TREATMENT AND RESPONSE SUMMARY FORM Breast Cancer (NCT00390455)

CALGB 40302 TREATMENT AND RESPONSE SUMMARY FORM (SUBSET OF PATIENTS) Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive NCT00390455 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F5BC1727-9755-553F-E034-0003BA3F9857

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink.

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Form ID CALGB
Item
CALGB Form
text
C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)
Protocol ID CALGB
Item
CALGB Study No
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Reporting Period End Date
Item
Last date of reporting period
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient Hospital No
Item
Patient Hospital No
text
C25337 (NCI Thesaurus ValueDomain)
C0421459 (UMLS CUI-1)
C16960 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C16696 (NCI Thesaurus ObjectClass)
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)
Participating Group
Item
Participating Group
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 Protocol 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)
Follow-Up Date
Item
Date of last clinical assessment
date
C9305 (NCI Thesaurus ObjectClass)
C3694716 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Lapatinib/placebo
Cycle Number Chemotherapeutics
Item
Current cycle number
text
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25471 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property-2)
Chemotherapy Cycle Start Date
Item
Cycle start date
date
C25164 (NCI Thesaurus ValueDomain)
C1302181 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain-2)
C3173309 (UMLS CUI-2)
C25379 (NCI Thesaurus Property)
Chemotherapy Cycle End Date
Item
Cycle end date
date
C25164 (NCI Thesaurus ValueDomain)
C1302181 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0806020 (UMLS CUI-2)
PillsReceivedCount
Item
Number of tablets issued
text
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25394 (NCI Thesaurus ObjectClass)
C0994475 (UMLS 2011AA ObjectClass)
Agent dose prescribed
Item
Prescribed dose
float
C28180 (NCI Thesaurus ObjectClass)
C0678766 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass-2)
C0278329 (UMLS CUI-2)
C25256 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ValueDomain-2)
PillsRemainingCount
Item
Number of tablets remaining
float
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25394 (NCI Thesaurus ObjectClass)
C0994475 (UMLS 2011AA ObjectClass)
C25649 (NCI Thesaurus Property)
C1527428 (UMLS 2011AA Property)
AgentActualDose
Item
Actual Dose
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25274 (NCI Thesaurus ObjectClass-2)
C0237400 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Dose Modification (Change)
text
C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)
Code List
Dose Modification (Change)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
DoseModificationAmount
Item
Modified Dose
float
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25417 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)
PlannedDoseModificationSpecify
Item
Specify reason for modification
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25619 (NCI Thesaurus ObjectClass)
C1301732 (UMLS 2011AA ObjectClass)
C25488 (NCI Thesaurus ObjectClass-2)
C0178602 (UMLS 2011AA ObjectClass-2)
C25572 (NCI Thesaurus Property)
DoseDelayedInd-3
Item
Were there any delays in dose administration
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25477 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
Treatment delay duration
Item
Number of days delayed
float
C25301 (NCI Thesaurus ValueDomain)
C0087111 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain-2)
C2985752 (UMLS CUI-2)
C25476 (NCI Thesaurus Property)
BladderTreatmentDelayedCycleReason
Item
Specify reason for delay
text
C12414 (NCI Thesaurus ObjectClass)
C0005682 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25477 (NCI Thesaurus Property)
C25472 (NCI Thesaurus Property-2)
C1511572 (UMLS 2011AA Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
Item Group
Fluvestrant
FulvestrantAgentFirstDayAdministeredDose
Item
Dose day 1
float
C1379 (NCI Thesaurus ObjectClass)
C0701491 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25301 (NCI Thesaurus Property)
C0439228 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
FulvestrantAgentFirstCourseAdministeredDose
Item
Dose day 15 cycle 1 (cycle 1 only)
float
C1379 (NCI Thesaurus ObjectClass)
C0701491 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25379 (NCI Thesaurus Property-2)
C0750729 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
TreatmentDelayedReasonText
Item
Specify reason for delay
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item Group
Laboratory Values
HeartLVEFTestPercentageValue
Item
Heart LVEF Test Percentage Value (%)
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
INR
Item
Lab, Hematology, INR
float
C20200 (NCI Thesaurus Property)
C0525032 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25352 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
LaboratoryProcedureGranulocyteResultCount
Item
Peripheral Granulocytes Count
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12530 (NCI Thesaurus Property-2)
C0018183 (UMLS 2011AA Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
HematologyPlateletLabUnspecifiedValue
Item
Peripheral Platelet Count
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
RenalCreatinineLabSpecifiedValue
Item
Creatinine
float
C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
HepaticBilirubinLabValue
Item
Bilirubin
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property-2)
C0005437 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
HepaticSGOT(AST)LabUnspecifiedValue
Item
Lab, Hepatic, SGOT
float
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property-2)
C0022877 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
HepaticSGPT(ALT)LabUnspecifiedValue
Item
Lab, Hepatic, SGPT
float
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Item Group
Response Assessment
TumorResponseInd-3
Item
Has the patient achieved a response?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25755 (NCI Thesaurus ValueDomain-2)
C0871261 (UMLS 2011AA ValueDomain-2)
Partial Response First Observed Date
Item
Partial response first observed date (PR)
date
C25755 (NCI Thesaurus ObjectClass)
C1521726 (UMLS CUI-1)
C25378 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Complete Response First Observed Date
Item
Complete response first observed date (CR)
date
C25755 (NCI Thesaurus ObjectClass)
C0677874 (UMLS CUI-1)
C25250 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
DiseaseNewProgressionInd-2
Item
Has the patient been diagnosed with a new progression (during this reporting period not previously reported?)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25331 (NCI Thesaurus Property-2)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
SpecimenNotSubmittedSpecify
Item
No, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25695 (NCI Thesaurus Property-2)
C1515023 (UMLS 2011AA Property-2)
ResponseLastDocumentedDate
Item
Date response last documented
date
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25356 (NCI Thesaurus Property-2)
C1301725 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Yes,specify
Item
Yes, specify
text
ProgressionFirstObservedDate
Item
Progressive disease first observed date (PD)
date
C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property-2)
C1441672 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Progressive disease documentation (Mark one with an X.)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus ObjectClass)
C25466 (NCI Thesaurus Property)
C0243161 (UMLS 2011AA Property)
Code List
Progressive disease documentation (Mark one with an X.)
CL Item
Target Lesions (at Least A 20% Increase In The Sum Of Longest Diameters Of Target Lesions, Taking As Reference The Smallest Sum Recorded Since The Treatment Started) (Target lesions)
CL Item
Nontarget Lesions (unequivocal Progression Of Existing Nontarget Lesions) (Nontarget lesions)
CL Item
Progressive Disease Defined By New Lesions (Appearance of one or more new lesions)
CL Item
Other, Specify (Other)
ProgressionAssessmentSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25331 (NCI Thesaurus ObjectClass)
Person Completing Form
Item
Completed by (Last name, First name)
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
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)

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