ID

42726

Description

Z1031 Registration Worksheet Form Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=02F0FC02-607A-58B8-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=02F0FC02-607A-58B8-E044-0003BA3F9857

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  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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Endometrial Cancer NCT00265759 Registration - Z1031 Registration Worksheet Form - 2417050v1.0

English

No Instruction available.

1 forms  
  1. StudyEvent: Z1031 Registration Worksheet Form
    1. No Instruction available.
Header Module
Description

Header Module

Visit
Description

AmericanCollegeofSurgeonsOncologyGroupVisitPeriodAmericanCollegeofSurgeonsOncologyGroupVisitPeriodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C19712
UMLS 2011AA ObjectClass
C1515944
NCI Thesaurus ObjectClass-2
C25716
UMLS 2011AA ObjectClass-2
C0545082
Patient ID (Pt. ID issued during registration or previously issued 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
Patient Initials (F M L)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Institution No.
Description

Institution Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
Institution Name
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Registration Date (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-2
C25367
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
Header
Description

Header

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 Protocol Number
Description

Protocol ID Coordinating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1711341
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Patient Information
Description

Patient Information

Date of Birth (mm dd yyyy)
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
Description

Gender

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C0079399
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17357
Race (Mark all that apply)
Description

Racial Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C0034510
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17049
Ethnicity (Mark only one)
Description

Ethnic Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C0015031
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C16564
Method of payment (Mark all that apply)
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
Other, specify (e.g., Provincial Insurance Plan)
Description

PatientPaymentSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25371
UMLS 2011AA Property
C0680264
Weight (kg)
Description

Patient Weight

Data type

float

Measurement units
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Height (cm)
Description

Patient Height

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0489786
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
cm
Patient Zip Code (USA)
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
Postal code (Or Canada)
Description

CanadaAddressPostalCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C16380
UMLS 2011AA ObjectClass
C0006823
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
Other Country Postal Code
Description

PatientOtherCountryAddressPostalCode

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25464
UMLS 2011AA Property-2
C0454664
NCI Thesaurus Property-3
C25407
UMLS 2011AA Property-3
C1442065
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
Country of Residence (If other than USA or Canada)
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
Date Informed Consent Signed (mm dd yyyy)
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
HIPAA Authorization form
Description

HealthInsurancePortabilityandAccountabilityActAuthorizationStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C62504
UMLS 2011AA ObjectClass
C0600593
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C41192
UMLS 2011AA Property
C1524004
HIPAA Authorization Date (If signed as a separate form mm dd yyyy)
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
Unnamed 4
Description

Unnamed 4

Consent for correlative studies and specimen banking signed
Description

PatientCorrelativeStudySpecimenConsentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C19157
UMLS 2011AA Property
C0370003
NCI Thesaurus Property-2
C25460
UMLS 2011AA Property-2
C1511481
NCI Thesaurus Property-3
C16100
UMLS 2011AA Property-3
C1511524
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date signed (mm dd yyyy If yes, [Complete the Specimen Banking Consent SBC CRF.])
Description

PatientCorrelativeStudySpecimenConsentDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C19157
UMLS 2011AA Property
C0370003
NCI Thesaurus Property-2
C25460
UMLS 2011AA Property-2
C1511481
NCI Thesaurus Property-3
C16100
UMLS 2011AA Property-3
C1511524
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Inclusion Criteria
Description

Inclusion Criteria

Patient must have an ECOG performance status of <= 2 (Zubrod)
Description

EasternCooperativeOncologyGroupPerformanceStatusAssessmentIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C25491
UMLS 2011AA ObjectClass
C1512162
NCI Metathesaurus ObjectClass
CL092952
Patient must have T2-T4c, any N, M0 breast cancer, by clinical staging (NOTE: Primary tumor must be palpable and measure > 2 cm by tape, ruler or caliper measurements in at least one dimension)
Description

PatientNorthCentralCancerTreatmentGroupAdvancedBreastCarcinomaCancerProgressionEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25581
UMLS 2011AA Property
C1518419
NCI Thesaurus Property-2
C25411
UMLS 2011AA Property-2
C0205179
NCI Thesaurus Property-3
C4872
UMLS 2011AA Property-3
C0678222
NCI Thesaurus Property-4
C25171
UMLS 2011AA Property-4
C0013893
NCI Thesaurus Property-5
C19987
UMLS 2011AA Property-5
C0242656
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient must be postmenopausal, verified by bilateral surgical oophorectomy, no spontaneous menses >= 1 year, or no menses for < 1 year with FSH and estradiol levels in postmenopausal range, according to institutional standards
Description

PatientMenopauseInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3231
UMLS 2011AA Property
C0025320
Patient, as documented by the treating physician, is clinically staged as one of the following: T4 a-c for whom modified radical mastectomy with negative margins is the goal T2 or T3 for whom conversion from needing mastectomy to breast conservation is the goal T2 for whom lumpectomy at first attempt is the goal
Description

PatientAdvancedMalignantNeoplasmPriorRegistrationEligibilityDeterminationIndicator

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25411
UMLS 2011AA Property-2
C0205179
NCI Thesaurus Property-3
C9305
UMLS 2011AA Property-3
C0006826
NCI Thesaurus Property-4
C25629
UMLS 2011AA Property-4
C0332152
NCI Thesaurus Property-5
C25171
UMLS 2011AA Property-5
C0013893
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Patient has ER+ tumor with an Allred score of 6, 7, or 8 (NOTE: patients with > 66.6% two-thirds of cells staining positive have a minimum Allred score of 6 and are eligible)
Description

BreastCarcinomaTumorMarkerPositiveFindingEstrogenReceptorStatusInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C4872
UMLS 2011AA ObjectClass
C0678222
NCI Thesaurus ObjectClass-2
C17220
UMLS 2011AA ObjectClass-2
C0041365
NCI Thesaurus Property
C38758
UMLS 2011AA Property
C1514241
NCI Thesaurus Property-2
C16150
UMLS 2011AA Property-2
C1516974
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Patient must have mammogram and ultrasound within 42 days prior to registration
Description

MammogramPerformedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C20178
UMLS 2011AA ObjectClass
C0024671
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
If patient is a cancer survivor, all of the following criteria must be met Patient has undergone potentially curative therapy for all prior malignancies, No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, contralateral DCIS treated with mastectomy or lumpectomy and radiation but without tamoxifen treatment, or non-melanoma skin cancer with no evidence of recurrence), and Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies
Description

PriorCancerDiagnosisIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Exclusion Criteria
Description

Exclusion Criteria

Patient has inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema NOTE: Patient with T4d disease are ineligible)
Description

DermalLymphaticsInvasionInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25478
UMLS 2011AA ObjectClass
C0221928
NCI Thesaurus ObjectClass-2
C12746
UMLS 2011AA ObjectClass-2
C0024235
NCI Thesaurus Property
C20625
UMLS 2011AA Property
C1269955
Patient has received prior treatment for breast cancer, including radiation, endocrine therapy, chemotherapy or investigational agent. Patients whose diagnosis was established by incisional biopsy are not eligible
Description

PriorCancerTreatmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C49236
UMLS 2011AA Property
C0087111
Patient has received hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration
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
Patient has distant metastasis (M1), excluding isolated ipsilateral supraclavicular node involvement
Description

DistantMetastasisPresentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C25321
UMLS 2011AA ObjectClass
C0443203
NCI Thesaurus ObjectClass-2
C19151
UMLS 2011AA ObjectClass-2
C0027627
Patient does not agree to undergo mastectomy or lumpectomy after neoadjuvant aromatose inhibitor therapy
Description

TotalMastectomyPerformedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15281
UMLS 2011AA ObjectClass
C0024886
Patient is enrolled in another neoadjuvant clinical trial for treatment of the existing breast cancer
Description

PriorSystemicTherapyInvasiveBreastCarcinomaAdministeredIndicator

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15698
UMLS 2011AA ObjectClass
C1515119
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C9245
UMLS 2011AA Property
C0853879
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Patient has undergone prior sentinel lymph node biopsy (Cohort B only)
Description

SentinelNodeBiopsyInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
Unnamed Module 3
Description

Unnamed Module 3

In the opinion of the investigator, is the patient eligible?
Description

Eligibility for trial

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1302261
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25171
Assessment Date (mm dd yyyy)
Description

LesionAssessmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ValueDomain-2
C25367
Baseline Performace Status (ECOG/Zubrod scale Note: Document patient's performance status in the medical record.)
Description

BaselinePerformanceStatusEasternCooperativeOncologyGroupScale

Data type

text

Alias
NCI Thesaurus ObjectClass
C25213
UMLS 2011AA ObjectClass
C1442488
NCI Metathesaurus ObjectClass
CL092952
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
Clinical Stage
Description

Clinical Stage

Clinical T Stage (mark one)
Description

PatientTStageBreastCarcinomaClinicalTrialEligibilityCriteriaStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C4872
UMLS 2011AA Property
C0678222
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
NCI Thesaurus Property-3
C25728
UMLS 2011AA Property-3
C0475455
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Clinical N Stage (mark one)
Description

BreastTumorClinicalNStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property-2
C25580
UMLS 2011AA Property-2
C0456532
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Dimension 1 (Longest axis cm)
Description

TumorLargestDimensionMeasurement

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25550
UMLS 2011AA Property
C0443228
NCI Thesaurus Property-2
C25483
UMLS 2011AA Property-2
C0439534
cm
Dimension 2 (Longest perpendicular axis cm)
Description

TumorSecondDimensionMeasurement

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25666
UMLS 2011AA Property
C0205436
NCI Thesaurus Property-2
C25483
UMLS 2011AA Property-2
C0439534
cm
Primary Tumor Biopsy
Description

Primary Tumor Biopsy

Receptor Status, ER
Description

ERLevelTumorStatus

Data type

text

Alias
NCI Thesaurus ValueDomain
C3262
UMLS 2011AA ValueDomain
C0027651
NCI Thesaurus ObjectClass
C17069
UMLS 2011AA ObjectClass
C0034804
NCI Thesaurus ValueDomain-2
C25688
UMLS 2011AA ValueDomain-2
C0449438
NCI Thesaurus Property
C25554
UMLS 2011AA Property
C0441889
Marker Test Method (Mark one. If both were performed, mark confirmatory test)
Description

TumorMarkerTestType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus ObjectClass
C17220
UMLS 2011AA ObjectClass
C0041365
HER-2/neu status
Description

HER2/neuStatusType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C17756
UMLS 2011AA ObjectClass
C0242957
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Histologic Grade (mark one)
Description

HistologicNottinghamScoreNuclearPleomorphismGrade

Data type

text

Alias
NCI Thesaurus ObjectClass
C25526
UMLS 2011AA ObjectClass
C0205462
NCI Thesaurus ObjectClass-2
C25595
UMLS 2011AA ObjectClass-2
C1527124
NCI Thesaurus Property
C13361
UMLS 2011AA Property
C0521447
NCI Thesaurus Property-2
C17000
UMLS 2011AA Property-2
C0032219
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
Histologic Type (mark one)
Description

BreastTumorHistologicCategory

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property-2
C25161
UMLS 2011AA Property-2
C0008902
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ValueDomain-2
C25526
UMLS 2011AA ValueDomain-2
C0205462
Other specify
Description

Histologic Type, other

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1299220
NCI Thesaurus ObjectClass
C3262
NCI Thesaurus Property
C25526
NCI Thesaurus Property-2
C25161
Was FNA done on the axillary nodes prior to study initiation
Description

AxillaryLymphNodeCoreBiopsyFine-NeedleAspirationLymphNodeBiopsyPriorClinicalStudyPerformedInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15680
UMLS 2011AA ObjectClass
C1318309
NCI Thesaurus ObjectClass-2
C15361
UMLS 2011AA ObjectClass-2
C1510483
NCI Thesaurus ObjectClass-3
C51900
UMLS 2011AA ObjectClass-3
C0193842
NCI Thesaurus ObjectClass-4
C12904
UMLS 2011AA ObjectClass-4
C0729594
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-3
C0008972
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of FNA (mm dd yyyy)
Description

AxillaryLymphNodeCoreBiopsyFine-NeedleAspirationLymphNodeBiopsyPriorClinicalStudyPerformedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15680
UMLS 2011AA ObjectClass
C1318309
NCI Thesaurus ObjectClass-2
C15361
UMLS 2011AA ObjectClass-2
C1510483
NCI Thesaurus ObjectClass-3
C51900
UMLS 2011AA ObjectClass-3
C0193842
NCI Thesaurus ObjectClass-4
C12904
UMLS 2011AA ObjectClass-4
C0729594
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-3
C0008972
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
FNA Results (biopsy)
Description

BiopsyAspirateType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus Property
C13347
UMLS 2011AA Property
C0370199
Allred score (refer to the Appendix section for table and scoring instructions)
Description

EstrogenReceptorPercentageIntensityStainDescriptionScore

Data type

float

Alias
NCI Thesaurus ObjectClass
C17069
UMLS 2011AA ObjectClass
C0034804
NCI Thesaurus Property
C25613
UMLS 2011AA Property
C0439165
NCI Thesaurus Property-2
C25539
UMLS 2011AA Property-2
C0522510
NCI Thesaurus Property-3
C25365
UMLS 2011AA Property-3
C0678257
NCI Metathesaurus Property
C0038128
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
Method of Evaluation (imaging within 42 days prior to registration)
Description

Evaluation method

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
Not done
Description

AssessmentMethodText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
Image Date (mm dd yyyy)
Description

MedicalImageDate

Data type

date

Alias
NCI Thesaurus Property
C25164
UMLS 2011AA Property
C0011008
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C19477
UMLS 2011AA ObjectClass
C1704254
Postmenopausal verification (mark one)
Description

PatientPostmenopausalAssessmentStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C15421
UMLS 2011AA Property-2
C0232970
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Surgery status according to investigator (mark one)
Description

PatientBreastSurgeryStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17173
UMLS 2011AA Property
C0038894
NCI Thesaurus Property-2
C12971
UMLS 2011AA Property-2
C0006141
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Treatment Arm (Please indicate which aromatase inhibitor the patient will receive)
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
Investigator Signature (I have reviewed all data recorded on the Registration form and certify that they are accurate and complete to the best of my knowledge)
Description

Investigator Signature

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Date Signed (mm dd yyyy)
Description

ResponsiblePersonSignatureDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass-2
C25657
UMLS 2011AA ObjectClass-2
C1273518
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
Did the Investigator sign the CRF indicating review of all data and certifying data are accurate and complete to the best of their knowledge
Description

CaseReportFormInvestigatorReviewInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C40988
UMLS 2011AA ObjectClass
C1516308
NCI Thesaurus Property
C25936
UMLS 2011AA Property
C0035173
NCI Thesaurus Property-2
C42729
UMLS 2011AA Property-2
C1552617
Date of Investigator Signature (mm dd yyyy)
Description

Investigator Signature Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
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1 forms
  1. StudyEvent: Z1031 Registration Worksheet Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
Item
Visit
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C19712 (NCI Thesaurus ObjectClass)
C1515944 (UMLS 2011AA ObjectClass)
C25716 (NCI Thesaurus ObjectClass-2)
C0545082 (UMLS 2011AA ObjectClass-2)
CL.1
Code List
Visit
CL Item
Prior To Registration (Prior to Registration)
Patient Study ID
Item
Patient ID (Pt. ID issued during registration or previously issued patient ID)
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Patient Initials
Item
Patient Initials (F M L)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Institution Number
Item
Institution No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
PatientRegistrationDate
Item
Registration Date (mm dd yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
Item Group
Header
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)
Protocol ID Coordinating Group
Item
Coordinating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1711341 (UMLS CUI-2)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Patient Information
PersonBirthDate
Item
Date of Birth (mm dd yyyy)
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
text
C25372 (NCI Thesaurus ValueDomain)
C0079399 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17357 (NCI Thesaurus Property)
CL.3
Code List
Gender
CL Item
Male (Male)
C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)
CL Item
Female (Female)
C46110 (NCI Thesaurus)
C0086287 (UMLS 2011AA)
Item
Race (Mark all that apply)
text
C25372 (NCI Thesaurus ValueDomain)
C0034510 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17049 (NCI Thesaurus Property)
CL.4
Code List
Race (Mark all that apply)
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
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 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 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
Could Not Be Determined Or Unsure (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Ethnicity (Mark only one)
text
C25372 (NCI Thesaurus ValueDomain)
C0015031 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C16564 (NCI Thesaurus Property)
CL.5
Code List
Ethnicity (Mark only one)
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
Could Not Be Determined Or Unsure (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Method of payment (Mark all that apply)
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.6
Code List
Method of payment (Mark all that apply)
CL Item
Private Insurance (Private insurance)
CL Item
Medicare (Medicare)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
CL Item
Medicare And Private Insurance (Medicare and private insurance)
CL Item
Medicaid (Medicaid)
C0025071 (NCI Metathesaurus)
CL Item
Medicaid And Medicare (Medicaid and medicare)
CL Item
Military Or Veterans Sponsored Nos (Military or veterans sponsored NOS)
CL Item
Military Sponsored (including Champus & Tricare) (Military sponsored)
CL Item
Veterans Sponsored (Veterans sponsored)
CL Item
Self Pay (no Insurance) (Self pay)
CL Item
No Means Of Payment (no Insurance) (No means of payment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
PatientPaymentSpecify
Item
Other, specify (e.g., Provincial Insurance Plan)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)
Patient Weight
Item
Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Patient Height
Item
Height (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
PersonAddressPostalCode
Item
Patient Zip Code (USA)
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)
CanadaAddressPostalCode
Item
Postal code (Or Canada)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C16380 (NCI Thesaurus ObjectClass)
C0006823 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
PatientOtherCountryAddressPostalCode
Item
Other Country Postal Code
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25464 (NCI Thesaurus Property-2)
C0454664 (UMLS 2011AA Property-2)
C25407 (NCI Thesaurus Property-3)
C1442065 (UMLS 2011AA Property-3)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
PersonAddressCountryName
Item
Country of Residence (If other than USA or Canada)
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)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed (mm dd yyyy)
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)
Item
HIPAA Authorization form
text
C62504 (NCI Thesaurus ObjectClass)
C0600593 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)
CL.7
Code List
HIPAA Authorization form
CL Item
Included In Study Informed Consent (Included in Study Informed Consent)
PatientSignedDischargeMedicalRecordDate
Item
HIPAA Authorization Date (If signed as a separate form mm dd yyyy)
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)
PatientCorrelativeStudySpecimenConsentInd-3
Item
Consent for correlative studies and specimen banking signed
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)
C16100 (NCI Thesaurus Property-3)
C1511524 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientCorrelativeStudySpecimenConsentDate
Item
Date signed (mm dd yyyy If yes, [Complete the Specimen Banking Consent SBC CRF.])
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)
C16100 (NCI Thesaurus Property-3)
C1511524 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Inclusion Criteria
Item
Patient must have an ECOG performance status of <= 2 (Zubrod)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25491 (NCI Thesaurus ObjectClass)
C1512162 (UMLS 2011AA ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
CL.9
Code List
Patient must have an ECOG performance status of <= 2 (Zubrod)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Available (N/A)
PatientNorthCentralCancerTreatmentGroupAdvancedBreastCarcinomaCancerProgressionEligibilityDeterminationInd-2
Item
Patient must have T2-T4c, any N, M0 breast cancer, by clinical staging (NOTE: Primary tumor must be palpable and measure > 2 cm by tape, ruler or caliper measurements in at least one dimension)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25581 (NCI Thesaurus Property)
C1518419 (UMLS 2011AA Property)
C25411 (NCI Thesaurus Property-2)
C0205179 (UMLS 2011AA Property-2)
C4872 (NCI Thesaurus Property-3)
C0678222 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C19987 (NCI Thesaurus Property-5)
C0242656 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientMenopauseInd-2
Item
Patient must be postmenopausal, verified by bilateral surgical oophorectomy, no spontaneous menses >= 1 year, or no menses for < 1 year with FSH and estradiol levels in postmenopausal range, according to institutional standards
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3231 (NCI Thesaurus Property)
C0025320 (UMLS 2011AA Property)
Item
Patient, as documented by the treating physician, is clinically staged as one of the following: T4 a-c for whom modified radical mastectomy with negative margins is the goal T2 or T3 for whom conversion from needing mastectomy to breast conservation is the goal T2 for whom lumpectomy at first attempt is the goal
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25411 (NCI Thesaurus Property-2)
C0205179 (UMLS 2011AA Property-2)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-3)
C25629 (NCI Thesaurus Property-4)
C0332152 (UMLS 2011AA Property-4)
C25171 (NCI Thesaurus Property-5)
C0013893 (UMLS 2011AA Property-5)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.12
Code List
Patient, as documented by the treating physician, is clinically staged as one of the following: T4 a-c for whom modified radical mastectomy with negative margins is the goal T2 or T3 for whom conversion from needing mastectomy to breast conservation is the goal T2 for whom lumpectomy at first attempt is the goal
CL Item
Not Available (N/A)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
BreastCarcinomaTumorMarkerPositiveFindingEstrogenReceptorStatusInd-3
Item
Patient has ER+ tumor with an Allred score of 6, 7, or 8 (NOTE: patients with > 66.6% two-thirds of cells staining positive have a minimum Allred score of 6 and are eligible)
boolean
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C17220 (NCI Thesaurus ObjectClass-2)
C0041365 (UMLS 2011AA ObjectClass-2)
C38758 (NCI Thesaurus Property)
C1514241 (UMLS 2011AA Property)
C16150 (NCI Thesaurus Property-2)
C1516974 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
MammogramPerformedInd-3
Item
Patient must have mammogram and ultrasound within 42 days prior to registration
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C20178 (NCI Thesaurus ObjectClass)
C0024671 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
Item
If patient is a cancer survivor, all of the following criteria must be met Patient has undergone potentially curative therapy for all prior malignancies, No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, contralateral DCIS treated with mastectomy or lumpectomy and radiation but without tamoxifen treatment, or non-melanoma skin cancer with no evidence of recurrence), and Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
CL.15
Code List
If patient is a cancer survivor, all of the following criteria must be met Patient has undergone potentially curative therapy for all prior malignancies, No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, contralateral DCIS treated with mastectomy or lumpectomy and radiation but without tamoxifen treatment, or non-melanoma skin cancer with no evidence of recurrence), and Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (NA)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item Group
Exclusion Criteria
DermalLymphaticsInvasionInd-3
Item
Patient has inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema NOTE: Patient with T4d disease are ineligible)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25478 (NCI Thesaurus ObjectClass)
C0221928 (UMLS 2011AA ObjectClass)
C12746 (NCI Thesaurus ObjectClass-2)
C0024235 (UMLS 2011AA ObjectClass-2)
C20625 (NCI Thesaurus Property)
C1269955 (UMLS 2011AA Property)
PriorCancerTreatmentInd-2
Item
Patient has received prior treatment for breast cancer, including radiation, endocrine therapy, chemotherapy or investigational agent. Patients whose diagnosis was established by incisional biopsy are not eligible
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
PatientBreastCarcinomaEndocrineTherapyAdministeredEligibilityDeterminationInd-2
Item
Patient has received hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration
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)
DistantMetastasisPresentInd-2
Item
Patient has distant metastasis (M1), excluding isolated ipsilateral supraclavicular node involvement
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25321 (NCI Thesaurus ObjectClass)
C0443203 (UMLS 2011AA ObjectClass)
C19151 (NCI Thesaurus ObjectClass-2)
C0027627 (UMLS 2011AA ObjectClass-2)
TotalMastectomyPerformedInd-2
Item
Patient does not agree to undergo mastectomy or lumpectomy after neoadjuvant aromatose inhibitor therapy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15281 (NCI Thesaurus ObjectClass)
C0024886 (UMLS 2011AA ObjectClass)
PriorSystemicTherapyInvasiveBreastCarcinomaAdministeredIndicator
Item
Patient is enrolled in another neoadjuvant clinical trial for treatment of the existing breast cancer
boolean
C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C9245 (NCI Thesaurus Property)
C0853879 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
SentinelNodeBiopsyInd-2
Item
Patient has undergone prior sentinel lymph node biopsy (Cohort B only)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
Item Group
Unnamed Module 3
Eligibility for trial
Item
In the opinion of the investigator, is the patient eligible?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1302261 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property)
LesionAssessmentDate
Item
Assessment Date (mm dd yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Baseline Performace Status (ECOG/Zubrod scale Note: Document patient's performance status in the medical record.)
text
C25213 (NCI Thesaurus ObjectClass)
C1442488 (UMLS 2011AA ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
CL.24
Code List
Baseline Performace Status (ECOG/Zubrod scale Note: Document patient's performance status in the medical record.)
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)
Item Group
Clinical Stage
Item
Clinical T Stage (mark one)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C4872 (NCI Thesaurus Property)
C0678222 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C25728 (NCI Thesaurus Property-3)
C0475455 (UMLS 2011AA Property-3)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.25
Code List
Clinical T Stage (mark one)
CL Item
T2 (T2)
CL Item
T3 (T3)
CL Item
T4a-c (T4a-c)
Item
Clinical N Stage (mark one)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property-2)
C0456532 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.26
Code List
Clinical N Stage (mark one)
CL Item
No Regional Lymph Node Metastasis (N0)
CL Item
Metastasis To Movable Ipsilateral Axillary Lymph Node(s) (N1)
CL Item
Metastasis To Ipsilateral Axillary Lymph Node(s) Fixed Or Matted, Or In Clinically Apparent* Ipsilateral Internal Mammary Nodes In The Absence Of Clinically Evident Lymph Node Metastasis (N2)
CL Item
Metastasis In Ipsilateral Infraclavicular Lymph Node(s) With Or Without Axillary Lymph Node Involvement, Or In Clinically Apparent* Ipsilateral Internal Mammary Lymph Node(s) And In The Presence Of Clinically Evident Axillary Lymph Node Metastasis; Or, Me (N3)
TumorLargestDimensionMeasurement
Item
Dimension 1 (Longest axis cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25550 (NCI Thesaurus Property)
C0443228 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property-2)
C0439534 (UMLS 2011AA Property-2)
TumorSecondDimensionMeasurement
Item
Dimension 2 (Longest perpendicular axis cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25666 (NCI Thesaurus Property)
C0205436 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property-2)
C0439534 (UMLS 2011AA Property-2)
Item Group
Primary Tumor Biopsy
Item
Receptor Status, ER
text
C3262 (NCI Thesaurus ValueDomain)
C0027651 (UMLS 2011AA ValueDomain)
C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain-2)
C0449438 (UMLS 2011AA ValueDomain-2)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)
CL.27
Code List
Receptor Status, ER
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
Item
Marker Test Method (Mark one. If both were performed, mark confirmatory test)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C17220 (NCI Thesaurus ObjectClass)
C0041365 (UMLS 2011AA ObjectClass)
CL.28
Code List
Marker Test Method (Mark one. If both were performed, mark confirmatory test)
CL Item
Fluorescence In Situ Hybridization (fish) (Fluorescence in situ hybridization (FISH))
CL Item
Immunohistochemistry (ihc) (Immunohistochemistry (IHC))
Item
HER-2/neu status
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17756 (NCI Thesaurus ObjectClass)
C0242957 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.29
Code List
HER-2/neu status
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Never Done Or Unknown (Never done or unknown)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
Item
Histologic Grade (mark one)
text
C25526 (NCI Thesaurus ObjectClass)
C0205462 (UMLS 2011AA ObjectClass)
C25595 (NCI Thesaurus ObjectClass-2)
C1527124 (UMLS 2011AA ObjectClass-2)
C13361 (NCI Thesaurus Property)
C0521447 (UMLS 2011AA Property)
C17000 (NCI Thesaurus Property-2)
C0032219 (UMLS 2011AA Property-2)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
CL.30
Code List
Histologic Grade (mark one)
CL Item
Small Regular Nuclei (Grade I (low, 1 pt))
CL Item
Moderate Increase In Size, Etc (Grade II (intermediate, 2 pts))
CL Item
Marked Variation In Size, Nucleoli, Chromatin Clumping, Etc (Grade III (high, 3 pts))
Item
Histologic Type (mark one)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property-2)
C0008902 (UMLS 2011AA Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain-2)
C0205462 (UMLS 2011AA ValueDomain-2)
CL.31
Code List
Histologic Type (mark one)
CL Item
Ductal (Ductal)
C25732 (NCI Thesaurus)
C1512083 (UMLS 2011AA)
CL Item
Lobular (Lobular (pure > or =90%))
C25557 (NCI Thesaurus)
C0205417 (UMLS 2011AA)
C25557 (NCI Thesaurus-3)
C0205417 (UMLS 2011AA-4)
CL Item
Other Specify (Other)
Histologic Type, other
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1299220 (UMLS CUI-1)
C3262 (NCI Thesaurus ObjectClass)
C25526 (NCI Thesaurus Property)
C25161 (NCI Thesaurus Property-2)
AxillaryLymphNodeCoreBiopsyFine-NeedleAspirationLymphNodeBiopsyPriorClinicalStudyPerformedInd-2
Item
Was FNA done on the axillary nodes prior to study initiation
boolean
C15680 (NCI Thesaurus ObjectClass)
C1318309 (UMLS 2011AA ObjectClass)
C15361 (NCI Thesaurus ObjectClass-2)
C1510483 (UMLS 2011AA ObjectClass-2)
C51900 (NCI Thesaurus ObjectClass-3)
C0193842 (UMLS 2011AA ObjectClass-3)
C12904 (NCI Thesaurus ObjectClass-4)
C0729594 (UMLS 2011AA ObjectClass-4)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
AxillaryLymphNodeCoreBiopsyFine-NeedleAspirationLymphNodeBiopsyPriorClinicalStudyPerformedDate
Item
Date of FNA (mm dd yyyy)
date
C15680 (NCI Thesaurus ObjectClass)
C1318309 (UMLS 2011AA ObjectClass)
C15361 (NCI Thesaurus ObjectClass-2)
C1510483 (UMLS 2011AA ObjectClass-2)
C51900 (NCI Thesaurus ObjectClass-3)
C0193842 (UMLS 2011AA ObjectClass-3)
C12904 (NCI Thesaurus ObjectClass-4)
C0729594 (UMLS 2011AA ObjectClass-4)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
FNA Results (biopsy)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C13347 (NCI Thesaurus Property)
C0370199 (UMLS 2011AA Property)
CL.33
Code List
FNA Results (biopsy)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
EstrogenReceptorPercentageIntensityStainDescriptionScore
Item
Allred score (refer to the Appendix section for table and scoring instructions)
float
C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C25613 (NCI Thesaurus Property)
C0439165 (UMLS 2011AA Property)
C25539 (NCI Thesaurus Property-2)
C0522510 (UMLS 2011AA Property-2)
C25365 (NCI Thesaurus Property-3)
C0678257 (UMLS 2011AA Property-3)
C0038128 (NCI Metathesaurus Property)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
Item
Method of Evaluation (imaging within 42 days prior to registration)
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
CL.35
Code List
Method of Evaluation (imaging within 42 days prior to registration)
CL Item
Mammogram (Mammogram)
C20178 (NCI Thesaurus)
C0024671 (UMLS 2011AA)
CL Item
Ultrasound (Ultrasound)
C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)
AssessmentMethodText
Item
Not done
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
MedicalImageDate
Item
Image Date (mm dd yyyy)
date
C25164 (NCI Thesaurus Property)
C0011008 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19477 (NCI Thesaurus ObjectClass)
C1704254 (UMLS 2011AA ObjectClass)
Item
Postmenopausal verification (mark one)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C15421 (NCI Thesaurus Property-2)
C0232970 (UMLS 2011AA Property-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.36
Code List
Postmenopausal verification (mark one)
CL Item
Bilateral Surgical Oophorectomy (Bilateral surgical oophorectomy)
CL Item
No Spontaneous Menses >= 1 Year, Not Related To Hormone Replacement Therapy (hrt) (No spontaneous menses >= 1 year, not related to hormone replacement therapy (HRT))
CL Item
No Spontaneous Menses < 1 Year, With Fsh And Estradiol Levels In Postmenopausal Range, According To Local Institutional Standards (No spontaneous menses < 1 year, with FSH and estradiol levels in postmenopausal range, according to local institutional standards)
Item
Surgery status according to investigator (mark one)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17173 (NCI Thesaurus Property)
C0038894 (UMLS 2011AA Property)
C12971 (NCI Thesaurus Property-2)
C0006141 (UMLS 2011AA Property-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.37
Code List
Surgery status according to investigator (mark one)
CL Item
Candidate For Lumpectomy (Candidate for lumpectomy)
CL Item
Candidate For Modified Radical Mastectomy (Candidate for modified radical mastectomy)
CL Item
Inoperable (Inoperable)
Item
Treatment Arm (Please indicate which aromatase inhibitor the patient will receive)
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.38
Code List
Treatment Arm (Please indicate which aromatase inhibitor the patient will receive)
CL Item
Letrozole: Neoadjuvant Treatment For 16 Weeks With Letrozole 2.5 Mg (1 Capsule) Once Daily Followed By Surgery (Letrozole: Neoadjuvant treatment for 16 weeks with letrozole 2.5 mg (1 capsule) once daily followed by surgery)
CL Item
Anastrozole: Neoadjuvant Treatment For 16 Weeks With Anastrozole 1 Mg (1 Capsule) Once Daily Followed By Surgery (Anastrozole: Neoadjuvant treatment for 16 weeks with anastrozole 1 mg (1 capsule) once daily followed by surgery)
Investigator Signature
Item
Investigator Signature (I have reviewed all data recorded on the Registration form and certify that they are accurate and complete to the best of my knowledge)
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
ResponsiblePersonSignatureDate
Item
Date Signed (mm dd yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C1273518 (UMLS 2011AA ObjectClass-2)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
CaseReportFormInvestigatorReviewInd-2
Item
Did the Investigator sign the CRF indicating review of all data and certifying data are accurate and complete to the best of their knowledge
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25936 (NCI Thesaurus Property)
C0035173 (UMLS 2011AA Property)
C42729 (NCI Thesaurus Property-2)
C1552617 (UMLS 2011AA Property-2)
Investigator Signature Date
Item
Date of Investigator Signature (mm dd yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
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