ID

43427

Descrizione

NSABP Protocol B-47 Worksheet for Form Entry A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women With Node- Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=942D0C00-2D04-589C-E040-BB89AD433FFB

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=942D0C00-2D04-589C-E040-BB89AD433FFB

Keywords

D016430

Registration

Breast Neoplasms

Caricato su

20 settembre 2021

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT01275677 Registration - NSABP Protocol B-47 Worksheet for Form Entry - 3155372v1.0

model
Dettagli

No Instruction available.

1 moduli

StudyEvent: NSABP Protocol B-47 Worksheet for Form Entry
1. No Instruction available.

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Header

Item Group

Header

Patient Initials

Item

Patient Initials (Last, First Middle)

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)

Social Security Number

Item

Patient Social Security Number (USA only)

text

C25337 (NCI Thesaurus ValueDomain)
C1301821 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25686 (NCI Thesaurus Property)

Patient Consent

Item Group

Unnamed4

ClinicalTrialSiteName64CharacterText

Item

Site Name

text

C71104 (NCI Thesaurus ObjectClass)
C0008976 (UMLS 2011AA ObjectClass)
C37901 (NCI Thesaurus ObjectClass-2)
C0205145 (UMLS 2011AA ObjectClass-2)
C42614 (NCI Thesaurus Property)
C0027365 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C45253 (NCI Thesaurus ValueDomain-2)
C1547402 (UMLS 2011AA ValueDomain-2)

TreatingPhysicianName

Item

Treating physician

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)

ClinicalTrialProtocolChemotherapyAdministeredType

Item

Intended chemotherapy regimen

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus ObjectClass-2)
C0392920 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.1

Code List

Intended chemotherapy regimen

CL Item

Tc: Docetaxel 75 Mg/m2 And Cyclophosphamide 600 Mg/m2 (iv) (TC: docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2 (IV))

CL Item

Ac - Wp: Doxorubicin 60 Mg/m2 And Cyclophosphamide 600 Mg/m2 (iv) Followed By Paclitaxel 80 Mg/m2 (iv) (AC - WP: doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 (IV) followed by paclitaxel 80 mg/m2 (IV))

InformedConsentFormSignedDate

Item

Date Informed Consent Signed (Month Day Year)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)

PatientPHIConsentIndicator

Item

Has the patient authorized the release of Protected Health Information to the NSABP?

boolean

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)

PatientBloodSpecimenConsentInd-2

Item

Did the patient consent to use of blood samples for research related to this study?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientCorrelativeStudyBloodSpecimenConsentIndicator

Item

Did the patient consent to use of blood samples for the B-47 Menstrual History study?

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C16100 (NCI Thesaurus Property-4)
C1511524 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.4

Code List

Did the patient consent to use of blood samples for the B-47 Menstrual History study?

CL Item

Yes: C49488 (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No: C49487 (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

Item

Did the patient consent to future contact about more research?

boolean

C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property-2)
C0439849 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

SECTION 1 - HER2 Status

Item Group

Section 2 - Diagnostic

BreastCytogeneticsHER2/neuPolyclonalAntibodyTestScore

Item

IHC Staining Score (If multiple IHC assays were performed, report the one with the highest staining intensity score. Please refer to Protocol - Section 4.2.7 for more information. - A copy of the IHC report must be provided.)

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)

CL.6

Code List

CL Item

0 (0)

C0919414 (NCI Metathesaurus)

CL Item

1+ (1+)

CL Item

2+ (2+)

CL Item

3+ (3+)

LaboratoryProcedureFluorescenceinsituHybridizationHER2/neuCopyNumberPolymorphismOutcomeValue

Item

HER2 gene copy number (If multiple assay results were performed, report the assay result with the highest HER2 gene copy number.)

float

LaboratoryProcedureHER2/neuinsituHybridizationOutcomeInd-2

Item

Was HER2 status assessed by ISH assay

boolean

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17562 (NCI Thesaurus Property)
C0162788 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C17756 (NCI Thesaurus Property-3)
C0242957 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

LaboratoryProcedureHER2/neuChromosome17ProbeFluorescenceInSituHybridizationPerformedInd-3

Item

Was HER2 to CEP17 ratio performed?

boolean

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus Property)
C0162789 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C17756 (NCI Thesaurus Property-3)
C0242957 (UMLS 2011AA Property-3)
C43523 (NCI Thesaurus Property-4)
C1704681 (UMLS 2011AA Property-4)
C13212 (NCI Thesaurus Property-5)
C0008659 (UMLS 2011AA Property-5)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

LaboratoryProcedureHER2/neuChromosome17ProbeFluorescenceInSituHybridizationPerformedRatioValue

Item

HER2 to CEP17 ratio (If multiple HER2 to CEP17 ratios were performed, report the highest one.)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus Property)
C0162789 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C17756 (NCI Thesaurus Property-3)
C0242957 (UMLS 2011AA Property-3)
C43523 (NCI Thesaurus Property-4)
C1704681 (UMLS 2011AA Property-4)
C13212 (NCI Thesaurus Property-5)
C0008659 (UMLS 2011AA Property-5)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C44256 (NCI Thesaurus ValueDomain-2)
C0456603 (UMLS 2011AA ValueDomain-2)

SECTION 2 - Surgery and Pathology

Item Group

Section 4 - Surgery After Neoadjuvant Chemotherapy1

BreastPrimaryInvasiveAdenocarcinomaHistologicallyConfirmedInd-3

Item

Does the patient have unilateral invasive adenocarcinoma of the breast on histologic examination?

boolean

C2852 (NCI Thesaurus ObjectClass)
C0001418 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C12971 (NCI Thesaurus ObjectClass-3)
C0006141 (UMLS 2011AA ObjectClass-3)
C14159 (NCI Thesaurus ObjectClass-4)
C0205281 (UMLS 2011AA ObjectClass-4)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25527 (NCI Thesaurus Property-2)
C0205462 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

BreastSurgicalPathologySpecimenLateralityNCIConceptCode

Item

Tumor Laterality

text

C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C16958 (NCI Thesaurus ObjectClass-3)
C0030669 (UMLS 2011AA ObjectClass-3)
C25185 (NCI Thesaurus Property)
C0332304 (UMLS 2011AA Property)
C43516 (NCI Thesaurus ValueDomain)
C1705251 (UMLS 2011AA ValueDomain)

CL.10

Code List

Tumor Laterality

CL Item

Left Breast (Left breast)

CL Item

Right Breast (Right breast)

SurgicalProcedureLumpectomyExcisionalBiopsyPerformed

Item

Was lumpectomy performed?

boolean

C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C15755 (NCI Thesaurus Property)
C0024885 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C15385 (NCI Thesaurus Property-3)
C0184921 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

LumpectomyPerformedDate

Item

Date lumpectomy performed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15755 (NCI Thesaurus ObjectClass)
C0024885 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)

TotalMastectomyPerformedInd-2

Item

Was total mastectomy performed?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15281 (NCI Thesaurus ObjectClass)
C0024886 (UMLS 2011AA ObjectClass)

TotalMastectomyPerformedDate

Item

Date Total Mastectomy Performed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15281 (NCI Thesaurus ObjectClass)
C0024886 (UMLS 2011AA ObjectClass)

SurgicalMarginMastectomyNoMicroscopicInvolvementInd-2

Item

Were mastectomy margins free of gross residual tumor?

boolean

C41227 (NCI Thesaurus ObjectClass)
C0229985 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C15277 (NCI Thesaurus Property-2)
C0024881 (UMLS 2011AA Property-2)
C25252 (NCI Thesaurus Property-3)
C0205288 (UMLS 2011AA Property-3)
C25548 (NCI Thesaurus Property-4)
C1314939 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

SurgicalMarginMastectomyMicroscopicInvolvementInd-2

Item

Were mastectomy margins microscopically positive?

boolean

C41227 (NCI Thesaurus ObjectClass)
C0229985 (UMLS 2011AA ObjectClass)
C15277 (NCI Thesaurus Property)
C0024881 (UMLS 2011AA Property)
C25252 (NCI Thesaurus Property-2)
C0205288 (UMLS 2011AA Property-2)
C25548 (NCI Thesaurus Property-3)
C1314939 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

ChestWallRadiationTherapyPostMastectomyAdministrationInd-2

Item

Will post-mastectomy RT of the chest wall be administered?

boolean

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C62484 (NCI Thesaurus ObjectClass-2)
C0205076 (UMLS 2011AA ObjectClass-2)
C15277 (NCI Thesaurus Property)
C0024881 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property-2)
C0687676 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

LumpectomySurgicalMarginNoMicroscopicInvolvementInd-2

Item

Were lumpectomy margins histologically free of invasive tumor and DCIS, either initially or after one or more re-excisions?

boolean

C15755 (NCI Thesaurus ObjectClass)
C0024885 (UMLS 2011AA ObjectClass)
C41227 (NCI Thesaurus ObjectClass-2)
C0229985 (UMLS 2011AA ObjectClass-2)
C25252 (NCI Thesaurus Property)
C0205288 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property-2)
C1314939 (UMLS 2011AA Property-2)
C0028423 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

EstrogenReceptorAnalysisPerformedInd-2

Item

Was estrogen receptor status determined from the primary tumor?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25391 (NCI Thesaurus ObjectClass)
C0936012 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C17069 (NCI Thesaurus ObjectClass-2)
C0034804 (UMLS 2011AA ObjectClass-2)

ERLevelTumorStatus

Item

Receptor Status, ER

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)

CL.18

Code List

Receptor Status, ER

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

ProgesteroneReceptorAnalysisPerformedInd-2

Item

Was progesterone receptor status determined from the primary tumor?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25391 (NCI Thesaurus ObjectClass)
C0936012 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C17075 (NCI Thesaurus ObjectClass-2)
C0034833 (UMLS 2011AA ObjectClass-2)

PgRStatusType

Item

Receptor Status, PgR

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)

CL.20

Code List

Receptor Status, PgR

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

BreastTumorHistologicCategory

Item

Histologic Type (Mark predominant tumor type.)

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)

CL.21

Code List

Histologic Type (Mark predominant tumor type.)

CL Item

Ductal (Ductal)

C25732 (NCI Thesaurus)
C1512083 (UMLS 2011AA)

CL Item

Lobular (Lobular)

C25557 (NCI Thesaurus)
C0205417 (UMLS 2011AA)
C25557 (NCI Thesaurus-3)
C0205417 (UMLS 2011AA-4)

CL Item

Other Specify (Other)

Histologic Type, other

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1299220 (UMLS CUI-1)
C3262 (NCI Thesaurus ObjectClass)
C25526 (NCI Thesaurus Property)
C25161 (NCI Thesaurus Property-2)

BreastCarcinomaCombinedHistologicGradeCategory

Item

Histologic Grade (Use combined histologic grade classification.)

text

C25454 (NCI Thesaurus Property)
C0205195 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus Property-2)
C0919553 (UMLS 2011AA Property-2)

CL.22

Code List

Histologic Grade (Use combined histologic grade classification.)

CL Item

Low (Low)

CL124342 (NCI Metathesaurus)

CL Item

Intermediate (Intermediate)

C0205103 (NCI Metathesaurus)

CL Item

High (High)

C25227 (NCI Thesaurus)
C0205250 (UMLS 2011AA)

LaboratoryProcedureOncotypeDXBreastCancerAssayResultInd-2

Item

Was Oncotype DX Recurrence Score determined?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C52159 (NCI Thesaurus Property-2)
C1709318 (UMLS 2011AA Property-2)

LaboratoryProcedureOncotypeDXBreastCancerAssayResultScore

Item

Oncotype DX Recurrence Score (A copy of the report must be provided.)

float

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C52159 (NCI Thesaurus Property-2)
C1709318 (UMLS 2011AA Property-2)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

SentinelNodeSurgicalDissectionInd-2

Item

Was sentinel lymphadenectomy performed?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)

SentinelNodeDissectionDate

Item

Date of Sentinel Lymphadenectomy

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)

SentinelNodeExaminedCount

Item

Number of Sentinel Nodes Examined

float

C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)

SentinelNodePositiveAssessmentCount

Item

Number of Positive Sentinel Nodes

float

C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C0205159 (NCI Metathesaurus Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)

LymphNodePositiveCount

Item

Total Number of Positive Nodes (Pathologic; all procedures)

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)

SurgicalProcedureLymphadenectomyPerformedType

Item

Surgical Procedure for Evaluation of Pathological Nodal Status

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C15275 (NCI Thesaurus Property-2)
C0024203 (UMLS 2011AA Property-2)

CL.25

Code List

Surgical Procedure for Evaluation of Pathological Nodal Status

CL Item

Regional Lymph Node Dissection Sentinel Lymph Node (Sentinel lymphadenectomy alone)

C48935 (NCI Thesaurus)
C1709883 (UMLS 2011AA)
C12947 (NCI Thesaurus-3)
C1522495 (UMLS 2011AA-4)

CL Item

Sentinel Lymph Node Biopsy With Axillary Lymph Node Dissection (Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes)

C47854 (NCI Thesaurus)
C1710051 (UMLS 2011AA)

CL Item

Axillary Lymph Node Dissection (Axillary lymphadenectomy with or without SN isolation procedure)

C15677 (NCI Thesaurus)
C0193867 (UMLS 2011AA)

SurgicalProcedureMalignantBreastNeoplasmPerformedLastDate

Item

Date of Last Surgery for Breast Cancer Treatment or Staging

date

C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C9335 (NCI Thesaurus Property-2)
C0006142 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25551 (NCI Thesaurus ValueDomain-2)
C1517741 (UMLS 2011AA ValueDomain-2)

BreastTumorSeventhPathologicTStage

Item

Pathologic T Stage

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.26

Code List

Pathologic T Stage

CL Item

Microinvasion 0.1 Cm Or Less In Greatest Dimension (pT1mi)

CL Item

Tumor More Than 0.1 Cm But Not More Than 0.5 Cm In Greatest Dimension (pT1a)

CL Item

Tumor More Than 0.5 Cm But Not More Than 1 Cm In Greatest Dimension (pT1b)

CL Item

Tumor More Than 1 Cm But Not More Than 2 Cm In Greatest Dimension (pT1c)

CL Item

Tumor More Than 2 Cm But Not More Than 5 Cm In Greatest Dimension (pT2)

CL Item

Tumor More Than 5 Cm In Greatest Dimension (pT3)

BreastTumorPathologicNStage

Item

Pathologic N Stage (pathologic evaluation of ipsilateral nodes)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property-2)
C0456532 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.27

Code List

Pathologic N Stage (pathologic evaluation of ipsilateral nodes)

CL Item

No Regional Lymph Node Metastasis Histologically, No Additional Examination For Isolated Tumor Cells (itc) (pN0)

CL Item

Micrometastasis (>0.2 Mm But <=2.0 Mm) (pN1mi)

CL Item

Metastasis In 1 To 3 Axillary Lymph Nodes (pN1a)

CL Item

Metastasis In Internal Mammary Nodes With Microscopic Disease Detected By Sln Dissection But Not Clinically Apparent (pN1b)

CL Item

Metastasis In 1 To 3 Axillary Lymph Nodes And In Internal Mammary Lymph Nodes With Microscopic Disease Detected By Sln Dissection But Not Clinically Apparent. (pN1c)

CL Item

Metastasis In 4 To 9 Axillary Lymph Nodes (at Least 1 Tumor Deposit >2.0 Mm) (pN2a)

CL Item

Metastasis In Clinically Apparent* Internal Mammary Lymph Nodes In The Absence Of Axillary Lymph Node Metastasis (pN2b)

CL Item

Metastasis In >=10 Axillary Lymph Nodes (at Least 1 Tumor Deposit >2.0 Mm); Or, Metastasis To The Infraclavicular Lymph Nodes (pN3a)

CL Item

Metastasis In Clinically Apparent* Ipsilateral Internal Mammary Lymph Nodes In The Presence Of >=1 Positive Axillary Lymph Node(s); Or, In >3 Axillary Lymph Nodes And In Internal Mammary Lymph Nodes With Microscopic Disease Detected By Sentinel Lymph Node (pN3b)

Section 3 - Baseline Values (I)

Item Group

Patient Characteristics

Patient Height

Item

Patient Height (cm)

float

C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)

Patient Weight

Item

Patient Weight (kg)

float

C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)

Assessment Date

Item

Date of Assessment

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

Assessment Date

Item

Date of Assessment

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

Systolic blood pressure

Item

Blood Pressure, Systolic (most recent)

float

C25209 (NCI Thesaurus ValueDomain)
C0871470 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25298 (NCI Thesaurus ObjectClass)

Diastolic blood pressure

Item

Blood pressure, Diastolic (most recent)

float

C25209 (NCI Thesaurus ValueDomain)
C0428883 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25299 (NCI Thesaurus ObjectClass)

BloodPressurePhysicalExaminationMostRecentDate

Item

Date of most recent blood pressure assessment

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C54706 (NCI Thesaurus ObjectClass)
C0005823 (UMLS 2011AA ObjectClass)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)

HypertensionTreatmentReceivedInd-2

Item

Are anti-hypertensive medication(s) needed to sustain systolic BP <= 150 mmHg and diastolic BP <= 90 mmHg?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3117 (NCI Thesaurus ObjectClass)
C0020538 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass-2)

HeartLVEFTestPercentageValue

Item

LVEF (%)

float

C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

HeartLVEFTestDate

Item

Date LVEF performed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)

Evaluation method

Item

Assessment Type

text

C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)

CL.29

Code List

Assessment Type

CL Item

2-d Echocardiogram (2-D Echocardiogram)

CL Item

Muga Scan (MUGA scan)

Section 3 - Baseline Values (II)

Item Group

Section 3 (continued)

LaboratoryProcedureAbsoluteNeutrophilCountAssessmentInd-2

Item

ANC

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C63321 (NCI Thesaurus Property-2)
C0948762 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

ANC

Item

ANC (thousand/mm^3)

float

C25294 (NCI Thesaurus ObjectClass)
C0948762 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C63321 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedureAbsoluteNeutrophilCountResultDate

Item

Date of Collection

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63321 (NCI Thesaurus Property-2)
C0948762 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

LaboratoryProcedurePlateletAssessmentInd-2

Item

Platelet Count

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C0005821 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

Platelets

Item

Platelet count (thousand/mm^3)

float

C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

Platelets date

Item

Date of Collection

date

C25164 (NCI Thesaurus ValueDomain)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)

LaboratoryProcedureHemoglobinAssessmentInd-2

Item

Hemoglobin

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C16676 (NCI Thesaurus Property-2)
C0019046 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

Hemoglobin

Item

Hemoglobin (g/dL)

float

C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)

Hemoglobin Date

Item

Date of Collection

date

C25164 (NCI Thesaurus ValueDomain)
C0019046 (UMLS CUI-1)
C16676 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)

Section 3 - Baseline Values (III)

Item Group

Section 3 (continued)

LaboratoryProcedureAspartateAminotransferaseMeasurementAssessmentsInd-2

Item

AST

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C64467 (NCI Thesaurus Property-2)
C0201899 (UMLS 2011AA Property)

SGOT (AST)

Item

AST (units/L)

float

C25202 (NCI Thesaurus Property)
C0201899 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Item

AST ULN (units/L)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultDate

Item

Date of Collection

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

LaboratoryProcedureSerumGlutamicPyruvicTransaminasePerformedInd-3

Item

ALT (required only when SGOT AST is not available)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)

SGPT (ALT)

Item

ALT (units/L)

float

C25294 (NCI Thesaurus ObjectClass)
C0201836 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Item

ALT ULN (units/L)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultDate

Item

Date of Collection

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)

LaboratoryProcedureAlkalinePhosphataseAssessmentInd-2

Item

Alkaline Phosphatase

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property)

Alkaline Phosphatase

Item

Alkaline Phosphatase (units/L)

float

C20200 (NCI Thesaurus Property)
C0201850 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C16276 (NCI Thesaurus Property-2)

Alkaline Phosphatase ULN

Item

Alkaline Phosphatase ULN (units/L)

float

C25294 (NCI Thesaurus ObjectClass)
C0151420 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedureAlkalinePhosphataseResultDate

Item

Date of Collection

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property-2)

LaboratoryProcedureBilirubinAssessmentInd-2

Item

Total Bilirubin

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C305 (NCI Thesaurus Property-2)
C0005437 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

LaboratoryProcedureTotalBilirubinResultSpecifiedValue

Item

Total Bilirubin

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0205369 (UMLS 2011AA ValueDomain-2)

Bilirubin, Total ULN

Item

Total bilirubin ULN (mg/dL)

float

C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C25706 (NCI Thesaurus ValueDomain-3)

LaboratoryProcedureBilirubinOutcomeDate

Item

Date of Collection

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property-2)
C0005437 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

LaboratoryProcedureCreatinineAssessmentInd-2

Item

Serum Creatinine

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

Creatinine, Serum

Item

Serum creatinine (mg/dL)

float

C20200 (NCI Thesaurus Property)
C0201976 (UMLS CUI-1)
C399 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)

Creatinine, serum ULN

Item

Serum Creatinine ULN (mg/dL)

float

C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedureCreatinineClearanceOutcomeDate

Item

Date of Collection

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25747 (NCI Thesaurus Property-2)
C0373595 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

SECTION 3 - Baseline Values (IV)

Item Group

Baseline Values2

LiverDiagnosticImagingAssessmentInd-2

Item

Was liver imaging performed? (CT, MRI, PET scan, or PET-CT)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C12392 (NCI Thesaurus ObjectClass-2)
C0023884 (UMLS 2011AA ObjectClass-2)

LiverMetastasisDiagnosticImagingPresentInd-3

Item

Does liver imaging demonstrate metastatic disease?

boolean

C12392 (NCI Thesaurus ObjectClass)
C0023884 (UMLS 2011AA ObjectClass)
C19151 (NCI Thesaurus ObjectClass-2)
C0027627 (UMLS 2011AA ObjectClass-2)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C16502 (NCI Thesaurus Property-2)
C0011923 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

LiverDiagnosticImagingAssessmentDate

Item

Date of Assessment

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C12392 (NCI Thesaurus ObjectClass-2)
C0023884 (UMLS 2011AA ObjectClass-2)

BonePainInd-2

Item

Does the patient have unexplained bone pain?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3303 (NCI Thesaurus Property)
C0030193 (UMLS 2011AA Property)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)

BoneScanMedicalImagingAssessmentInd-3

Item

Was bone scan, PET-CT scan, or PET scan performed?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C17646 (NCI Thesaurus ObjectClass)
C0203668 (UMLS 2011AA ObjectClass)
C16831 (NCI Thesaurus ObjectClass-2)

BoneScanMagneticResonanceImagingDiagnosticImagingMetastaticMalignantNeoplasmtotheBonePresentInd-2

Item

Does bone scan, PET-CT scan, or PET scan demonstrate metastatic disease?

boolean

C17646 (NCI Thesaurus ObjectClass)
C0203668 (UMLS 2011AA ObjectClass)
C16502 (NCI Thesaurus ObjectClass-2)
C0011923 (UMLS 2011AA ObjectClass-2)
C16809 (NCI Thesaurus ObjectClass-3)
C0024485 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3580 (NCI Thesaurus Property-2)
C0153690 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

BoneAssessmentDate

Item

Date of Assessment (if applicable)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)

PatientElevatedBilirubinPersonalMedicalHistoryInd-2

Item

Is bilirubin elevation due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C27088 (NCI Thesaurus Property)
C0311468 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)

DiagnosticImagingChestAssessmentInd-3

Item

Was chest imaging performed?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25389 (NCI Thesaurus Property-2)
C0817096 (UMLS 2011AA Property-2)

ChestDiagnosticImagingMetastasisPresentInd-3

Item

Did chest imaging demonstrate metastatic disease?

boolean

C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25389 (NCI Thesaurus ObjectClass-2)
C0817096 (UMLS 2011AA ObjectClass-2)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C19151 (NCI Thesaurus Property-2)
C0027627 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

DiagnosticImagingChestAssessmentDate

Item

Date chest imaging performed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25389 (NCI Thesaurus Property-2)
C0817096 (UMLS 2011AA Property-2)

SECTION 4 - Patient History

Item Group

Section 4 - Patient History

InflammatoryBreastCarcinomaPresentIndicator

Item

Was the breast cancer staged as T4, including inflammatory breast cancer?

boolean

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C4001 (NCI Thesaurus ObjectClass)
C0278601 (UMLS 2011AA ObjectClass)

MetastaticNeoplasmConfirmedDiagnosisInd-2

Item

Is there definitive clinical or radiologic evidence of metastatic disease for this patient?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C3261 (NCI Thesaurus ObjectClass)
C2939420 (UMLS 2011AA ObjectClass)

ContralateralBreastCancerDiagnosisInd-2

Item

Did the patient have synchronous or previous contralateral invasive breast cancer?

boolean

C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C25307 (NCI Thesaurus ObjectClass-3)
C0441988 (UMLS 2011AA ObjectClass-3)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

RecurrentIpsilateralBreastNeoplasmDiagnosisInd-2

Item

Does the patient have a history of ipsilateral invasive breast cancer or ipsilateral DCIS?

boolean

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C14173 (NCI Thesaurus ObjectClass-3)
C2945760 (UMLS 2011AA ObjectClass-3)
C25308 (NCI Thesaurus ObjectClass-4)
C0441989 (UMLS 2011AA ObjectClass-4)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonNoMalignantBreastNeoplasmPersonalMedicalHistoryInd-2

Item

Does the patient have a history of non-breast malignancies within the past 5 years?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
C9335 (NCI Thesaurus Property-3)
C0006142 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientNeoplasmPersonalMedicalHistoryInd-2

Item

Were the other malignancies limited to one or more of the following: in situ cancers treated only by local excision, and basal and squamous cell carcinomas of the skin?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)

PatientChemotherapyPersonalMedicalHistoryPlatinum-BasedTaxaneCompoundTherapeuticProcedureInd-2

Item

Has the patient had previous therapy with anthracyclines, taxanes, or trastuzumab for any malignancy?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
C25620 (NCI Thesaurus Property-3)
C1514162 (UMLS 2011AA Property-3)
C1490 (NCI Thesaurus Property-4)
C0796419 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PriorBreastCarcinomaChemotherapyAdministeredIndicator

Item

Has the patient had chemotherapy or HER2-targeted therapy administered for the currently diagnosed breast cancer?

boolean

C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C4872 (NCI Thesaurus ObjectClass-3)
C0678222 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

PersonBreastRadiationTherapyCompleteRandomizationInd-3

Item

Has the patient had whole breast RT prior to randomization or partial breast RT that cannot be completed on or before the date of randomization?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25196 (NCI Thesaurus Property-2)
C0034656 (UMLS 2011AA Property-2)
C15313 (NCI Thesaurus Property-3)
C1522449 (UMLS 2011AA Property-3)
C12971 (NCI Thesaurus Property-4)
C0006141 (UMLS 2011AA Property-4)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

PersonEndocrineTherapyAromataseInhibitorRandomizationInd-3

Item

Will the patient receive continued endocrine therapy with any hormonal agent such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor after randomization?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C15445 (NCI Thesaurus Property-2)
C0279025 (UMLS 2011AA Property-2)
C1740 (NCI Thesaurus Property-3)
C0593802 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

PersonEndocrineTherapyRandomizationInd-3

Item

Will the patient receive continued sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy after randomization?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C15445 (NCI Thesaurus Property-2)
C0279025 (UMLS 2011AA Property-2)

AnginaDiseasePresentInd-3

Item

Does the patient have angina pectoris that requires the use of anti-anginal medication?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C51221 (NCI Thesaurus ObjectClass-2)
C0002962 (UMLS 2011AA ObjectClass-2)

ArrhythmiaHistoryInd-3

Item

Does the patient have ventricular arrhythmias except for benign premature ventricular contractions?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2881 (NCI Thesaurus ObjectClass)
C0003811 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)

DiseaseorDisorderSupraventricularArrhythmiaNodalArrhythmiaPresentInd-3

Item

Does the patient have supraventricular or nodal arrhythmias requiring a pacemaker or not controlled with medication?

boolean

C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C27045 (NCI Thesaurus Property-2)
C0264893 (UMLS 2011AA Property-2)
C27158 (NCI Thesaurus Property-3)
C0428974 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

DiseaseorDisorderHeartConductionDisorderBiventricularPacemakerPresentInd-3

Item

Does the patient have a conduction abnormality requiring a pacemaker?

boolean

C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C80460 (NCI Thesaurus Property-2)
C1719274 (UMLS 2011AA Property-2)
C78245 (NCI Thesaurus Property-3)
C0264886 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CardiacDiseasePresentInd-2

Item

Does the patient have valvular disease with documented compromise in cardiac function?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

DiseaseorDisorderPericarditisPresentChronicDiseaseInd-3

Item

Does the patient have symptomatic pericarditis?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C34915 (NCI Thesaurus Property-2)
C0031046 (UMLS 2011AA Property-2)

SymptomaticCongestiveHeartFailurePresentInd-3

Item

Does the patient have a history of documented CHF?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3080 (NCI Thesaurus ObjectClass)
C0018802 (UMLS 2011AA ObjectClass)
C25269 (NCI Thesaurus ObjectClass-2)
C0231220 (UMLS 2011AA ObjectClass-2)

DiseaseorDisorderCardiomyopathyPresentInd-3

Item

Does the patient have a history of documented cardiomyopathy?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C34830 (NCI Thesaurus Property-2)
C0878544 (UMLS 2011AA Property-2)

PatientCerebrovascularAccidentMyocardialInfarctionPersonalMedicalHistoryInd-3

Item

Does the patient have a history of myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C27996 (NCI Thesaurus Property)
C0027051 (UMLS 2011AA Property)
C3390 (NCI Thesaurus Property-2)
C0038454 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

DiseaseorDisorderCardiacHeartPersonalMedicalHistoryInd-3

Item

Does the patient have any other cardiac disease (history of and/or active disease) that would preclude the use of drugs included in the treatment regimen?

boolean

C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C13306 (NCI Thesaurus ObjectClass-2)
C1522601 (UMLS 2011AA ObjectClass-2)
C2991 (NCI Thesaurus ObjectClass-3)
C0012634 (UMLS 2011AA ObjectClass-3)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

HepaticInfectionPersonalMedicalHistoryInd-3

Item

Does the patient have active hepatitis B or hepatitis C with abnormal liver function tests?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C0021311 (NCI Metathesaurus ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)

DyspneaDiseasePresentInd-2

Item

Does the patient have intrinsic lung disease resulting in dyspnea?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2998 (NCI Thesaurus ObjectClass)
C0013404 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)

PatientLesserControlDiabetesMellitusEligibilityDeterminationInd-2

Item

Does the patient have poorly controlled diabetes mellitus?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C2985 (NCI Thesaurus Property)
C0011849 (UMLS 2011AA Property)
C61299 (NCI Thesaurus Property-2)
C2587213 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C61422 (NCI Thesaurus Property-4)
C0547044 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

ChronicDiseaseInfectionInd-3

Item

Does the patient have active infection or chronic infection requiring chronic suppressive antibiotics?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C14141 (NCI Thesaurus ObjectClass-2)
C0205191 (UMLS 2011AA ObjectClass-2)

PatientCentralNervousSystemDiseaseorDisorderEligibilityDeterminationInd-2

Item

Does the patient have a nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the CTCAE v4.0?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12438 (NCI Thesaurus Property)
C3714787 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

DiseaseorDisorderRestrictionCorticosteroidAdministrationPresentInd-3

Item

Does the patient have any conditions that would prohibit administration of corticosteroids?

boolean

C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2322 (NCI Thesaurus Property-2)
C0001617 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C53452 (NCI Thesaurus Property-4)
C0443288 (UMLS 2011AA Property-4)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

PatientClinicalStudyAgentHypersensitivityPersonalMedicalHistoryInd-2

Item

Does the patient have known hypersensitivity reaction to any of the study drugs or excipients, e.g. polysorbate 80 and Cremophor EL?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3114 (NCI Thesaurus Property)
C0020517 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property-2)
C0450442 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C18772 (NCI Thesaurus Property-4)
C0262926 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientCorticosteroidUsePersonalMedicalHistoryInd-2

Item

Does the patient have chronic daily treatment with corticosteroids with a dose >= 10 mg/day methylprednisolone equivalent (excluding inhaled steroids)?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C2322 (NCI Thesaurus Property)
C0001617 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
C25340 (NCI Thesaurus Property-3)
C0457083 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

SystemicDiseaseHistoryInd-2

Item

Does the patient have other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)

PatientStudyRequirementInd-2

Item

Does the patient have psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude the patient from meeting the study requirements?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C38015 (NCI Thesaurus Property)

PatientInvestigationalClinicalTrialCurrentParticipationExclusionCriteriaInd-2

Item

Has the patient used any investigational product within the past 30 days?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C15207 (NCI Thesaurus Property-3)
C28041 (NCI Thesaurus Property-4)
C1517586 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-5)
C0680251 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

FemalePatientPotentialPregnancyInd-2

Item

Is patient a woman of childbearing potential?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16576 (NCI Thesaurus ObjectClass-2)
C0086287 (UMLS 2011AA ObjectClass-2)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
C0237399 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientPregnancyTestIndicator

Item

Was a pregnancy test performed?

boolean

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0032976 (NCI Metathesaurus Property)

PatientMostRecentPregnancyTestDate

Item

Date of pregnancy test

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0032976 (NCI Metathesaurus Property)
C25577 (NCI Thesaurus Property)
C1513491 (UMLS 2011AA Property)

PatientPregnancyInd-2

Item

Is the patient pregnant or lactating at time of study entry?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)

EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2

Item

Does the patient have an ECOG performance status of 0 or 1?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25491 (NCI Thesaurus ObjectClass)
C1512162 (UMLS 2011AA ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)

SECTION 5 - Menopausal Status

Item Group

Section 5 - Menapausal Status

HysterectomyPerformedInd-3

Item

Has the patient had a hysterectomy?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15256 (NCI Thesaurus ObjectClass)
C0020699 (UMLS 2011AA ObjectClass)

HysterectomyPerformedDate

Item

Date of Hysterectomy (Please provide surgical report.)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15256 (NCI Thesaurus ObjectClass)
C0020699 (UMLS 2011AA ObjectClass)

MensesOccurrenceInd-3

Item

Has the patient had any spontaneous menses in the past 12 months?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C3232 (NCI Thesaurus ObjectClass)
C0025344 (UMLS 2011AA ObjectClass)

LastMenstrualCycleOccurrenceDate

Item

Date of last menstrual period (If unsure of the date, please provide a close approximation.)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25551 (NCI Thesaurus ObjectClass)
C1517741 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C16838 (NCI Thesaurus ObjectClass-2)
C0025329 (UMLS 2011AA ObjectClass-2)

OvaryRemovedInd-3

Item

Has the patient had both ovaries removed?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12404 (NCI Thesaurus ObjectClass)
C0029939 (UMLS 2011AA ObjectClass)
C25650 (NCI Thesaurus Property)
C0849355 (UMLS 2011AA Property)

CL.84

Code List

Has the patient had both ovaries removed?

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)

OvaryRemovedDate

Item

Date both (or second) ovaries were removed (Please provide all surgical reports related to oophorectomies. If unsure of the date, please report a close approximation.)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12404 (NCI Thesaurus ObjectClass)
C0029939 (UMLS 2011AA ObjectClass)
C25650 (NCI Thesaurus Property)
C0849355 (UMLS 2011AA Property)

PersonEstradiolMeasurementPostmenopausalEvaluationAssessmentInd-3

Item

Has the patient had a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard? (If yes, please provide documentation of estradiol level.)

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C15421 (NCI Thesaurus Property-2)
C0232970 (UMLS 2011AA Property-2)
C74782 (NCI Thesaurus Property-3)
C0337434 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

Footer Module

Item Group

Footer

Research Comments

Item

Comments (optional)

text

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

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Breast Cancer NCT01275677 Registration - NSABP Protocol B-47 Worksheet for Form Entry - 3155372v1.0

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