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

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
Form completed by
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)
Item
Are data amended
text
Code List
Are data amended
CL Item
Yes (yes)
Item Group
Breast
SurgicalProcedureBreastNeoplasmPerformedInd-2
Item
Was primary breast surgery performed
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C2910 (NCI Thesaurus Property-2)
C0042875 (UMLS 2011AA Property-2)
PrimaryBreastNeoplasmSurgicalProcedurePerformedDate
Item
Date of procedure (primary breast surgery)
date
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C2910 (NCI Thesaurus ObjectClass-3)
C0042875 (UMLS 2011AA ObjectClass-3)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Type of procedure performed (provide pathology report)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C2910 (NCI Thesaurus Property-2)
C0042875 (UMLS 2011AA Property-2)
Code List
Type of procedure performed (provide pathology report)
CL Item
Lumpectomy (Lumpectomy)
C15755 (NCI Thesaurus)
C0024885 (UMLS 2011AA)
CL Item
Mastectomy (Mastectomy)
C15277 (NCI Thesaurus)
C0024881 (UMLS 2011AA)
InvasiveBreastCarcinomaHistologicallyConfirmedInd-2
Item
Was there any histologic evidence of invasive tumor cells in the surgical breast specimen
boolean
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C14159 (NCI Thesaurus ObjectClass-2)
C0205281 (UMLS 2011AA ObjectClass-2)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25527 (NCI Thesaurus Property-2)
C0205462 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
DuctalBreastCarcinomainSituHistologicallyConfirmedInd-2
Item
Was there any histologic evidence of DCIS in the surgical breast specimen
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C2924 (NCI Thesaurus ObjectClass)
C0007124 (UMLS 2011AA ObjectClass)
C25527 (NCI Thesaurus Property-2)
C0205462 (UMLS 2011AA Property-2)
EpidermalGrowthFactorReceptorAssessmentInd-2
Item
Was HER-2/neu status determined (from surgical breast specimen)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25217 (NCI Thesaurus Property)
C1516048 (UMLS 2011AA Property)
C17068 (NCI Thesaurus ObjectClass)
C0034802 (UMLS 2011AA ObjectClass)
Item
HER-2/neu status (if yes)
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)
Code List
HER-2/neu status (if yes)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
HormoneReceptorAssayIndicator
Item
Was receptor status determined (ER or PgRfrom surgical breast specimen?)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16341 (NCI Thesaurus Property)
C0005507 (UMLS 2011AA Property)
C28154 (NCI Thesaurus ObjectClass)
C0019929 (UMLS 2011AA ObjectClass)
Item
Receptor Status, ER (If yes,)
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)
Code List
Receptor Status, ER (If yes,)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Receptor Status, PgR
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)
Code List
Receptor Status, PgR
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Axilla
LymphNodeAssessedInd-2
Item
Was patient nodal status determined
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25217 (NCI Thesaurus Property)
C1516048 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
CoreBiopsyFine-NeedleAspirationSentinelLymphNodeLymphNodeBiopsyPriorClinicalStudyPerformedInd-2
Item
Was FNA or core biopsy or sentinel node biopsy of axillary nodes performed before initiation of therapy
boolean
C15680 (NCI Thesaurus ObjectClass)
C1318309 (UMLS 2011AA ObjectClass)
C12947 (NCI Thesaurus ObjectClass-2)
C1522495 (UMLS 2011AA ObjectClass-2)
C15361 (NCI Thesaurus ObjectClass-3)
C1510483 (UMLS 2011AA ObjectClass-3)
C62658 (NCI Thesaurus ObjectClass-4)
C0398434 (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)
CoreBiopsyFine-NeedleAspirationSentinelLymphNodeAxillaryLymphNodeBiopsyPositiveFindingInd-2
Item
Was the cytology/biopsy positive (If yes,)
boolean
C15680 (NCI Thesaurus ObjectClass)
C1318309 (UMLS 2011AA ObjectClass)
C12947 (NCI Thesaurus ObjectClass-2)
C1522495 (UMLS 2011AA ObjectClass-2)
C15361 (NCI Thesaurus ObjectClass-3)
C1510483 (UMLS 2011AA ObjectClass-3)
C62658 (NCI Thesaurus ObjectClass-4)
C0398434 (UMLS 2011AA ObjectClass-4)
C38758 (NCI Thesaurus Property)
C1514241 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Axillary Staging Method (provide applicable pathology reports)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
C16899 (NCI Thesaurus ObjectClass-2)
C1300072 (UMLS 2011AA ObjectClass-2)
Code List
Axillary Staging Method (provide applicable pathology reports)
CL Item
Sentinel Node Biopsy Alone (Sentinel node biopsy alone)
CL Item
Sentinel Node Biopsy Followed By Surgical Evaluation Of Axilla (Sentinel node biopsy followed by surgical evaluation of axilla)
CL Item
Surgical Evaluation Of The Axilla Without Prior Sentinel Node Biopsy (Surgical evaluation of the axilla without prior sentinel node biopsy)
AxillaryNodeExaminedTotalCount
Item
Total number examined (Axillary Nodes Both Sentinel and Non-Sentinel)
float
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
PositiveAxillaryNodeExaminedTotalCount
Item
Number of positive axillary lymph nodes
float
C25246 (NCI Thesaurus ObjectClass)
C1446409 (UMLS 2011AA ObjectClass)
C12904 (NCI Thesaurus ObjectClass-2)
C0729594 (UMLS 2011AA ObjectClass-2)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
NotAxillarySentinelLymphNodeExaminedCount
Item
Number Examined (Non-Axillary Sentinel Nodes)
float
C25594 (NCI Thesaurus ObjectClass)
C1518422 (UMLS 2011AA ObjectClass)
C13351 (NCI Thesaurus ObjectClass-2)
C0004454 (UMLS 2011AA ObjectClass-2)
C12947 (NCI Thesaurus ObjectClass-3)
C1522495 (UMLS 2011AA ObjectClass-3)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
NotAxillarySentinelNodePositiveAssessmentCount
Item
Number Positive (Non-Axillary Sentinel Nodes)
float
C25594 (NCI Thesaurus ObjectClass)
C1518422 (UMLS 2011AA ObjectClass)
C13351 (NCI Thesaurus ObjectClass-2)
C0004454 (UMLS 2011AA ObjectClass-2)
C12947 (NCI Thesaurus ObjectClass-3)
C1522495 (UMLS 2011AA ObjectClass-3)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C0205159 (NCI Metathesaurus Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

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