INSTRUCTIONS: Complete all information on this form. Submit within one week of registration along with the On-Study Form.

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
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)
Item Group
Patient demographics
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)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
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 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)
Item Group
Eligibility Criteria
Item
Eligibility criteria
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25442 (NCI Thesaurus ObjectClass-2)
C1516238 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25532 (NCI Thesaurus Property-2)
C1512693 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Eligibility criteria
CL Item
>= 18 Years Of Age (>= 18 years of age)
CL Item
>= 2 Weeks Since Prior Radiotherapy And All Toxicities Resolved (>= 2 weeks since prior radiotherapy and all toxicities resolved)
CL Item
Beta-hcg Negative (in Premenopausal Women) (Beta-Hcg negative (in premenopausal women))
CL Item
Bilirubin <= 1.5 X Uln Unless Due To Gilbert's Syndrome (Bilirubin <= 1.5 x ULN unless due to Gilbert's Syndrome)
CL Item
Bisphosphonate Therapy Allowed (Bisphosphonate therapy allowed)
CL Item
Creatinine <= 2.0 Mg/dl (Creatinine <= 2.0 mg/dl)
CL Item
Ecog (zubrod) Ps <= 1; Life Expectancy >=12 Wk (ECOG (Zubrod) PS <= 1; life expectancy >=12 wk)
CL Item
Granulocytes >= 1000/ul (Granulocytes >= 1000/ul)
CL Item
Histologic Dx Of Primary, Metastatic Stage Iv Or Locally Advanced, Unresectable Stage Iiib Cancer Of The Female Breast (using Ajcc Criteria, 6th Edition) Not Amenable To Local Therapy (Histologic dx of primary, metastatic Stage IV or locally advanced, unresectable Stage IIIB cancer of the female breast (using AJCC criteria, 6th edition) not amenable to local therapy)
CL Item
Inr <= 1.6, Unless On Full Dose Warfarin (INR <= 1.6, unless on full dose warfarin)
CL Item
Measurable/non-measurable Disease By Recist Criteria (Measurable/non-measurable disease by RECIST criteria)
CL Item
No Arterial Thrombotic Events, Tia, Cva, Acute Mi Or Unstable Angina Within 6 Months Of Registration (No arterial thrombotic events, TIA, CVA, acute MI or unstable angina within 6 months of registration)
CL Item
No Clinically Significant Cardiovascular Disease (No clinically significant cardiovascular disease)
CL Item
No Concurrent Active Secondary Malignancy (No concurrent active secondary malignancy)
CL Item
No History Of Abdominal Fistula Or Intraabdominal Abscess Within 6 Months Nor Gi Perforation Within 12 Months Of Registration (No history of abdominal fistula or intraabdominal abscess within 6 months nor GI perforation within 12 months of registration)
CL Item
No History Of Significant Bleeding Within 6 Months Of Registration (No history of significant bleeding within 6 months of registration)
CL Item
No Known Allergies To Aromatase Inhibitors Or Estrogen Receptor Modulators (No known allergies to aromatase inhibitors or estrogen receptor modulators)
CL Item
No Known Cns Metastases (No known CNS metastases)
CL Item
No Major Surgery Within 28 Days Of Registration (No major surgery within 28 days of registration)
CL Item
No Prior Bevacizumab Or Anti-vegf Therapy (No prior bevacizumab or anti-VEGF therapy)
CL Item
No Prior Chemotherapy For Metastatic Disease (No prior chemotherapy for metastatic disease)
CL Item
No Serious, Non-healing Wound, Ulcer Or Bone Fx (No serious, non-healing wound, ulcer or bone fx)
CL Item
Ovarian Suppression Required For Premenopausal Women (Ovarian suppression required for premenopausal women)
CL Item
Patients On Full Dose Anticoagulant Must Be On A Stable Dose Of Warfarin (Patients on full dose anticoagulant must be on a stable dose of warfarin)
CL Item
Platelet Count >= 100,000/ul (Platelet count >= 100,000/ul)
CL Item
Prior Adjuvant Or Neoadjuvant Chemotherapy Allowed (Prior adjuvant or neoadjuvant chemotherapy allowed)
CL Item
Prior Endocrine Therapy Not Required, But Is Permitted In Adjuvant Setting; No Prior Endocrine Therapy For Metastatic Disease Unless Initiated Within 4 Weeks Prior To Protocol Registration (Prior endocrine therapy not required, but is permitted in adjuvant setting; No prior endocrine therapy for metastatic disease unless initiated within 4 weeks prior to protocol registration)
CL Item
Transaminases (alt, Ast) <= 2.5 X Uln (Transaminases (ALT, AST) <= 2.5 x ULN)
CL Item
Tumors That Are Er And/or Pgr Positive (Tumors that are ER and/or PgR positive)
CL Item
Urinalysis <= 1+ Protein (Urinalysis <= 1+ protein)
CL Item
Women Can Be Either Pre- Or Postmenopausal (Women can be either pre- or postmenopausal)
Item Group
Footer Module
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 (MM DD YYYY)
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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