ID

42626

Description

ACOSOG-Z1041 OPEN Registration Worksheet Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=89DFC49B-B721-6DA7-E040-BB89AD43356A

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=89DFC49B-B721-6DA7-E040-BB89AD43356A

Keywords

Versions (3)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00513292 Registration - ACOSOG-Z1041 OPEN Registration Worksheet - 3114475v1.0

English

No Instruction available.

1 forms  
  1. StudyEvent: ACOSOG-Z1041 OPEN Registration Worksheet
    1. No Instruction available.
Patient Information
Description

Patient Information

Date of Birth (month day year)
Description

PersonBirthDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25155
UMLS 2011AA Property
C0005615
Gender of a Person
Description

PersonGenderTextType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C17357
UMLS 2011AA Property
C0079399
Ethnicity
Description

EthnicGroupCategoryText

Data type

text

Alias
NCI Thesaurus Property
C25372
UMLS 2011AA Property
C0683312
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C16564
UMLS 2011AA ObjectClass
C0015031
Country of Residence
Description

PersonAddressCountryName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ValueDomain
C25464
UMLS 2011AA ValueDomain
C0454664
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
NCI Thesaurus ValueDomain-2
C42614
UMLS 2011AA ValueDomain-2
C0027365
Zip code
Description

PersonAddressPostalCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
Race
Description

Racial Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C0034510
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17049
Method of Payment
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
General Information
Description

General Information

Pt ID# (Local Patient Identifier)
Description

PatientIdentifier

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25364
UMLS 2011AA ValueDomain
C0600091
Last (initial)
Description

Patient Initials Last

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1517741
NCI Thesaurus Property
C25536
NCI Thesaurus Property-2
C25551
First (initial)
Description

Patient Initials First

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C0205435
NCI Thesaurus Property
C25536
NCI Thesaurus Property-2
C25509
Middle (initial optional)
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-2
C25569
UMLS 2011AA Property-2
C0444598
E-mail (for Registration Confirmation)
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
Has patient previously been registered to an ACOSOG study
Description

PriorTherapyPatientAmericanCollegeofSurgeonsOncologyGroupStudyInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C16124
UMLS 2011AA ObjectClass-2
C1514463
NCI Thesaurus Property
C19712
UMLS 2011AA Property
C1515944
NCI Metathesaurus Property
CL238692
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Coordinating Group Patient ID (if yes previously issued ACOSOG Patient ID)
Description

Patient Study ID

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Date Informed Consent Signed (month day year)
Description

InformedConsentFormSignedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Was HIPAA Authorization included in Study Informed Consent
Description

HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C62504
UMLS 2011AA ObjectClass
C0600593
NCI Thesaurus Property
C41192
UMLS 2011AA Property
C1524004
HIPAA Authorization Date (If no month day year)
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-2
C45258
UMLS 2011AA Property
C0025102
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Stratification Factors
Description

Stratification Factors

Clinical Tumor Size (mark one)
Description

AmericanCollegeofSurgeonsOncologyGroupPatientMalignantNeoplasmSizeEligibilityDeterminationType

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C19712
UMLS 2011AA ObjectClass-2
C1515944
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C25681
UMLS 2011AA Property-3
C0456389
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Hormone Receptor Status (mark one)
Description

PersonHormoneReceptorStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C28154
UMLS 2011AA Property
C0019929
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
Age (mark one)
Description

PatientFirstProtocolRegistrationAgeYearCount

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25320
UMLS 2011AA Property
C1507394
NCI Thesaurus Property-2
C25646
UMLS 2011AA Property-2
C1514821
NCI Thesaurus Property-3
C25509
UMLS 2011AA Property-3
C1279901
NCI Thesaurus ValueDomain
C29848
UMLS 2011AA ValueDomain
C0439234
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
Eligibility Criteria
Description

Eligibility Criteria

Female (Patients must be)
Description

PatientGenderInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17357
UMLS 2011AA Property
C0079399
Age >= 18 years
Description

PatientAgeInd-2

Data type

boolean

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
ECOG Performance Status 0-1
Description

EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2

Data type

boolean

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
ECOG Performance Status (0 or 1)
Description

ECOG Performance Status

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy (NOTE: FNA is acceptable for evaluation of breast primaries < 2 cm and lymph node metastases)
Description

InvasiveBreastCarcinomaHistologicallyConfirmedInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C4872
UMLS 2011AA ObjectClass
C0678222
NCI Thesaurus ObjectClass-2
C14159
UMLS 2011AA ObjectClass-2
C0205281
NCI Thesaurus ObjectClass-3
C25527
UMLS 2011AA ObjectClass-3
C0205462
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patients must have a breast primary >= 2.0 cm and/or one or more biopsy-positive lymph nodes (Patients with prior excisional biopsy of the breast primary are eligible, provided biopsy-positive lymph nodes are present)
Description

LymphNodePathologicConfirmedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
The breast cancer must be determined to be HER2-positive prior to study entry (Assays performed using fluorescent in situ hybridization FISH require gene amplification. Assays using immunohistochemistry IHC require a strongly positive 3+ staining intensity score)
Description

PatientHER2/neuEligibilityDeterminationInd-2

Data type

boolean

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-2
C17756
UMLS 2011AA Property-2
C0242957
Within 3 months prior to entry, the patient must have a baseline left ventricular ejection fraction (LVEF) measured by MUGA scan >= 55 (Note: Echocardiogram may be substituted for MUGA at baseline, but the same method of assessment should be used throughout the study. See Section 3.1,#7 "Note" regarding LVEF and MUGA)
Description

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25294
UMLS 2011AA Property-3
C0022885
NCI Thesaurus Property-4
C25171
UMLS 2011AA Property-4
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
ANC >= 1200/mm^3
Description

LaboratoryProcedureAbsoluteNeutrophilCountEligibilityDeterminationInd-2

Data type

boolean

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-2
C25171
UMLS 2011AA Property-2
C0013893
ANC (>= 1200)
Description

ANC

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0948762
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C63321
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Platelet count >= 100,000/mm^3
Description

LaboratoryProcedurePlateletCountEligibilityDeterminationInd-2

Data type

boolean

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-2
C25171
UMLS 2011AA Property-2
C0013893
Platelet count (>= 100000)
Description

Platelets

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0005821
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C12520
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Total bilirubin <= ULN unless the patient has a grade 1 bilirubin elevation (> ULN to 1.5 x ULN) resulting from Gilbert's disease or similar syndrome due to slow conjugation of bilirubin
Description

LaboratoryProcedureWithinClinicalStudyProtocolUpperLimitofNormalTotalBilirubinMeasurementInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25320
UMLS 2011AA Property
C1507394
NCI Thesaurus Property-2
C38037
UMLS 2011AA Property-2
C0201913
NCI Thesaurus Property-3
C25282
UMLS 2011AA Property-3
C0332285
NCI Thesaurus Property-4
C25706
UMLS 2011AA Property-4
C1519815
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does this patient have a grade 1 bilirubin elevation (> ULN to 1.5 x ULN) resulting from Gilbert's disease or similar syndrome due to slow conjugation of bilirubin
Description

PatientElevatedBilirubinPersonalMedicalHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C27088
UMLS 2011AA Property
C0311468
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
Total Bilirubin (If No, <= ULN)
Description

Bilirubin, Total

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201913
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Total Bilirubin (If No, <= ULN)
Description

Bilirubin, Total

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201913
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Total Bilirubin ULN
Description

Bilirubin, Total ULN

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201913
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
Total Bilirubin ULN
Description

Bilirubin, Total ULN

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201913
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
Alkaline phosphatase <= 2.5 x ULN
Description

LaboratoryProcedureAlkalinePhosphataseEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property-2
C16276
UMLS 2011AA Property-2
C0002059
Alkaline Phosphatase (<= 2.5 x ULN)
Description

Alkaline Phosphatase

Data type

float

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0201850
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property-2
C16276
Alkaline Phosphatase ULN
Description

Alkaline Phosphatase ULN

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0151420
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C16276
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
SGOT (AST) <= 1.5 x ULN
Description

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseUpperLimitofNormalResultInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C25706
UMLS 2011AA Property-3
C1519815
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
SGOT (AST) (<= 1.5 x ULN)
Description

SGOT (AST)

Data type

float

Measurement units
  • U/L
Alias
NCI Thesaurus Property
C25202
UMLS CUI-1
C0201899
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
U/L
SGOT (AST) ULN
Description

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Creatinine <= ULN
Description

LaboratoryProcedureCreatinineResultInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C399
UMLS 2011AA Property-2
C0010294
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Creatinine (<= ULN)
Description

LaboratoryProcedureCreatinineResultUnspecifiedValue

Data type

float

Alias
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C399
UMLS 2011AA Property-2
C0010294
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Creatinine ULN
Description

Creatinine, serum ULN

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201976
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
Patients with either skeletal pain or alkaline phosphatase that is > ULN but <= 2.5 x ULN are eligible for inclusion in the study if bone scans fail to demonstrate metastatic disease (Suspicious findings on bone scan must be confirmed as benign by x-ray, MRI, or biopsy)
Description

BoneScanPatientAlkalinePhosphataseUpperLimitofNormalEligibilityInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C17646
UMLS 2011AA ObjectClass-2
C0203668
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property-2
C16276
UMLS 2011AA Property-2
C0002059
NCI Thesaurus Property-3
C25706
UMLS 2011AA Property-3
C1519815
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patients with a history of DCIS or synchronous DCIS of the contralateral breast regardless of therapy are eligible (Those with synchronous invasive breast cancer are NOT eligible)
Description

ContralateralBreastCancerDiagnosisInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus ObjectClass-3
C25307
UMLS 2011AA ObjectClass-3
C0441988
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patients with a history of ipsilateral DCIS treated by local excision with or without hormonal therapy are eligible (Those treated with radiation therapy are NOT eligible)
Description

IpsilateralDiseasePresentInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C25308
UMLS 2011AA ObjectClass-2
C0441989
Patients with a history of non-breast malignancies are eligible if they have remained disease-free for 5 years since completing their initial treatment regimen and are deemed by their physician to be at low risk for recurrence (Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, colon carcinoma in situ, melanoma in situ, and basal cell and squamous cell carcinoma of the skin)
Description

PreviousCancerIdentifiedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25737
UMLS 2011AA Property
C0205396
Patients must not have had any surgical axillary staging procedure prior to study entry (However, patients who have had non-excisional biopsy of an axillary node are eligible)
Description

AxillaryNodeDissectionInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C15227
UMLS 2011AA Property
C0012737
NCI Thesaurus ObjectClass
C12904
UMLS 2011AA ObjectClass
C0729594
Patients must not have definitive clinical or radiologic evidence of metastatic disease
Description

MetastaticNeoplasmConfirmedDiagnosisInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
NCI Thesaurus ObjectClass
C3261
UMLS 2011AA ObjectClass
C2939420
Patients must not have a prior history of invasive breast cancer
Description

PatientInvasiveBreastCarcinomaPersonalMedicalHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C9245
UMLS 2011AA Property
C0853879
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
Patients must not have had treatment given for this breast cancer prior to study entry (The only exception is hormonal therapy, which may have been given for up to a total of 28 days anytime after diagnosis and before study entry. In such a case, hormonal therapy must stop at or before study entry and be re-started, if indicated, following surgery.)
Description

CancerPriorTreatmentInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C15368
Patients must not be taking any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (Patients are eligible if this therapy is discontinued prior to study entry. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy)
Description

PatientBreastCarcinomaEndocrineTherapyAdministeredEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C15445
UMLS 2011AA Property
C0279025
NCI Thesaurus Property-2
C4872
UMLS 2011AA Property-2
C0678222
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-4
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patients must not be receiving therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulator (SERM), either for osteoporosis or breast cancer prevention (Patients are eligible only if these medications are discontinued prior to study entry.)
Description

RecentEndocrineTherapyReceiveInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass-2
C25280
UMLS 2011AA ObjectClass-2
C0332185
Patients must not have had prior therapy with anthracyclines or taxanes for any malignancy
Description

PatientBreastCarcinomaAnthracyclineAntibioticChemotherapyAdministeredEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C15632
UMLS 2011AA Property
C0392920
NCI Thesaurus Property-2
C4872
UMLS 2011AA Property-2
C0678222
NCI Thesaurus Property-3
C1594
UMLS 2011AA Property-3
C0003234
NCI Thesaurus Property-4
C25171
UMLS 2011AA Property-4
C0013893
NCI Thesaurus Property-5
C25382
UMLS 2011AA Property-5
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patients must not have non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude treatment with either of the treatment regimens
Description

PatientConcurrentSystemicDiseaseorDisorderExclusionCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C13310
UMLS 2011AA Property
C0205373
NCI Thesaurus Property-2
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-3
C25456
UMLS 2011AA Property-3
C0205420
NCI Thesaurus Property-4
C25370
UMLS 2011AA Property-4
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patients must not have cardiac disease that would preclude the use of epirubicin or trastuzumab (This includes: Active cardiac disease angina pectoris that requires the use of antianginal medication; cardiac arrhythmia requiring medication; severe conduction abnormality; clinically significant valvular disease; cardiomegaly on chest x-ray; ventricular hypertrophy on EKG; or poorly controlled hypertension, i.e., diastolic greater than 100 mm/Hg. Patients with hypertension that is well controlled on medication are eligible. History of cardiac disease myocardial infarction documented as a clinical diagnosis or by EKG or any other tests; documented congestive heart failure; or documented cardiomyopathy)
Description

PatientCardiacFunctionRequiredInd-2

Data type

boolean

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
Patients must not have sensory/motor neuropathy >= grade 2, as defined by the NCI's Common Terminology Criteria for Adverse Events Version 3.0
Description

CommonTerminologyCriteriaforAdverseEventsLowNeuropathyInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C54722
UMLS 2011AA Property
C0205251
NCI Thesaurus Property-2
C4731
UMLS 2011AA Property-2
C0031117
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
Patients must not have had administration of any investigational agents within 30 days before study entry
Description

PriorInvestigationalTherapiesAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Metathesaurus ObjectClass
C0949266
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Women of child-bearing potential must have a negative urine or serum pregnancy test within 2 weeks of registration (Women who are breast feeding are NOT eligible. If not a female of child-bearing 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 female of child-bearing potential urine or serum mm/dd/yyyy)
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
Patients must not have psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
Description

OtherPatientMedicalContraindicatedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C37933
UMLS 2011AA Property
C1444657
Randomization
Description

Randomization

Randomization
Description

AmericanCollegeofSurgeonsOncologyGroupTreatmentArmRandomizationAmericanCollegeofSurgeonsOncologyGroupTreatmentArmRandomizationType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25196
UMLS 2011AA Property
C0034656
NCI Thesaurus ObjectClass
C19712
UMLS 2011AA ObjectClass
C1515944
NCI Thesaurus ObjectClass-2
C15538
UMLS 2011AA ObjectClass-2
C1522541
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1 forms
  1. StudyEvent: ACOSOG-Z1041 OPEN Registration Worksheet
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient Information
PersonBirthDate
Item
Date of Birth (month day year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)
Item
Gender of a Person
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C17357 (NCI Thesaurus Property)
C0079399 (UMLS 2011AA Property)
CL.1
Code List
Gender of a Person
CL Item
Female Gender (Female Gender)
C46110 (NCI Thesaurus)
C0086287 (UMLS 2011AA)
CL Item
Male Gender (Male Gender)
C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Ethnicity
text
C25372 (NCI Thesaurus Property)
C0683312 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16564 (NCI Thesaurus ObjectClass)
C0015031 (UMLS 2011AA ObjectClass)
CL.2
Code List
Ethnicity
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)
PersonAddressCountryName
Item
Country of Residence
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25464 (NCI Thesaurus ValueDomain)
C0454664 (UMLS 2011AA ValueDomain)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain-2)
C0027365 (UMLS 2011AA ValueDomain-2)
PersonAddressPostalCode
Item
Zip code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
Item
Race
text
C25372 (NCI Thesaurus ValueDomain)
C0034510 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17049 (NCI Thesaurus Property)
CL.3
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
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)
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)
Item
Method of Payment
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
CL Item
Medicaid (Medicaid)
C0025071 (NCI Metathesaurus)
CL Item
Medicaid And Medicare (Medicaid and Medicare)
CL Item
Medicare (Medicare)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
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
No Means Of Payment (no Insurance) (No means of payment (no insurance))
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Private Insurance (Private Insurance)
CL Item
Self Pay (no Insurance) (Self Pay (No Insurance))
CL Item
Veterans Sponsored (Veterans Sponsored)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
General Information
PatientIdentifier
Item
Pt ID# (Local Patient Identifier)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25364 (NCI Thesaurus ValueDomain)
C0600091 (UMLS 2011AA ValueDomain)
Patient Initials Last
Item
Last (initial)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1517741 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
Patient Initials First
Item
First (initial)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C0205435 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
PatientMiddleInitialsName
Item
Middle (initial optional)
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-2)
C0444598 (UMLS 2011AA Property-2)
ResponsiblePersonE-mailAddressText
Item
E-mail (for Registration Confirmation)
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)
PriorTherapyPatientAmericanCollegeofSurgeonsOncologyGroupStudyInd-2
Item
Has patient previously been registered to an ACOSOG study
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16124 (NCI Thesaurus ObjectClass-2)
C1514463 (UMLS 2011AA ObjectClass-2)
C19712 (NCI Thesaurus Property)
C1515944 (UMLS 2011AA Property)
CL238692 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Patient Study ID
Item
Coordinating Group Patient ID (if yes previously issued ACOSOG Patient ID)
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed (month day year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator
Item
Was HIPAA Authorization included in Study Informed Consent
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C62504 (NCI Thesaurus ObjectClass)
C0600593 (UMLS 2011AA ObjectClass)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)
PatientSignedDischargeMedicalRecordDate
Item
HIPAA Authorization Date (If no month day year)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C0012621 (NCI Metathesaurus Property)
C45258 (NCI Thesaurus Property-2)
C0025102 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Stratification Factors
Item
Clinical Tumor Size (mark one)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19712 (NCI Thesaurus ObjectClass-2)
C1515944 (UMLS 2011AA ObjectClass-2)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C25681 (NCI Thesaurus Property-3)
C0456389 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.7
Code List
Clinical Tumor Size (mark one)
CL Item
Z1041-f1-l1 (Breast tumor size 2 cm - 4 cm (any nodal))
CL Item
Z1041-f1-l5 (Breast tumor size < 2 cm and nodal metastases < 2 cm)
CL Item
Z1041-f1-l4 (Breast tumor size < 2 cm and nodal metastases >= 2 cm)
CL Item
Z1041-f1-l2 (Breast tumor size > 4 cm (any nodal))
Item
Hormone Receptor Status (mark one)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C28154 (NCI Thesaurus Property)
C0019929 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
CL.8
Code List
Hormone Receptor Status (mark one)
CL Item
Er- And/or Pgr-positive (ER- and/or PgR-positive)
CL Item
Er- And Pgr-negative (ER- and PgR-negative)
Item
Age (mark one)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C25646 (NCI Thesaurus Property-2)
C1514821 (UMLS 2011AA Property-2)
C25509 (NCI Thesaurus Property-3)
C1279901 (UMLS 2011AA Property-3)
C29848 (NCI Thesaurus ValueDomain)
C0439234 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
CL.9
Code List
Age (mark one)
CL Item
< 50 (< 50)
CL Item
>= 50 (>= 50)
Item Group
Eligibility Criteria
PatientGenderInd-2
Item
Female (Patients must be)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17357 (NCI Thesaurus Property)
C0079399 (UMLS 2011AA Property)
PatientAgeInd-2
Item
Age >= 18 years
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2
Item
ECOG Performance Status 0-1
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25491 (NCI Thesaurus ObjectClass)
C1512162 (UMLS 2011AA ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
Item
ECOG Performance Status (0 or 1)
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
CL.13
Code List
ECOG Performance Status (0 or 1)
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)
InvasiveBreastCarcinomaHistologicallyConfirmedInd-2
Item
The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy (NOTE: FNA is acceptable for evaluation of breast primaries < 2 cm and lymph node metastases)
boolean
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C14159 (NCI Thesaurus ObjectClass-2)
C0205281 (UMLS 2011AA ObjectClass-2)
C25527 (NCI Thesaurus ObjectClass-3)
C0205462 (UMLS 2011AA ObjectClass-3)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LymphNodePathologicConfirmedInd-2
Item
Patients must have a breast primary >= 2.0 cm and/or one or more biopsy-positive lymph nodes (Patients with prior excisional biopsy of the breast primary are eligible, provided biopsy-positive lymph nodes are present)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
PatientHER2/neuEligibilityDeterminationInd-2
Item
The breast cancer must be determined to be HER2-positive prior to study entry (Assays performed using fluorescent in situ hybridization FISH require gene amplification. Assays using immunohistochemistry IHC require a strongly positive 3+ staining intensity score)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property-2)
C0242957 (UMLS 2011AA Property-2)
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationInd-2
Item
Within 3 months prior to entry, the patient must have a baseline left ventricular ejection fraction (LVEF) measured by MUGA scan >= 55 (Note: Echocardiogram may be substituted for MUGA at baseline, but the same method of assessment should be used throughout the study. See Section 3.1,#7 "Note" regarding LVEF and MUGA)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus Property-3)
C0022885 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LaboratoryProcedureAbsoluteNeutrophilCountEligibilityDeterminationInd-2
Item
ANC >= 1200/mm^3
boolean
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-2)
C0013893 (UMLS 2011AA Property-2)
ANC
Item
ANC (>= 1200)
float
C25294 (NCI Thesaurus ObjectClass)
C0948762 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C63321 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedurePlateletCountEligibilityDeterminationInd-2
Item
Platelet count >= 100,000/mm^3
boolean
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-2)
C0013893 (UMLS 2011AA Property-2)
Platelets
Item
Platelet count (>= 100000)
float
C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureWithinClinicalStudyProtocolUpperLimitofNormalTotalBilirubinMeasurementInd-2
Item
Total bilirubin <= ULN unless the patient has a grade 1 bilirubin elevation (> ULN to 1.5 x ULN) resulting from Gilbert's disease or similar syndrome due to slow conjugation of bilirubin
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C25282 (NCI Thesaurus Property-3)
C0332285 (UMLS 2011AA Property-3)
C25706 (NCI Thesaurus Property-4)
C1519815 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientElevatedBilirubinPersonalMedicalHistoryInd-2
Item
Does this patient have a grade 1 bilirubin elevation (> ULN to 1.5 x ULN) resulting from Gilbert's disease or similar syndrome due to slow conjugation of bilirubin
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C27088 (NCI Thesaurus Property)
C0311468 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
Bilirubin, Total
Item
Total Bilirubin (If No, <= ULN)
float
C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C38037 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Bilirubin, Total
Item
Total Bilirubin (If No, <= ULN)
float
C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C38037 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Bilirubin, Total ULN
Item
Total Bilirubin ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
Bilirubin, Total ULN
Item
Total Bilirubin ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureAlkalinePhosphataseEligibilityDeterminationInd-2
Item
Alkaline phosphatase <= 2.5 x ULN
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property-2)
Alkaline Phosphatase
Item
Alkaline Phosphatase (<= 2.5 x ULN)
float
C20200 (NCI Thesaurus Property)
C0201850 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C16276 (NCI Thesaurus Property-2)
Alkaline Phosphatase ULN
Item
Alkaline Phosphatase ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0151420 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseUpperLimitofNormalResultInd-2
Item
SGOT (AST) <= 1.5 x ULN
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25706 (NCI Thesaurus Property-3)
C1519815 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
SGOT (AST)
Item
SGOT (AST) (<= 1.5 x ULN)
float
C25202 (NCI Thesaurus Property)
C0201899 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
SGOT (AST) ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureCreatinineResultInd-2
Item
Creatinine <= ULN
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property-2)
C0010294 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
LaboratoryProcedureCreatinineResultUnspecifiedValue
Item
Creatinine (<= ULN)
float
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property-2)
C0010294 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Creatinine, serum ULN
Item
Creatinine ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
BoneScanPatientAlkalinePhosphataseUpperLimitofNormalEligibilityInd-2
Item
Patients with either skeletal pain or alkaline phosphatase that is > ULN but <= 2.5 x ULN are eligible for inclusion in the study if bone scans fail to demonstrate metastatic disease (Suspicious findings on bone scan must be confirmed as benign by x-ray, MRI, or biopsy)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17646 (NCI Thesaurus ObjectClass-2)
C0203668 (UMLS 2011AA ObjectClass-2)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property-2)
C25706 (NCI Thesaurus Property-3)
C1519815 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ContralateralBreastCancerDiagnosisInd-2
Item
Patients with a history of DCIS or synchronous DCIS of the contralateral breast regardless of therapy are eligible (Those with synchronous invasive breast cancer are NOT eligible)
boolean
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C25307 (NCI Thesaurus ObjectClass-3)
C0441988 (UMLS 2011AA ObjectClass-3)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
IpsilateralDiseasePresentInd-3
Item
Patients with a history of ipsilateral DCIS treated by local excision with or without hormonal therapy are eligible (Those treated with radiation therapy are NOT eligible)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25308 (NCI Thesaurus ObjectClass-2)
C0441989 (UMLS 2011AA ObjectClass-2)
PreviousCancerIdentifiedInd-2
Item
Patients with a history of non-breast malignancies are eligible if they have remained disease-free for 5 years since completing their initial treatment regimen and are deemed by their physician to be at low risk for recurrence (Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, colon carcinoma in situ, melanoma in situ, and basal cell and squamous cell carcinoma of the skin)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25737 (NCI Thesaurus Property)
C0205396 (UMLS 2011AA Property)
AxillaryNodeDissectionInd-3
Item
Patients must not have had any surgical axillary staging procedure prior to study entry (However, patients who have had non-excisional biopsy of an axillary node are eligible)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
MetastaticNeoplasmConfirmedDiagnosisInd-2
Item
Patients must not have definitive clinical or radiologic evidence of metastatic disease
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C3261 (NCI Thesaurus ObjectClass)
C2939420 (UMLS 2011AA ObjectClass)
PatientInvasiveBreastCarcinomaPersonalMedicalHistoryInd-2
Item
Patients must not have a prior history of invasive breast cancer
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C9245 (NCI Thesaurus Property)
C0853879 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
CancerPriorTreatmentInd-3
Item
Patients must not have had treatment given for this breast cancer prior to study entry (The only exception is hormonal therapy, which may have been given for up to a total of 28 days anytime after diagnosis and before study entry. In such a case, hormonal therapy must stop at or before study entry and be re-started, if indicated, following surgery.)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property-2)
PatientBreastCarcinomaEndocrineTherapyAdministeredEligibilityDeterminationInd-2
Item
Patients must not be taking any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (Patients are eligible if this therapy is discontinued prior to study entry. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus Property)
C0279025 (UMLS 2011AA Property)
C4872 (NCI Thesaurus Property-2)
C0678222 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
RecentEndocrineTherapyReceiveInd-2
Item
Patients must not be receiving therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulator (SERM), either for osteoporosis or breast cancer prevention (Patients are eligible only if these medications are discontinued prior to study entry.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25280 (NCI Thesaurus ObjectClass-2)
C0332185 (UMLS 2011AA ObjectClass-2)
PatientBreastCarcinomaAnthracyclineAntibioticChemotherapyAdministeredEligibilityDeterminationInd-2
Item
Patients must not have had prior therapy with anthracyclines or taxanes for any malignancy
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C4872 (NCI Thesaurus Property-2)
C0678222 (UMLS 2011AA Property-2)
C1594 (NCI Thesaurus Property-3)
C0003234 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C25382 (NCI Thesaurus Property-5)
C1521801 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientConcurrentSystemicDiseaseorDisorderExclusionCriteriaInd-2
Item
Patients must not have non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude treatment with either of the treatment regimens
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13310 (NCI Thesaurus Property)
C0205373 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25456 (NCI Thesaurus Property-3)
C0205420 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-4)
C0680251 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientCardiacFunctionRequiredInd-2
Item
Patients must not have cardiac disease that would preclude the use of epirubicin or trastuzumab (This includes: Active cardiac disease angina pectoris that requires the use of antianginal medication; cardiac arrhythmia requiring medication; severe conduction abnormality; clinically significant valvular disease; cardiomegaly on chest x-ray; ventricular hypertrophy on EKG; or poorly controlled hypertension, i.e., diastolic greater than 100 mm/Hg. Patients with hypertension that is well controlled on medication are eligible. History of cardiac disease myocardial infarction documented as a clinical diagnosis or by EKG or any other tests; documented congestive heart failure; or documented cardiomyopathy)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
CommonTerminologyCriteriaforAdverseEventsLowNeuropathyInd-2
Item
Patients must not have sensory/motor neuropathy >= grade 2, as defined by the NCI's Common Terminology Criteria for Adverse Events Version 3.0
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C54722 (NCI Thesaurus Property)
C0205251 (UMLS 2011AA Property)
C4731 (NCI Thesaurus Property-2)
C0031117 (UMLS 2011AA Property-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
PriorInvestigationalTherapiesAdministeredInd-2
Item
Patients must not have had administration of any investigational agents within 30 days before study entry
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C0949266 (NCI Metathesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Women of child-bearing potential must have a negative urine or serum pregnancy test within 2 weeks of registration (Women who are breast feeding are NOT eligible. If not a female of child-bearing 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.40
Code List
Women of child-bearing potential must have a negative urine or serum pregnancy test within 2 weeks of registration (Women who are breast feeding are NOT eligible. If not a female of child-bearing potential check NA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
N/a (N/A)
PatientNegativePregnancyTestDate
Item
Negative pregnancy test date (If female of child-bearing potential urine or serum mm/dd/yyyy)
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)
OtherPatientMedicalContraindicatedInd-2
Item
Patients must not have psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C37933 (NCI Thesaurus Property)
C1444657 (UMLS 2011AA Property)
Item Group
Randomization
Item
Randomization
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C19712 (NCI Thesaurus ObjectClass)
C1515944 (UMLS 2011AA ObjectClass)
C15538 (NCI Thesaurus ObjectClass-2)
C1522541 (UMLS 2011AA ObjectClass-2)
CL.42
Code List
Randomization
CL Item
Fec-75 Q 3 Weeks X 4 Cycles Paclitaxel 80 Mg/m^2 Iv Weekly X 12 + Trastuzumab Weekly X 12 (FEC-75 q 3 weeks x 4 cycles Paclitaxel 80 mg/m^2 IV weekly x 12 + Trastuzumab weekly x 12)
CL Item
Paclitaxel 80 Mg/m^2 Iv Weekly X 12 + Trastuzumab Weekly X 12 Fec-75 Q 3 Weeks X 4 Cycles + Trastuzumab Weekly X 12 (Paclitaxel 80 mg/m^2 IV weekly x 12 + Trastuzumab weekly x 12 FEC-75 q 3 weeks x 4 cycles + Trastuzumab weekly x 12)
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