ID

6689

Descrizione

S1007 Treatment Form (TX1007) Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=90CA1C57-43D2-A228-E040-BB89AD43458D

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=90CA1C57-43D2-A228-E040-BB89AD43458D

Keywords

versioni (2)
  1. 27/08/12 27/08/12 -
  2. 08/01/15 08/01/15 - Martin Dugas
Caricato su

8 gennaio 2015

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT01272037 Treatment - S1007 Treatment Form (TX1007) - 3140038v1.0

Inglese

Instructions: Please complete this form at 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 4 years, and 5 years after randomization. All dates are MONTH, DAY, YEAR. Explain any blank dates or fields in a Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across the top of the form

1 moduli  
Header
Descrizione

Header

SWOG Patient ID
Descrizione

Trial subject ID SWOG

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1519429
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
SWOG Study No.
Descrizione

Protocol ID SWOG

Tipo di dati

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
Descrizione

Registration Number

Tipo di dati

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)
Descrizione

Patient Initials

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Reporting Period
Descrizione

Clinical Trial Period

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
Institution/Affiliate
Descrizione

Institution Name

Tipo di dati

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
Descrizione

Investigator Name

Tipo di dati

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
Descrizione

Participating Group

Tipo di dati

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.
Descrizione

Study Number Participating Group

Tipo di dati

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
Descrizione

Trial subject ID Participating Group

Tipo di dati

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
Status
Descrizione

Status

Vital Status
Descrizione

Patient Status

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C3846084
NCI Thesaurus ValueDomain
C18003
NCI Thesaurus ValueDomain-2
C25688
NCI Thesaurus Property
C25717
Date of Last Contact or Death (MM DD YYYY)
Descrizione

Date last contact

Tipo di dati

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C0805839
NCI Thesaurus Property
C25461
NCI Thesaurus Property-2
C25551
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Has the patient progressed per the definition in Section 10.0 of the protocol
Descrizione

Tumor Progression

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0178874
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25320
NCI Thesaurus Property-2
C19987
Treatment For This Cycle
Descrizione

Treatment For This Cycle

Assigned Treatment Arm
Descrizione

Protocol Treatment Arm

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C42651
UMLS CUI-1
C1522541
NCI Thesaurus Property
C32141
NCI Thesaurus Property-2
C25426
NCI Thesaurus ValueDomain
C25284
Was the patient treated on the assigned arm during this reporting period
Descrizione

ProtocolTreatmentArmAssignmentInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C42651
UMLS 2011AA ObjectClass
C0442711
NCI Thesaurus Property
C32141
UMLS 2011AA Property
C1140618
NCI Thesaurus Property-2
C25426
UMLS 2011AA Property-2
C1516050
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Reporting Period Start Date (MM DD YYYY)
Descrizione

Reporting Period Start Date

Tipo di dati

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS CUI-1
C2361257
NCI Thesaurus Property-2
C25651
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Reporting Period End Date (MM DD YYYY)
Descrizione

Reporting Period End Date

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2361259
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
Weight (kg)
Descrizione

Patient Weight

Tipo di dati

float

Unità di misura
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Has the patient received any chemotherapy during this reporting period?
Descrizione

ChemotherapyAdministeredInd

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Section Iv - Treatment
Descrizione

Section Iv - Treatment

Has the patient received any endocrine therapy during this reporting period
Descrizione

HormoneTherapyReportPeriodAdministeredInd-3

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25375
UMLS 2011AA Property-2
C0684224
NCI Thesaurus Property-3
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Did patient switch type of endocrine therapy during this reporting period
Descrizione

AdjuvantHormoneTherapyChangeInd-3

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25446
UMLS 2011AA Property
C0392747
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
Specify reason for switch in endocrine therapy (If yes)
Descrizione

AdjuvantHormoneTherapyChangeReason

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25446
UMLS 2011AA Property
C0392747
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
Other, specify
Descrizione

AdjuvantHormoneTherapyChangeSpecify

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25446
UMLS 2011AA Property
C0392747
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
Start date of new endocrine therapy (MM DD YYYY)
Descrizione

NewAdjuvantHormoneTherapyAdministeredDate

Tipo di dati

date

Alias
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C15445
UMLS 2011AA ObjectClass-2
C0279025
NCI Thesaurus ObjectClass-3
C2140
UMLS 2011AA ObjectClass-3
C0001552
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Specify new type of endocrine therapy given
Descrizione

AdjuvantHormoneTherapyChangeType

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25446
UMLS 2011AA Property
C0392747
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
Other, specify
Descrizione

NewAdjuvantHormoneTherapyAdministeredSpecify

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C15445
UMLS 2011AA ObjectClass-2
C0279025
NCI Thesaurus ObjectClass-3
C2140
UMLS 2011AA ObjectClass-3
C0001552
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Specify which Aromatase Inhibitor was given (If Aromatase Inhibitor)
Descrizione

AdjuvantAromataseInhibitorHormoneTherapyChangeType

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C1740
UMLS 2011AA ObjectClass-2
C0593802
NCI Thesaurus ObjectClass-3
C2140
UMLS 2011AA ObjectClass-3
C0001552
NCI Thesaurus Property
C25446
UMLS 2011AA Property
C0392747
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify
Descrizione

AdjuvantAromataseInhibitorHormoneTherapyChangeSpecify

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C1740
UMLS 2011AA ObjectClass-2
C0593802
NCI Thesaurus ObjectClass-3
C2140
UMLS 2011AA ObjectClass-3
C0001552
NCI Thesaurus Property
C25446
UMLS 2011AA Property
C0392747
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Tamoxifen (If no, Answer Yes or No for each of the following therapies the patient consistently took during this reporting period)
Descrizione

HormoneTherapyTamoxifenReceivedInd-3

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C855
UMLS 2011AA Property
C0039286
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
Aromatase Inhibitor (If no, Answer Yes or No for each of the following therapies the patient consistently took during this reporting period)
Descrizione

AromataseInhibitorReceivedInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass
C1740
UMLS 2011AA ObjectClass
C0593802
Specify which Aromatase Inhibitor was given
Descrizione

AromataseInhibitorReceivedType

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass
C1740
UMLS 2011AA ObjectClass
C0593802
Specify
Descrizione

AromataseInhibitorReceivedSpecify

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass
C1740
UMLS 2011AA ObjectClass
C0593802
Other
Descrizione

HormoneTherapyOtherReceivedInd-3

Tipo di dati

boolean

Alias
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
Specify (If yes,)
Descrizione

HormoneTherapyOtherReceivedSpecify

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
If the patient was premenopausal at registration, is she currently having regular menstrual periods
Descrizione

MenstrualCycleAssessmentInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C16838
UMLS 2011AA ObjectClass
C0025329
Did patient receive Ovarian Function Suppression (OFS) during this reporting period
Descrizione

OvarianAntiestrogenHormoneTherapyAdministeredInd-3

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C15757
UMLS 2011AA ObjectClass-2
C0854638
NCI Thesaurus ObjectClass-3
C28047
UMLS 2011AA ObjectClass-3
C0205065
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Ovarian Function Suppression Type (If yes)
Descrizione

OvarianAntiestrogenHormoneTherapyAdministeredType

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C15757
UMLS 2011AA ObjectClass-2
C0854638
NCI Thesaurus ObjectClass-3
C28047
UMLS 2011AA ObjectClass-3
C0205065
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify
Descrizione

OvarianAntiestrogenHormoneTherapyAdministeredSpecify

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C15757
UMLS 2011AA ObjectClass-2
C0854638
NCI Thesaurus ObjectClass-3
C28047
UMLS 2011AA ObjectClass-3
C0205065
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Was all endocrine therapy discontinued this reporting period
Descrizione

HormoneTherapyDiscontinuedInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
Date any endocrine therapy last given (If yes MM DD YYYY)
Descrizione

HormoneTherapyLastAdministeredDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25551
UMLS 2011AA Property
C1517741
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Concurrent Medications/clinical Trials
Descrizione

Concurrent Medications/clinical Trials

Did the patient receive bisphosphonates during this reporting period (select all that apply)
Descrizione

Bisphosphonates type

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C0012544
NCI Thesaurus ObjectClass
C443
UMLS CUI-2
C0683312
NCI Thesaurus ObjectClass-2
C37902
NCI Thesaurus Property
C25382
Is the patient currently co-enrolled on another CTEP or NCI-sponsored clinical trial for breast cancer
Descrizione

OtherClinicalTrialsCooperativeGroupPatientEnrollmentInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C17649
UMLS 2011AA ObjectClass
C0205394
NCI Thesaurus ObjectClass-2
C16960
UMLS 2011AA ObjectClass-2
C0030705
NCI Thesaurus ObjectClass-3
C18205
UMLS 2011AA ObjectClass-3
C1521808
NCI Thesaurus Property
C37948
UMLS 2011AA Property
C1516879
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Specify
Descrizione

OtherStudyEnrollmentSpecify

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15206
UMLS 2011AA ObjectClass
C0008972
NCI Thesaurus Property
C37948
UMLS 2011AA Property
C1516879
Date of enrollment (MM DD YYYY)
Descrizione

PatientEnrollmentDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Comments
Descrizione

Comments

Comments
Descrizione

Research Comments

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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Similar models

Instructions: Please complete this form at 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 4 years, and 5 years after randomization. All dates are MONTH, DAY, YEAR. Explain any blank dates or fields in a Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across the top of the form

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Header
Trial subject ID SWOG
Item
SWOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-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)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Item
Reporting Period
text
C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)
CL.1
Code List
Reporting Period
CL Item
6 Months (6 months)
CL Item
12 Months (12 months)
CL Item
18 Months (18 months)
CL Item
24 Months (24 months)
CL Item
30 Months (30 months)
CL Item
36 Months (36 months)
CL Item
48 Months (48 months)
CL Item
60 Months (60 months)
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
Status
Item
Vital Status
text
C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)
CL.2
Code List
Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Date last contact
Item
Date of Last Contact or Death (MM DD YYYY)
date
C16960 (NCI Thesaurus ObjectClass)
C0805839 (UMLS CUI-1)
C25461 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Tumor Progression
Item
Has the patient progressed per the definition in Section 10.0 of the protocol
boolean
C38147 (NCI Thesaurus ValueDomain)
C0178874 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25320 (NCI Thesaurus Property)
C19987 (NCI Thesaurus Property-2)
Item Group
Treatment For This Cycle
Item
Assigned Treatment Arm
text
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C1522541 (UMLS CUI-1)
C32141 (NCI Thesaurus Property)
C25426 (NCI Thesaurus Property-2)
C25284 (NCI Thesaurus ValueDomain)
CL.4
Code List
Assigned Treatment Arm
CL Item
Arm 1: Chemotherapy + Endocrine Therapy (Arm 1: Chemotherapy + endocrine therapy)
CL Item
Arm 2: Endocrine Therapy Only (Arm 2: Endocrine therapy only)
ProtocolTreatmentArmAssignmentInd-2
Item
Was the patient treated on the assigned arm during this reporting period
boolean
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C0442711 (UMLS 2011AA ObjectClass)
C32141 (NCI Thesaurus Property)
C1140618 (UMLS 2011AA Property)
C25426 (NCI Thesaurus Property-2)
C1516050 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Reporting Period Start Date
Item
Reporting Period Start Date (MM DD YYYY)
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Reporting Period End Date
Item
Reporting Period End Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Patient Weight
Item
Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Item
Has the patient received any chemotherapy during this reporting period?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.6
Code List
Has the patient received any chemotherapy during this reporting period?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Chemotherapy Continuing (Yes, chemotherapy continuing)
CL Item
Yes, Chemotherapy Completed (Yes, chemotherapy completed)
Item Group
Section Iv - Treatment
HormoneTherapyReportPeriodAdministeredInd-3
Item
Has the patient received any endocrine therapy during this reporting period
boolean
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property-2)
C0684224 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
AdjuvantHormoneTherapyChangeInd-3
Item
Did patient switch type of endocrine therapy during this reporting period
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
Item
Specify reason for switch in endocrine therapy (If yes)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
CL.9
Code List
Specify reason for switch in endocrine therapy (If yes)
CL Item
Planned Switch For Therapeutic Reason (Planned switch for therapeutic reason)
CL Item
Adverse Events From Prior Endocrine Therapy (Adverse events from prior endocrine therapy)
CL Item
Both Planned Switch For Therapeutic Reason And For Adverse Events From Prior Hormonal Therapy (Both)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AdjuvantHormoneTherapyChangeSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
NewAdjuvantHormoneTherapyAdministeredDate
Item
Start date of new endocrine therapy (MM DD YYYY)
date
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass-2)
C0279025 (UMLS 2011AA ObjectClass-2)
C2140 (NCI Thesaurus ObjectClass-3)
C0001552 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Specify new type of endocrine therapy given
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
CL.10
Code List
Specify new type of endocrine therapy given
CL Item
Tamoxifen (Tamoxifen)
C855 (NCI Thesaurus)
C0039286 (UMLS 2011AA)
CL Item
Aromatase Inhibitor (Aromatase Inhibitor)
C1740 (NCI Thesaurus)
C0593802 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
NewAdjuvantHormoneTherapyAdministeredSpecify
Item
Other, specify
text
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass-2)
C0279025 (UMLS 2011AA ObjectClass-2)
C2140 (NCI Thesaurus ObjectClass-3)
C0001552 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Specify which Aromatase Inhibitor was given (If Aromatase Inhibitor)
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C1740 (NCI Thesaurus ObjectClass-2)
C0593802 (UMLS 2011AA ObjectClass-2)
C2140 (NCI Thesaurus ObjectClass-3)
C0001552 (UMLS 2011AA ObjectClass-3)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.11
Code List
Specify which Aromatase Inhibitor was given (If Aromatase Inhibitor)
CL Item
Anastrozole (ANASTROZOLE)
C1607 (NCI Thesaurus)
C0290882 (UMLS 2011AA)
CL Item
Letrozole (LETROZOLE)
C1527 (NCI Thesaurus)
C0246421 (UMLS 2011AA)
CL Item
Exemestane (EXEMESTANE)
C1097 (NCI Thesaurus)
C0060116 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AdjuvantAromataseInhibitorHormoneTherapyChangeSpecify
Item
Other, specify
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C1740 (NCI Thesaurus ObjectClass-2)
C0593802 (UMLS 2011AA ObjectClass-2)
C2140 (NCI Thesaurus ObjectClass-3)
C0001552 (UMLS 2011AA ObjectClass-3)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
HormoneTherapyTamoxifenReceivedInd-3
Item
Tamoxifen (If no, Answer Yes or No for each of the following therapies the patient consistently took during this reporting period)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C855 (NCI Thesaurus Property)
C0039286 (UMLS 2011AA Property)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
AromataseInhibitorReceivedInd-2
Item
Aromatase Inhibitor (If no, Answer Yes or No for each of the following therapies the patient consistently took during this reporting period)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C1740 (NCI Thesaurus ObjectClass)
C0593802 (UMLS 2011AA ObjectClass)
Item
Specify which Aromatase Inhibitor was given
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C1740 (NCI Thesaurus ObjectClass)
C0593802 (UMLS 2011AA ObjectClass)
CL.14
Code List
Specify which Aromatase Inhibitor was given
CL Item
Anastrozole (ANASTROZOLE)
C1607 (NCI Thesaurus)
C0290882 (UMLS 2011AA)
CL Item
Letrozole (LETROZOLE)
C1527 (NCI Thesaurus)
C0246421 (UMLS 2011AA)
CL Item
Exemestane (EXEMESTANE)
C1097 (NCI Thesaurus)
C0060116 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AromataseInhibitorReceivedSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C1740 (NCI Thesaurus ObjectClass)
C0593802 (UMLS 2011AA ObjectClass)
HormoneTherapyOtherReceivedInd-3
Item
Other
boolean
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
HormoneTherapyOtherReceivedSpecify
Item
Specify (If yes,)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
MenstrualCycleAssessmentInd-2
Item
If the patient was premenopausal at registration, is she currently having regular menstrual periods
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C16838 (NCI Thesaurus ObjectClass)
C0025329 (UMLS 2011AA ObjectClass)
Item
Did patient receive Ovarian Function Suppression (OFS) during this reporting period
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C15757 (NCI Thesaurus ObjectClass-2)
C0854638 (UMLS 2011AA ObjectClass-2)
C28047 (NCI Thesaurus ObjectClass-3)
C0205065 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.17
Code List
Did patient receive Ovarian Function Suppression (OFS) during this reporting period
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Ovarian Function Suppression Type (If yes)
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C15757 (NCI Thesaurus ObjectClass-2)
C0854638 (UMLS 2011AA ObjectClass-2)
C28047 (NCI Thesaurus ObjectClass-3)
C0205065 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.18
Code List
Ovarian Function Suppression Type (If yes)
CL Item
Radiation Therapy (Ovarian radiation)
C15313 (NCI Thesaurus)
C1522449 (UMLS 2011AA)
CL Item
Bilateral Surgical Oophorectomy (Oophorectomy)
CL Item
Medical Suppression Of Ovarian Function (Medical suppression)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
OvarianAntiestrogenHormoneTherapyAdministeredSpecify
Item
Other, specify
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C15757 (NCI Thesaurus ObjectClass-2)
C0854638 (UMLS 2011AA ObjectClass-2)
C28047 (NCI Thesaurus ObjectClass-3)
C0205065 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
HormoneTherapyDiscontinuedInd-2
Item
Was all endocrine therapy discontinued this reporting period
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
HormoneTherapyLastAdministeredDate
Item
Date any endocrine therapy last given (If yes MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
Item Group
Concurrent Medications/clinical Trials
Item
Did the patient receive bisphosphonates during this reporting period (select all that apply)
text
C25284 (NCI Thesaurus ValueDomain)
C0012544 (UMLS CUI-1)
C443 (NCI Thesaurus ObjectClass)
C0683312 (UMLS CUI-2)
C37902 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
CL.20
Code List
Did the patient receive bisphosphonates during this reporting period (select all that apply)
CL Item
Bisphosphonates For Prevention Of Bone Loss (Bisphosphonates for prevention of bone loss)
CL Item
Bisphosphonates For Breast Cancer Treatment (Bisphosphonates for breast cancer treatment)
OtherClinicalTrialsCooperativeGroupPatientEnrollmentInd-2
Item
Is the patient currently co-enrolled on another CTEP or NCI-sponsored clinical trial for breast cancer
boolean
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus ObjectClass-2)
C0030705 (UMLS 2011AA ObjectClass-2)
C18205 (NCI Thesaurus ObjectClass-3)
C1521808 (UMLS 2011AA ObjectClass-3)
C37948 (NCI Thesaurus Property)
C1516879 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
OtherStudyEnrollmentSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
C37948 (NCI Thesaurus Property)
C1516879 (UMLS 2011AA Property)
PatientEnrollmentDate
Item
Date of enrollment (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
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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