ID

1128

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

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

August 27, 2012

DOI

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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

English

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

1 forms  
Unnamed1
Description

Unnamed1

SWOG Patient ID
Description

PatientSouthwestOncologyGroupIdentifierNumber

Data type

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25699
UMLS 2011AA Property
C1519429
SWOG Study No.
Description

ProtocolSWOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25699
UMLS 2011AA Property
C1519429
Registration Step
Description

RegistrationStepNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25646
UMLS 2011AA ObjectClass
C1514821
NCI Thesaurus Property
C16154
UMLS 2011AA Property
C1704379
NCI Thesaurus ValueDomain
C16154
UMLS 2011AA ValueDomain
C1704379
Patient Initials (L, F M)
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Institution/Affiliate
Description

CombinedInstitutionName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS 2011AA ObjectClass
C0205195
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
Physician
Description

RegisteredInvestigatorName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
NCI Thesaurus ObjectClass
C25644
Participating Group Name
Description

ParticipatingGroupName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25608
UMLS 2011AA ObjectClass
C0679823
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Participating Group Study No.
Description

ProtocolParticipatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Participating Group Patient ID
Description

PatientParticipatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Disease Description
Description

Disease Description

Performance Status
Description

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C25491
UMLS 2011AA ValueDomain
C1512162
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
Weight (kg)
Description

PatientWeightMeasurement

Data type

double

Measurement units
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25208
UMLS 2011AA Property
C0043100
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
C3231
UMLS 2011AA ValueDomain
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
C25509
UMLS 2011AA ObjectClass
C1279901
NCI Thesaurus Property
C25246
UMLS 2011AA Property
C1446409
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
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
C25251
UMLS 2011AA ObjectClass
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

double

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C25610
UMLS 2011AA ObjectClass
C1521733
NCI Thesaurus Property
C25251
UMLS 2011AA Property
C0205225
NCI Thesaurus Property
C25681
UMLS 2011AA Property
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

double

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
C25688
UMLS 2011AA ValueDomain
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
C16487
UMLS 2011AA ObjectClass
C0010802
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property
C17756
UMLS 2011AA Property
C0242957
NCI Thesaurus Property
C61381
UMLS 2011AA Property
C0312586
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
FISH ratio
Description

FISHAssessmentChromosome17ResultHER2NeuNumber

Data type

double

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus ObjectClass
C17563
UMLS 2011AA ObjectClass
C0162789
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C13212
UMLS 2011AA Property
C0008659
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ValueDomain
C17756
UMLS 2011AA ValueDomain
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
C4872
UMLS 2011AA ObjectClass
C0678222
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property
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
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
NCI Thesaurus ValueDomain
C25526
UMLS 2011AA ValueDomain
C0205462
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
Nuclear Grade
Description

BreastNeoplasmNuclearGradeCategory

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus Property
C13361
UMLS 2011AA Property
C0521447
NCI Thesaurus Property
C48309
UMLS 2011AA Property
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
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property
C25161
UMLS 2011AA Property
C0008902
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ValueDomain
C25526
UMLS 2011AA ValueDomain
C0205462
Specify
Description

BreastTumorHistologicClassificationSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property
C25161
UMLS 2011AA Property
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
C25561
UMLS 2011AA Property
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
C25504
UMLS 2011AA Property
C1517067
Multifocal Tumors
Description

TumorMultifocalDescriptionInd-3

Data type

text

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
C25365
UMLS 2011AA Property
C0678257
Multicentric Tumors
Description

TumorMulticentricDescriptionInd-3

Data type

text

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
C25303
UMLS 2011AA Property
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
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
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
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Was sentinel node sampling performed
Description

SentinelNodeBiopsyInd-3

Data type

text

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
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
C20200
UMLS 2011AA Property
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

double

Measurement units
  • mm
Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus Property
C19151
UMLS 2011AA Property
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

text

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
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C15227
UMLS 2011AA Property
C0012737
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
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

double

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

ResearchCommentsText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
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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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed1
PatientSouthwestOncologyGroupIdentifierNumber
Item
SWOG Patient ID
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property)
C1519429 (UMLS 2011AA Property)
ProtocolSWOGIdentifierNumber
Item
SWOG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property)
C1519429 (UMLS 2011AA Property)
RegistrationStepNumber
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C16154 (NCI Thesaurus Property)
C1704379 (UMLS 2011AA Property)
C16154 (NCI Thesaurus ValueDomain)
C1704379 (UMLS 2011AA ValueDomain)
PatientInitialsName
Item
Patient Initials (L, F M)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
CombinedInstitutionName
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
RegisteredInvestigatorName
Item
Physician
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C25644 (NCI Thesaurus ObjectClass)
ParticipatingGroupName
Item
Participating Group Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
ProtocolParticipatingIdentifierNumber
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientParticipatingIdentifierNumber
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Item Group
Disease Description
PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale
Item
Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
PatientWeightMeasurement
Item
Weight (kg)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA 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)
C0025320 (UMLS 2011AA ValueDomain)
CL.1
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)
C1279901 (UMLS 2011AA ObjectClass)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
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)
C0205225 (UMLS 2011AA ObjectClass)
C25185 (NCI Thesaurus Property)
C0332304 (UMLS 2011AA Property)
CL.2
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)
double
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus ObjectClass)
C1521733 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus Property)
C0205225 (UMLS 2011AA Property)
C25681 (NCI Thesaurus Property)
C0456389 (UMLS 2011AA Property)
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.)
double
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)
C0449438 (UMLS 2011AA ValueDomain)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)
CL.3
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)
CL.4
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)
C0010802 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property)
C0242957 (UMLS 2011AA Property)
C61381 (NCI Thesaurus Property)
C0312586 (UMLS 2011AA Property)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
CL.5
Code List
HER2 results/IHC
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1+ (1+)
CL Item
2+ (2+)
FISHAssessmentChromosome17ResultHER2NeuNumber
Item
FISH ratio
double
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C13212 (NCI Thesaurus Property)
C0008659 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C17756 (NCI Thesaurus ValueDomain)
C0242957 (UMLS 2011AA ValueDomain)
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)
C0678222 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25481 (NCI Thesaurus Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.6
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)
C0006141 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
CL.7
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)
C0006141 (UMLS 2011AA ObjectClass)
C13361 (NCI Thesaurus Property)
C0521447 (UMLS 2011AA Property)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
CL.8
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)
C0006141 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
CL.9
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)
C0006141 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
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)
C1518090 (UMLS 2011AA Property)
CL.10
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)
C1517067 (UMLS 2011AA Property)
CL.11
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)
Item
Multifocal Tumors
text
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)
C0678257 (UMLS 2011AA Property)
CL.12
Code List
Multifocal Tumors
CL Item
Yes (YES)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (NO)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Multicentric Tumors
text
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)
C0439743 (UMLS 2011AA Property)
CL.13
Code List
Multicentric Tumors
CL Item
Yes (YES)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (NO)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
C0006141 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.14
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)
C0543467 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
Item
Was sentinel node sampling performed
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
CL.15
Code List
Was sentinel node sampling performed
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
SentinelNodeBiopsyDate
Item
Sentinel Node Biopsy Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
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)
C1274040 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.16
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)
double
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C19151 (NCI Thesaurus Property)
C0027627 (UMLS 2011AA Property)
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)
Item
Was axillary dissection performed?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
CL.17
Code List
Was axillary dissection performed?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
AxillarySurgeryDissectionDate
Item
Date of Axillary Dissection (MM DD YYYY)
date
C13351 (NCI Thesaurus ObjectClass)
C0004454 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
LymphNodeExaminedCount
Item
Number of Lymph Nodes Examined (If sentinel node biopsy and axillary node dissection were performed, enter the sum of nodes examined.)
double
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
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
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