Patient Demographics / Pre-treatment Characteristics
PatientMedicalRecordNumber
text
PatientLastInitialsName
text
PatientFirstInitialsName
text
PatientMiddleInitialsName
text
PatientGenderCategory
text
PatientEthnicGroupCategory
text
PatientBirthDate
date
PatientAddressPostalCode
text
PatientAddressCountryCode
text
PatientPaymentType
text
Race
PatientRaceCategory
text
Pre-treatment Requirements
PatientAgeInd-2
text
PatientAgeYearCount
double
PatientNorthCentralCancerTreatmentGroupAdvancedBreastCarcinomaCancerProgressionEligibilityDeterminationInd-2
text
PatientPriorTrastuzumabTaxaneCompoundAdjuvantTherapyEligibilityDeterminationEligibilityInd-2
text
PriorBreastCarcinomaChemotherapyAdministeredIndicator
text
PatientBreastCarcinomaEndocrineTherapyAdministeredEligibilityDeterminationInd-2
text
PatientHER2/neuPositiveFindingEligibilityDeterminationInd-2
text
PatientMeasurableDiseaseResponseEvaluationCriteriainSolidTumorsEligibilityDeterminationInd-2
text
PatientNegativePregnancyTestIndicator
text
PatientNegativePregnancyTestDate
date
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationInd-2
text
LaboratoryProcedureEvaluationPerformedFirstDate
date
LaboratoryProcedureEvaluationPerformedMostRecentDate
date
HematologyHemoglobinAssessmentInd-2
text
LaboratoryProcedureHemoglobinResultSpecifiedValue
double
LaboratoryProcedureLeukocyteEligibilityDeterminationInd-2
text
LaboratoryProcedureLeukocyteResultUnspecifiedValue
double
LaboratoryProcedureAbsoluteNeutrophilCountEligibilityDeterminationInd-2
text
LaboratoryProcedureAbsoluteNeutrophilCountResultUnspecifiedValue
double
LaboratoryProcedurePlateletCountEligibilityDeterminationInd-2
text
LaboratoryProcedurePlateletResultUnspecifiedValue
double
LaboratoryProcedureWithinClinicalStudyProtocolUpperLimitofNormalTotalBilirubinMeasurementInd-2
text
LaboratoryProcedureTotalBilirubinResultUnspecifiedValue
double
LaboratoryProcedureTotalBilirubinResultUpperLimitNormalValue
double
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseSerumGlutamicOxaloaceticTransferaseEligibilityDeterminationInd-2
text
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseSerumGlutamicOxaloaceticTransferaseMetastaticMalignantNeoplasmtotheLiverEligibilityDeterminationInd-2
text
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultSpecifiedValue
double
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
double
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUnspecifiedValue
double
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue
double
LaboratoryProcedureCreatinineEligibilityDeterminationind-2
text
LaboratoryProcedureCreatinineResultUnspecifiedValue
double
LaboratoryProcedureCreatinineResultUpperLimitofNormalValue
double
LaboratoryProcedureCreatinineClearanceEligibilityDeterminationInd-2
text
LaboratoryProcedureCreatinineClearanceOutcomeValue
double
LaboratoryProcedureFastingPlasmaGlucoseMeasurementEligibilityDeterminationInd-2
text
LaboratoryProcedureFastingPlasmaGlucoseMeasurementOutcomeValue
double
LaboratoryProcedureInternationalNormalizedRatioEligibilityDeterminationInd-2
text
LaboratoryProcedureInternationalNormalizationRatioResultValue
double
LaboratoryProcedureInternationalNormalizationRatioResultUpperLimitofNormalValue
double
EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2
text
PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale
text
PatientCardiacFunctionRequiredInd-2
text
PatientLifeExpectancyEligibilityDeterminationInd-2
text
PatientSignatureConsentInd-2
text
PatientTherapeuticProcedureFollow-upEligibilityDeterminationInd-2
text
PersonSpecimenUseConsentEligibilityDeterminationIndicator
text
EvaluationDiagnosticSpecimenPathologyReportEligibilityDeterminationind-2
text
PatientQuestionnaireCompleteEligibilityDeterminationInd-2
text
Exclusion Criteria
PatientReproductionPregnancyBreastFeedingExclusionCriteriaInd-2
text
PatientAdvancedMalignantNeoplasmPriorRegistrationEligibilityDeterminationInd-2
text
PatientCurrentTherapeuticProcedureMalignantNeoplasmExclusionCriteriaInd-2
text
PatientNewYorkHeartAssociationClassIII/IVEligibilityDeterminationInd-2
text
PatientCurrentHepaticDisorderBiliaryDiseaseorDisorderExclusionCriteriaInd-2
text
PatientMetastaticMalignantNeoplasmtotheBrainExclusionCriteriaInd-2
text
PatientSurgicalProcedureChemotherapyImmunotherapyPriorRegistrationExclusionCriteriaInd-2
text
PatientRadiationTherapyPriorRegistrationExclusionCriteriaInd-2
text
PatientInsulin-LikeGrowthFactorTherapeuticProcedureExclusionCriteriaInd-2
text
PatientEpidermalGrowthFactorReceptorERBB2ReceptorProtein-TyrosineKinaseTherapeuticProcedureExclusionCriteriaInd-2
text
PatientContraindicatedAgentExclusionCriteriaInd-2
text
PatientUncontrolledConcurrentDiseaseorDisorderExclusionCriteriaInd-2
text
PatientConcurrentSystemicDiseaseorDisorderExclusionCriteriaInd-2
text
PatientInvestigationalClinicalTrialCurrentParticipationExclusionCriteriaInd-2
text
PatientImmunocompromisedExclusionCriteriaind-2
text
Registration Check
InformedConsentFormSignedInd-2
text
InformedConsentFormSignedDate
date
PatientHealthRecordIndicator
text
PatientSignedDischargeMedicalRecordDate
date
PatientRegisteredInd-2
text
ClinicalTrialTherapeuticProcedurePostRegistrationChecklistInd-2
text
PatientPriorRegistrationLaboratoryProcedureVerificationInd-2
text
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationBeginDate
date
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationEndDate
date
PatientPriorRegistrationDiagnosticImagingEligibilityDeterminationBeginDate
date
PatientPriorRegistrationDiagnosticImagingEligibilityDeterminationEndDate
date
DiagnosticElectrocardiogramPerformedDate
date
ClinicalTrialBaselineDiseaseDocumentedChecklistInd-2
text
ClinicalTrialProtocolAgentAvailabilityChecklistInd-2
text
ClinicalTrialBloodSpecimenCollectionAvailabilityChecklistInd-2
text
ClinicalTrialQualityAssuranceERBB2ReceptorProtein-TyrosineKinaseDiagnosisChecklistInd-2
text
ClinicalTrialQualityofLifeAvailabilityChecklistInd-2
text
ClinicalTrialStudyMonitorChecklistInd-2
text
At The Time Of Registration/randomization, The Following Will Also Be Recorded:
PersonSpecimenMalignantNeoplasmResearchConsentInd-2
text
BloodTissueSpecimenOtherDiseasesandDisordersResearchConsentInd-3
text
PersonSpecimenExternalInvestigatorConsentInd-2
text
Stratification Factors
BreastHormoneReceptorTumorMarkerFinalDiagnosisResultType
text
PriorChemotherapyMetastaticRegimenChemotherapyRegimenCount
text
PatientSubgroupCharacteristicsStratificationDescriptionType
text