ID

11472

Description

NSABP Protocol B-40 - Postoperative Adjuvant Treatments NCT00408408 A Randomized Phase III Trial of Neoadjuvant Therapy in Patients With Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel When Administered Before AC With or Without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR With Each of the Regimens Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1B7DA758-8A3B-186C-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1B7DA758-8A3B-186C-E044-0003BA3F9857

Keywords

Versions (3)
  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 7/5/15 7/5/15 -
Uploaded on

July 5, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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NSABP Protocol B-40 - Postoperative Adjuvant Treatments NCT00408408

English

Submit every 6 months from date of randomization for the first 5 years; yearly thereafter, and when a protocol event occurs. Fax Form F to 412-622-2111

1 forms  
Header
Description

Header

Patient Initials (Last First Middle)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
NSABP Patient ID
Description

Patient ID NSABP

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1513905
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C15818
Person Completing Form
Description

Person Completing Form

Institution/Affiliate
Description

CombinedInstitutionName

Data type

text

Person Completing Form, Last Name
Description

ResponsiblePersonLastName

Data type

text

Person Completing Form, First Name
Description

ResponsiblePersonFirstName

Data type

text

Person Completing Form, Phone
Description

ResponsiblePersonPhoneNumber

Data type

text

Date Form Completed
Description

Date Form Completed

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
Are data amended
Description

DataAmendedInd-3

Data type

boolean

Postoperative Radiation Therapy (RT)
Description

Postoperative Radiation Therapy (RT)

Post-lumpectomy breast RT
Description

BreastRadiationTherapyPostLumpectomyAdministrationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C15755
UMLS 2011AA Property
C0024885
NCI Thesaurus Property-2
C38008
UMLS 2011AA Property-2
C0687676
NCI Thesaurus Property-3
C25409
UMLS 2011AA Property-3
C1533734
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Post-mastectomy chest wall RT
Description

ChestWallRadiationTherapyPostMastectomyAdministrationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass-2
C62484
UMLS 2011AA ObjectClass-2
C0205076
NCI Thesaurus Property
C15277
UMLS 2011AA Property
C0024881
NCI Thesaurus Property-2
C38008
UMLS 2011AA Property-2
C0687676
NCI Thesaurus Property-3
C25409
UMLS 2011AA Property-3
C1533734
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Regional nodal RT
Description

RegionalLymphNodeRadiationTherapyAdministrationInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ObjectClass-2
C49018
UMLS 2011AA ObjectClass-2
C1184738
Postoperative Systemic Adjuvant Therapy
Description

Postoperative Systemic Adjuvant Therapy

Postoperative Adjuvant Hormonal Therapy
Description

AdjuvantHormoneTherapyPostoperativeAdministeredInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
NCI Thesaurus Property
C28006
UMLS 2011AA Property
C0032790
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Postoperative Bevacizumab
Description

BevacizumabChemotherapyPostoperativeAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C2039
UMLS 2011AA ObjectClass-2
C0796392
NCI Thesaurus Property
C28006
UMLS 2011AA Property
C0032790
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Postoperative Trastuzumab
Description

TrastuzumabAgentPostoperativeAdministrationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C1647
UMLS 2011AA ObjectClass
C0338204
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C28006
UMLS 2011AA Property
C0032790
NCI Thesaurus Property-2
C25409
UMLS 2011AA Property-2
C1533734
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Postoperative Chemotherapy
Description

ChemotherapyPostoperativeAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C28006
UMLS 2011AA Property
C0032790
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Other
Description

AdjuvantTherapyPostoperativeOtherAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15675
UMLS 2011AA ObjectClass
C0677850
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C28006
UMLS 2011AA Property-2
C0032790
NCI Thesaurus Property-3
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Specify (If yes)
Description

AdjuvantTherapyPostoperativeOtherAdministeredSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C15675
UMLS 2011AA ObjectClass
C0677850
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C28006
UMLS 2011AA Property-2
C0032790
NCI Thesaurus Property-3
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
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Similar models

Submit every 6 months from date of randomization for the first 5 years; yearly thereafter, and when a protocol event occurs. Fax Form F to 412-622-2111

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Patient Initials
Item
Patient Initials (Last First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient ID NSABP
Item
NSABP Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)
Item Group
Person Completing Form
CombinedInstitutionName
Item
Institution/Affiliate
text
ResponsiblePersonLastName
Item
Person Completing Form, Last Name
text
ResponsiblePersonFirstName
Item
Person Completing Form, First Name
text
ResponsiblePersonPhoneNumber
Item
Person Completing Form, Phone
text
Date Form Completed
Item
Date Form Completed
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
DataAmendedInd-3
Item
Are data amended
boolean
Item Group
Postoperative Radiation Therapy (RT)
BreastRadiationTherapyPostLumpectomyAdministrationInd-2
Item
Post-lumpectomy breast RT
boolean
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C15755 (NCI Thesaurus Property)
C0024885 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property-2)
C0687676 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ChestWallRadiationTherapyPostMastectomyAdministrationInd-2
Item
Post-mastectomy chest wall RT
boolean
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C62484 (NCI Thesaurus ObjectClass-2)
C0205076 (UMLS 2011AA ObjectClass-2)
C15277 (NCI Thesaurus Property)
C0024881 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property-2)
C0687676 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
RegionalLymphNodeRadiationTherapyAdministrationInd-2
Item
Regional nodal RT
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C49018 (NCI Thesaurus ObjectClass-2)
C1184738 (UMLS 2011AA ObjectClass-2)
Item Group
Postoperative Systemic Adjuvant Therapy
AdjuvantHormoneTherapyPostoperativeAdministeredInd-3
Item
Postoperative Adjuvant Hormonal Therapy
boolean
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C28006 (NCI Thesaurus Property)
C0032790 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
BevacizumabChemotherapyPostoperativeAdministeredInd-2
Item
Postoperative Bevacizumab
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C2039 (NCI Thesaurus ObjectClass-2)
C0796392 (UMLS 2011AA ObjectClass-2)
C28006 (NCI Thesaurus Property)
C0032790 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
TrastuzumabAgentPostoperativeAdministrationInd-2
Item
Postoperative Trastuzumab
boolean
C1647 (NCI Thesaurus ObjectClass)
C0338204 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C28006 (NCI Thesaurus Property)
C0032790 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ChemotherapyPostoperativeAdministeredInd-2
Item
Postoperative Chemotherapy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C28006 (NCI Thesaurus Property)
C0032790 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
AdjuvantTherapyPostoperativeOtherAdministeredInd-2
Item
Other
boolean
C15675 (NCI Thesaurus ObjectClass)
C0677850 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C28006 (NCI Thesaurus Property-2)
C0032790 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
AdjuvantTherapyPostoperativeOtherAdministeredSpecify
Item
Specify (If yes)
text
C15675 (NCI Thesaurus ObjectClass)
C0677850 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C28006 (NCI Thesaurus Property-2)
C0032790 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
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