ID

1058

Description

NCCTG N0733 Eligibility Checklist Capecitabine and Lapatinib With or Without Cixutumumab in Treating Patients With Previously Treated HER2-Positive Stage IIIB, Stage IIIC, or Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=555F4502-A448-6B03-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=555F4502-A448-6B03-E044-0003BA3F9857

Keywords

Versions (6)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 8/4/15 8/4/15 - Martin Dugas
  5. 8/4/15 8/4/15 - Martin Dugas
  6. 9/20/21 9/20/21 -
Uploaded on

August 26, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00684983 Eligibility - NCCTG N0733 Eligibility Checklist - 2777789v1.0

English

First 10 patients only: Prior to discussing this protocol with the patient call the CTSU office 1-888-462-3009 to see if there is a place available for your patient.

1 forms  
Header
Description

Header

NCCTG Patient ID (provided at time of Reg/Random)
Description

PatientNorthCentralCancerTreatmentGroupIdentifierNumber

Data type

text

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
C25581
UMLS 2011AA Property
C1518419
Patient Hospital No.
Description

PatientMedicalRecordNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25261
UMLS 2011AA Property
C0205476
NCI Thesaurus Property
C25198
UMLS 2011AA Property
C0034869
Participating Group Code (Cooperative Group where credit will be applied)
Description

ParticipatingGroupIdentifierCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C25608
UMLS 2011AA ObjectClass
C0679823
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institution Name (treating location/performance site)
Description

InstitutionName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institution Code (CTEP assigned number)
Description

NationalCancerInstituteInstituteCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Physician of Record
Description

PhysicianPerformingImagingSeriesName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25674
UMLS 2011AA ObjectClass
C0205549
NCI Thesaurus ObjectClass
C18843
UMLS 2011AA ObjectClass
C1704382
NCI Thesaurus Property
C25741
UMLS 2011AA Property
C0031831
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
IRB/REB Approval Date (mm/dd/yyyy)
Description

ProtocolIRBApprovedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C16741
UMLS 2011AA Property
C0086911
NCI Thesaurus Property
C25425
UMLS 2011AA Property
C0205540
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Date of Registration (mm/dd/yyyy)
Description

PatientRegistrationDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
Last name
Description

ResponsiblePersonLastName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25551
UMLS 2011AA Property
C1517741
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
First Name
Description

ResponsiblePersonFirstName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
Phone
Description

ResponsiblePersonPhoneNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25395
UMLS 2011AA Property
C0039457
Fax
Description

ResponsiblePersonFaxNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25210
UMLS 2011AA Property
C0085205
E-mail
Description

ResponsiblePersonE-mailAddressText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C42775
UMLS 2011AA Property
C1705961
Patient Demographics / Pre-treatment Characteristics
Description

Patient Demographics / Pre-treatment Characteristics

Patient Hospital No.
Description

PatientMedicalRecordNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25261
UMLS 2011AA Property
C0205476
NCI Thesaurus Property
C25198
UMLS 2011AA Property
C0034869
Last
Description

PatientLastInitialsName

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
NCI Thesaurus Property
C25551
UMLS 2011AA Property
C1517741
First
Description

PatientFirstInitialsName

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
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
Middle
Description

PatientMiddleInitialsName

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
NCI Thesaurus Property
C25569
UMLS 2011AA Property
C0444598
Gender
Description

PatientGenderCategory

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17357
UMLS 2011AA Property
C0079399
Ethnicity (U.S. and Canada only)
Description

PatientEthnicGroupCategory

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16564
UMLS 2011AA Property
C0015031
Patient's Date of Birth (mm/dd/yyyy)
Description

PatientBirthDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C25155
UMLS 2011AA Property
C0005615
Patient Zip Code
Description

PatientAddressPostalCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
Country of residence
Description

PatientAddressCountryCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
Method of Payment (check oneUSA only)
Description

PatientPaymentType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25371
UMLS 2011AA Property
C0680264
Race
Description

Race

Race
Description

PatientRaceCategory

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17049
UMLS 2011AA Property
C0034510
Pre-treatment Requirements
Description

Pre-treatment Requirements

Women or men >=18 years of age
Description

PatientAgeInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25150
UMLS 2011AA Property
C0001779
Age
Description

PatientAgeYearCount

Data type

double

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C29848
UMLS 2011AA ValueDomain
C0439234
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus Property
C25150
UMLS 2011AA Property
C0001779
Histologically confirmed, locally advanced (a T4 primary tumor and stage IIIB or IIIC disease) or metastatic breast cancer that has progressed after treatment with regimens that included trastuzumab and either an anthracycline or a taxane or both. (NOTE: Agents need not have been given concurrently nor in the same regimen. NOTE: Prior treatment with trastuzumab is required unless there is a contraindication for trastuzumab treatment.)
Description

PatientNorthCentralCancerTreatmentGroupAdvancedBreastCarcinomaCancerProgressionEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25581
UMLS 2011AA Property
C1518419
NCI Thesaurus Property
C25411
UMLS 2011AA Property
C0205179
NCI Thesaurus Property
C4872
UMLS 2011AA Property
C0678222
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property
C19987
UMLS 2011AA Property
C0242656
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Prior treatment with trastuzumab in the neo-adjuvant, adjuvant, or metastatic setting is required. (NOTE: Prior treatment with trastuzumab is required unless there is a contraindication for trastuzumab treatment. - NOTE: Concomitant use of trastuzumab is not allowed in this study.)
Description

PatientPriorTrastuzumabTaxaneCompoundAdjuvantTherapyEligibilityDeterminationEligibilityInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C1647
UMLS 2011AA Property
C0338204
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C15675
UMLS 2011AA Property
C0677850
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property
C1490
UMLS 2011AA Property
C0796419
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Prior chemotherapy allowed in the neo-adjuvant, adjuvant, or metastatic setting. Unlimited prior chemotherapy is allowed.
Description

PriorBreastCarcinomaChemotherapyAdministeredIndicator

Data type

text

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C4872
UMLS 2011AA ObjectClass
C0678222
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Prior hormonal therapy allowed in the neo-adjuvant, adjuvant, or metastatic setting. Unlimited prior hormonal therapy is allowed.
Description

PatientBreastCarcinomaEndocrineTherapyAdministeredEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C15445
UMLS 2011AA Property
C0279025
NCI Thesaurus Property
C4872
UMLS 2011AA Property
C0678222
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
HER2 positive, defined as: Validated IHC assay score of 3+ (defined as uniform, intense staining of >30% of invasive tumor cells) -OR- Average HER2 gene copy number of >6 -OR- Gene amplified (HER2:D17Z1) ratio >2.20
Description

PatientHER2/neuPositiveFindingEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C38758
UMLS 2011AA Property
C1514241
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property
C17756
UMLS 2011AA Property
C0242957
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Must have measurable disease according to RECIST criteria (See Section 11.0)
Description

PatientMeasurableDiseaseResponseEvaluationCriteriainSolidTumorsEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C8507
UMLS 2011AA Property
C1513041
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property
C49164
UMLS 2011AA Property
C1709926
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Negative pregnancy test done <=7 days prior to registration, for women of childbearing potential only. (If not a woman of childbearing potential check NA)
Description

PatientNegativePregnancyTestIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25247
UMLS 2011AA Property
C0205160
NCI Metathesaurus Property
C0032976
Negative pregnancy test date (If a woman of childbearing potential)
Description

PatientNegativePregnancyTestDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25247
UMLS 2011AA Property
C0205160
NCI Metathesaurus Property
C0032976
The following laboratory values obtained <=7 days prior to registration
Description

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Earliest laboratory test date (Note: These dates pertain to the following labs only.)
Description

LaboratoryProcedureEvaluationPerformedFirstDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25509
UMLS 2011AA ValueDomain
C1279901
latest laboratory test date
Description

LaboratoryProcedureEvaluationPerformedMostRecentDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25577
UMLS 2011AA ValueDomain
C1513491
Hemoglobin >9.0 g/dL
Description

HematologyHemoglobinAssessmentInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C16673
UMLS 2011AA ObjectClass
C0018943
Hemoglobin
Description

LaboratoryProcedureHemoglobinResultSpecifiedValue

Data type

double

Measurement units
  • g/dL
Alias
NCI Thesaurus Property
C16676
UMLS 2011AA Property
C0019046
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
g/dL
WBC >= 3,000/mL
Description

LaboratoryProcedureLeukocyteEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C12529
UMLS 2011AA Property
C0023516
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
WBC
Description

LaboratoryProcedureLeukocyteResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12529
UMLS 2011AA Property
C0023516
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
ANC >= 1500/mL
Description

LaboratoryProcedureAbsoluteNeutrophilCountEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C63321
UMLS 2011AA Property
C0948762
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
ANC
Description

LaboratoryProcedureAbsoluteNeutrophilCountResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C63321
UMLS 2011AA Property
C0948762
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Platelet Count >= 75,000/mL
Description

LaboratoryProcedurePlateletCountEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C51951
UMLS 2011AA Property
C0032181
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Platelet count
Description

LaboratoryProcedurePlateletResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C12520
UMLS 2011AA Property
C0005821
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Total bilirubin <= 1.5 x ULN
Description

LaboratoryProcedureWithinClinicalStudyProtocolUpperLimitofNormalTotalBilirubinMeasurementInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25320
UMLS 2011AA Property
C1507394
NCI Thesaurus Property
C38037
UMLS 2011AA Property
C0201913
NCI Thesaurus Property
C25282
UMLS 2011AA Property
C0332285
NCI Thesaurus Property
C25706
UMLS 2011AA Property
C1519815
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Total Bilirubin
Description

LaboratoryProcedureTotalBilirubinResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C38037
UMLS 2011AA Property
C0201913
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Total Bilirubin ULN
Description

LaboratoryProcedureTotalBilirubinResultUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C38037
UMLS 2011AA Property
C0201913
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
SGOT(AST) and SGPT(ALT) <=2.5 x ULN or SGOT(AST) and SGPT(ALT) <5 x ULN if elevations are due to liver metastases.
Description

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseSerumGlutamicOxaloaceticTransferaseEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property
C25293
UMLS 2011AA Property
C0376147
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
SGOT(AST) and SGPT(ALT) >2.5 x ULN due to liver metastases (This question may be answered "Yes" or "No")
Description

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseSerumGlutamicOxaloaceticTransferaseMetastaticMalignantNeoplasmtotheLiverEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property
C25293
UMLS 2011AA Property
C0376147
NCI Thesaurus Property
C4758
UMLS 2011AA Property
C0494165
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
SGOT (AST)
Description

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultSpecifiedValue

Data type

double

Measurement units
  • U/L
Alias
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
U/L
SGOT (AST) ULN
Description

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
SGPT (ALT)
Description

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C25293
UMLS 2011AA Property
C0376147
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
SGPT (ALT) ULN
Description

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C25293
UMLS 2011AA Property
C0376147
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Serum Creatinine <=1.5 x ULN
Description

LaboratoryProcedureCreatinineEligibilityDeterminationind-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Serum Creatinine
Description

LaboratoryProcedureCreatinineResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Serum Creatinine ULN
Description

LaboratoryProcedureCreatinineResultUpperLimitofNormalValue

Data type

double

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
mg/dL
Creatinine clearance >=30 mL/min (calculated according to Cockcroft and Gault - see Appendix II)
Description

LaboratoryProcedureCreatinineClearanceEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25747
UMLS 2011AA Property
C0373595
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Creatinine Clearance (NOTE: In patients with moderate renal impairment calculated creatinine clearance 30-50 mL/min at baseline, a dose reduction to 80% of the capecitabine starting dose is required. See Section 8.0.)
Description

LaboratoryProcedureCreatinineClearanceOutcomeValue

Data type

double

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C25747
UMLS 2011AA Property
C0373595
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Fasting glucose <120 mg/dL (NOTE: Patients with diabetes are allowed to participate, provided that their blood glucose is within the guidelines above upon enrollment.)
Description

LaboratoryProcedureFastingPlasmaGlucoseMeasurementEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C41376
UMLS 2011AA Property
C0202042
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property
C63663
UMLS 2011AA Property
C0015663
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Fasting glucose
Description

LaboratoryProcedureFastingPlasmaGlucoseMeasurementOutcomeValue

Data type

double

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C41376
UMLS 2011AA Property
C0202042
NCI Thesaurus Property
C63663
UMLS 2011AA Property
C0015663
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
International Normalization Ratio (INR) <= 1.5 X ULN
Description

LaboratoryProcedureInternationalNormalizedRatioEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25352
UMLS 2011AA Property
C0525032
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
International Normalization Ratio (INR)
Description

LaboratoryProcedureInternationalNormalizationRatioResultValue

Data type

double

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25352
UMLS 2011AA Property
C0525032
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
International Normalization Ratio ULN
Description

LaboratoryProcedureInternationalNormalizationRatioResultUpperLimitofNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C25352
UMLS 2011AA Property
C0525032
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
ECOG performance status (PS) 0, 1, or 2
Description

EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C25491
UMLS 2011AA ObjectClass
C1512162
NCI Metathesaurus ObjectClass
CL092952
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
Adequate cardiac function as defined as an ejection fraction 50% as determined by MUGA or echocardiogram
Description

PatientCardiacFunctionRequiredInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25518
UMLS 2011AA Property
C0542341
Life expectancy >3 months
Description

PatientLifeExpectancyEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C37987
UMLS 2011AA Property
C0376558
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property
C25359
UMLS 2011AA Property
C0679138
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has written informed consent been obtained
Description

PatientSignatureConsentInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
Willingness to return to an NCCTG or other participating cooperative group institution for treatment and follow-up
Description

PatientTherapeuticProcedureFollow-upEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16033
UMLS 2011AA Property
C1522577
NCI Thesaurus Property
C49236
UMLS 2011AA Property
C0087111
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient willing to provide tissue and blood samples for research purposes (see Sections 6.0 14.0 and 17.0)
Description

PersonSpecimenUseConsentEligibilityDeterminationIndicator

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C19157
UMLS 2011AA Property
C0370003
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Availability of diagnostic material (i.e., diagnostic slides confirming locally advanced/metastatic disease and HER2 stained slides) and operative and pathology reports from diagnosis of locally advanced or metastatic breast cancer (NOTE: Biopsy of recurrent disease and submission of these materials is not required if materials available from initial diagnosis of locally advanced/metastatic disease.)
Description

EvaluationDiagnosticSpecimenPathologyReportEligibilityDeterminationind-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25214
UMLS 2011AA ObjectClass
C0220825
NCI Thesaurus ObjectClass
C25482
UMLS 2011AA ObjectClass
C0348026
NCI Thesaurus Property
C28277
UMLS 2011AA Property
C0807321
NCI Thesaurus Property
C19157
UMLS 2011AA Property
C0370003
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Ability to complete questionnaire(s) by themselves or with assistance (All responses in above section must be "Yes" unless specified as "NA.")
Description

PatientQuestionnaireCompleteEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property
C17048
UMLS 2011AA Property
C0034394
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Exclusion Criteria
Description

Exclusion Criteria

Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus newborn are unknown: - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician).
Description

PatientReproductionPregnancyBreastFeedingExclusionCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25742
UMLS 2011AA Property
C0032961
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus Property
C25596
UMLS 2011AA Property
C0006147
NCI Thesaurus Property
C17087
UMLS 2011AA Property
C0035150
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Stage III or IV invasive cancer, other than breast cancer, in <=5 years prior to registration.
Description

PatientAdvancedMalignantNeoplasmPriorRegistrationEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C25411
UMLS 2011AA Property
C0205179
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Actively being treated for other malignancy, excepting non-melanotic skin cancer or carcinoma-in-situ of the cervix (If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.)
Description

PatientCurrentTherapeuticProcedureMalignantNeoplasmExclusionCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C49236
UMLS 2011AA Property
C0087111
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
New York Heart Association class III or IV cardiovascular disease
Description

PatientNewYorkHeartAssociationClassIII/IVEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property
C7922
UMLS 2011AA Property
C0278962
Current, active hepatic or biliary disease except Gilbert's syndrome or asymptomatic gallstones
Description

PatientCurrentHepaticDisorderBiliaryDiseaseorDisorderExclusionCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property
C3196
UMLS 2011AA Property
C0023895
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus Property
C28011
UMLS 2011AA Property
C0521378
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Evidence of active brain metastasis including leptomeningeal involvement. CNS metastasis controlled by prior surgery and/or radiotherapy is allowed. (NOTE: To be considered controlled, there must be at least 2 months of no symptoms or evidence of progression prior to study entry and corticosteriod therapy must have been discontinued.)
Description

PatientMetastaticMalignantNeoplasmtotheBrainExclusionCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3813
UMLS 2011AA Property
C0220650
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
Major surgery, chemotherapy, or immunologic therapy <=6 weeks prior to registration
Description

PatientSurgicalProcedureChemotherapyImmunotherapyPriorRegistrationExclusionCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C15632
UMLS 2011AA Property
C0392920
NCI Thesaurus Property
C15262
UMLS 2011AA Property
C0021083
NCI Thesaurus Property
C15329
UMLS 2011AA Property
C0543467
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Radiotherapy <=4 weeks prior to registration, except if to a non-target lesion only. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed. (If patient receives single dose radiation for palliation or radiation to non-target lesion, they may immediately proceed to registration without waiting 4 weeks. Acute adverse events from radiation must have resolved to <=CTCAE v3.0 Grade 1.)
Description

PatientRadiationTherapyPriorRegistrationExclusionCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C15313
UMLS 2011AA Property
C1522449
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Prior treatment with any therapy targeting IGF-I, IGF-II or its receptors(either monoclonal antibody or tyrosine kinase inhibitor), including but not limited to any of the following (which would have been received on a previous clinical trial): - IMC-A12 (cixutumumab) - CP-751,871 (figitumumab) - AMG-479 - INSM-18 - MK0646 (h7C10) - SCH717454 (19D12, robatumumab) - R1507 - OSI-906 - BMS-754807 - PPP - NVP-AEW541 - AVE-1642 - MEDI-573
Description

PatientInsulin-LikeGrowthFactorTherapeuticProcedureExclusionCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C49236
UMLS 2011AA Property
C0087111
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus Property
C20442
UMLS 2011AA Property
C0037657
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Prior therapy with any therapy targeting HER1 (EGFR) and/or HER2 (either monoclonal antibody or tyrosine kinase) other than trastuzumab, including but not limited to any of the following: (lapatinib Tykerb, gefitinib Iressa, erlotinib Tarveca, cetuximab Erbitux, panitumumab Vectibix)
Description

PatientEpidermalGrowthFactorReceptorERBB2ReceptorProtein-TyrosineKinaseTherapeuticProcedureExclusionCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C49236
UMLS 2011AA Property
C0087111
NCI Thesaurus Property
C17068
UMLS 2011AA Property
C0034802
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus Property
C17319
UMLS 2011AA Property
C0069515
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Currently receiving treatment with any agents that are contraindicated by study therapies: A) IMC-A12 - none identified to date B) Lapatinib - CYPA34 inhibitors and inducers (see Appendix IV) including grapefruit and grapefruit juice (C Capecitabine - warfarinCoumadin, cimetidineTagamet, allopurinolLopurin, sorivudineUsevir, brivudineBrivex, ketoconazoleNizoral, itraconazoleSporanox, ritonavirNorvir, amprenavirAgenerase, or indinavirCrixivan)
Description

PatientContraindicatedAgentExclusionCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C1708
UMLS 2011AA Property
C0450442
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus Property
C37933
UMLS 2011AA Property
C1444657
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Uncontrolled intercurrent illness (including, but not limited to: - Poorly controlled diabetes - Ongoing or active infection - Symptomatic congestive heart failure - Unstable angina pectoris - Cardiac arrhythmia - Psychiatric illness/social situations that would limit compliance with study requirements)
Description

PatientUncontrolledConcurrentDiseaseorDisorderExclusionCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property
C25456
UMLS 2011AA Property
C0205420
NCI Thesaurus Property
C48932
UMLS 2011AA Property
C0205318
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of the safety (of the prescribed regimens.)
Description

PatientConcurrentSystemicDiseaseorDisorderExclusionCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C13310
UMLS 2011AA Property
C0205373
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property
C25456
UMLS 2011AA Property
C0205420
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered
Description

PatientInvestigationalClinicalTrialCurrentParticipationExclusionCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property
C15207
NCI Thesaurus Property
C28041
UMLS 2011AA Property
C1517586
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive with an AIDS-defining illness. (HIV positive patients with CD4 count within institutional normal range and no history of an AIDS-defining illness are eligible, however, some antiviral/antiretroviral medications which have CYP3A4 interactions are prohibited on this study.)
Description

PatientImmunocompromisedExclusionCriteriaind-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus Property
C14139
UMLS 2011AA Property
C0085393
Registration Check
Description

Registration Check

Consent form signed and dated
Description

InformedConsentFormSignedInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Date Informed Consent Signed
Description

InformedConsentFormSignedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Authorization for use and disclosure of protected health information signed and dated (Non-USA institution only check NA)
Description

PatientHealthRecordIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25178
UMLS 2011AA Property
C0018684
Date of authorization
Description

PatientSignedDischargeMedicalRecordDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25679
NCI Metathesaurus Property
C0012621
NCI Thesaurus Property
C45258
UMLS 2011AA Property
C0025102
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
A mandatory translational research component is part of this study, patients will automatically be registered to the translational research component of this study at the time of registration. (see Section 14.0 and 17.0)
Description

PatientRegisteredInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25644
Treatment cannot begin prior to registration and must begin <=7 days after registration
Description

ClinicalTrialTherapeuticProcedurePostRegistrationChecklistInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C38008
UMLS 2011AA Property
C0687676
NCI Thesaurus Property
C49236
UMLS 2011AA Property
C0087111
NCI Thesaurus Property
C49073
UMLS 2011AA Property
C1707357
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Pretreatment tests/procedures must be completed <= 7 days prior to registration (NOTE: The earliest pretreatment test/procedure date must be less than or equal to the earliest laboratory test/procedure date and the latest pretreatment test/procedure date must be greater than or equal to the latest laboratory test/procedure date.)
Description

PatientPriorRegistrationLaboratoryProcedureVerificationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property
C45513
UMLS 2011AA Property
C1711411
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Earliest pretreatment test/procedure date
Description

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
Latest pretreatment test/procedure date
Description

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationEndDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Earliest exception test date (Tumor measurement, Chest x-ray or CT, Bone scan, Brain MRI or CT, must be done <=21 days prior to registration see Section 4.0.)
Description

PatientPriorRegistrationDiagnosticImagingEligibilityDeterminationBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16502
UMLS 2011AA Property
C0011923
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
latest exception test date
Description

PatientPriorRegistrationDiagnosticImagingEligibilityDeterminationEndDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16502
UMLS 2011AA Property
C0011923
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Date of EKG (Electrocardiogram EKG must be done <=28 days prior to registration see Section 4.0.)
Description

DiagnosticElectrocardiogramPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25482
UMLS 2011AA ObjectClass
C0348026
NCI Metathesaurus ObjectClass
C0013798
All required baseline symptoms (see Section 10.3) must be documented and graded
Description

ClinicalTrialBaselineDiseaseDocumentedChecklistInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C25213
UMLS 2011AA Property
C1442488
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property
C25356
UMLS 2011AA Property
C1301725
NCI Thesaurus Property
C49073
UMLS 2011AA Property
C1707357
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Study drug availability checked (Study drug must be in site pharmacy for this patient prior to registration)
Description

ClinicalTrialProtocolAgentAvailabilityChecklistInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C41161
UMLS 2011AA Property
C1521826
NCI Thesaurus Property
C25429
UMLS 2011AA Property
C0470187
NCI Thesaurus Property
C49073
UMLS 2011AA Property
C1707357
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Blood draw kit availability checked (Site must have a kit on hand for this patient prior to registration)
Description

ClinicalTrialBloodSpecimenCollectionAvailabilityChecklistInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C12434
UMLS 2011AA Property
C0229664
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus Property
C19157
UMLS 2011AA Property
C0370003
NCI Thesaurus Property
C25429
UMLS 2011AA Property
C0470187
NCI Thesaurus Property
C49073
UMLS 2011AA Property
C1707357
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
This protocol has a mandatory quality assurance (QA) audit submission of diagnostic slides and HER2 stained slides used to make a HER2 positive metastatic breast cancer diagnosis, plus corresponding operating and pathology reports (If these materials are not available, the patient is not eligible for this trial)
Description

ClinicalTrialQualityAssuranceERBB2ReceptorProtein-TyrosineKinaseDiagnosisChecklistInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus Property
C49073
UMLS 2011AA Property
C1707357
NCI Thesaurus Property
C17319
UMLS 2011AA Property
C0069515
NCI Thesaurus Property
C15381
UMLS 2011AA Property
C0178932
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient QOL booklet availability checked; copies are not acceptable for this submission (Site must have booklets on hand for this patient prior to registration)
Description

ClinicalTrialQualityofLifeAvailabilityChecklistInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C17047
UMLS 2011AA Property
C0518214
NCI Thesaurus Property
C25429
UMLS 2011AA Property
C0470187
NCI Thesaurus Property
C49073
UMLS 2011AA Property
C1707357
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
This protocol has mandatory monitoring for the Safety Cohort - sites must participate in monthly conference calls (see Section 16.8.4)
Description

ClinicalTrialStudyMonitorChecklistInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C49073
UMLS 2011AA Property
C1707357
NCI Thesaurus Property
C41201
UMLS 2011AA Property
C1521743
At The Time Of Registration/randomization, The Following Will Also Be Recorded:
Description

At The Time Of Registration/randomization, The Following Will Also Be Recorded:

Patient has given permission to keep sample(s) for use in future research to learn about, prevent, or treat cancer
Description

PersonSpecimenMalignantNeoplasmResearchConsentInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15319
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C19157
UMLS 2011AA Property
C0370003
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient has given permission to keep sample(s) for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
Description

BloodTissueSpecimenOtherDiseasesandDisordersResearchConsentInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass
C12434
UMLS 2011AA ObjectClass
C0229664
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property
C15319
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Patient has given NCCTG permission to give sample(s) to outside researchers
Description

PersonSpecimenExternalInvestigatorConsentInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C44280
UMLS 2011AA Property
C0205101
NCI Thesaurus Property
C19157
UMLS 2011AA Property
C0370003
NCI Thesaurus Property
C25936
UMLS 2011AA Property
C0035173
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Stratification Factors
Description

Stratification Factors

Receptor Status (Hormone)
Description

BreastHormoneReceptorTumorMarkerFinalDiagnosisResultType

Data type

text

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass
C17220
UMLS 2011AA ObjectClass
C0041365
NCI Thesaurus ObjectClass
C28154
UMLS 2011AA ObjectClass
C0019929
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus Property
C25508
UMLS 2011AA Property
C0205088
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Number of prior chemotherapy regimens in the metastatic setting
Description

PriorChemotherapyMetastaticRegimenChemotherapyRegimenCount

Data type

text

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Subgroup Code
Description

PatientSubgroupCharacteristicsStratificationDescriptionType

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass
C25693
UMLS 2011AA ObjectClass
C1515021
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
NCI Thesaurus Property
C25689
UMLS 2011AA Property
C1514983
NCI Thesaurus Property
C25447
UMLS 2011AA Property
C1521970
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
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First 10 patients only: Prior to discussing this protocol with the patient call the CTSU office 1-888-462-3009 to see if there is a place available for your patient.

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
PatientNorthCentralCancerTreatmentGroupIdentifierNumber
Item
NCCTG Patient ID (provided at time of Reg/Random)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25581 (NCI Thesaurus Property)
C1518419 (UMLS 2011AA Property)
PatientMedicalRecordNumber
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (UMLS 2011AA Property)
ParticipatingGroupIdentifierCode
Item
Participating Group Code (Cooperative Group where credit will be applied)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (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)
InstitutionName
Item
Institution Name (treating location/performance site)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
NationalCancerInstituteInstituteCode
Item
Institution Code (CTEP assigned number)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PhysicianPerformingImagingSeriesName
Item
Physician of Record
text
C25674 (NCI Thesaurus ObjectClass)
C0205549 (UMLS 2011AA ObjectClass)
C18843 (NCI Thesaurus ObjectClass)
C1704382 (UMLS 2011AA ObjectClass)
C25741 (NCI Thesaurus Property)
C0031831 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
ProtocolIRBApprovedDate
Item
IRB/REB Approval Date (mm/dd/yyyy)
date
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C16741 (NCI Thesaurus Property)
C0086911 (UMLS 2011AA Property)
C25425 (NCI Thesaurus Property)
C0205540 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
PatientRegistrationDate
Item
Date of Registration (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
ResponsiblePersonLastName
Item
Last name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
ResponsiblePersonFirstName
Item
First Name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
ResponsiblePersonPhoneNumber
Item
Phone
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25395 (NCI Thesaurus Property)
C0039457 (UMLS 2011AA Property)
ResponsiblePersonFaxNumber
Item
Fax
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25210 (NCI Thesaurus Property)
C0085205 (UMLS 2011AA Property)
ResponsiblePersonE-mailAddressText
Item
E-mail
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C42775 (NCI Thesaurus Property)
C1705961 (UMLS 2011AA Property)
Item Group
Patient Demographics / Pre-treatment Characteristics
PatientMedicalRecordNumber
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (UMLS 2011AA Property)
PatientLastInitialsName
Item
Last
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)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
PatientFirstInitialsName
Item
First
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)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
PatientMiddleInitialsName
Item
Middle
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)
C25569 (NCI Thesaurus Property)
C0444598 (UMLS 2011AA Property)
Item
Gender
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17357 (NCI Thesaurus Property)
C0079399 (UMLS 2011AA Property)
CL.1
Code List
Gender
CL Item
Male (MALE)
C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)
CL Item
Female (FEMALE)
C46110 (NCI Thesaurus)
C0015780 (UMLS 2011AA)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Ethnicity (U.S. and Canada only)
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16564 (NCI Thesaurus Property)
C0015031 (UMLS 2011AA Property)
CL.2
Code List
Ethnicity (U.S. and Canada only)
CL Item
A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (HISPANIC OR LATINO)
C17459 (NCI Thesaurus)
C0086409 (UMLS 2011AA)
CL Item
A Person Not Meeting The Definition For Hispanic Or Latino. (NOT HISPANIC OR LATINO)
C41222 (NCI Thesaurus)
C1518424 (UMLS 2011AA)
CL Item
Not Provided Or Available (Not reported)
C43234 (NCI Thesaurus)
C1706613 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PatientBirthDate
Item
Patient's Date of Birth (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)
PatientAddressPostalCode
Item
Patient Zip Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
Item
Country of residence
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
CL.3
Code List
Country of residence
CL Item
Ascension Island (AC)
CL Item
Andorra (AD)
C16289 (NCI Thesaurus)
C0002838 (UMLS 2011AA)
CL Item
United Arab Emirates (AE)
C17232 (NCI Thesaurus)
C0041698 (UMLS 2011AA)
CL Item
Afghanistan (AF)
C16267 (NCI Thesaurus)
C0001732 (UMLS 2011AA)
CL Item
Antigua And Barbuda (AG)
C16303 (NCI Thesaurus)
C0003354 (UMLS 2011AA)
CL Item
Anguilla (AI)
C20133 (NCI Thesaurus)
C0003353 (UMLS 2011AA)
CL Item
Albania (AL)
CL Item
Armenia (AM)
C16306 (NCI Thesaurus)
C0003798 (UMLS 2011AA)
CL Item
Netherland Antilles (AN)
CL Item
Angola (AO)
C16292 (NCI Thesaurus)
C0003023 (UMLS 2011AA)
CL Item
Antarctica (AQ)
C18007 (NCI Thesaurus)
C0454691 (UMLS 2011AA)
CL Item
Argentina (AR)
C16305 (NCI Thesaurus)
C0003761 (UMLS 2011AA)
CL Item
American Samoa (AS)
C17739 (NCI Thesaurus)
C0242536 (UMLS 2011AA)
CL Item
Austria (AT)
C16312 (NCI Thesaurus)
C0004348 (UMLS 2011AA)
CL Item
Australia (AU)
C16311 (NCI Thesaurus)
C0004340 (UMLS 2011AA)
CL Item
Aruba (AW)
C17884 (NCI Thesaurus)
C0282379 (UMLS 2011AA)
CL Item
Azerbaidjan (AZ)
CL Item
Bosnia-herzegovina (BA)
C16361 (NCI Thesaurus)
C0006036 (UMLS 2011AA)
CL Item
Barbados (BB)
C16324 (NCI Thesaurus)
C0004739 (UMLS 2011AA)
CL Item
Bangladesh (BD)
C16323 (NCI Thesaurus)
C0004732 (UMLS 2011AA)
CL Item
Belgium (BE)
C16329 (NCI Thesaurus)
C0004950 (UMLS 2011AA)
CL Item
Burkina Faso (BF)
C16369 (NCI Thesaurus)
C0006409 (UMLS 2011AA)
CL Item
Bulgaria (BG)
C16368 (NCI Thesaurus)
C0006368 (UMLS 2011AA)
CL Item
Bahrain (BH)
C16322 (NCI Thesaurus)
C0004684 (UMLS 2011AA)
CL Item
Burundi (BI)
C16371 (NCI Thesaurus)
C0006448 (UMLS 2011AA)
CL Item
Benin (BJ)
CL Item
Bermuda (BM)
C16334 (NCI Thesaurus)
C0005126 (UMLS 2011AA)
CL Item
Brunei Darussalam (BN)
C16367 (NCI Thesaurus)
C0006320 (UMLS 2011AA)
CL Item
Bolivia (BO)
C16359 (NCI Thesaurus)
C0005918 (UMLS 2011AA)
CL Item
Brazil (BR)
C16364 (NCI Thesaurus)
C0006137 (UMLS 2011AA)
CL Item
Bahamas (BS)
C16321 (NCI Thesaurus)
C0004683 (UMLS 2011AA)
CL Item
Bhutan (BT)
C16336 (NCI Thesaurus)
C0005341 (UMLS 2011AA)
CL Item
Bouvet Island (BV)
C20104 (NCI Thesaurus)
C1511278 (UMLS 2011AA)
CL Item
Botswana (BW)
C16363 (NCI Thesaurus)
C0006041 (UMLS 2011AA)
CL Item
Belarus (BY)
C16372 (NCI Thesaurus)
C0006539 (UMLS 2011AA)
CL Item
Belize (BZ)
C16331 (NCI Thesaurus)
C0004952 (UMLS 2011AA)
CL Item
Canada (CA)
C16380 (NCI Thesaurus)
C0006823 (UMLS 2011AA)
CL Item
Cocos Isl. (CC)
CL Item
Rep. Dem. Congo (CD)
CL Item
Central African Rep. (CF)
CL Item
Congo (CG)
C16467 (NCI Thesaurus)
C0009738 (UMLS 2011AA)
CL Item
Switzerland (CH)
C17181 (NCI Thesaurus)
C0039021 (UMLS 2011AA)
CL Item
Ivory Coast (CI)
CL Item
Cook Islands (CK)
C16469 (NCI Thesaurus)
C0009956 (UMLS 2011AA)
CL Item
Chile (CL)
CL Item
Cameroon (CM)
C16379 (NCI Thesaurus)
C0006802 (UMLS 2011AA)
CL Item
China (CN)
C16428 (NCI Thesaurus)
C0008115 (UMLS 2011AA)
CL Item
Colombia (CO)
C16449 (NCI Thesaurus)
C0009367 (UMLS 2011AA)
CL Item
Costa Rica (CR)
C16470 (NCI Thesaurus)
C0010182 (UMLS 2011AA)
CL Item
Cuba (CU)
C16477 (NCI Thesaurus)
C0010435 (UMLS 2011AA)
CL Item
Cape Verde (CV)
C16382 (NCI Thesaurus)
C0006893 (UMLS 2011AA)
CL Item
Christmas Island (CX)
C44482 (NCI Thesaurus)
C0006888 (UMLS 2011AA)
CL Item
Cyprus (CY)
C16480 (NCI Thesaurus)
C0010622 (UMLS 2011AA)
CL Item
Czech Republic (CZ)
C17668 (NCI Thesaurus)
C0206578 (UMLS 2011AA)
CL Item
Germany (DE)
CL Item
Djibouti (DJ)
CL Item
Denmark (DK)
CL Item
Dominica (DM)
CL Item
Dominican Republic (DO)
CL Item
Algeria (DZ)
CL Item
Ecuador (EC)
CL Item
Estonia (EE)
CL Item
Egypt (EG)
CL Item
Western Sahara (EH)
CL Item
Eritrea (ER)
CL Item
Spain (ES)
CL Item
Ethiopia (ET)
CL Item
Finland (FI)
CL Item
Fiji (FJ)
CL Item
Falkland Isl. (FK)
CL Item
Micronesia (FM)
CL Item
Faroe Islands (FO)
CL Item
France (FR)
CL Item
France (european Ter.) (FX)
CL Item
Gabon (GA)
CL Item
Great Britain (GB)
CL Item
Grenada (GD)
CL Item
Georgia (GE)
CL Item
Guiana (fr.) (GF)
CL Item
Guernsey (GG)
CL Item
Ghana (GH)
CL Item
Gibraltar (GI)
CL Item
Greenland (GL)
CL Item
Gambia (GM)
CL Item
Guinea (GN)
CL Item
Guadeloupe (fr.) (GP)
CL Item
Equatorial Guinea (GQ)
CL Item
Greece (GR)
CL Item
South Georgia And South Sandwich Islands (GS)
CL Item
Guatemala (GT)
CL Item
Guam (us) (GU)
CL Item
Guinea Bissau (GW)
CL Item
Guyana (GY)
CL Item
Hong Kong (HK)
CL Item
Heard & Mcdonald Isl. (HM)
CL Item
Honduras (HN)
C16694 (NCI Thesaurus)
C0019905 (UMLS 2011AA)
CL Item
Croatia (HR)
C16474 (NCI Thesaurus)
C0010343 (UMLS 2011AA)
CL Item
Haiti (HT)
C16660 (NCI Thesaurus)
C0018510 (UMLS 2011AA)
CL Item
Hungary (HU)
C16699 (NCI Thesaurus)
C0020174 (UMLS 2011AA)
CL Item
Indonesia (ID)
C16728 (NCI Thesaurus)
C0021247 (UMLS 2011AA)
CL Item
Ireland (IE)
C16757 (NCI Thesaurus)
C0022067 (UMLS 2011AA)
CL Item
Israel (IL)
C16760 (NCI Thesaurus)
C0022271 (UMLS 2011AA)
CL Item
Isle Of Man (IM)
C0022132 (NCI Metathesaurus)
CL Item
India (IN)
C16727 (NCI Thesaurus)
C0021201 (UMLS 2011AA)
CL Item
British Indian O. Ter. (IO)
CL Item
Iraq (IQ)
C16756 (NCI Thesaurus)
C0022066 (UMLS 2011AA)
CL Item
Iran (IR)
C16755 (NCI Thesaurus)
C0022065 (UMLS 2011AA)
CL Item
Iceland (IS)
C16704 (NCI Thesaurus)
C0020750 (UMLS 2011AA)
CL Item
Italy (IT)
C16761 (NCI Thesaurus)
C0022277 (UMLS 2011AA)
CL Item
Jersey (JE)
CL Item
Jamaica (JM)
C16763 (NCI Thesaurus)
C0022337 (UMLS 2011AA)
CL Item
Jordan (JO)
C16765 (NCI Thesaurus)
C0022418 (UMLS 2011AA)
CL Item
Japan (JP)
C16764 (NCI Thesaurus)
C0022341 (UMLS 2011AA)
CL Item
Kenya (KE)
C16769 (NCI Thesaurus)
C0022558 (UMLS 2011AA)
CL Item
Kyrgyz Republic (KG)
CL Item
Cambodia (KH)
C16378 (NCI Thesaurus)
C0006797 (UMLS 2011AA)
CL Item
Kiribati (KI)
C16639 (NCI Thesaurus)
C0017550 (UMLS 2011AA)
CL Item
Comoros (KM)
C16458 (NCI Thesaurus)
C0009490 (UMLS 2011AA)
CL Item
St. Kitts Nevis Anguilla (KN)
CL Item
Korea (north) (KP)
CL Item
Korea (south) (KR)
CL Item
Kuwait (KW)
C16775 (NCI Thesaurus)
C0022804 (UMLS 2011AA)
CL Item
Cayman Islands (KY)
C16391 (NCI Thesaurus)
C0007481 (UMLS 2011AA)
CL Item
Kazakstan (KZ)
CL Item
Laos (LA)
CL Item
Lebanon (LB)
C16784 (NCI Thesaurus)
C0023190 (UMLS 2011AA)
CL Item
Saint Lucia (LC)
C17113 (NCI Thesaurus)
C0036056 (UMLS 2011AA)
CL Item
Liechtenstein (LI)
C16794 (NCI Thesaurus)
C0023668 (UMLS 2011AA)
CL Item
Sri Lanka (LK)
C17163 (NCI Thesaurus)
C0038088 (UMLS 2011AA)
CL Item
Liberia (LR)
C16791 (NCI Thesaurus)
C0023617 (UMLS 2011AA)
CL Item
Lesotho (LS)
CL Item
Lithuania (LT)
C16799 (NCI Thesaurus)
C0023879 (UMLS 2011AA)
CL Item
Luxembourg (LU)
C16803 (NCI Thesaurus)
C0024176 (UMLS 2011AA)
CL Item
Latvia (LV)
C16783 (NCI Thesaurus)
C0023128 (UMLS 2011AA)
CL Item
Libya (LY)
CL Item
Morocco (MA)
C16878 (NCI Thesaurus)
C0026544 (UMLS 2011AA)
CL Item
Monaco (MC)
C16874 (NCI Thesaurus)
C0026405 (UMLS 2011AA)
CL Item
Moldova (MD)
C16871 (NCI Thesaurus)
C0026374 (UMLS 2011AA)
CL Item
Madagascar (MG)
C16808 (NCI Thesaurus)
C0024443 (UMLS 2011AA)
CL Item
Marshall Islands (MH)
C16822 (NCI Thesaurus)
C0024851 (UMLS 2011AA)
CL Item
Macedonia (MK)
C0700290 (NCI Metathesaurus)
CL Item
Mali (ML)
C16816 (NCI Thesaurus)
C0024581 (UMLS 2011AA)
CL Item
Myanmar (MM)
C16370 (NCI Thesaurus)
C0006416 (UMLS 2011AA)
CL Item
Mongolia (MN)
C16875 (NCI Thesaurus)
C0026410 (UMLS 2011AA)
CL Item
Macau (MO)
C16807 (NCI Thesaurus)
C0024403 (UMLS 2011AA)
CL Item
Northern Mariana Isl. (MP)
CL Item
Martinique (fr.) (MQ)
CL Item
Mauritania (MR)
C16826 (NCI Thesaurus)
C0024943 (UMLS 2011AA)
CL Item
Montserrat (MS)
C16876 (NCI Thesaurus)
C0026514 (UMLS 2011AA)
CL Item
Malta (MT)
C16817 (NCI Thesaurus)
C0024653 (UMLS 2011AA)
CL Item
Mauritius (MU)
C16827 (NCI Thesaurus)
C0024944 (UMLS 2011AA)
CL Item
Maldives (MV)
C16815 (NCI Thesaurus)
C0024553 (UMLS 2011AA)
CL Item
Malawi (MW)
C16813 (NCI Thesaurus)
C0024548 (UMLS 2011AA)
CL Item
Mexico (MX)
C16850 (NCI Thesaurus)
C0025885 (UMLS 2011AA)
CL Item
Malaysia (MY)
C16814 (NCI Thesaurus)
C0024552 (UMLS 2011AA)
CL Item
Mozambique (MZ)
C16882 (NCI Thesaurus)
C0026655 (UMLS 2011AA)
CL Item
Namibia (NA)
C16891 (NCI Thesaurus)
C0027366 (UMLS 2011AA)
CL Item
New Caledonia (fr.) (NC)
CL Item
Niger (NE)
C16916 (NCI Thesaurus)
C0028074 (UMLS 2011AA)
CL Item
Norfolk Island (NF)
C16919 (NCI Thesaurus)
C0028366 (UMLS 2011AA)
CL Item
Nigeria (NG)
C16917 (NCI Thesaurus)
C0028075 (UMLS 2011AA)
CL Item
Nicaragua (NI)
C16915 (NCI Thesaurus)
C0028002 (UMLS 2011AA)
CL Item
Netherlands (NL)
C16903 (NCI Thesaurus)
C0027778 (UMLS 2011AA)
CL Item
Norway (NO)
C16920 (NCI Thesaurus)
C0028423 (UMLS 2011AA)
CL Item
Nepal (NP)
C16901 (NCI Thesaurus)
C0027689 (UMLS 2011AA)
CL Item
Nauru (NR)
C16896 (NCI Thesaurus)
C0027496 (UMLS 2011AA)
CL Item
Niue (NU)
C16918 (NCI Thesaurus)
C0028219 (UMLS 2011AA)
CL Item
New Zealand (NZ)
C16914 (NCI Thesaurus)
C0027978 (UMLS 2011AA)
CL Item
Oman (OM)
C16933 (NCI Thesaurus)
C0028971 (UMLS 2011AA)
CL Item
Other (Other)
CL Item
Panama (PA)
C16951 (NCI Thesaurus)
C0030266 (UMLS 2011AA)
CL Item
Peru (PE)
C16972 (NCI Thesaurus)
C0031238 (UMLS 2011AA)
CL Item
Polynesia (fr.) (PF)
CL Item
Papua New Guinea (PG)
C16952 (NCI Thesaurus)
C0030375 (UMLS 2011AA)
CL Item
Philippines (PH)
CL Item
Pakistan (PK)
C16949 (NCI Thesaurus)
C0030211 (UMLS 2011AA)
CL Item
Poland (PL)
C17002 (NCI Thesaurus)
C0032356 (UMLS 2011AA)
CL Item
St. Pierre & Miquelon (PM)
CL Item
Pitcairn (PN)
C16993 (NCI Thesaurus)
C0031995 (UMLS 2011AA)
CL Item
Puerto Rico (PR)
C17043 (NCI Thesaurus)
C0034044 (UMLS 2011AA)
CL Item
Portugal (PT)
C17006 (NCI Thesaurus)
C0032729 (UMLS 2011AA)
CL Item
Palau (PW)
C17733 (NCI Thesaurus)
C0242397 (UMLS 2011AA)
CL Item
Paraguay (PY)
C16953 (NCI Thesaurus)
C0030428 (UMLS 2011AA)
CL Item
Qatar (QA)
C17045 (NCI Thesaurus)
C0034366 (UMLS 2011AA)
CL Item
Reunion (fr.) (RE)
CL Item
Romania (RO)
C17108 (NCI Thesaurus)
C0035826 (UMLS 2011AA)
CL Item
Russian Federation (RU)
CL Item
Rwanda (RW)
C17112 (NCI Thesaurus)
C0035978 (UMLS 2011AA)
CL Item
Saudi Arabia (SA)
C17117 (NCI Thesaurus)
C0036243 (UMLS 2011AA)
CL Item
Solomon Islands (SB)
C17148 (NCI Thesaurus)
C0037623 (UMLS 2011AA)
CL Item
Seychelles (SC)
C17129 (NCI Thesaurus)
C0036919 (UMLS 2011AA)
CL Item
Sudan (SD)
C17170 (NCI Thesaurus)
C0038642 (UMLS 2011AA)
CL Item
Sweden (SE)
C17180 (NCI Thesaurus)
C0038995 (UMLS 2011AA)
CL Item
Singapore (SG)
C17134 (NCI Thesaurus)
C0037173 (UMLS 2011AA)
CL Item
St. Helena (SH)
CL Item
Slovenia (SI)
C17138 (NCI Thesaurus)
C0037334 (UMLS 2011AA)
CL Item
Svalbard & Jan Mayen Isl. (SJ)
CL Item
Slovakia (SK)
C17669 (NCI Thesaurus)
C0206579 (UMLS 2011AA)
CL Item
Sierra Leone (SL)
C17130 (NCI Thesaurus)
C0037063 (UMLS 2011AA)
CL Item
San Marino (SM)
C17115 (NCI Thesaurus)
C0036154 (UMLS 2011AA)
CL Item
Senegal (SN)
C17121 (NCI Thesaurus)
C0036644 (UMLS 2011AA)
CL Item
Somalia (SO)
C17149 (NCI Thesaurus)
C0037640 (UMLS 2011AA)
CL Item
Suriname (SR)
C17175 (NCI Thesaurus)
C0038944 (UMLS 2011AA)
CL Item
St. Tome And Principe (ST)
CL Item
Soviet Union (SU)
CL Item
El Salvador (SV)
C16532 (NCI Thesaurus)
C0013754 (UMLS 2011AA)
CL Item
Syria (SY)
C17182 (NCI Thesaurus)
C0039138 (UMLS 2011AA)
CL Item
Swaziland (SZ)
C17179 (NCI Thesaurus)
C0038983 (UMLS 2011AA)
CL Item
Turks & Caicos Islands (TC)
CL Item
Chad (TD)
C16412 (NCI Thesaurus)
C0007928 (UMLS 2011AA)
CL Item
French Southern Terr. (TF)
CL Item
Togo (TG)
C17202 (NCI Thesaurus)
C0040363 (UMLS 2011AA)
CL Item
Thailand (TH)
C17192 (NCI Thesaurus)
C0039725 (UMLS 2011AA)
CL Item
Tadjikistan (TJ)
CL Item
Tokelau (TK)
C17704 (NCI Thesaurus)
C0220928 (UMLS 2011AA)
CL Item
Turkmenistan (TM)
C17223 (NCI Thesaurus)
C0041403 (UMLS 2011AA)
CL Item
Tunisia (TN)
C17221 (NCI Thesaurus)
C0041388 (UMLS 2011AA)
CL Item
Tonga (TO)
CL Item
East Timor (TP)
C17200 (NCI Thesaurus)
C1452561 (UMLS 2011AA)
CL Item
Turkey (TR)
C17222 (NCI Thesaurus)
C0041400 (UMLS 2011AA)
CL Item
Trinidad & Tobago (TT)
CL Item
Tuvalu (TV)
C17225 (NCI Thesaurus)
C0041413 (UMLS 2011AA)
CL Item
Taiwan (TW)
C17184 (NCI Thesaurus)
C0039260 (UMLS 2011AA)
CL Item
Tanzania (TZ)
C17185 (NCI Thesaurus)
C0039298 (UMLS 2011AA)
CL Item
Ukraine (UA)
C17229 (NCI Thesaurus)
C0041580 (UMLS 2011AA)
CL Item
Uganda (UG)
C17228 (NCI Thesaurus)
C0041573 (UMLS 2011AA)
CL Item
United Kingdom (UK)
C17233 (NCI Thesaurus)
C0041700 (UMLS 2011AA)
CL Item
Us Minor Outlying Isl. (UM)
CL Item
Usa (US)
CL Item
Uruguay (UY)
C17244 (NCI Thesaurus)
C0042113 (UMLS 2011AA)
CL Item
Uzbekistan (UZ)
C17246 (NCI Thesaurus)
C0042177 (UMLS 2011AA)
CL Item
Vatican City State (VA)
CL Item
St. Vincent & Grenadines (VC)
CL Item
Venezuela (VE)
C17250 (NCI Thesaurus)
C0042469 (UMLS 2011AA)
CL Item
Virgin Islands (brit) (VG)
CL Item
Virgin Islands (us) (VI)
CL Item
Vietnam (VN)
C17252 (NCI Thesaurus)
C0042658 (UMLS 2011AA)
CL Item
Vanuatu (VU)
C17247 (NCI Thesaurus)
C0042321 (UMLS 2011AA)
CL Item
Wallis & Futuna Islands (WF)
CL Item
Western Samoa (WS)
CL Item
Yemen (YE)
C17264 (NCI Thesaurus)
C0043402 (UMLS 2011AA)
CL Item
Mayotte (YT)
C16828 (NCI Thesaurus)
C0024974 (UMLS 2011AA)
CL Item
Yugoslavia (YU)
CL Item
South Africa (ZA)
CL Item
Zambia (ZM)
C17267 (NCI Thesaurus)
C0043445 (UMLS 2011AA)
CL Item
Dem. Rep. Of Congo (ZR)
CL Item
Zimbabwe (ZW)
C17268 (NCI Thesaurus)
C0043476 (UMLS 2011AA)
Item
Method of Payment (check oneUSA only)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)
CL.4
Code List
Method of Payment (check oneUSA only)
CL Item
Private Insurance (Private Insurance)
CL Item
Medicare (Medicare)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
CL Item
Medicaid (Medicaid)
C0025071 (NCI Metathesaurus)
CL Item
Medicaid And Medicare (Medicaid and Medicare)
CL Item
Medicare And Private Insurance (Medicare and Private Insurance)
CL Item
Military Or Veterans Sponsored Nos (Military or Veterans Sponsored, Not Otherwise Specified (NOS))
CL Item
Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS & TRICARE))
CL Item
Veterans Sponsored (Veterans Sponsored)
CL Item
Self Pay (no Insurance) (Self Pay (No Insurance))
CL Item
No Means Of Payment (no Insurance) (No means of payment (no insurance))
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Race
Item
Race
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS 2011AA Property)
CL.5
Code List
Race
CL Item
A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)
C41259 (NCI Thesaurus)
C1515945 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)
C41260 (NCI Thesaurus)
C0078988 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)
C16352 (NCI Thesaurus)
C0085756 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)
C41219 (NCI Thesaurus)
C1513907 (UMLS 2011AA)
CL Item
Not Provided Or Available (Not Reported)
C43234 (NCI Thesaurus)
C1706613 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)
C41261 (NCI Thesaurus)
C0007457 (UMLS 2011AA)
Item Group
Pre-treatment Requirements
Item
Women or men >=18 years of age
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
CL.6
Code List
Women or men >=18 years of age
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
PatientAgeYearCount
Item
Age
double
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C29848 (NCI Thesaurus ValueDomain)
C0439234 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
Item
Histologically confirmed, locally advanced (a T4 primary tumor and stage IIIB or IIIC disease) or metastatic breast cancer that has progressed after treatment with regimens that included trastuzumab and either an anthracycline or a taxane or both. (NOTE: Agents need not have been given concurrently nor in the same regimen. NOTE: Prior treatment with trastuzumab is required unless there is a contraindication for trastuzumab treatment.)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25581 (NCI Thesaurus Property)
C1518419 (UMLS 2011AA Property)
C25411 (NCI Thesaurus Property)
C0205179 (UMLS 2011AA Property)
C4872 (NCI Thesaurus Property)
C0678222 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C19987 (NCI Thesaurus Property)
C0242656 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.7
Code List
Histologically confirmed, locally advanced (a T4 primary tumor and stage IIIB or IIIC disease) or metastatic breast cancer that has progressed after treatment with regimens that included trastuzumab and either an anthracycline or a taxane or both. (NOTE: Agents need not have been given concurrently nor in the same regimen. NOTE: Prior treatment with trastuzumab is required unless there is a contraindication for trastuzumab treatment.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Prior treatment with trastuzumab in the neo-adjuvant, adjuvant, or metastatic setting is required. (NOTE: Prior treatment with trastuzumab is required unless there is a contraindication for trastuzumab treatment. - NOTE: Concomitant use of trastuzumab is not allowed in this study.)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C1647 (NCI Thesaurus Property)
C0338204 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15675 (NCI Thesaurus Property)
C0677850 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C1490 (NCI Thesaurus Property)
C0796419 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.8
Code List
Prior treatment with trastuzumab in the neo-adjuvant, adjuvant, or metastatic setting is required. (NOTE: Prior treatment with trastuzumab is required unless there is a contraindication for trastuzumab treatment. - NOTE: Concomitant use of trastuzumab is not allowed in this study.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Prior chemotherapy allowed in the neo-adjuvant, adjuvant, or metastatic setting. Unlimited prior chemotherapy is allowed.
text
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.9
Code List
Prior chemotherapy allowed in the neo-adjuvant, adjuvant, or metastatic setting. Unlimited prior chemotherapy is allowed.
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Prior hormonal therapy allowed in the neo-adjuvant, adjuvant, or metastatic setting. Unlimited prior hormonal therapy is allowed.
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus Property)
C0279025 (UMLS 2011AA Property)
C4872 (NCI Thesaurus Property)
C0678222 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.10
Code List
Prior hormonal therapy allowed in the neo-adjuvant, adjuvant, or metastatic setting. Unlimited prior hormonal therapy is allowed.
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
HER2 positive, defined as: Validated IHC assay score of 3+ (defined as uniform, intense staining of >30% of invasive tumor cells) -OR- Average HER2 gene copy number of >6 -OR- Gene amplified (HER2:D17Z1) ratio >2.20
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C38758 (NCI Thesaurus Property)
C1514241 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property)
C0242957 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.11
Code List
HER2 positive, defined as: Validated IHC assay score of 3+ (defined as uniform, intense staining of >30% of invasive tumor cells) -OR- Average HER2 gene copy number of >6 -OR- Gene amplified (HER2:D17Z1) ratio >2.20
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Must have measurable disease according to RECIST criteria (See Section 11.0)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C8507 (NCI Thesaurus Property)
C1513041 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C49164 (NCI Thesaurus Property)
C1709926 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.12
Code List
Must have measurable disease according to RECIST criteria (See Section 11.0)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Negative pregnancy test done <=7 days prior to registration, for women of childbearing potential only. (If not a woman of childbearing potential check NA)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)
CL.13
Code List
Negative pregnancy test done <=7 days prior to registration, for women of childbearing potential only. (If not a woman of childbearing potential check NA)
CL Item
N/a (N/A)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
PatientNegativePregnancyTestDate
Item
Negative pregnancy test date (If a woman of childbearing potential)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)
Item
The following laboratory values obtained <=7 days prior to registration
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.14
Code List
The following laboratory values obtained <=7 days prior to registration
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
LaboratoryProcedureEvaluationPerformedFirstDate
Item
Earliest laboratory test date (Note: These dates pertain to the following labs only.)
date
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25509 (NCI Thesaurus ValueDomain)
C1279901 (UMLS 2011AA ValueDomain)
LaboratoryProcedureEvaluationPerformedMostRecentDate
Item
latest laboratory test date
date
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25577 (NCI Thesaurus ValueDomain)
C1513491 (UMLS 2011AA ValueDomain)
Item
Hemoglobin >9.0 g/dL
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
CL.15
Code List
Hemoglobin >9.0 g/dL
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
LaboratoryProcedureHemoglobinResultSpecifiedValue
Item
Hemoglobin
double
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
WBC >= 3,000/mL
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.16
Code List
WBC >= 3,000/mL
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
LaboratoryProcedureLeukocyteResultUnspecifiedValue
Item
WBC
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
ANC >= 1500/mL
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C63321 (NCI Thesaurus Property)
C0948762 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.17
Code List
ANC >= 1500/mL
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
LaboratoryProcedureAbsoluteNeutrophilCountResultUnspecifiedValue
Item
ANC
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63321 (NCI Thesaurus Property)
C0948762 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
Platelet Count >= 75,000/mL
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C51951 (NCI Thesaurus Property)
C0032181 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.18
Code List
Platelet Count >= 75,000/mL
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
LaboratoryProcedurePlateletResultUnspecifiedValue
Item
Platelet count
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
Total bilirubin <= 1.5 x ULN
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C25282 (NCI Thesaurus Property)
C0332285 (UMLS 2011AA Property)
C25706 (NCI Thesaurus Property)
C1519815 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.19
Code List
Total bilirubin <= 1.5 x ULN
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
LaboratoryProcedureTotalBilirubinResultUnspecifiedValue
Item
Total Bilirubin
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureTotalBilirubinResultUpperLimitNormalValue
Item
Total Bilirubin ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Item
SGOT(AST) and SGPT(ALT) <=2.5 x ULN or SGOT(AST) and SGPT(ALT) <5 x ULN if elevations are due to liver metastases.
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property)
C0376147 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.20
Code List
SGOT(AST) and SGPT(ALT) <=2.5 x ULN or SGOT(AST) and SGPT(ALT) <5 x ULN if elevations are due to liver metastases.
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
SGOT(AST) and SGPT(ALT) >2.5 x ULN due to liver metastases (This question may be answered "Yes" or "No")
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property)
C0376147 (UMLS 2011AA Property)
C4758 (NCI Thesaurus Property)
C0494165 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.21
Code List
SGOT(AST) and SGPT(ALT) >2.5 x ULN due to liver metastases (This question may be answered "Yes" or "No")
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultSpecifiedValue
Item
SGOT (AST)
double
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
SGOT (AST) ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUnspecifiedValue
Item
SGPT (ALT)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property)
C0376147 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue
Item
SGPT (ALT) ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property)
C0376147 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Item
Serum Creatinine <=1.5 x ULN
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.22
Code List
Serum Creatinine <=1.5 x ULN
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
LaboratoryProcedureCreatinineResultUnspecifiedValue
Item
Serum Creatinine
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCreatinineResultUpperLimitofNormalValue
Item
Serum Creatinine ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Item
Creatinine clearance >=30 mL/min (calculated according to Cockcroft and Gault - see Appendix II)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25747 (NCI Thesaurus Property)
C0373595 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.23
Code List
Creatinine clearance >=30 mL/min (calculated according to Cockcroft and Gault - see Appendix II)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
LaboratoryProcedureCreatinineClearanceOutcomeValue
Item
Creatinine Clearance (NOTE: In patients with moderate renal impairment calculated creatinine clearance 30-50 mL/min at baseline, a dose reduction to 80% of the capecitabine starting dose is required. See Section 8.0.)
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25747 (NCI Thesaurus Property)
C0373595 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
Fasting glucose <120 mg/dL (NOTE: Patients with diabetes are allowed to participate, provided that their blood glucose is within the guidelines above upon enrollment.)
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C41376 (NCI Thesaurus Property)
C0202042 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C63663 (NCI Thesaurus Property)
C0015663 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.24
Code List
Fasting glucose <120 mg/dL (NOTE: Patients with diabetes are allowed to participate, provided that their blood glucose is within the guidelines above upon enrollment.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
LaboratoryProcedureFastingPlasmaGlucoseMeasurementOutcomeValue
Item
Fasting glucose
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C41376 (NCI Thesaurus Property)
C0202042 (UMLS 2011AA Property)
C63663 (NCI Thesaurus Property)
C0015663 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
International Normalization Ratio (INR) <= 1.5 X ULN
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25352 (NCI Thesaurus Property)
C0525032 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.25
Code List
International Normalization Ratio (INR) <= 1.5 X ULN
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
LaboratoryProcedureInternationalNormalizationRatioResultValue
Item
International Normalization Ratio (INR)
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25352 (NCI Thesaurus Property)
C0525032 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureInternationalNormalizationRatioResultUpperLimitofNormalValue
Item
International Normalization Ratio ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25352 (NCI Thesaurus Property)
C0525032 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Item
ECOG performance status (PS) 0, 1, or 2
text
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)
CL.26
Code List
ECOG performance status (PS) 0, 1, or 2
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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)
CL.27
Code List
Performance Status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
CL Item
Dead (5)
Item
Adequate cardiac function as defined as an ejection fraction 50% as determined by MUGA or echocardiogram
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
CL.28
Code List
Adequate cardiac function as defined as an ejection fraction 50% as determined by MUGA or echocardiogram
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Life expectancy >3 months
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C37987 (NCI Thesaurus Property)
C0376558 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C25359 (NCI Thesaurus Property)
C0679138 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.29
Code List
Life expectancy >3 months
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Has written informed consent been obtained
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
CL.30
Code List
Has written informed consent been obtained
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Willingness to return to an NCCTG or other participating cooperative group institution for treatment and follow-up
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.31
Code List
Willingness to return to an NCCTG or other participating cooperative group institution for treatment and follow-up
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Patient willing to provide tissue and blood samples for research purposes (see Sections 6.0 14.0 and 17.0)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.32
Code List
Patient willing to provide tissue and blood samples for research purposes (see Sections 6.0 14.0 and 17.0)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Availability of diagnostic material (i.e., diagnostic slides confirming locally advanced/metastatic disease and HER2 stained slides) and operative and pathology reports from diagnosis of locally advanced or metastatic breast cancer (NOTE: Biopsy of recurrent disease and submission of these materials is not required if materials available from initial diagnosis of locally advanced/metastatic disease.)
text
C25214 (NCI Thesaurus ObjectClass)
C0220825 (UMLS 2011AA ObjectClass)
C25482 (NCI Thesaurus ObjectClass)
C0348026 (UMLS 2011AA ObjectClass)
C28277 (NCI Thesaurus Property)
C0807321 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.33
Code List
Availability of diagnostic material (i.e., diagnostic slides confirming locally advanced/metastatic disease and HER2 stained slides) and operative and pathology reports from diagnosis of locally advanced or metastatic breast cancer (NOTE: Biopsy of recurrent disease and submission of these materials is not required if materials available from initial diagnosis of locally advanced/metastatic disease.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Ability to complete questionnaire(s) by themselves or with assistance (All responses in above section must be "Yes" unless specified as "NA.")
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C17048 (NCI Thesaurus Property)
C0034394 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.34
Code List
Ability to complete questionnaire(s) by themselves or with assistance (All responses in above section must be "Yes" unless specified as "NA.")
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Exclusion Criteria
Item
Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus newborn are unknown: - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician).
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C25596 (NCI Thesaurus Property)
C0006147 (UMLS 2011AA Property)
C17087 (NCI Thesaurus Property)
C0035150 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.35
Code List
Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus newborn are unknown: - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician).
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Stage III or IV invasive cancer, other than breast cancer, in <=5 years prior to registration.
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25411 (NCI Thesaurus Property)
C0205179 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.36
Code List
Stage III or IV invasive cancer, other than breast cancer, in <=5 years prior to registration.
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Actively being treated for other malignancy, excepting non-melanotic skin cancer or carcinoma-in-situ of the cervix (If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.37
Code List
Actively being treated for other malignancy, excepting non-melanotic skin cancer or carcinoma-in-situ of the cervix (If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
New York Heart Association class III or IV cardiovascular disease
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C7922 (NCI Thesaurus Property)
C0278962 (UMLS 2011AA Property)
CL.38
Code List
New York Heart Association class III or IV cardiovascular disease
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Current, active hepatic or biliary disease except Gilbert's syndrome or asymptomatic gallstones
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C3196 (NCI Thesaurus Property)
C0023895 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C28011 (NCI Thesaurus Property)
C0521378 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.39
Code List
Current, active hepatic or biliary disease except Gilbert's syndrome or asymptomatic gallstones
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Evidence of active brain metastasis including leptomeningeal involvement. CNS metastasis controlled by prior surgery and/or radiotherapy is allowed. (NOTE: To be considered controlled, there must be at least 2 months of no symptoms or evidence of progression prior to study entry and corticosteriod therapy must have been discontinued.)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3813 (NCI Thesaurus Property)
C0220650 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
CL.40
Code List
Evidence of active brain metastasis including leptomeningeal involvement. CNS metastasis controlled by prior surgery and/or radiotherapy is allowed. (NOTE: To be considered controlled, there must be at least 2 months of no symptoms or evidence of progression prior to study entry and corticosteriod therapy must have been discontinued.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Major surgery, chemotherapy, or immunologic therapy <=6 weeks prior to registration
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C15262 (NCI Thesaurus Property)
C0021083 (UMLS 2011AA Property)
C15329 (NCI Thesaurus Property)
C0543467 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.41
Code List
Major surgery, chemotherapy, or immunologic therapy <=6 weeks prior to registration
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Radiotherapy <=4 weeks prior to registration, except if to a non-target lesion only. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed. (If patient receives single dose radiation for palliation or radiation to non-target lesion, they may immediately proceed to registration without waiting 4 weeks. Acute adverse events from radiation must have resolved to <=CTCAE v3.0 Grade 1.)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.42
Code List
Radiotherapy <=4 weeks prior to registration, except if to a non-target lesion only. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed. (If patient receives single dose radiation for palliation or radiation to non-target lesion, they may immediately proceed to registration without waiting 4 weeks. Acute adverse events from radiation must have resolved to <=CTCAE v3.0 Grade 1.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Prior treatment with any therapy targeting IGF-I, IGF-II or its receptors(either monoclonal antibody or tyrosine kinase inhibitor), including but not limited to any of the following (which would have been received on a previous clinical trial): - IMC-A12 (cixutumumab) - CP-751,871 (figitumumab) - AMG-479 - INSM-18 - MK0646 (h7C10) - SCH717454 (19D12, robatumumab) - R1507 - OSI-906 - BMS-754807 - PPP - NVP-AEW541 - AVE-1642 - MEDI-573
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C20442 (NCI Thesaurus Property)
C0037657 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.43
Code List
Prior treatment with any therapy targeting IGF-I, IGF-II or its receptors(either monoclonal antibody or tyrosine kinase inhibitor), including but not limited to any of the following (which would have been received on a previous clinical trial): - IMC-A12 (cixutumumab) - CP-751,871 (figitumumab) - AMG-479 - INSM-18 - MK0646 (h7C10) - SCH717454 (19D12, robatumumab) - R1507 - OSI-906 - BMS-754807 - PPP - NVP-AEW541 - AVE-1642 - MEDI-573
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Prior therapy with any therapy targeting HER1 (EGFR) and/or HER2 (either monoclonal antibody or tyrosine kinase) other than trastuzumab, including but not limited to any of the following: (lapatinib Tykerb, gefitinib Iressa, erlotinib Tarveca, cetuximab Erbitux, panitumumab Vectibix)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C17068 (NCI Thesaurus Property)
C0034802 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C17319 (NCI Thesaurus Property)
C0069515 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.44
Code List
Prior therapy with any therapy targeting HER1 (EGFR) and/or HER2 (either monoclonal antibody or tyrosine kinase) other than trastuzumab, including but not limited to any of the following: (lapatinib Tykerb, gefitinib Iressa, erlotinib Tarveca, cetuximab Erbitux, panitumumab Vectibix)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Currently receiving treatment with any agents that are contraindicated by study therapies: A) IMC-A12 - none identified to date B) Lapatinib - CYPA34 inhibitors and inducers (see Appendix IV) including grapefruit and grapefruit juice (C Capecitabine - warfarinCoumadin, cimetidineTagamet, allopurinolLopurin, sorivudineUsevir, brivudineBrivex, ketoconazoleNizoral, itraconazoleSporanox, ritonavirNorvir, amprenavirAgenerase, or indinavirCrixivan)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus Property)
C0450442 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C37933 (NCI Thesaurus Property)
C1444657 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.45
Code List
Currently receiving treatment with any agents that are contraindicated by study therapies: A) IMC-A12 - none identified to date B) Lapatinib - CYPA34 inhibitors and inducers (see Appendix IV) including grapefruit and grapefruit juice (C Capecitabine - warfarinCoumadin, cimetidineTagamet, allopurinolLopurin, sorivudineUsevir, brivudineBrivex, ketoconazoleNizoral, itraconazoleSporanox, ritonavirNorvir, amprenavirAgenerase, or indinavirCrixivan)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Uncontrolled intercurrent illness (including, but not limited to: - Poorly controlled diabetes - Ongoing or active infection - Symptomatic congestive heart failure - Unstable angina pectoris - Cardiac arrhythmia - Psychiatric illness/social situations that would limit compliance with study requirements)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25456 (NCI Thesaurus Property)
C0205420 (UMLS 2011AA Property)
C48932 (NCI Thesaurus Property)
C0205318 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.46
Code List
Uncontrolled intercurrent illness (including, but not limited to: - Poorly controlled diabetes - Ongoing or active infection - Symptomatic congestive heart failure - Unstable angina pectoris - Cardiac arrhythmia - Psychiatric illness/social situations that would limit compliance with study requirements)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of the safety (of the prescribed regimens.)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13310 (NCI Thesaurus Property)
C0205373 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25456 (NCI Thesaurus Property)
C0205420 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.47
Code List
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of the safety (of the prescribed regimens.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C15207 (NCI Thesaurus Property)
C28041 (NCI Thesaurus Property)
C1517586 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.48
Code List
Currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive with an AIDS-defining illness. (HIV positive patients with CD4 count within institutional normal range and no history of an AIDS-defining illness are eligible, however, some antiviral/antiretroviral medications which have CYP3A4 interactions are prohibited on this study.)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C14139 (NCI Thesaurus Property)
C0085393 (UMLS 2011AA Property)
CL.49
Code List
Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive with an AIDS-defining illness. (HIV positive patients with CD4 count within institutional normal range and no history of an AIDS-defining illness are eligible, however, some antiviral/antiretroviral medications which have CYP3A4 interactions are prohibited on this study.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Registration Check
Item
Consent form signed and dated
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
CL.50
Code List
Consent form signed and dated
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
Item
Authorization for use and disclosure of protected health information signed and dated (Non-USA institution only check NA)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25178 (NCI Thesaurus Property)
C0018684 (UMLS 2011AA Property)
CL.51
Code List
Authorization for use and disclosure of protected health information signed and dated (Non-USA institution only check NA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
PatientSignedDischargeMedicalRecordDate
Item
Date of authorization
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C0012621 (NCI Metathesaurus Property)
C45258 (NCI Thesaurus Property)
C0025102 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
A mandatory translational research component is part of this study, patients will automatically be registered to the translational research component of this study at the time of registration. (see Section 14.0 and 17.0)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25644 (NCI Thesaurus Property)
CL.52
Code List
A mandatory translational research component is part of this study, patients will automatically be registered to the translational research component of this study at the time of registration. (see Section 14.0 and 17.0)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Treatment cannot begin prior to registration and must begin <=7 days after registration
text
C15207 (NCI Thesaurus ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C49073 (NCI Thesaurus Property)
C1707357 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.53
Code List
Treatment cannot begin prior to registration and must begin <=7 days after registration
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Pretreatment tests/procedures must be completed <= 7 days prior to registration (NOTE: The earliest pretreatment test/procedure date must be less than or equal to the earliest laboratory test/procedure date and the latest pretreatment test/procedure date must be greater than or equal to the latest laboratory test/procedure date.)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C45513 (NCI Thesaurus Property)
C1711411 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.54
Code List
Pretreatment tests/procedures must be completed <= 7 days prior to registration (NOTE: The earliest pretreatment test/procedure date must be less than or equal to the earliest laboratory test/procedure date and the latest pretreatment test/procedure date must be greater than or equal to the latest laboratory test/procedure date.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationBeginDate
Item
Earliest pretreatment test/procedure date
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationEndDate
Item
Latest pretreatment test/procedure date
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PatientPriorRegistrationDiagnosticImagingEligibilityDeterminationBeginDate
Item
Earliest exception test date (Tumor measurement, Chest x-ray or CT, Bone scan, Brain MRI or CT, must be done <=21 days prior to registration see Section 4.0.)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16502 (NCI Thesaurus Property)
C0011923 (UMLS 2011AA Property)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
PatientPriorRegistrationDiagnosticImagingEligibilityDeterminationEndDate
Item
latest exception test date
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16502 (NCI Thesaurus Property)
C0011923 (UMLS 2011AA Property)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
DiagnosticElectrocardiogramPerformedDate
Item
Date of EKG (Electrocardiogram EKG must be done <=28 days prior to registration see Section 4.0.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25482 (NCI Thesaurus ObjectClass)
C0348026 (UMLS 2011AA ObjectClass)
C0013798 (NCI Metathesaurus ObjectClass)
Item
All required baseline symptoms (see Section 10.3) must be documented and graded
text
C15207 (NCI Thesaurus ObjectClass)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25356 (NCI Thesaurus Property)
C1301725 (UMLS 2011AA Property)
C49073 (NCI Thesaurus Property)
C1707357 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.55
Code List
All required baseline symptoms (see Section 10.3) must be documented and graded
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Study drug availability checked (Study drug must be in site pharmacy for this patient prior to registration)
text
C15207 (NCI Thesaurus ObjectClass)
C41161 (NCI Thesaurus Property)
C1521826 (UMLS 2011AA Property)
C25429 (NCI Thesaurus Property)
C0470187 (UMLS 2011AA Property)
C49073 (NCI Thesaurus Property)
C1707357 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.56
Code List
Study drug availability checked (Study drug must be in site pharmacy for this patient prior to registration)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Blood draw kit availability checked (Site must have a kit on hand for this patient prior to registration)
text
C15207 (NCI Thesaurus ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25429 (NCI Thesaurus Property)
C0470187 (UMLS 2011AA Property)
C49073 (NCI Thesaurus Property)
C1707357 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.57
Code List
Blood draw kit availability checked (Site must have a kit on hand for this patient prior to registration)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
This protocol has a mandatory quality assurance (QA) audit submission of diagnostic slides and HER2 stained slides used to make a HER2 positive metastatic breast cancer diagnosis, plus corresponding operating and pathology reports (If these materials are not available, the patient is not eligible for this trial)
text
C15207 (NCI Thesaurus ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C49073 (NCI Thesaurus Property)
C1707357 (UMLS 2011AA Property)
C17319 (NCI Thesaurus Property)
C0069515 (UMLS 2011AA Property)
C15381 (NCI Thesaurus Property)
C0178932 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.58
Code List
This protocol has a mandatory quality assurance (QA) audit submission of diagnostic slides and HER2 stained slides used to make a HER2 positive metastatic breast cancer diagnosis, plus corresponding operating and pathology reports (If these materials are not available, the patient is not eligible for this trial)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Patient QOL booklet availability checked; copies are not acceptable for this submission (Site must have booklets on hand for this patient prior to registration)
text
C15207 (NCI Thesaurus ObjectClass)
C17047 (NCI Thesaurus Property)
C0518214 (UMLS 2011AA Property)
C25429 (NCI Thesaurus Property)
C0470187 (UMLS 2011AA Property)
C49073 (NCI Thesaurus Property)
C1707357 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.59
Code List
Patient QOL booklet availability checked; copies are not acceptable for this submission (Site must have booklets on hand for this patient prior to registration)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
This protocol has mandatory monitoring for the Safety Cohort - sites must participate in monthly conference calls (see Section 16.8.4)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15207 (NCI Thesaurus ObjectClass)
C49073 (NCI Thesaurus Property)
C1707357 (UMLS 2011AA Property)
C41201 (NCI Thesaurus Property)
C1521743 (UMLS 2011AA Property)
CL.60
Code List
This protocol has mandatory monitoring for the Safety Cohort - sites must participate in monthly conference calls (see Section 16.8.4)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
At The Time Of Registration/randomization, The Following Will Also Be Recorded:
Item
Patient has given permission to keep sample(s) for use in future research to learn about, prevent, or treat cancer
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.61
Code List
Patient has given permission to keep sample(s) for use in future research to learn about, prevent, or treat cancer
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Patient has given permission to keep sample(s) for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
text
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15319 (NCI Thesaurus Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.62
Code List
Patient has given permission to keep sample(s) for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Patient has given NCCTG permission to give sample(s) to outside researchers
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C44280 (NCI Thesaurus Property)
C0205101 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25936 (NCI Thesaurus Property)
C0035173 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.63
Code List
Patient has given NCCTG permission to give sample(s) to outside researchers
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Stratification Factors
Item
Receptor Status (Hormone)
text
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C17220 (NCI Thesaurus ObjectClass)
C0041365 (UMLS 2011AA ObjectClass)
C28154 (NCI Thesaurus ObjectClass)
C0019929 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25508 (NCI Thesaurus Property)
C0205088 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.64
Code List
Receptor Status (Hormone)
CL Item
Er Or Pgr Positive (ER or PgR positive)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item
Number of prior chemotherapy regimens in the metastatic setting
text
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
CL.65
Code List
Number of prior chemotherapy regimens in the metastatic setting
CL Item
Two Or More (Two or more)
CL Item
One (One)
C66832 (NCI Thesaurus)
C0205447 (UMLS 2011AA)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
Item
Subgroup Code
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25693 (NCI Thesaurus ObjectClass)
C1515021 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C25689 (NCI Thesaurus Property)
C1514983 (UMLS 2011AA Property)
C25447 (NCI Thesaurus Property)
C1521970 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.66
Code List
Subgroup Code
CL Item
Er/pgr+, Two Prior Regimens (SG01: ER/PgR+, two prior reg.)
CL Item
Er/pgr+, One Prior Regimen (SG02: ER/PgR+, one prior reg.)
CL Item
Er/pgr+, No Prior Regimens (SG03: ER/PgR+, no prior reg.)
CL Item
Other, Two Prior Regimens (SG04: Other, two prior reg.)
CL Item
Other, One Prior Regimen (SG05: Other, one prior reg.)
CL Item
Other, No Prior Regimen (SG06: Other, none prior reg.)
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