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ID

7313

Description

S1007 Prestudy Form (45282) Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=90DB6C43-AEA1-137D-E040-BB89AD432116

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=90DB6C43-AEA1-137D-E040-BB89AD432116

Keywords

  1. 8/27/12 8/27/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

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License

Creative Commons BY-NC 3.0 Legacy

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    Breast Cancer NCT01272037 Pre-Study - S1007 Prestudy Form (45282) - 3141026v1.0

    Instructions: Submit this form within 7 days of registration. All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across top of form

    Header
    Description

    Header

    SWOG Patient ID
    Description

    Trial subject ID SWOG

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1519429
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25699
    SWOG Study No.
    Description

    Protocol ID SWOG

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1519429
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25699
    Registration Step
    Description

    Registration Number

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1514821
    NCI Thesaurus ObjectClass
    C25646
    UMLS CUI-2
    C0237753
    NCI Thesaurus Property
    C16154
    NCI Thesaurus ValueDomain-2
    C16154
    Patient Initials (L, F M)
    Description

    Patient Initials

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Institution/Affiliate
    Description

    Institution Name

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25454
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass-2
    C21541
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ValueDomain
    C25191
    NCI Thesaurus ValueDomain-2
    C21541
    Physician
    Description

    Investigator Name

    Data type

    text

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

    Participating Group

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2347449
    NCI Thesaurus ObjectClass
    C25608
    NCI Thesaurus ObjectClass-2
    C17005
    NCI Thesaurus Property
    C25364
    Participating Group Study No.
    Description

    Study Number Participating Group

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    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
    Disease Description
    Description

    Disease Description

    Performance Status
    Description

    ECOG Performance Status

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1520224
    NCI Thesaurus Property
    C25367
    NCI Thesaurus ValueDomain-2
    C25491
    NCI Thesaurus ObjectClass
    C20641
    Weight (kg)
    Description

    Patient Weight

    Data type

    float

    Measurement units
    • Kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0005910
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25208
    Kg
    Menopausal Status (select one)
    Description

    PatientMenopauseCategory

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    UMLS 2011AA ValueDomain
    C0683312
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C3231
    UMLS 2011AA Property
    C0025320
    NCI Thesaurus ValueDomain-2
    C3231
    UMLS 2011AA ValueDomain-2
    C0025320
    Date of Initial Diagnosis of Primary Tumor (MM DD YYYY)
    Description

    FirstBiopsyPositiveDate

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C15189
    UMLS 2011AA ObjectClass
    C0005558
    NCI Thesaurus ObjectClass-2
    C25509
    UMLS 2011AA ObjectClass-2
    C1279901
    NCI Thesaurus Property
    C25246
    UMLS 2011AA Property
    C1446409
    NCI Thesaurus Property-2
    C25275
    UMLS 2011AA Property-2
    C2745955
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    Tumor Laterality (select one)
    Description

    PrimaryTumorLateralityType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus ObjectClass-2
    C25251
    UMLS 2011AA ObjectClass-2
    C0205225
    NCI Thesaurus Property
    C25185
    UMLS 2011AA Property
    C0332304
    Pathologic Primary Tumor Size (cm Maximum diameter of the invasive component; if multiple lesions, use longest lesion)
    Description

    PathologicTumorPrimarySizeMeasurement

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus ObjectClass-2
    C25610
    UMLS 2011AA ObjectClass-2
    C1521733
    NCI Thesaurus Property
    C25251
    UMLS 2011AA Property
    C0205225
    NCI Thesaurus Property-2
    C25681
    UMLS 2011AA Property-2
    C0456389
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
    Number of Positive Lymph Nodes (If sentinel node biopsy and axillary node dissection were performed, enter the sum of positive nodes.)
    Description

    LymphNodePositiveCount

    Data type

    float

    Alias
    NCI Thesaurus Property
    C25246
    UMLS 2011AA Property
    C1446409
    NCI Thesaurus ObjectClass
    C12745
    UMLS 2011AA ObjectClass
    C0024204
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    ER Status
    Description

    ERLevelTumorStatus

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C3262
    UMLS 2011AA ValueDomain
    C0027651
    NCI Thesaurus ObjectClass
    C17069
    UMLS 2011AA ObjectClass
    C0034804
    NCI Thesaurus ValueDomain-2
    C25688
    UMLS 2011AA ValueDomain-2
    C0449438
    NCI Thesaurus Property
    C25554
    UMLS 2011AA Property
    C0441889
    PgR Status
    Description

    PgRStatusType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C17075
    UMLS 2011AA ObjectClass
    C0034833
    NCI Metathesaurus Property
    C0678257
    HER2 results/IHC
    Description

    BreastCytogeneticsHER2/neuPolyclonalAntibodyTestScore

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C12971
    UMLS 2011AA ObjectClass
    C0006141
    NCI Thesaurus ObjectClass-2
    C16487
    UMLS 2011AA ObjectClass-2
    C0010802
    NCI Thesaurus Property
    C25294
    UMLS 2011AA Property
    C0022885
    NCI Thesaurus Property-2
    C17756
    UMLS 2011AA Property-2
    C0242957
    NCI Thesaurus Property-3
    C61381
    UMLS 2011AA Property-3
    C0312586
    NCI Thesaurus ValueDomain
    C25338
    UMLS 2011AA ValueDomain
    C0449820
    FISH ratio
    Description

    FISHAssessmentChromosome17ResultHER2NeuNumber

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C20989
    UMLS 2011AA ObjectClass
    C0031809
    NCI Thesaurus ObjectClass-2
    C17563
    UMLS 2011AA ObjectClass-2
    C0162789
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C13212
    UMLS 2011AA Property-2
    C0008659
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ValueDomain-2
    C17756
    UMLS 2011AA ValueDomain-2
    C0242957
    Additional Prestudy Data
    Description

    Additional Prestudy Data

    Breast cancer was first detected by (select one)
    Description

    BreastCarcinomaDiseaseFirstDetectedType

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus ObjectClass-2
    C4872
    UMLS 2011AA ObjectClass-2
    C0678222
    NCI Thesaurus Property
    C25509
    UMLS 2011AA Property
    C1279901
    NCI Thesaurus Property-2
    C25481
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Histologic Grade (combined histologic grade by SBR/Elston classification)
    Description

    BreastTumorHistologicGrade

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus ObjectClass-2
    C12971
    UMLS 2011AA ObjectClass-2
    C0006141
    NCI Thesaurus Property
    C25526
    UMLS 2011AA Property
    C0205462
    NCI Thesaurus Property-2
    C25365
    UMLS 2011AA Property-2
    C0678257
    NCI Thesaurus ValueDomain
    C25526
    UMLS 2011AA ValueDomain
    C0205462
    NCI Thesaurus ValueDomain-2
    C18000
    UMLS 2011AA ValueDomain-2
    C0919553
    Nuclear Grade
    Description

    BreastNeoplasmNuclearGradeCategory

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus ObjectClass-2
    C12971
    UMLS 2011AA ObjectClass-2
    C0006141
    NCI Thesaurus Property
    C13361
    UMLS 2011AA Property
    C0521447
    NCI Thesaurus Property-2
    C48309
    UMLS 2011AA Property-2
    C0441800
    NCI Thesaurus ValueDomain
    C25372
    UMLS 2011AA ValueDomain
    C0683312
    Histology
    Description

    BreastTumorHistologicCategory

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus ObjectClass-2
    C12971
    UMLS 2011AA ObjectClass-2
    C0006141
    NCI Thesaurus Property
    C25526
    UMLS 2011AA Property
    C0205462
    NCI Thesaurus Property-2
    C25161
    UMLS 2011AA Property-2
    C0008902
    NCI Thesaurus ValueDomain
    C25372
    UMLS 2011AA ValueDomain
    C0683312
    NCI Thesaurus ValueDomain-2
    C25526
    UMLS 2011AA ValueDomain-2
    C0205462
    Specify
    Description

    BreastTumorHistologicClassificationSpecify

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus ObjectClass-2
    C12971
    UMLS 2011AA ObjectClass-2
    C0006141
    NCI Thesaurus Property
    C25526
    UMLS 2011AA Property
    C0205462
    NCI Thesaurus Property-2
    C25161
    UMLS 2011AA Property-2
    C0008902
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    Lymphovascular space invasion
    Description

    TumorLymphovascularInvasionInd

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus Property
    C20625
    UMLS 2011AA Property
    C1269955
    NCI Thesaurus Property-2
    C25561
    UMLS 2011AA Property-2
    C1518090
    Extranodal extension
    Description

    TumorExtranodalExtensionIndicator

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus Property
    C25270
    UMLS 2011AA Property
    C0231448
    NCI Thesaurus Property-2
    C25504
    UMLS 2011AA Property-2
    C1517067
    Multifocal Tumors
    Description

    TumorMultifocalDescriptionInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus Property
    C25253
    UMLS 2011AA Property
    C0205292
    NCI Thesaurus Property-2
    C25365
    UMLS 2011AA Property-2
    C0678257
    Multicentric Tumors
    Description

    TumorMulticentricDescriptionInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    NCI Thesaurus Property-2
    C25303
    UMLS 2011AA Property-2
    C0439743
    Breast: Surgical Procedures
    Description

    Breast: Surgical Procedures

    Most Extensive Primary Surgery (select one)
    Description

    BreastPrimarySurgicalProcedurePerformedType

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25251
    UMLS 2011AA ObjectClass
    C0205225
    NCI Thesaurus ObjectClass-2
    C12971
    UMLS 2011AA ObjectClass-2
    C0006141
    NCI Thesaurus ObjectClass-3
    C15329
    UMLS 2011AA ObjectClass-3
    C0543467
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Date of Most Extensive Primary Surgery (MM DD YYYY If required, use last re-excision date)
    Description

    PrimarySurgeryDate

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C25251
    UMLS 2011AA ObjectClass
    C0205225
    NCI Thesaurus ObjectClass-2
    C15329
    UMLS 2011AA ObjectClass-2
    C0543467
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    Was sentinel node sampling performed
    Description

    SentinelNodeBiopsyInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus Property
    C15189
    UMLS 2011AA Property
    C0005558
    NCI Thesaurus ObjectClass
    C12947
    UMLS 2011AA ObjectClass
    C1522495
    Sentinel Node Biopsy Date (MM DD YYYY)
    Description

    SentinelNodeBiopsyDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus Property
    C15189
    UMLS 2011AA Property
    C0005558
    NCI Thesaurus ObjectClass
    C12947
    UMLS 2011AA ObjectClass
    C1522495
    Sentinel Node Biopsy Results
    Description

    SentinelNodeBiopsyResultStatus

    Data type

    text

    Alias
    NCI Thesaurus Property
    C15189
    UMLS 2011AA Property
    C0005558
    NCI Thesaurus Property-2
    C20200
    UMLS 2011AA Property-2
    C1274040
    NCI Thesaurus ObjectClass
    C12947
    UMLS 2011AA ObjectClass
    C1522495
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    Maximum size of sentinel lymph node metastasis (mm)
    Description

    BreastSentinelNodeLargestMetastasisDiameterMeasurement

    Data type

    float

    Measurement units
    • mm
    Alias
    NCI Thesaurus ObjectClass
    C12971
    UMLS 2011AA ObjectClass
    C0006141
    NCI Thesaurus ObjectClass-2
    C12947
    UMLS 2011AA ObjectClass-2
    C1522495
    NCI Thesaurus Property
    C25285
    UMLS 2011AA Property
    C1301886
    NCI Thesaurus Property-2
    C19151
    UMLS 2011AA Property-2
    C0027627
    NCI Metathesaurus Property
    C0549177
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
    mm
    Unknown
    Description

    DataUnknownText

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C25474
    UMLS 2011AA ObjectClass
    C1511726
    NCI Thesaurus Property
    C17998
    UMLS 2011AA Property
    C0439673
    Was axillary dissection performed?
    Description

    AxillaryNodeDissectionInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus Property
    C15227
    UMLS 2011AA Property
    C0012737
    NCI Thesaurus ObjectClass
    C12904
    UMLS 2011AA ObjectClass
    C0729594
    Date of Axillary Dissection (MM DD YYYY)
    Description

    AxillarySurgeryDissectionDate

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C13351
    UMLS 2011AA ObjectClass
    C0004454
    NCI Thesaurus ObjectClass-2
    C15329
    UMLS 2011AA ObjectClass-2
    C0543467
    NCI Thesaurus Property
    C15227
    UMLS 2011AA Property
    C0012737
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    Number of Lymph Nodes Examined (If sentinel node biopsy and axillary node dissection were performed, enter the sum of nodes examined.)
    Description

    LymphNodeExaminedCount

    Data type

    float

    Alias
    NCI Thesaurus Property
    C25500
    UMLS 2011AA Property
    C0332128
    NCI Thesaurus ObjectClass
    C12745
    UMLS 2011AA ObjectClass
    C0024204
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    Comments
    Description

    Comments

    Comments
    Description

    Research Comments

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393

    Similar models

    Instructions: Submit this form within 7 days of registration. All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across top of form

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Header
    Trial subject ID SWOG
    Item
    SWOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1519429 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25699 (NCI Thesaurus Property-2)
    Protocol ID SWOG
    Item
    SWOG Study No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1519429 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25699 (NCI Thesaurus Property-2)
    Registration Number
    Item
    Registration Step
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1514821 (UMLS CUI-1)
    C25646 (NCI Thesaurus ObjectClass)
    C0237753 (UMLS CUI-2)
    C16154 (NCI Thesaurus Property)
    C16154 (NCI Thesaurus ValueDomain-2)
    Patient Initials
    Item
    Patient Initials (L, F M)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Institution Name
    Item
    Institution/Affiliate
    text
    C25454 (NCI Thesaurus ObjectClass)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C25191 (NCI Thesaurus ValueDomain)
    C21541 (NCI Thesaurus ValueDomain-2)
    Investigator Name
    Item
    Physician
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2826892 (UMLS CUI-1)
    C25364 (NCI Thesaurus Property)
    C17089 (NCI Thesaurus ObjectClass)
    C25644 (NCI Thesaurus ObjectClass-2)
    Participating Group
    Item
    Participating Group Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2347449 (UMLS CUI-1)
    C25608 (NCI Thesaurus ObjectClass)
    C17005 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    Study Number Participating Group
    Item
    Participating Group Study No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    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)
    Item Group
    Disease Description
    ECOG Performance Status
    Item
    Performance Status
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1520224 (UMLS CUI-1)
    C25367 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus ValueDomain-2)
    C20641 (NCI Thesaurus ObjectClass)
    Patient Weight
    Item
    Weight (kg)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0005910 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25208 (NCI Thesaurus Property)
    Item
    Menopausal Status (select one)
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0683312 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C3231 (NCI Thesaurus Property)
    C0025320 (UMLS 2011AA Property)
    C3231 (NCI Thesaurus ValueDomain-2)
    C0025320 (UMLS 2011AA ValueDomain-2)
    Code List
    Menopausal Status (select one)
    CL Item
    Pre (< 6 Mo Since Lmp And No Prior Bilateral Oophorectomy And Not On Estrogen Replacement) (Pre (< 6 mo since LMP and no prior bilateral oophorectomy and not on estrogen replacement))
    CL Item
    Post (prior Bilateral Oophorectomy Or > 12 Mo Since Lmp With No Prior Hysterectomy) (Post (prior bilateral oophorectomy OR > 12 mo since LMP with no prior hysterectomy))
    CL Item
    Above Categories Not Applicable And Age <50 (Above categories not applicable AND Age < 50)
    CL Item
    Above Categories Not Applicable And Age >= 50 (Above categories not applicable AND Age >= 50)
    FirstBiopsyPositiveDate
    Item
    Date of Initial Diagnosis of Primary Tumor (MM DD YYYY)
    date
    C15189 (NCI Thesaurus ObjectClass)
    C0005558 (UMLS 2011AA ObjectClass)
    C25509 (NCI Thesaurus ObjectClass-2)
    C1279901 (UMLS 2011AA ObjectClass-2)
    C25246 (NCI Thesaurus Property)
    C1446409 (UMLS 2011AA Property)
    C25275 (NCI Thesaurus Property-2)
    C2745955 (UMLS 2011AA Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    Item
    Tumor Laterality (select one)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C25251 (NCI Thesaurus ObjectClass-2)
    C0205225 (UMLS 2011AA ObjectClass-2)
    C25185 (NCI Thesaurus Property)
    C0332304 (UMLS 2011AA Property)
    Code List
    Tumor Laterality (select one)
    CL Item
    Left (Left)
    C25229 (NCI Thesaurus)
    C0205091 (UMLS 2011AA)
    CL Item
    Right (Right)
    C25228 (NCI Thesaurus)
    C0205090 (UMLS 2011AA)
    CL Item
    Bilateral (Bilateral)
    C13332 (NCI Thesaurus)
    C0238767 (UMLS 2011AA)
    PathologicTumorPrimarySizeMeasurement
    Item
    Pathologic Primary Tumor Size (cm Maximum diameter of the invasive component; if multiple lesions, use longest lesion)
    float
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C25610 (NCI Thesaurus ObjectClass-2)
    C1521733 (UMLS 2011AA ObjectClass-2)
    C25251 (NCI Thesaurus Property)
    C0205225 (UMLS 2011AA Property)
    C25681 (NCI Thesaurus Property-2)
    C0456389 (UMLS 2011AA Property-2)
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
    LymphNodePositiveCount
    Item
    Number of Positive Lymph Nodes (If sentinel node biopsy and axillary node dissection were performed, enter the sum of positive nodes.)
    float
    C25246 (NCI Thesaurus Property)
    C1446409 (UMLS 2011AA Property)
    C12745 (NCI Thesaurus ObjectClass)
    C0024204 (UMLS 2011AA ObjectClass)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    Item
    ER Status
    text
    C3262 (NCI Thesaurus ValueDomain)
    C0027651 (UMLS 2011AA ValueDomain)
    C17069 (NCI Thesaurus ObjectClass)
    C0034804 (UMLS 2011AA ObjectClass)
    C25688 (NCI Thesaurus ValueDomain-2)
    C0449438 (UMLS 2011AA ValueDomain-2)
    C25554 (NCI Thesaurus Property)
    C0441889 (UMLS 2011AA Property)
    Code List
    ER Status
    CL Item
    Negative (Negative)
    C25247 (NCI Thesaurus)
    C0205160 (UMLS 2011AA)
    CL Item
    Positive (Positive)
    C25246 (NCI Thesaurus)
    C1446409 (UMLS 2011AA)
    Item
    PgR Status
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C17075 (NCI Thesaurus ObjectClass)
    C0034833 (UMLS 2011AA ObjectClass)
    C0678257 (NCI Metathesaurus Property)
    Code List
    PgR Status
    CL Item
    Negative (Negative)
    C25247 (NCI Thesaurus)
    C0205160 (UMLS 2011AA)
    CL Item
    Positive (Positive)
    C25246 (NCI Thesaurus)
    C1446409 (UMLS 2011AA)
    Item
    HER2 results/IHC
    text
    C12971 (NCI Thesaurus ObjectClass)
    C0006141 (UMLS 2011AA ObjectClass)
    C16487 (NCI Thesaurus ObjectClass-2)
    C0010802 (UMLS 2011AA ObjectClass-2)
    C25294 (NCI Thesaurus Property)
    C0022885 (UMLS 2011AA Property)
    C17756 (NCI Thesaurus Property-2)
    C0242957 (UMLS 2011AA Property-2)
    C61381 (NCI Thesaurus Property-3)
    C0312586 (UMLS 2011AA Property-3)
    C25338 (NCI Thesaurus ValueDomain)
    C0449820 (UMLS 2011AA ValueDomain)
    Code List
    HER2 results/IHC
    CL Item
    0 (0)
    C0919414 (NCI Metathesaurus)
    CL Item
    1+ (1+)
    CL Item
    2+ (2+)
    FISHAssessmentChromosome17ResultHER2NeuNumber
    Item
    FISH ratio
    float
    C20989 (NCI Thesaurus ObjectClass)
    C0031809 (UMLS 2011AA ObjectClass)
    C17563 (NCI Thesaurus ObjectClass-2)
    C0162789 (UMLS 2011AA ObjectClass-2)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C13212 (NCI Thesaurus Property-2)
    C0008659 (UMLS 2011AA Property-2)
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C17756 (NCI Thesaurus ValueDomain-2)
    C0242957 (UMLS 2011AA ValueDomain-2)
    Item Group
    Additional Prestudy Data
    Item
    Breast cancer was first detected by (select one)
    text
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C4872 (NCI Thesaurus ObjectClass-2)
    C0678222 (UMLS 2011AA ObjectClass-2)
    C25509 (NCI Thesaurus Property)
    C1279901 (UMLS 2011AA Property)
    C25481 (NCI Thesaurus Property-2)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    Code List
    Breast cancer was first detected by (select one)
    CL Item
    Screening Mammogram (Screening mammogram)
    CL Item
    Physical Exam Or Diagnostic Mammogram Due To Symptoms Of Breast Cancer Or Other Reason (Physical exam or diagnostic mammogram due to symptoms of breast cancer or other reason)
    Item
    Histologic Grade (combined histologic grade by SBR/Elston classification)
    text
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C12971 (NCI Thesaurus ObjectClass-2)
    C0006141 (UMLS 2011AA ObjectClass-2)
    C25526 (NCI Thesaurus Property)
    C0205462 (UMLS 2011AA Property)
    C25365 (NCI Thesaurus Property-2)
    C0678257 (UMLS 2011AA Property-2)
    C25526 (NCI Thesaurus ValueDomain)
    C0205462 (UMLS 2011AA ValueDomain)
    C18000 (NCI Thesaurus ValueDomain-2)
    C0919553 (UMLS 2011AA ValueDomain-2)
    Code List
    Histologic Grade (combined histologic grade by SBR/Elston classification)
    CL Item
    G1 Low Combined Histologic Grade (favorable) (G1)
    CL Item
    G2 Intermediate Combined Histologic Grade (moderately Favorable) (G2)
    CL Item
    G3 High Combined Histologic Grade (unfavorable) (G3)
    CL Item
    Gx Grade Cannot Be Assessed (GX)
    Item
    Nuclear Grade
    text
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C12971 (NCI Thesaurus ObjectClass-2)
    C0006141 (UMLS 2011AA ObjectClass-2)
    C13361 (NCI Thesaurus Property)
    C0521447 (UMLS 2011AA Property)
    C48309 (NCI Thesaurus Property-2)
    C0441800 (UMLS 2011AA Property-2)
    C25372 (NCI Thesaurus ValueDomain)
    C0683312 (UMLS 2011AA ValueDomain)
    Code List
    Nuclear Grade
    CL Item
    Low (Low)
    CL124342 (NCI Metathesaurus)
    CL Item
    Intermediate (Intermediate)
    C0205103 (NCI Metathesaurus)
    CL Item
    High (High)
    C25227 (NCI Thesaurus)
    C0205250 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Histology
    text
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C12971 (NCI Thesaurus ObjectClass-2)
    C0006141 (UMLS 2011AA ObjectClass-2)
    C25526 (NCI Thesaurus Property)
    C0205462 (UMLS 2011AA Property)
    C25161 (NCI Thesaurus Property-2)
    C0008902 (UMLS 2011AA Property-2)
    C25372 (NCI Thesaurus ValueDomain)
    C0683312 (UMLS 2011AA ValueDomain)
    C25526 (NCI Thesaurus ValueDomain-2)
    C0205462 (UMLS 2011AA ValueDomain-2)
    Code List
    Histology
    CL Item
    Invasive Ductal Carcinoma, Not Otherwise Specified (Invasive Ductal Carcinoma)
    C4194 (NCI Thesaurus)
    C1134719 (UMLS 2011AA)
    CL Item
    Invasive Lobular Breast Carcinoma (Invasive Lobular Carcinoma)
    C7950 (NCI Thesaurus)
    C0279565 (UMLS 2011AA)
    CL Item
    Invasive Mixed Ductal/lobular Carcinoma (Invasive mixed ductal/lobular carcinoma)
    CL Item
    Other Specify (Other)
    BreastTumorHistologicClassificationSpecify
    Item
    Specify
    text
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C12971 (NCI Thesaurus ObjectClass-2)
    C0006141 (UMLS 2011AA ObjectClass-2)
    C25526 (NCI Thesaurus Property)
    C0205462 (UMLS 2011AA Property)
    C25161 (NCI Thesaurus Property-2)
    C0008902 (UMLS 2011AA Property-2)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    Item
    Lymphovascular space invasion
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C20625 (NCI Thesaurus Property)
    C1269955 (UMLS 2011AA Property)
    C25561 (NCI Thesaurus Property-2)
    C1518090 (UMLS 2011AA Property-2)
    Code List
    Lymphovascular space invasion
    CL Item
    Yes (YES)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (NO)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Unknown (UNKNOWN)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Extranodal extension
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C25270 (NCI Thesaurus Property)
    C0231448 (UMLS 2011AA Property)
    C25504 (NCI Thesaurus Property-2)
    C1517067 (UMLS 2011AA Property-2)
    Code List
    Extranodal extension
    CL Item
    Yes (YES)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (NO)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Unknown (UNKNOWN)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    TumorMultifocalDescriptionInd-3
    Item
    Multifocal Tumors
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C25253 (NCI Thesaurus Property)
    C0205292 (UMLS 2011AA Property)
    C25365 (NCI Thesaurus Property-2)
    C0678257 (UMLS 2011AA Property-2)
    TumorMulticentricDescriptionInd-3
    Item
    Multicentric Tumors
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    C25303 (NCI Thesaurus Property-2)
    C0439743 (UMLS 2011AA Property-2)
    Item Group
    Breast: Surgical Procedures
    Item
    Most Extensive Primary Surgery (select one)
    text
    C25251 (NCI Thesaurus ObjectClass)
    C0205225 (UMLS 2011AA ObjectClass)
    C12971 (NCI Thesaurus ObjectClass-2)
    C0006141 (UMLS 2011AA ObjectClass-2)
    C15329 (NCI Thesaurus ObjectClass-3)
    C0543467 (UMLS 2011AA ObjectClass-3)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    Code List
    Most Extensive Primary Surgery (select one)
    CL Item
    Partial Mastectomy, Lumpectomy Or Excisional Biopsy (Partial mastectomy/lumpectomy/excisional biopsy)
    CL Item
    Mastectomy, Nos (Mastectomy NOS)
    PrimarySurgeryDate
    Item
    Date of Most Extensive Primary Surgery (MM DD YYYY If required, use last re-excision date)
    date
    C25251 (NCI Thesaurus ObjectClass)
    C0205225 (UMLS 2011AA ObjectClass)
    C15329 (NCI Thesaurus ObjectClass-2)
    C0543467 (UMLS 2011AA ObjectClass-2)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    SentinelNodeBiopsyInd-3
    Item
    Was sentinel node sampling performed
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C15189 (NCI Thesaurus Property)
    C0005558 (UMLS 2011AA Property)
    C12947 (NCI Thesaurus ObjectClass)
    C1522495 (UMLS 2011AA ObjectClass)
    SentinelNodeBiopsyDate
    Item
    Sentinel Node Biopsy Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    C15189 (NCI Thesaurus Property)
    C0005558 (UMLS 2011AA Property)
    C12947 (NCI Thesaurus ObjectClass)
    C1522495 (UMLS 2011AA ObjectClass)
    Item
    Sentinel Node Biopsy Results
    text
    C15189 (NCI Thesaurus Property)
    C0005558 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property-2)
    C1274040 (UMLS 2011AA Property-2)
    C12947 (NCI Thesaurus ObjectClass)
    C1522495 (UMLS 2011AA ObjectClass)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    Code List
    Sentinel Node Biopsy Results
    CL Item
    Positive (Positive)
    C25246 (NCI Thesaurus)
    C1446409 (UMLS 2011AA)
    CL Item
    Negative (Negative)
    C25247 (NCI Thesaurus)
    C0205160 (UMLS 2011AA)
    BreastSentinelNodeLargestMetastasisDiameterMeasurement
    Item
    Maximum size of sentinel lymph node metastasis (mm)
    float
    C12971 (NCI Thesaurus ObjectClass)
    C0006141 (UMLS 2011AA ObjectClass)
    C12947 (NCI Thesaurus ObjectClass-2)
    C1522495 (UMLS 2011AA ObjectClass-2)
    C25285 (NCI Thesaurus Property)
    C1301886 (UMLS 2011AA Property)
    C19151 (NCI Thesaurus Property-2)
    C0027627 (UMLS 2011AA Property-2)
    C0549177 (NCI Metathesaurus Property)
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
    DataUnknownText
    Item
    Unknown
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C25474 (NCI Thesaurus ObjectClass)
    C1511726 (UMLS 2011AA ObjectClass)
    C17998 (NCI Thesaurus Property)
    C0439673 (UMLS 2011AA Property)
    AxillaryNodeDissectionInd-3
    Item
    Was axillary dissection performed?
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C15227 (NCI Thesaurus Property)
    C0012737 (UMLS 2011AA Property)
    C12904 (NCI Thesaurus ObjectClass)
    C0729594 (UMLS 2011AA ObjectClass)
    AxillarySurgeryDissectionDate
    Item
    Date of Axillary Dissection (MM DD YYYY)
    date
    C13351 (NCI Thesaurus ObjectClass)
    C0004454 (UMLS 2011AA ObjectClass)
    C15329 (NCI Thesaurus ObjectClass-2)
    C0543467 (UMLS 2011AA ObjectClass-2)
    C15227 (NCI Thesaurus Property)
    C0012737 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    LymphNodeExaminedCount
    Item
    Number of Lymph Nodes Examined (If sentinel node biopsy and axillary node dissection were performed, enter the sum of nodes examined.)
    float
    C25500 (NCI Thesaurus Property)
    C0332128 (UMLS 2011AA Property)
    C12745 (NCI Thesaurus ObjectClass)
    C0024204 (UMLS 2011AA ObjectClass)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    Item Group
    Comments
    Research Comments
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)

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