Item
Has informed consent been obtained for Pharmacogenetic Research?
text
C0021430 (UMLS CUI [1])
Code List
Has informed consent been obtained for Pharmacogenetic Research?
Date informed consent obtained
Item
Date informed consent obtained for Pharmacogenetic Research
date
C0514044 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If NO, specify reason below, check one:
text
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Code List
If NO, specify reason below, check one:
CL Item
Subject declined (SD)
CL Item
Subject not asked by investigator (SI)
Item
Has a blood sample been collected for Pharmacogenetic Research?
text
C0005834 (UMLS CUI [1])
Code List
Has a blood sample been collected for Pharmacogenetic Research?
Date sample taken
Item
Date sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
Item
Has this subject withdrawn consent for Pharmacogenetic Research?
text
C2349954 (UMLS CUI [1])
Code List
Has this subject withdrawn consent for Pharmacogenetic Research?
Item
Has a request been made for sample destruction?
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Code List
Has a request been made for sample destruction?
Item
If YES, check one reason:
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Code List
If YES, check one reason:
CL Item
Subject’s request (R)
CL Item
Screen failure (F)
Item
Has informed consent been obtained for Pharmacogenetic Research?
text
C0021430 (UMLS CUI [1])
Code List
Has informed consent been obtained for Pharmacogenetic Research?
Date informed consent obtained
Item
Date informed consent obtained for Pharmacogenetic Research
date
C0514044 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If NO, specify reason below, check one:
text
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Code List
If NO, specify reason below, check one:
CL Item
Subject declined (SD)
CL Item
Subject not asked by investigator (SI)
Item
Has a tumor sample been collected for Pharmacogenetic Research?
text
C0475358 (UMLS CUI [1])
Code List
Has a tumor sample been collected for Pharmacogenetic Research?
Date tumor sample taken
Item
Date tumor sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0475358 (UMLS CUI [1,3])
Item
Has this subject withdrawn consent for Pharmacogenetic Research?
text
C2349954 (UMLS CUI [1])
Code List
Has this subject withdrawn consent for Pharmacogenetic Research?
Item
Has the subject provided signed informed consent?
text
C0021430 (UMLS CUI [1])
Code List
Has the subject provided signed informed consent?
Item
Does the subject have histologically or cytologically confirmed invasive breast cancer with stage IIIb, stage IIIc with T4 lesion, or stage IV disease?
text
C0853879 (UMLS CUI [1])
C0278488 (UMLS CUI [2])
Code List
Does the subject have histologically or cytologically confirmed invasive breast cancer with stage IIIb, stage IIIc with T4 lesion, or stage IV disease?
Item
Does the subject have documentation of ErbB2 overexpression (IHC 3+ or IHC 2+ with FISH confirmation) based on local, central laboratory or initial diagnostic results?
text
C1515559 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0853879 (UMLS CUI [2])
Code List
Does the subject have documentation of ErbB2 overexpression (IHC 3+ or IHC 2+ with FISH confirmation) based on local, central laboratory or initial diagnostic results?
Item
Does the subject have documented progressive advanced or metastatic breast cancer?
text
C0278488 (UMLS CUI [1])
C0853879 (UMLS CUI [2])
Code List
Does the subject have documented progressive advanced or metastatic breast cancer?
Item
Subjects must have refractory breast cancer defined as progression in the metastatic setting after prior therapy which must include: At least 4 cycles of anthracycline- and taxane-containing regimens (concurrently or sequentially) At least 2 cycles, provided disease progresssion occurred while on the respective anthracycline or taxane containing chemotherapy regimen(s) Subjects who relapse > 6 months after completion of adjuvant anthracycline- containing chemotherapy, and for whom further anthracycline therapy is not indicated, are eligible for the study if the remaining inclusion criteria are met. Check YES if this is applicable for the subject. NOTE: Prior treatment with capecitabine is not permitted.
text
C0678222 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
Code List
Subjects must have refractory breast cancer defined as progression in the metastatic setting after prior therapy which must include: At least 4 cycles of anthracycline- and taxane-containing regimens (concurrently or sequentially) At least 2 cycles, provided disease progresssion occurred while on the respective anthracycline or taxane containing chemotherapy regimen(s) Subjects who relapse > 6 months after completion of adjuvant anthracycline- containing chemotherapy, and for whom further anthracycline therapy is not indicated, are eligible for the study if the remaining inclusion criteria are met. Check YES if this is applicable for the subject. NOTE: Prior treatment with capecitabine is not permitted.
Item
Prior treatment must contain trastuzumab (Herceptin®) alone or in combination with other chemotherapy for at least 6 weeks of standard doses unless the trastuzumab local label requirements indicate the subject is not eligible for trastuzumab treatment.
text
C1514463 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
Code List
Prior treatment must contain trastuzumab (Herceptin®) alone or in combination with other chemotherapy for at least 6 weeks of standard doses unless the trastuzumab local label requirements indicate the subject is not eligible for trastuzumab treatment.
Item
Subjects with hormone receptor positive tumors must have disease progression following hormonal therapy unless intolerant to hormonal therapy or hormonal therapy is not considered to be clinically appropriate.
text
C1563119 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
Code List
Subjects with hormone receptor positive tumors must have disease progression following hormonal therapy unless intolerant to hormonal therapy or hormonal therapy is not considered to be clinically appropriate.
Item
Subject has no CNS metastases or has stable CNS metastases (asymptomatic and off systemic steroids and anticonvulsants for at least 3 months) are eligible.
text
C0686377 (UMLS CUI [1])
Code List
Subject has no CNS metastases or has stable CNS metastases (asymptomatic and off systemic steroids and anticonvulsants for at least 3 months) are eligible.
Item
Is the subject female 18 years of age or older?
text
C0001779 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Code List
Is the subject female 18 years of age or older?
Item
Does the subject have an ECOG Performance status of 0 or 1?
text
C1520224 (UMLS CUI [1])
Code List
Does the subject have an ECOG Performance status of 0 or 1?
Item
Does the subject have measurable disease according to RECIST (Response Evaluation Criteria in Solid Tumors)?
text
C1513041 (UMLS CUI [1,1])
C1709926 (UMLS CUI [1,2])
Code List
Does the subject have measurable disease according to RECIST (Response Evaluation Criteria in Solid Tumors)?
Item
Does the subject have archived tumor tissue available to re-evaluate intra- tumoral expression levels of ErbB1 and ErbB2 by IHC and FISH testing performed by the study central laboratory? NOTE: Central laboratory results will not be used to determine subject eligibility for the study, unless testing is being used for required documentation of ErbB2 overexpression.
text
C0003738 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
Code List
Does the subject have archived tumor tissue available to re-evaluate intra- tumoral expression levels of ErbB1 and ErbB2 by IHC and FISH testing performed by the study central laboratory? NOTE: Central laboratory results will not be used to determine subject eligibility for the study, unless testing is being used for required documentation of ErbB2 overexpression.
Item
Does the subject have a life expectancy of ≥12 weeks?
text
C0023671 (UMLS CUI [1])
Code List
Does the subject have a life expectancy of ≥12 weeks?
Item
Has the subject recovered from clinically significant side effects associated with prior radiotherapy and chemotherapy?
text
C2004454 (UMLS CUI [1])
C0001688 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0001688 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
Code List
Has the subject recovered from clinically significant side effects associated with prior radiotherapy and chemotherapy?
Item
Measurable lesions may be in the field of prior irradiation. However, there must be at least a 4-week period between the last radiation treatment and the baseline scan documenting disease status for the lesion to be measurable.
text
C1522449 (UMLS CUI [1])
Code List
Measurable lesions may be in the field of prior irradiation. However, there must be at least a 4-week period between the last radiation treatment and the baseline scan documenting disease status for the lesion to be measurable.
Item
Does the subject have a cardiac ejection fraction within the institutional range of normal as measured by echocardiogram (or MUGA if echocardiogram is not available)?
text
C0232174 (UMLS CUI [1])
Code List
Does the subject have a cardiac ejection fraction within the institutional range of normal as measured by echocardiogram (or MUGA if echocardiogram is not available)?
swallow and retain oral medication
Item
Is the subject able to swallow and retain oral medication?
text
C0175795 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
Item
Has the subject completed all screening assessments as outlined in the protocol?
text
C1710477 (UMLS CUI [1])
Code List
Has the subject completed all screening assessments as outlined in the protocol?
Item
Does the subject have adequate Renal Function defined as a Creatinine Clearance ≥50mL/min, determined by calculated creatinine clearance using Cockcroft and Gault Method and normalized to Body Surface Area (BSA)?
text
C0232804 (UMLS CUI [1])
Code List
Does the subject have adequate Renal Function defined as a Creatinine Clearance ≥50mL/min, determined by calculated creatinine clearance using Cockcroft and Gault Method and normalized to Body Surface Area (BSA)?
Item
Does the subject have adequate hematologic and hepatic function as defined below?
text
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
Code List
Does the subject have adequate hematologic and hepatic function as defined below?
Item
Is the subject pregnant, or a lactating female, or planning to become pregnant during the study?
text
C0549206 (UMLS CUI [1])
Code List
Is the subject pregnant, or a lactating female, or planning to become pregnant during the study?
Item
Does the subject have Malabsorption Syndrome, disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, or ulcerative colitis?
text
C0024523 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
Code List
Does the subject have Malabsorption Syndrome, disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, or ulcerative colitis?
Item
Does the subject have a history of other malignancy? NOTE: A subject who has been disease-free for 5 years, or has a history of completely resected non-melanoma skin cancer or has been successfully treated for in situ carcinoma is eligible.
text
C0027651 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Code List
Does the subject have a history of other malignancy? NOTE: A subject who has been disease-free for 5 years, or has a history of completely resected non-melanoma skin cancer or has been successfully treated for in situ carcinoma is eligible.
Item
Does the subject have a concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject’s safety?
text
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
Code List
Does the subject have a concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject’s safety?
Item
Does the subject have unresolved or unstable, serious toxicity from prior administration of another investigational drug?
text
C0013221 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Code List
Does the subject have unresolved or unstable, serious toxicity from prior administration of another investigational drug?
Item
Does the subject have active or uncontrolled infection?
text
C0009450 (UMLS CUI [1])
Code List
Does the subject have active or uncontrolled infection?
Item
Does the subject have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent?
text
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Code List
Does the subject have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent?
Item
Does the subject have a known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure?
text
C0018799 (UMLS CUI [1])
Code List
Does the subject have a known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure?
Item
Is the subject taking coumarin-derivative anticoagulants such as warfarin and phenprocoumon?
text
C0003280 (UMLS CUI [1])
C0010207 (UMLS CUI [2])
Code List
Is the subject taking coumarin-derivative anticoagulants such as warfarin and phenprocoumon?
Item
Does the subject have a known history of, or clinical evidence of leptomeningeal carcinomatosis?
text
C0220654 (UMLS CUI [1])
Code List
Does the subject have a known history of, or clinical evidence of leptomeningeal carcinomatosis?
Item
Is the subject receiving concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than capecitabine?
text
C0920425 (UMLS CUI [1])
Code List
Is the subject receiving concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than capecitabine?
Item
Bisphosphonates should not be initiated following first dose of study medication for the treatment of bone metastases. Additionally, bisphosphonates for prophylactic use in subjects without bone disease is not permitted.
text
C0012544 (UMLS CUI [1])
Code List
Bisphosphonates should not be initiated following first dose of study medication for the treatment of bone metastases. Additionally, bisphosphonates for prophylactic use in subjects without bone disease is not permitted.
Item
Is the subject receiving concurrent treatment with an investigational agent or participating in another clinical trial?
text
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Code List
Is the subject receiving concurrent treatment with an investigational agent or participating in another clinical trial?
Item
Has the subject used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of randomized therapy?
text
C0013230 (UMLS CUI [1])
Code List
Has the subject used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of randomized therapy?
Item
Does the subject have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GW572016 or excipients of GW572016?
text
C0020517 (UMLS CUI [1,1])
C1384663 (UMLS CUI [1,2])
C0231191 (UMLS CUI [2,1])
C1384663 (UMLS CUI [2,2])
Code List
Does the subject have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GW572016 or excipients of GW572016?
Item
Does the subject have known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to capecitabine, fluorouracil or any excipients?
text
C0020517 (UMLS CUI [1,1])
C0231191 (UMLS CUI [1,2])
C0671970 (UMLS CUI [2,1])
C0016360 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Code List
Does the subject have known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to capecitabine, fluorouracil or any excipients?
Item
Does the subject have known dihydropyrimidine dehydrogenase (DPD) deficiency? Yes No
text
C1959620 (UMLS CUI [1])
Code List
Does the subject have known dihydropyrimidine dehydrogenase (DPD) deficiency? Yes No
Protocol code
Item
Protocol code
text
C1507394 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Session number
Item
Session number
integer
C1883017 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Did the subject meet all entry criteria (i.e., All "YES" answers for inclusion criteria, all "NO" answers for exclusion criteria)? See INCLUSION / EXCLUSION CRITERIA WORKSHEET.
text
C0013893 (UMLS CUI [1])
Code List
Did the subject meet all entry criteria (i.e., All "YES" answers for inclusion criteria, all "NO" answers for exclusion criteria)? See INCLUSION / EXCLUSION CRITERIA WORKSHEET.
Item
Check all boxes that represent a violation of the inclusion criteria:
integer
C1709750 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C1516637 (UMLS CUI [2])
Code List
Check all boxes that represent a violation of the inclusion criteria:
Item
Check all boxes that represent a violation of the exclusion criteria:
integer
C1709750 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C1516637 (UMLS CUI [2])
Code List
Check all boxes that represent a violation of the exclusion criteria:
Item
Does the subject have any current medical conditions, baseline signs or symptoms when assessed at screening (i.e., within 2 weeks prior to the first dose of investigational product)?
text
C0012634 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Code List
Does the subject have any current medical conditions, baseline signs or symptoms when assessed at screening (i.e., within 2 weeks prior to the first dose of investigational product)?
Current Medical Conditions or Baseline Signs and symptoms
Item
Current Medical Conditions or Baseline Signs and symptoms
text
C0012634 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Item
NCI CTCAE Grade
integer
C3887242 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Code List
NCI CTCAE Grade
CL Item
Life Threatening (4)
Item
Was a 12-lead ECG performed?
text
C0430456 (UMLS CUI [1])
Code List
Was a 12-lead ECG performed?
Date of assessment
Item
Date of assessment
date
C0011008 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
Item
Check the appropriate box to indicate ECG results.
text
C1623258 (UMLS CUI [1])
Code List
Check the appropriate box to indicate ECG results.
Item
If ABNORMAL, check to indicate if the abnormalities are clinically significant.
text
C1623258 (UMLS CUI [1])
Code List
If ABNORMAL, check to indicate if the abnormalities are clinically significant.
Item
Was an Echocardiogram (ECHO) performed?
text
C0013516 (UMLS CUI [1])
Code List
Was an Echocardiogram (ECHO) performed?
Institution name
Item
Institution name
text
C1301943 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
Left ventricular ejection fraction
integer
C0428772 (UMLS CUI [1])
C0013516 (UMLS CUI [2])
Lower limit of normal
Item
Lower limit of normal
integer
C1518030 (UMLS CUI [1,1])
C0428772 (UMLS CUI [1,2])
C0013516 (UMLS CUI [2])
Item
Was a Multi-gated acquisition (MUGA) scan performed?
text
C0521317 (UMLS CUI [1])
Code List
Was a Multi-gated acquisition (MUGA) scan performed?
Institution name
Item
Institution name
text
C1301943 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
Left ventricular ejection fraction
integer
C0428772 (UMLS CUI [1])
C0521317 (UMLS CUI [2])
Lower limit of normal
Item
Lower limit of normal
integer
C1518030 (UMLS CUI [1,1])
C0428772 (UMLS CUI [1,2])
C0521317 (UMLS CUI [2])
Lab ID
Item
Lab ID
integer
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Lab name
Item
Lab name
text
C1882331 (UMLS CUI [1])
Date hematology sample taken
Item
Date hematology sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0474523 (UMLS CUI [2])
Item
Units for differential, check one:
integer
C1519795 (UMLS CUI [1])
Code List
Units for differential, check one:
CL Item
Absolute Count (2)
Hemoglobin
Item
Hemoglobin
float
C0518015 (UMLS CUI [1])
Hematocrit
Item
Hematocrit
float
C0518014 (UMLS CUI [1])
RBC
Item
RBC
integer
C0014772 (UMLS CUI [1])
Platelets
Item
Platelets
integer
C0032181 (UMLS CUI [1])
Total WBC
Item
Total WBC
integer
C0023508 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
integer
C0948762 (UMLS CUI [1])
Granulocytes
Item
Granulocytes
integer
C0857490 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
integer
C0200635 (UMLS CUI [1])
Monocytes
Item
Monocytes
integer
C0200637 (UMLS CUI [1])
Eosinophils
Item
Eosinophils
integer
C0200638 (UMLS CUI [1])
Basophils
Item
Basophils
integer
C0200641 (UMLS CUI [1])
Lab ID
Item
Lab ID
integer
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Lab name
Item
Lab name
text
C1882331 (UMLS CUI [1])
Date clinical chemistry sample taken
Item
Date clinical chemistry sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C2347783 (UMLS CUI [2])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Chloride
Item
Chloride
float
C0201952 (UMLS CUI [1])
Bicarbonate
Item
Bicarbonate
float
C0202059 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Glucose
Item
Glucose
float
C0202042 (UMLS CUI [1])
Total Protein
Item
Total Protein
float
C0555903 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Uric acid
Item
Uric acid
float
C0202239 (UMLS CUI [1])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
BUN
Item
BUN
float
C0005845 (UMLS CUI [1])
Urea
Item
Urea
float
C0523961 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin
float
C0201913 (UMLS CUI [1])
Alkaline phosphatase
Item
Alkaline phosphatase
float
C0201850 (UMLS CUI [1])
AST (SGOT)
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
ALT (SGPT)
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
Calculated Creatinine Clearance
Item
Calculated Creatinine Clearance
float
C0373595 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Age
Item
Age
integer
C0001779 (UMLS CUI [1])
Serum Creatinine
Item
Serum Creatinine
float
C0201976 (UMLS CUI [1])
Item
Serum Creatinine Units, check one:
integer
C0201976 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
Serum Creatinine Units, check one: