Pre-Study Breast Cancer SWOG S0307 NCT00127205

SOUTHWEST ONCOLOGY GROUP S0307 PRESTUDY FORM Zoledronate, Clodronate, or Ibandronate in Treating Women Who Have Undergone Surgery for Stage I, Stage II, or Stage III Breast SOUTHWEST ONCOLOGY GROUP S0307 PRESTUDY FORM Zoledronate, Clodronate, or Ibandronate in Treating Women Who Have Undergone Surgery for Stage I, Stage II, or Stage III Breast Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DEA0B902-CDD3-54E6-E034-0003BA12F5E7

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  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0307 PRESTUDY FORM
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative documentation
C1320722 (UMLS CUI-1)
Patient ID SWOG
Item
SWOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
C1549740 (UMLS CUI-1)
C1519429 (UMLS CUI-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)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
C2986440 (UMLS CUI-1)
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)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Disease Description
Item
Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
C1520224 (UMLS CUI-1)
CL.1
Code List
Performance Status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
Item
Histologically confirmed primary invasive adenocarcinoma of the breast
text
C2852 (NCI Thesaurus ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C12971 (NCI Thesaurus ObjectClass-3)
C14159 (NCI Thesaurus ObjectClass-4)
C25458 (NCI Thesaurus Property)
C25527 (NCI Thesaurus Property-2)
C16899 (NCI Thesaurus ValueDomain)
C0001418 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C0205281 (UMLS CUI [1,4])
C0750484 (UMLS CUI [1,5])
CL.2
Code List
Histologically confirmed primary invasive adenocarcinoma of the breast
CL Item
Stage I (Stage I)
C27966 (NCI Thesaurus)
C0441766 (UMLS 2011AA)
CL Item
Stage Ii (Stage II)
C28054 (NCI Thesaurus)
C0441767 (UMLS 2011AA)
CL Item
Stage Iii (Stage III)
C27970 (NCI Thesaurus)
C0441771 (UMLS 2011AA)
Item Group
Laboratory Values
Creatinine, Serum
Item
Serum creatinine
float
C16960 (NCI Thesaurus ObjectClass)
C13325 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C0201976 (UMLS CUI [1])
Creatinine, Serum ULN
Item
Creatinine ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0201976 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
SpecimenCollectedDate
Item
Collection Date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property)
Item
Previous bisphosphonate
text
C443 (NCI Thesaurus ObjectClass)
C0012544 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.3
Code List
Previous bisphosphonate
CL Item
Intravenous: C13346 (IV)
C13346 (NCI Thesaurus)
C0348016 (UMLS 2011AA)
CL Item
Oral (Oral)
C25311 (NCI Thesaurus)
C0442027 (UMLS 2011AA)
CL Item
None: C41132 (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
DentalExamDate
Item
Date of dental examination (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41136 (NCI Thesaurus ObjectClass)
C0226984 (UMLS 2011AA ObjectClass)
Bone Pain
Item
Bone Pain
boolean
C38147 (NCI Thesaurus ValueDomain)
C3303 (NCI Thesaurus Property)
C12366 (NCI Thesaurus ObjectClass)
C0151825 (UMLS CUI-1)
Bone Metastasis
Item
Bone Metastasis
boolean
C9305 (NCI Thesaurus ObjectClass)
C14174 (NCI Thesaurus Property)
C12366 (NCI Thesaurus Property-2)
C25548 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)
C0153690 (UMLS CUI-1)
Item Group
Consent For Submission And Banking
Item
Consent for submission and banking
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C0087095 (NCI Metathesaurus Property)
CL.6
Code List
Consent for submission and banking
CL Item
Accepted Tissue Submission (Accepted tissue submission)
CL Item
Declined Tissue Submission (Declined tissue submission)
CL Item
Accepted Serum Submission (Accepted serum submission)
CL Item
Declined Serum Submission (Declined serum submission)
Item Group
Patient Characteristics
Item
Menopausal status (select one:)
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3231 (NCI Thesaurus Property)
C0025320 (UMLS 2011AA Property)
C3231 (NCI Thesaurus ValueDomain-2)
C0025320 (UMLS 2011AA ValueDomain-2)
CL.7
Code List
Menopausal status (select one:)
CL Item
Pre (<6 Mo Since Lmp And No Prior Bilateral Ovariectomy And Not On Estrogen Replacement) (Pre (< 6 mo since LMP and no prior bilateral ovariectomy and not on estrogen replacement))
CL Item
Post (prior Bilateral Ovariectomy Or >12 Mo Since Lmp With No Prior Hysterectomy) (Post (prior bilateral ovariectomy OR > 12 mo since LMP with no prior hysterectomy))
CL Item
Above Categories Not Applicable And Age <50 (Above not applicable AND age < 50)
CL Item
Above Categories Not Applicable And Age >= 50 (Above not applicable AND age >=50)
Height
Item
Height
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
C0005890 (UMLS CUI [1])
Weight
Item
Body weight
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
C0005910 (UMLS CUI [1])
BSA
Item
Body surface area
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS CUI [1])
Item Group
Disease Description
FirstBiopsyPositiveDate
Item
Date of Initial Diagnosis of Primary Tumor
date
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus ObjectClass-2)
C1279901 (UMLS 2011AA ObjectClass-2)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Tumor Laterality (select one:)
text
C25284 (NCI Thesaurus ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C25185 (NCI Thesaurus Property)
C0441987 (UMLS CUI-1)
C0475445 (UMLS CUI-2)
CL.8
Code List
Tumor Laterality (select one:)
CL Item
Left (Left)
C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)
CL Item
Right (Right)
C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)
CL Item
Bilateral (Bilateral)
C13332 (NCI Thesaurus)
C0238767 (UMLS 2011AA)
Tumor size
Item
Pathologic Primary Tumor Size (cm.)
float
C3262 (NCI Thesaurus ObjectClass)
C25610 (NCI Thesaurus ObjectClass-2)
C25251 (NCI Thesaurus Property)
C25681 (NCI Thesaurus Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0475440 (UMLS CUI-1)
Number of positive lymph nodes
Item
Number of Positive Lymph Nodes (If sentinel node biopsy and axillary node dissection were performed, enter the sum of positive nodes.)
integer
C25246 (NCI Thesaurus Property)
C12745 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0237753 (UMLS CUI-1)
C0746319 (UMLS CUI-2)
Item
ER Status
text
C3262 (NCI Thesaurus ValueDomain)
C17069 (NCI Thesaurus ObjectClass)
C25688 (NCI Thesaurus ValueDomain-2)
C25554 (NCI Thesaurus Property)
C2919271 (UMLS CUI-1)
CL.9
Code List
ER Status
CL Item
Negative (ER-)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (ER+)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
Item
PgR Status
text
C25284 (NCI Thesaurus ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0678257 (NCI Metathesaurus Property)
C2919590 (UMLS CUI-1)
CL.10
Code List
PgR Status
CL Item
Negative (PgR-)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (PgR+)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
HER-2/neu status determined
Item
Was HER-2/neu status determined?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS CUI-1)
Item
If Yes, HER2/neu final diagnosis
text
CL.12
Code List
If Yes, HER2/neu final diagnosis
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Equivocal (Equivocal)
C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)
Item Group
Treatment With Statins
TherapyHMG-CoAReductaseInhibitorAdministeredInd-3
Item
Is the patient currently taking a statin (atorvastatin Lipitor, pravastatin Pravachol, simvastatin Zocor, lovastatin Mevacor, fluvastatin Lescol, rosuvastatin Crestor?)
boolean
C38148 (NCI Thesaurus ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1655 (NCI Thesaurus Property-2)
C1512699 (UMLS CUI-1)
C1521801 (UMLS CUI-2)
C0360714 (UMLS CUI-3)
Item
Length of time on statin
text
C15368 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25330 (NCI Thesaurus ValueDomain)
C0449238 (UMLS 2011AA ValueDomain)
C1655 (NCI Thesaurus Property-2)
C0360714 (UMLS 2011AA Property-2)
CL.14
Code List
Length of time on statin
CL Item
< 1 Yr (< 1 yr)
CL Item
1-2 Yrs (1-2 yrs)
CL Item
2-3 Yrs (2-3 yrs)
CL Item
3-4 Yrs (3-4 yrs)
CL Item
>4 Yrs (>4 yrs)
Item Group
Patient Preference
Item
If oral and intravenous bisphosphonates are equally effective in preventing breast cancer recurrence in the bone, which would the patient prefer to receive? (Note that the answer to this question will not in any way affect which treatment the patient is randomly assigned to on this study.)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C443 (NCI Thesaurus Property)
C0012544 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
CL.15
Code List
If oral and intravenous bisphosphonates are equally effective in preventing breast cancer recurrence in the bone, which would the patient prefer to receive? (Note that the answer to this question will not in any way affect which treatment the patient is randomly assigned to on this study.)
CL Item
Oral (Oral)
C25311 (NCI Thesaurus)
C0442027 (UMLS 2011AA)
CL Item
Intravenous (Intravenous)
X-MO-6794 (MGED)
Item Group
Prior Treatment Related To This Cancer
Item
Most Extensive Primary Surgery (select one:)
text
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C15329 (NCI Thesaurus ObjectClass-3)
C0543467 (UMLS 2011AA ObjectClass-3)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.16
Code List
Most Extensive Primary Surgery (select one:)
CL Item
Partial Mastectomy, Lumpectomy Or Excisional Biopsy (Partial mastectomy/lumpectomy/excisional biopsy)
CL Item
Mastectomy, Nos (Mastectomy, NOS)
Primary surgery Date
Item
Date of surgery
date
C25251 (NCI Thesaurus ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C25275 (NCI Thesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C1628561 (UMLS CUI [1])
SentinelNodeBiopsyInd-3
Item
Was sentinel node sampling performed?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
SentinelNodeBiopsyDate
Item
Sentinel Node Biopsy Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
Item
Sentinel Node Biopsy Results
text
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25218 (NCI Thesaurus ValueDomain)
C1948041 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
CL.18
Code List
Sentinel Node Biopsy Results
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
AxillaryNodeDissectionPerformedInd-3
Item
Was axillary dissection performed?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
AxillarySurgeryDissectionDate
Item
Date of Axillary Dissection
date
C13351 (NCI Thesaurus ObjectClass)
C0004454 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Systemic Treatment For This Cancer
Item
Chemotherapy (select one:)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
CL.20
Code List
Chemotherapy (select one:)
CL Item
Currently Receiving (Currently receiving)
CL Item
Planned (Planned)
C25619 (NCI Thesaurus)
C1301732 (UMLS 2011AA)
CL Item
Not Planned (Not planned)
CL Item
Completed (Completed)
ChemotherapyAdministeredEndDate
Item
Date chemotherapy completed (If completed,)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Hormone therapy (select one:)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.21
Code List
Hormone therapy (select one:)
CL Item
Currently Receiving (Currently receiving)
CL Item
Planned (Planned)
C25619 (NCI Thesaurus)
C1301732 (UMLS 2011AA)
CL Item
Not Planned (Not planned)
Item
If currently receiving
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.22
Code List
If currently receiving
CL Item
Serm (SERM)
CL Item
Aromatase Inhibitor (Aromatase inhibitor)
C1740 (NCI Thesaurus)
C0593802 (UMLS 2011AA)
CL Item
Ovarian Suppression (Ovarian suppression)
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