ID

7488

Description

SOUTHWEST ONCOLOGY GROUP S0307 PRESTUDY FORM Zoledronate, Clodronate, or Ibandronate in Treating Women Who Have Undergone Surgery for Stage I, Stage II, or Stage III Breast Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DEA0B902-CDD3-54E6-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DEA0B902-CDD3-54E6-E034-0003BA12F5E7

Keywords

Versions (3)
  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 8/26/15 8/26/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00127205 Pre-Study - SOUTHWEST ONCOLOGY GROUP S0307 PRESTUDY FORM - 2286938v3.0

English

No Instruction available.

1 forms  
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0307 PRESTUDY FORM
    1. No Instruction available.
Administrative documentation
Description

Administrative documentation

Alias
UMLS CUI-1
C1320722
SWOG Patient ID
Description

Patient Southwest Oncology Group Identifier Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
UMLS CUI-1
C1549740
UMLS CUI-2
C1519429
SWOG Study No.
Description

Protocol ID SWOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1519429
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
Registration Step
Description

Registration Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Patient Initials (L, F M)
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
UMLS CUI-1
C2986440
Institution/Affiliate
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Physician
Description

Investigator Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2826892
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C17089
NCI Thesaurus ObjectClass-2
C25644
Participating Group Name
Description

Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Study No.
Description

Study Number Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Description

Trial subject ID Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Disease Description
Description

Disease Description

Performance Status
Description

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
UMLS CUI-1
C1520224
Histologically confirmed primary invasive adenocarcinoma of the breast
Description

BreastPrimaryInvasiveAdenocarcinomaHistologicallyConfirmedStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C2852
UMLS 2011AA ObjectClass
C0001418
NCI Thesaurus ObjectClass-2
C25251
UMLS 2011AA ObjectClass-2
C0205225
NCI Thesaurus ObjectClass-3
C12971
UMLS 2011AA ObjectClass-3
C0006141
NCI Thesaurus ObjectClass-4
C14159
UMLS 2011AA ObjectClass-4
C0205281
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus Property-2
C25527
UMLS 2011AA Property-2
C0205462
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Laboratory Values
Description

Laboratory Values

Serum creatinine
Description

PatientCreatinineSerumValue

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C13325
NCI Thesaurus Property-2
C399
UMLS CUI-1
C0201976
mg/dL
ULN (mg/dL)
Description

Creatinine, serum ULN

Data type

float

Measurement units
  • mg/dL
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
mg/dL
Collection Date (mm/dd/yyyy)
Description

SpecimenCollectedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C25452
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property
C2745955
Previous bisphosphonate
Description

PriorBisphosphonateTherapyType

Data type

text

Alias
NCI Thesaurus ObjectClass
C443
UMLS 2011AA ObjectClass
C0012544
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus ObjectClass-3
C15368
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Date of dental examination (mm/dd/yyyy)
Description

DentalExamDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C41136
UMLS 2011AA ObjectClass
C0226984
Bone Pain
Description

Bone Pain

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus Property
C3303
NCI Thesaurus ObjectClass
C12366
UMLS CUI-1
C0151825
Bone Metastasis
Description

MalignantNeoplasmBoneMetastaticInvolvementInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C9305
NCI Thesaurus Property
C14174
NCI Thesaurus Property-2
C12366
NCI Thesaurus Property-3
C25548
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0153690
Consent For Submission And Banking
Description

Consent For Submission And Banking

Consent for submission and banking
Description

PatientTissueBankingConsentStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Metathesaurus Property
C0087095
Patient Characteristics
Description

Patient Characteristics

Menopausal status (select one:)
Description

PatientMenopauseCategory

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3231
UMLS 2011AA Property
C0025320
NCI Thesaurus ValueDomain-2
C3231
UMLS 2011AA ValueDomain-2
C0025320
Height
Description

PatientHeightMeasurement

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
UMLS CUI-1
C0005890
cm
Weight
Description

PatientWeightMeasurement

Data type

float

Measurement units
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
UMLS CUI-1
C0005910
Kg
BSA
Description

PatientBodySurfaceAreaMeasurement

Data type

float

Measurement units
  • m^2
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
UMLS CUI-1
C0005902
m^2
Disease Description
Description

Disease Description

Date of Initial Diagnosis of Primary Tumor
Description

FirstBiopsyPositiveDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus ObjectClass-2
C25509
UMLS 2011AA ObjectClass-2
C1279901
NCI Thesaurus Property
C25246
UMLS 2011AA Property
C1446409
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property-2
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Tumor Laterality (select one:)
Description

PrimaryTumorLateralityType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C3262
NCI Thesaurus ObjectClass-2
C25251
NCI Thesaurus Property
C25185
UMLS CUI-1
C0441987
UMLS CUI-2
C0475445
Pathologic Primary Tumor Size (cm.)
Description

PathologicTumorPrimarySizeMeasurement

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ObjectClass
C3262
NCI Thesaurus ObjectClass-2
C25610
NCI Thesaurus Property
C25251
NCI Thesaurus Property-2
C25681
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0475440
cm
Number of Positive Lymph Nodes (If sentinel node biopsy and axillary node dissection were performed, enter the sum of positive nodes.)
Description

LymphNodePositiveCount

Data type

integer

Alias
NCI Thesaurus Property
C25246
NCI Thesaurus ObjectClass
C12745
NCI Thesaurus ValueDomain
C25463
UMLS CUI-1
C0237753
UMLS CUI-2
C0746319
ER Status
Description

ERLevelTumorStatus

Data type

text

Alias
NCI Thesaurus ValueDomain
C3262
NCI Thesaurus ObjectClass
C17069
NCI Thesaurus ValueDomain-2
C25688
NCI Thesaurus Property
C25554
UMLS CUI-1
C2919271
PgR Status
Description

PgRStatusType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C17075
NCI Metathesaurus Property
C0678257
UMLS CUI-1
C2919590
Was HER-2/neu status determined?
Description

WasHER-2/neustatusdetermined?

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1522602
If Yes, HER2/neu final diagnosis
Description

HER2/neu Final Diagnosis

Data type

text

Treatment With Statins
Description

Treatment With Statins

Is the patient currently taking a statin (atorvastatin Lipitor, pravastatin Pravachol, simvastatin Zocor, lovastatin Mevacor, fluvastatin Lescol, rosuvastatin Crestor?)
Description

TherapyHMG-CoAReductaseInhibitorAdministeredInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25382
NCI Thesaurus Property-2
C1655
UMLS CUI-1
C1512699
UMLS CUI-2
C1521801
UMLS CUI-3
C0360714
Length of time on statin
Description

TherapyHMG-CoAReductaseInhibitorAdministeredDuration

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25330
UMLS 2011AA ValueDomain
C0449238
NCI Thesaurus Property-2
C1655
UMLS 2011AA Property-2
C0360714
Patient Preference
Description

Patient Preference

If oral and intravenous bisphosphonates are equally effective in preventing breast cancer recurrence in the bone, which would the patient prefer to receive? (Note that the answer to this question will not in any way affect which treatment the patient is randomly assigned to on this study.)
Description

BisphosphonateTherapyAdministrationType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C443
UMLS 2011AA Property
C0012544
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Prior Treatment Related To This Cancer
Description

Prior Treatment Related To This Cancer

Most Extensive Primary Surgery (select one:)
Description

BreastPrimarySurgicalProcedurePerformedType

Data type

text

Alias
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus ObjectClass-3
C15329
UMLS 2011AA ObjectClass-3
C0543467
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Date of Most Extensive Primary Surgery (If required, use last re-excision date)
Description

PrimarySurgeryDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus ObjectClass-2
C15329
UMLS 2011AA ObjectClass-2
C0543467
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Was sentinel node sampling performed?
Description

SentinelNodeBiopsyInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
Sentinel Node Biopsy Date
Description

SentinelNodeBiopsyDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
Sentinel Node Biopsy Results
Description

SentinelNodePathologicResultProcedure

Data type

text

Alias
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus ValueDomain
C25218
UMLS 2011AA ValueDomain
C1948041
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
Was axillary dissection performed?
Description

AxillaryNodeDissectionPerformedInd-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
Date of Axillary Dissection
Description

AxillarySurgeryDissectionDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C13351
UMLS 2011AA ObjectClass
C0004454
NCI Thesaurus ObjectClass-2
C15329
UMLS 2011AA ObjectClass-2
C0543467
NCI Thesaurus Property
C15227
UMLS 2011AA Property
C0012737
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
SWOG Patient ID
Description

Patient Southwest Oncology Group Identifier Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
UMLS CUI-1
C1549740
UMLS CUI-2
C1519429
SWOG Study No.
Description

Protocol ID SWOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1519429
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
Registration Step
Description

Registration Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Patient Initials (L, F M)
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
UMLS CUI-1
C2986440
Systemic Treatment For This Cancer
Description

Systemic Treatment For This Cancer

Chemotherapy (select one:)
Description

ChemotherapyAdministrationIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
Date chemotherapy completed (If completed,)
Description

ChemotherapyAdministeredEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Hormone therapy (select one:)
Description

HormoneTherapyAdministeredInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
If currently receiving
Description

HormoneTherapyAdministeredType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Comments
Description

Comments

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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1 forms
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0307 PRESTUDY FORM
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative documentation
C1320722 (UMLS CUI-1)
Patient ID SWOG
Item
SWOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
C1549740 (UMLS CUI-1)
C1519429 (UMLS CUI-2)
Protocol ID SWOG
Item
SWOG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Patient Initials
Item
Patient Initials (L, F M)
text
C25191 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
C2986440 (UMLS CUI-1)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Investigator Name
Item
Physician
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
Participating Group
Item
Participating Group Name
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Disease Description
Item
Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
C1520224 (UMLS CUI-1)
CL.1
Code List
Performance Status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
Item
Histologically confirmed primary invasive adenocarcinoma of the breast
text
C2852 (NCI Thesaurus ObjectClass)
C0001418 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C12971 (NCI Thesaurus ObjectClass-3)
C0006141 (UMLS 2011AA ObjectClass-3)
C14159 (NCI Thesaurus ObjectClass-4)
C0205281 (UMLS 2011AA ObjectClass-4)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25527 (NCI Thesaurus Property-2)
C0205462 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.2
Code List
Histologically confirmed primary invasive adenocarcinoma of the breast
CL Item
Stage I (Stage I)
C27966 (NCI Thesaurus)
C0441766 (UMLS 2011AA)
CL Item
Stage Ii (Stage II)
C28054 (NCI Thesaurus)
C0441767 (UMLS 2011AA)
CL Item
Stage Iii (Stage III)
C27970 (NCI Thesaurus)
C0441771 (UMLS 2011AA)
Item Group
Laboratory Values
Serum creatinine
Item
Serum creatinine
float
C16960 (NCI Thesaurus ObjectClass)
C13325 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C0201976 (UMLS CUI-1)
Creatinine, serum ULN
Item
ULN (mg/dL)
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)
SpecimenCollectedDate
Item
Collection Date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property)
Item
Previous bisphosphonate
text
C443 (NCI Thesaurus ObjectClass)
C0012544 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.3
Code List
Previous bisphosphonate
CL Item
Intravenous: C13346 (IV)
C13346 (NCI Thesaurus)
C0348016 (UMLS 2011AA)
CL Item
Oral (Oral)
C25311 (NCI Thesaurus)
C0442027 (UMLS 2011AA)
CL Item
None: C41132 (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
DentalExamDate
Item
Date of dental examination (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41136 (NCI Thesaurus ObjectClass)
C0226984 (UMLS 2011AA ObjectClass)
Bone Pain
Item
Bone Pain
boolean
C38147 (NCI Thesaurus ValueDomain)
C3303 (NCI Thesaurus Property)
C12366 (NCI Thesaurus ObjectClass)
C0151825 (UMLS CUI-1)
Bone Metastasis
Item
Bone Metastasis
boolean
C9305 (NCI Thesaurus ObjectClass)
C14174 (NCI Thesaurus Property)
C12366 (NCI Thesaurus Property-2)
C25548 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)
C0153690 (UMLS CUI-1)
Item Group
Consent For Submission And Banking
Item
Consent for submission and banking
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C0087095 (NCI Metathesaurus Property)
CL.6
Code List
Consent for submission and banking
CL Item
Accepted Tissue Submission (Accepted tissue submission)
CL Item
Declined Tissue Submission (Declined tissue submission)
CL Item
Accepted Serum Submission (Accepted serum submission)
CL Item
Declined Serum Submission (Declined serum submission)
Item Group
Patient Characteristics
Item
Menopausal status (select one:)
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3231 (NCI Thesaurus Property)
C0025320 (UMLS 2011AA Property)
C3231 (NCI Thesaurus ValueDomain-2)
C0025320 (UMLS 2011AA ValueDomain-2)
CL.7
Code List
Menopausal status (select one:)
CL Item
Pre (<6 Mo Since Lmp And No Prior Bilateral Ovariectomy And Not On Estrogen Replacement) (Pre (< 6 mo since LMP and no prior bilateral ovariectomy and not on estrogen replacement))
CL Item
Post (prior Bilateral Ovariectomy Or >12 Mo Since Lmp With No Prior Hysterectomy) (Post (prior bilateral ovariectomy OR > 12 mo since LMP with no prior hysterectomy))
CL Item
Above Categories Not Applicable And Age <50 (Above not applicable AND age < 50)
CL Item
Above Categories Not Applicable And Age >= 50 (Above not applicable AND age >=50)
Height
Item
Height
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
C0005890 (UMLS CUI-1)
Weight
Item
Weight
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
C0005910 (UMLS CUI-1)
Body Surface Area
Item
BSA
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS CUI-1)
Item Group
Disease Description
FirstBiopsyPositiveDate
Item
Date of Initial Diagnosis of Primary Tumor
date
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus ObjectClass-2)
C1279901 (UMLS 2011AA ObjectClass-2)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Tumor Laterality (select one:)
text
C25284 (NCI Thesaurus ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C25185 (NCI Thesaurus Property)
C0441987 (UMLS CUI-1)
C0475445 (UMLS CUI-2)
CL.8
Code List
Tumor Laterality (select one:)
CL Item
Left (Left)
C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)
CL Item
Right (Right)
C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)
CL Item
Bilateral (Bilateral)
C13332 (NCI Thesaurus)
C0238767 (UMLS 2011AA)
Tumor size
Item
Pathologic Primary Tumor Size (cm.)
float
C3262 (NCI Thesaurus ObjectClass)
C25610 (NCI Thesaurus ObjectClass-2)
C25251 (NCI Thesaurus Property)
C25681 (NCI Thesaurus Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0475440 (UMLS CUI-1)
Number of positive lymph nodes
Item
Number of Positive Lymph Nodes (If sentinel node biopsy and axillary node dissection were performed, enter the sum of positive nodes.)
integer
C25246 (NCI Thesaurus Property)
C12745 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0237753 (UMLS CUI-1)
C0746319 (UMLS CUI-2)
Item
ER Status
text
C3262 (NCI Thesaurus ValueDomain)
C17069 (NCI Thesaurus ObjectClass)
C25688 (NCI Thesaurus ValueDomain-2)
C25554 (NCI Thesaurus Property)
C2919271 (UMLS CUI-1)
CL.9
Code List
ER Status
CL Item
Negative (ER-)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (ER+)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
Item
PgR Status
text
C25284 (NCI Thesaurus ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0678257 (NCI Metathesaurus Property)
C2919590 (UMLS CUI-1)
CL.10
Code List
PgR Status
CL Item
Negative (PgR-)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (PgR+)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
HER-2/neu status determined
Item
Was HER-2/neu status determined?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS CUI-1)
Item
If Yes, HER2/neu final diagnosis
text
CL.12
Code List
If Yes, HER2/neu final diagnosis
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Equivocal (Equivocal)
C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)
Item Group
Treatment With Statins
TherapyHMG-CoAReductaseInhibitorAdministeredInd-3
Item
Is the patient currently taking a statin (atorvastatin Lipitor, pravastatin Pravachol, simvastatin Zocor, lovastatin Mevacor, fluvastatin Lescol, rosuvastatin Crestor?)
boolean
C38148 (NCI Thesaurus ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1655 (NCI Thesaurus Property-2)
C1512699 (UMLS CUI-1)
C1521801 (UMLS CUI-2)
C0360714 (UMLS CUI-3)
Item
Length of time on statin
text
C15368 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25330 (NCI Thesaurus ValueDomain)
C0449238 (UMLS 2011AA ValueDomain)
C1655 (NCI Thesaurus Property-2)
C0360714 (UMLS 2011AA Property-2)
CL.14
Code List
Length of time on statin
CL Item
< 1 Yr (< 1 yr)
CL Item
1-2 Yrs (1-2 yrs)
CL Item
2-3 Yrs (2-3 yrs)
CL Item
3-4 Yrs (3-4 yrs)
CL Item
>4 Yrs (>4 yrs)
Item Group
Patient Preference
Item
If oral and intravenous bisphosphonates are equally effective in preventing breast cancer recurrence in the bone, which would the patient prefer to receive? (Note that the answer to this question will not in any way affect which treatment the patient is randomly assigned to on this study.)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C443 (NCI Thesaurus Property)
C0012544 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
CL.15
Code List
If oral and intravenous bisphosphonates are equally effective in preventing breast cancer recurrence in the bone, which would the patient prefer to receive? (Note that the answer to this question will not in any way affect which treatment the patient is randomly assigned to on this study.)
CL Item
Oral (Oral)
C25311 (NCI Thesaurus)
C0442027 (UMLS 2011AA)
CL Item
Intravenous (Intravenous)
X-MO-6794 (MGED)
Item Group
Prior Treatment Related To This Cancer
Item
Most Extensive Primary Surgery (select one:)
text
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C15329 (NCI Thesaurus ObjectClass-3)
C0543467 (UMLS 2011AA ObjectClass-3)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.16
Code List
Most Extensive Primary Surgery (select one:)
CL Item
Partial Mastectomy, Lumpectomy Or Excisional Biopsy (Partial mastectomy/lumpectomy/excisional biopsy)
CL Item
Mastectomy, Nos (Mastectomy, NOS)
PrimarySurgeryDate
Item
Date of Most Extensive Primary Surgery (If required, use last re-excision date)
date
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
SentinelNodeBiopsyInd-3
Item
Was sentinel node sampling performed?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
SentinelNodeBiopsyDate
Item
Sentinel Node Biopsy Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
Item
Sentinel Node Biopsy Results
text
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25218 (NCI Thesaurus ValueDomain)
C1948041 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
CL.18
Code List
Sentinel Node Biopsy Results
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
AxillaryNodeDissectionPerformedInd-3
Item
Was axillary dissection performed?
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)
AxillarySurgeryDissectionDate
Item
Date of Axillary Dissection
date
C13351 (NCI Thesaurus ObjectClass)
C0004454 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Patient ID SWOG
Item
SWOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
C1549740 (UMLS CUI-1)
C1519429 (UMLS CUI-2)
Protocol ID SWOG
Item
SWOG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Patient Initials
Item
Patient Initials (L, F M)
text
C25191 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
C2986440 (UMLS CUI-1)
Item Group
Systemic Treatment For This Cancer
Item
Chemotherapy (select one:)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
CL.20
Code List
Chemotherapy (select one:)
CL Item
Currently Receiving (Currently receiving)
CL Item
Planned (Planned)
C25619 (NCI Thesaurus)
C1301732 (UMLS 2011AA)
CL Item
Not Planned (Not planned)
CL Item
Completed (Completed)
ChemotherapyAdministeredEndDate
Item
Date chemotherapy completed (If completed,)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Hormone therapy (select one:)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.21
Code List
Hormone therapy (select one:)
CL Item
Currently Receiving (Currently receiving)
CL Item
Planned (Planned)
C25619 (NCI Thesaurus)
C1301732 (UMLS 2011AA)
CL Item
Not Planned (Not planned)
Item
If currently receiving
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.22
Code List
If currently receiving
CL Item
Serm (SERM)
CL Item
Aromatase Inhibitor (Aromatase inhibitor)
C1740 (NCI Thesaurus)
C0593802 (UMLS 2011AA)
CL Item
Ovarian Suppression (Ovarian suppression)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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