-2
    C0439849
    UMLS CUI-3
    C0314603
    UMLS CUI-4
    C1511481
    UMLS CUI-5
    C1512698
    Patient's Initial Consent given for specimen kept for future use in research to learn about, prevent, or treat cancer
    Description

    PersonSpecimenMalignantNeoplasmResearchConsentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25190
    NCI Thesaurus Property
    C15319
    NCI Thesaurus Property-2
    C9305
    NCI Thesaurus Property-3
    C19157
    NCI Thesaurus Property-4
    C25460
    NCI Thesaurus ValueDomain
    C38147
    UMLS CUI-1
    C0027361
    UMLS CUI-2
    C0006826
    UMLS CUI-3
    C0370003
    UMLS CUI-4
    C1511481
    UMLS CUI-5
    C1512698
    Patient's initial consent given for specimen(s) may be kept for use in research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
    Description

    PatientOtherDiseaseorDisorderClinicalStudyConsentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C17649
    NCI Thesaurus Property-2
    C2991
    NCI Thesaurus Property-3
    C15206
    NCI Thesaurus Property-4
    C25460
    NCI Thesaurus ValueDomain
    C38147
    UMLS CUI-1
    C0030705
    UMLS CUI-2
    C0205394
    UMLS CUI-3
    C0012634
    UMLS CUI-4
    C0008972
    UMLS CUI-5
    C1511481
    UMLS CUI-6
    C1512698
    Patient's initial consent given for further contact to participate in research on future studies
    Description

    PatientContactConsentInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C67527
    NCI Thesaurus Property-2
    C25460
    NCI Thesaurus Property-3
    C16452
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C1522577
    UMLS CUI-2
    C0521104
    Registration Information
    Description

    Registration Information

    CALGB Patient ID
    Description

    Patient CALGB Identifier Number

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25442
    UMLS CUI-1
    C1549740
    UMLS CUI-2
    C1516238
    Registration Date (MM DD YYYY)
    Description

    PatientRegistrationDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus Property
    C25646
    UMLS 2011AA Property
    C1514821
    Participating Group Patient ID
    Description

    Trial subject ID Participating Group

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    Registrar's Signature
    Description

    RegisteringPersonIdentifierSignatureName

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ObjectClass-2
    C25645
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ValueDomain-2
    C25678
    UMLS 2011AA ValueDomain-2
    C1519316
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    Similar models

    Endocrine Therapy in Combination with Anti-VEGF Therapy: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy plus for Women with Hormone Receptor-Positive Advanced Breast Cancer

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Header Module
    Leading Medical center
    Item
    Lead Institution
    text
    C21541 (NCI Thesaurus ObjectClass)
    C25552 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C25191 (NCI Thesaurus ValueDomain)
    C21541 (NCI Thesaurus ValueDomain-2)
    C1522538 (UMLS CUI-1)
    C0565990 (UMLS CUI-2)
    Institution name
    Item
    Inst/Affiliate
    text
    C25454 (NCI Thesaurus ObjectClass)
    C21541 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C25191 (NCI Thesaurus ValueDomain)
    C21541 (NCI Thesaurus ValueDomain-2)
    C0565990 (UMLS CUI-1)
    Patient ID CALGB
    Item
    CALGB Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C25364 (NCI Thesaurus Property)
    C25442 (NCI Thesaurus Property-2)
    C1549740 (UMLS CUI-1)
    C1516238 (UMLS CUI-2)
    Investigator Name
    Item
    Physician of Record
    text
    C25191 (NCI Thesaurus ValueDomain)
    C25364 (NCI Thesaurus Property)
    C17089 (NCI Thesaurus ObjectClass)
    C25644 (NCI Thesaurus ObjectClass-2)
    C2826892 (UMLS CUI-1)
    Participating Group
    Item
    Participating Group
    text
    C25191 (NCI Thesaurus ValueDomain)
    C25608 (NCI Thesaurus ObjectClass)
    C17005 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    Item Group
    Protocol Administration
    Protocol approval date
    Item
    IRB Approval Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C25320 (NCI Thesaurus ObjectClass)
    C25367 (NCI Thesaurus ValueDomain-2)
    C16741 (NCI Thesaurus Property)
    C25425 (NCI Thesaurus Property-2)
    C2346846 (UMLS CUI-1)
    C0011008 (UMLS CUI-2)
    Informed Consent Date
    Item
    Date Informed Consent Signed
    date
    C25164 (NCI Thesaurus ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    C16468 (NCI Thesaurus ObjectClass)
    C25679 (NCI Thesaurus Property)
    C2985782 (UMLS CUI-1)
    Treatment Projected Begin Date
    Item
    Projected Start Date of Treatment (MM DD YYYY)
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25631 (NCI Thesaurus ObjectClass-2)
    C25431 (NCI Thesaurus Property)
    C25275 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25431 (NCI Thesaurus ValueDomain-2)
    C0439659 (UMLS CUI-1)
    C2745955 (UMLS CUI-2)
    C0011008 (UMLS CUI-3)
    C0439659 (UMLS CUI-4)
    Patient Signed Discharge Medical Record Date
    Item
    HIPAA Authorization Date (MM DD YYYY)
    date
    C16960 (NCI Thesaurus ObjectClass)
    C25679 (NCI Thesaurus Property)
    C0012621 (NCI Metathesaurus Property)
    C45258 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C0030705 (UMLS CUI-1)
    C0025102 (UMLS CUI-2)
    C0011008 (UMLS CUI-3)
    InstitutionContactPersonName
    Item
    Contact Person at Institution
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C21541 (NCI Thesaurus ObjectClass)
    C0018704 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25461 (NCI Thesaurus ObjectClass-2)
    C0337611 (UMLS 2011AA ObjectClass-2)
    Person Completing Form Phone
    Item
    Phone
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1550483 (UMLS CUI-1)
    C25190 (NCI Thesaurus ObjectClass)
    C1515258 (UMLS CUI-2)
    C25657 (NCI Thesaurus ObjectClass-2)
    C25395 (NCI Thesaurus Property)
    ResponsiblePersonFaxNumber
    Item
    Fax
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25657 (NCI Thesaurus ObjectClass-2)
    C1273518 (UMLS 2011AA ObjectClass-2)
    C25210 (NCI Thesaurus Property)
    C0085205 (UMLS 2011AA Property)
    Item Group
    Patient Demographics/pre-treatment Characteristics
    Patient Initials
    Item
    Patient Initials (Last, First Middle)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    C2986440 (UMLS CUI-1)
    Patient Birth Date
    Item
    Patient Date of Birth
    date
    C25164 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C25367 (NCI Thesaurus ValueDomain-2)
    C25155 (NCI Thesaurus Property)
    C0421451 (UMLS CUI-1)
    Social Security Number
    Item
    Patient Social Security Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C25686 (NCI Thesaurus Property)
    C1301821 (UMLS CUI-1)
    Patient Medical Record Number
    Item
    Patient Hospital No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C25261 (NCI Thesaurus Property)
    C25198 (NCI Thesaurus Property-2)
    C1301894 (UMLS CUI-1)
    Item
    Gender
    text
    C25372 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C17357 (NCI Thesaurus Property)
    C0079399 (UMLS CUI-1)
    CL.1
    Code List
    Gender
    CL Item
    Female (F)
    CL Item
    Male (M)
    Item
    Race (Mark all that apply)
    text
    C25372 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C17049 (NCI Thesaurus Property)
    C0034510 (UMLS CUI-1)
    CL.2
    Code List
    Race (Mark all that apply)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)
    C41259 (NCI Thesaurus)
    C1515945 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)
    C41260 (NCI Thesaurus)
    C0078988 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)
    C16352 (NCI Thesaurus)
    C0085756 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)
    C41219 (NCI Thesaurus)
    C1513907 (UMLS 2011AA)
    CL Item
    Could Not Be Determined Or Unsure (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)
    C41261 (NCI Thesaurus)
    C0007457 (UMLS 2011AA)
    Item
    Ethnicity (Mark one)
    text
    C25372 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C16564 (NCI Thesaurus Property)
    C0015031 (UMLS CUI-1)
    CL.3
    Code List
    Ethnicity (Mark one)
    CL Item
    A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (Hispanic or Latino)
    C17459 (NCI Thesaurus)
    C0086409 (UMLS 2011AA)
    CL Item
    A Person Not Meeting The Definition For Hispanic Or Latino. (Not Hispanic or Latino)
    C41222 (NCI Thesaurus)
    C1518424 (UMLS 2011AA)
    CL Item
    Could Not Be Determined Or Unsure (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item Group
    Patient Demographics/pre-treatment Characteristics2
    Item
    Performance Status (ECOG/Zubrod scale)
    text
    C25664 (NCI Thesaurus ValueDomain)
    C25367 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus ValueDomain-2)
    C20641 (NCI Thesaurus ObjectClass)
    C1520224 (UMLS CUI-1)
    CL.4
    Code List
    Performance Status (ECOG/Zubrod scale)
    CL Item
    Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
    CL Item
    Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
    CL Item
    Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
    CL Item
    Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
    CL Item
    Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
    CL Item
    Dead (5)
    Patient Height
    Item
    Height
    integer
    C25209 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C25347 (NCI Thesaurus Property)
    C0489786 (UMLS CUI-1)
    Weight
    Item
    Body weight
    float
    C25209 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C25208 (NCI Thesaurus Property)
    C0005910 (UMLS CUI-1)
    BSA
    Item
    Body surface area
    float
    C25209 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C25157 (NCI Thesaurus Property)
    C0005902 (UMLS CUI-1)
    DiseaseDescriptionText
    Item
    Disease (Advanced Breast Cancer)
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    DiseaseDescriptionStage
    Item
    Stage (IIIB IV)
    text
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C16899 (NCI Thesaurus ValueDomain)
    C1300072 (UMLS 2011AA ValueDomain)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    Item
    Method of Payment (Adminstration USA only Mark one)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C25371 (NCI Thesaurus Property)
    C0680264 (UMLS CUI-1)
    CL.5
    Code List
    Method of Payment (Adminstration USA only Mark one)
    CL Item
    Medicaid (Medicaid)
    C0025071 (NCI Metathesaurus)
    CL Item
    Medicaid And Medicare (Medicaid and Medicare)
    CL Item
    Medicare (Medicare)
    C16665 (NCI Thesaurus)
    C0018717 (UMLS 2011AA)
    CL Item
    Medicare And Private Insurance (Medicare and Private Insurance)
    CL Item
    Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS & TRICARE))
    CL Item
    No Means Of Payment (no Insurance) (No means of payment (no insurance))
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    CL Item
    Private Insurance (Private Insurance)
    CL Item
    Self Pay (no Insurance) (Self Pay (No Insurance))
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CL Item
    Veterans Sponsored (Veterans Sponsored)
    Zip code
    Item
    Patient Zip Code
    text
    C25162 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C25407 (NCI Thesaurus Property)
    C1521842 (UMLS CUI-1)
    Country of Residence
    Item
    Country of Residence (if not USA)
    text
    C16960 (NCI Thesaurus ObjectClass)
    C25464 (NCI Thesaurus ValueDomain)
    C25407 (NCI Thesaurus Property)
    C42614 (NCI Thesaurus ValueDomain-2)
    C1562954 (UMLS CUI-1)
    Item Group
    Certification Of Eligibility And Protocol Design
    Eligibility for trial
    Item
    In the opinion of the investigator, is the patient eligible?
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1302261 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25171 (NCI Thesaurus Property)
    StudyStratificationText
    Item
    Stratification Factors
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C15206 (NCI Thesaurus ObjectClass)
    C0008972 (UMLS 2011AA ObjectClass)
    C25689 (NCI Thesaurus Property)
    C1514983 (UMLS 2011AA Property)
    Item
    Planned endocrine therapy
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C15445 (NCI Thesaurus ObjectClass)
    C0279025 (UMLS 2011AA ObjectClass)
    C25619 (NCI Thesaurus Property)
    C1301732 (UMLS 2011AA Property)
    CL.7
    Code List
    Planned endocrine therapy
    CL Item
    Letrozole (Letrozole)
    C1527 (NCI Thesaurus)
    C0246421 (UMLS 2011AA)
    CL Item
    Tamoxifen (Tamoxifen)
    C855 (NCI Thesaurus)
    C0039286 (UMLS 2011AA)
    Item
    Disease Free Interval (months from initial diagnosis to first progression)
    text
    C25331 (NCI Thesaurus ObjectClass)
    C38008 (NCI Thesaurus ObjectClass-2)
    C0687676 (UMLS 2011AA ObjectClass)
    C25509 (NCI Thesaurus ObjectClass-3)
    C1279901 (UMLS 2011AA ObjectClass-2)
    C15220 (NCI Thesaurus ObjectClass-4)
    C0011900 (UMLS 2011AA ObjectClass-3)
    C25626 (NCI Thesaurus Property)
    C0150312 (UMLS 2011AA Property)
    C25330 (NCI Thesaurus ValueDomain)
    C0449238 (UMLS 2011AA ValueDomain)
    CL.8
    Code List
    Disease Free Interval (months from initial diagnosis to first progression)
    CL Item
    <= 24 Months (<= 24 months)
    CL Item
    > 24 Months (> 24 months)
    Measurable Disease
    Item
    Is measurable disease present?
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C25626 (NCI Thesaurus Property)
    C2991 (NCI Thesaurus ObjectClass)
    C37894 (NCI Thesaurus ObjectClass-2)
    Protocol Treatment Arm
    Item
    Assigned Treatment Arm
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1522541 (UMLS CUI-1)
    C32141 (NCI Thesaurus Property)
    C15368 (NCI Thesaurus ObjectClass)
    BlindedProtocolAgentIdentifierNumber
    Item
    Kit number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C41161 (NCI Thesaurus ObjectClass)
    C1521826 (UMLS 2011AA ObjectClass)
    C49068 (NCI Thesaurus ObjectClass-2)
    C0150108 (UMLS 2011AA ObjectClass-2)
    Item Group
    Initial Patient Consent For Specimen Use
    SpecimenResearchConsentRelatedInd-3
    Item
    Patient's Initial Consent given for specimen use for research on the patient's cancer?
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C15319 (NCI Thesaurus Property)
    C19157 (NCI Thesaurus ObjectClass)
    C25460 (NCI Thesaurus Property-2)
    C1512699 (UMLS CUI-1)
    C0370003 (UMLS CUI-2)
    C1511481 (UMLS CUI-3)
    SpecimenRelatedGeneticResearchConsentInd-2
    Item
    Patient's initial consent given for specimen use for genetic research relating to the study treatment
    boolean
    C19157 (NCI Thesaurus ObjectClass)
    C15319 (NCI Thesaurus Property)
    C25648 (NCI Thesaurus Property-2)
    C17938 (NCI Thesaurus Property-3)
    C25460 (NCI Thesaurus Property-4)
    C38147 (NCI Thesaurus ValueDomain)
    C0370003 (UMLS CUI-1)
    C0439849 (UMLS CUI-2)
    C0314603 (UMLS CUI-3)
    C1511481 (UMLS CUI-4)
    C1512698 (UMLS CUI-5)
    PersonSpecimenMalignantNeoplasmResearchConsentInd-2
    Item
    Patient's Initial Consent given for specimen kept for future use in research to learn about, prevent, or treat cancer
    boolean
    C25190 (NCI Thesaurus ObjectClass)
    C15319 (NCI Thesaurus Property)
    C9305 (NCI Thesaurus Property-2)
    C19157 (NCI Thesaurus Property-3)
    C25460 (NCI Thesaurus Property-4)
    C38147 (NCI Thesaurus ValueDomain)
    C0027361 (UMLS CUI-1)
    C0006826 (UMLS CUI-2)
    C0370003 (UMLS CUI-3)
    C1511481 (UMLS CUI-4)
    C1512698 (UMLS CUI-5)
    PatientOtherDiseaseorDisorderClinicalStudyConsentInd-2
    Item
    Patient's initial consent given for specimen(s) may be kept for use in research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C17649 (NCI Thesaurus Property)
    C2991 (NCI Thesaurus Property-2)
    C15206 (NCI Thesaurus Property-3)
    C25460 (NCI Thesaurus Property-4)
    C38147 (NCI Thesaurus ValueDomain)
    C0030705 (UMLS CUI-1)
    C0205394 (UMLS CUI-2)
    C0012634 (UMLS CUI-3)
    C0008972 (UMLS CUI-4)
    C1511481 (UMLS CUI-5)
    C1512698 (UMLS CUI-6)
    Permission to contact Patient
    Item
    Patient's initial consent given for further contact to participate in research on future studies
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C67527 (NCI Thesaurus Property)
    C25460 (NCI Thesaurus Property-2)
    C16452 (NCI Thesaurus Property-3)
    C38148 (NCI Thesaurus ValueDomain)
    C1522577 (UMLS CUI-1)
    C0521104 (UMLS CUI-2)
    Item Group
    Registration Information
    Patient ID CALGB
    Item
    CALGB Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C25364 (NCI Thesaurus Property)
    C25442 (NCI Thesaurus Property-2)
    C1549740 (UMLS CUI-1)
    C1516238 (UMLS CUI-2)
    PatientRegistrationDate
    Item
    Registration Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25367 (NCI Thesaurus ValueDomain-2)
    C25646 (NCI Thesaurus Property)
    C1514821 (UMLS 2011AA Property)
    Trial subject ID Participating Group
    Item
    Participating Group Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    RegisteringPersonIdentifierSignatureName
    Item
    Registrar's Signature
    text
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25645 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C25678 (NCI Thesaurus ValueDomain-2)
    C1519316 (UMLS 2011AA ValueDomain-2)
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