Breast Cancer NCT00016276 Treatment - CALGB: 49808 TREATMENT SUMMARY FORM HERCEPTIN VS OBSERVATION - 2032660v3.0
Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer NCT00016276 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9E35395C-8C3D-227A-E034-080020C9C0E0

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  1. StudyEvent: CALGB: 49808 TREATMENT SUMMARY FORM HERCEPTIN VS OBSERVATION
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
CALGBForm
Item
CALGB Form
text
CALGBProtocolNumber
Item
CALGB Study No
text
CALGBPatientID
Item
CALGB Patient ID
text
Data amended
Item
Amended data?
boolean
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
C0680532 (UMLS CUI-1)
Patient Name
Item
Patient's Name
text
C1299487 (UMLS CUI-1)
ParticipatingGroup
Item
Participating Group
text
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientHospitalNumber
Item
Patient Hospital Number
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
MainMemberInstitution/Adjunct
Item
Main Member Institution/Adjunct
text
ParticipatingGroupPatientNo.
Item
Participating Group Patient No.
text
Comments
Item
Comments
text
Item Group
Treatment Plan
Herceptin
Item
Is patient taking Herceptin?
boolean
C0338204 (UMLS CUI-1)
Initialdosethisreportingperiod
Item
Initial dose this reporting period (Total dose in mg Herceptin if randomized)
text
Therapy end date
Item
Last date protocol therapy was given
date
C25164 (NCI Thesaurus ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1531784 (UMLS CUI-1)
Number of completed weeks
Item
Number of completed weeks during this reporting period
integer
Item
Reason Treatment Ended (mark one with an X)
text
Code List
Reason Treatment Ended (mark one with an X)
CL Item
Not applicable (Not applicable)
CL Item
Treatment completed per protocol criteria (Treatment completed per protocol criteria)
CL Item
Disease progression/relapse during active treatment (Disease progression/relapse during active treatment)
CL Item
Toxicity/side effects/complications (Toxicity/side effects/complications)
CL Item
Death on study (Death on study)
CL Item
Patient withdrawal or refusal after beginning protocol therapy (Patient withdrawal or refusal after beginning protocol therapy)
CL Item
Patient withdrawal or refusal prior to beginning protocol therapy (Patient withdrawal or refusal prior to beginning protocol therapy)
CL Item
Alternative therapy (Alternative therapy)
CL Item
Other complicating disease (Other complicating disease)
CL Item
Other, specify (Other, specify)
ReasonTreatmentEndedOther,specify
Item
Reason Treatment Ended Other, specify
text
Item Group
Treatment Schedule - Systemic Therapy
Item
Were there any dose modifications or additions/ omissions to protocol treatment? (mark one with an X)
text
C1705236 (UMLS CUI-1)
Code List
Were there any dose modifications or additions/ omissions to protocol treatment? (mark one with an X)
CL Item
No (0)
C1298908 (UMLS CUI-1)
CL Item
Yes, planned (1)
C1705108 (UMLS CUI-1)
C1301732 (UMLS CUI-2)
CL Item
Yes, Unplanned (2)
Optional protocol therapies
Item
Were any optional protocol therapies given?
boolean
OptionalProtocolTherapyName
Item
Optional Protocol Therapy Name
text
Non-protocol Therapy
Item
Were any non-protocol therapies given during protocol treatment?
boolean
C1518384 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
ConcurrentNon-ProtocolChemotherapyInd
Item
Concurrent Non-Protocol Chemotherapy?
boolean
ConcurrentNon-ProtocolHormonalTherapyInd
Item
Concurrent Non-Protocol Hormonal Therapy?
boolean
ConcurrentNon-ProtocolBRMInd
Item
Concurrent Non-Protocol Biologic Response Modifier Therapy?
boolean
ConcurrentNon-ProtocolRTInd
Item
Concurrent Non-Protocol Radiation Therapy?
boolean
ConcurrentNon-ProtocolHDC/ASCTInd
Item
Concurrent Non-Protocol High Dose Chemotherapy/Autologous Stem Cell Transplant?
boolean
PastTamoxifenInd
Item
Did this patient receive any tamoxifen?
boolean
Tamoxifen
Item
Did patient begin taking tamoxifen during this reporting period? (If Yes)
boolean
C0039286 (UMLS CUI-1)
Tamoxifen start date
Item
If Yes, date tamoxifen started
date
CurrentTamoxifenInd
Item
Is the patient still receiving tamoxifen?
boolean
Tamoxifen discontinuation date
Item
If patient discontinued tamoxifen since last follow-up, give date.
date