Patient Demographics / Pre-treatment Characteristics
Patient Initials Last
text
Patient Initials First
text
PatientMiddleInitialsName
text
Gender
text
Ethnic Group
text
Patient Birth Date
date
PatientAddressPostalCode
text
PatientAddressCountryCode
text
PatientPaymentType
text
Race
Racial Group
text
Pre-treatment Requirements
Age 18 Years and older
boolean
Age
integer
PatientNorthCentralCancerTreatmentGroupAdvancedBreastCarcinomaCancerProgressionEligibilityDeterminationInd-2
boolean
PatientPriorTrastuzumabTaxaneCompoundAdjuvantTherapyEligibilityDeterminationEligibilityInd-2
boolean
PriorBreastCarcinomaChemotherapyAdministeredIndicator
boolean
PatientBreastCarcinomaEndocrineTherapyAdministeredEligibilityDeterminationInd-2
boolean
PatientHER2/neuPositiveFindingEligibilityDeterminationInd-2
boolean
PatientMeasurableDiseaseResponseEvaluationCriteriainSolidTumorsEligibilityDeterminationInd-2
boolean
PatientNegativePregnancyTestIndicator
boolean
PatientNegativePregnancyTestDate
date
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationInd-2
boolean
LaboratoryProcedureEvaluationPerformedFirstDate
date
LaboratoryProcedureEvaluationPerformedMostRecentDate
date
HematologyHemoglobinAssessmentInd-2
boolean
Hemoglobin
float
LaboratoryProcedureLeukocyteEligibilityDeterminationInd-2
boolean
WBC
float
LaboratoryProcedureAbsoluteNeutrophilCountEligibilityDeterminationInd-2
boolean
ANC
float
LaboratoryProcedurePlateletCountEligibilityDeterminationInd-2
boolean
Peripheral Platelet Count
float
LaboratoryProcedureWithinClinicalStudyProtocolUpperLimitofNormalTotalBilirubinMeasurementInd-2
boolean
Bilirubin, Total
float
Bilirubin, Total ULN
float
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseSerumGlutamicOxaloaceticTransferaseEligibilityDeterminationInd-2
boolean
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseSerumGlutamicOxaloaceticTransferaseMetastaticMalignantNeoplasmtotheLiverEligibilityDeterminationInd-2
boolean
AST (SGOT)
float
AST (SGOT) ULN
float
ALT (SGPT)
float
ALT (SGPT) ULN
float
LaboratoryProcedureCreatinineEligibilityDeterminationind-2
boolean
Creatinine
float
Creatinine, serum ULN
float
LaboratoryProcedureCreatinineClearanceEligibilityDeterminationInd-2
boolean
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.)
float
LaboratoryProcedureFastingPlasmaGlucoseMeasurementEligibilityDeterminationInd-2
boolean
Fasting glucose
float
LaboratoryProcedureInternationalNormalizedRatioEligibilityDeterminationInd-2
boolean
INR
float
LaboratoryProcedureInternationalNormalizationRatioResultUpperLimitofNormalValue
float
EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2
boolean
ECOG Performance Status
text
PatientCardiacFunctionRequiredInd-2
boolean
PatientLifeExpectancyEligibilityDeterminationInd-2
boolean
Consent signed
boolean
PatientTherapeuticProcedureFollow-upEligibilityDeterminationInd-2
boolean
PersonSpecimenUseConsentEligibilityDeterminationIndicator
boolean
EvaluationDiagnosticSpecimenPathologyReportEligibilityDeterminationind-2
boolean
PatientQuestionnaireCompleteEligibilityDeterminationInd-2
boolean
Exclusion Criteria
PatientReproductionPregnancyBreastFeedingExclusionCriteriaInd-2
boolean
PatientAdvancedMalignantNeoplasmPriorRegistrationEligibilityDeterminationInd-2
boolean
PatientCurrentTherapeuticProcedureMalignantNeoplasmExclusionCriteriaInd-2
boolean
PatientNewYorkHeartAssociationClassIII/IVEligibilityDeterminationInd-2
boolean
PatientCurrentHepaticDisorderBiliaryDiseaseorDisorderExclusionCriteriaInd-2
boolean
PatientMetastaticMalignantNeoplasmtotheBrainExclusionCriteriaInd-2
boolean
PatientSurgicalProcedureChemotherapyImmunotherapyPriorRegistrationExclusionCriteriaInd-2
boolean
PatientRadiationTherapyPriorRegistrationExclusionCriteriaInd-2
boolean
PatientInsulin-LikeGrowthFactorTherapeuticProcedureExclusionCriteriaInd-2
boolean
PatientEpidermalGrowthFactorReceptorERBB2ReceptorProtein-TyrosineKinaseTherapeuticProcedureExclusionCriteriaInd-2
boolean
PatientContraindicatedAgentExclusionCriteriaInd-2
boolean
PatientUncontrolledConcurrentDiseaseorDisorderExclusionCriteriaInd-2
boolean
PatientConcurrentSystemicDiseaseorDisorderExclusionCriteriaInd-2
boolean
PatientInvestigationalClinicalTrialCurrentParticipationExclusionCriteriaInd-2
boolean
PatientImmunocompromisedExclusionCriteriaind-2
boolean
Registration Check
InformedConsentFormSignedInd-2
boolean
InformedConsentFormSignedDate
date
PatientHealthRecordIndicator
text
PatientSignedDischargeMedicalRecordDate
date
PatientRegisteredInd-2
boolean
ClinicalTrialTherapeuticProcedurePostRegistrationChecklistInd-2
boolean
PatientPriorRegistrationLaboratoryProcedureVerificationInd-2
boolean
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationBeginDate
date
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationEndDate
date
PatientPriorRegistrationDiagnosticImagingEligibilityDeterminationBeginDate
date
PatientPriorRegistrationDiagnosticImagingEligibilityDeterminationEndDate
date
DiagnosticElectrocardiogramPerformedDate
date
ClinicalTrialBaselineDiseaseDocumentedChecklistInd-2
boolean
ClinicalTrialProtocolAgentAvailabilityChecklistInd-2
boolean
ClinicalTrialBloodSpecimenCollectionAvailabilityChecklistInd-2
boolean
ClinicalTrialQualityAssuranceERBB2ReceptorProtein-TyrosineKinaseDiagnosisChecklistInd-2
boolean
ClinicalTrialQualityofLifeAvailabilityChecklistInd-2
boolean
ClinicalTrialStudyMonitorChecklistInd-2
boolean
At The Time Of Registration/randomization, The Following Will Also Be Recorded:
PersonSpecimenMalignantNeoplasmResearchConsentInd-2
boolean
BloodTissueSpecimenOtherDiseasesandDisordersResearchConsentInd-3
boolean
PersonSpecimenExternalInvestigatorConsentInd-2
boolean
Stratification Factors
BreastHormoneReceptorTumorMarkerFinalDiagnosisResultType
text
PriorChemotherapyMetastaticRegimenChemotherapyRegimenCount
text
PatientSubgroupCharacteristicsStratificationDescriptionType
text