age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Written informed consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Able to comply with the protocol
Item
Able to comply with the protocol
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
ECOG performance status 0-1
Item
ECOG performance status 0-1
boolean
C1520224 (UMLS CUI 2011AA)
Adequate contraception
Item
Adequate contraception
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Confirmed Her2/neu-positive, adenocarcinoma of the breast
Item
Confirmed Her2/neu-positive, adenocarcinoma of the breast
boolean
C0750484 (UMLS CUI 2011AA)
CL412284 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0858252 (UMLS CUI 2011AA)
10006173 (MedDRA 14.1)
At least one measurable lesion according to RECIST 1.1 criteria
Item
At least one measurable lesion according to RECIST 1.1 criteria
boolean
C1513040 (UMLS CUI 2011AA)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C1709926 (UMLS CUI 2011AA)
First or second chemotherapy after diagnosis of metastasis
Item
First or second chemotherapy after diagnosis of metastasis
boolean
C0205435 (UMLS CUI 2011AA)
255216001 (SNOMED CT 2011_0131)
C0205436 (UMLS CUI 2011AA)
81170007 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0027627 (UMLS CUI 2011AA)
128462008 (SNOMED CT 2011_0131)
10027449 (MedDRA 14.1)
Lapatinib treatment indicated (adjuvant trastuzumab treatment <12 months ago or progressive disease with trastuzumab treatment)
Item
Lapatinib treatment indicated (adjuvant trastuzumab treatment <12 months ago or progressive disease with trastuzumab treatment)
boolean
C1506770 (UMLS CUI 2011AA)
425466009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C1444656 (UMLS CUI 2011AA)
410535002 (SNOMED CT 2011_0131)
C0677850 (UMLS CUI 2011AA)
10068969 (MedDRA 14.1)
C0728747 (UMLS CUI 2011AA)
387003001 (SNOMED CT 2011_0131)
C1335499 (UMLS CUI 2011AA)
No signs and symptoms of CHF (chronic heart failure), LVEF (left ventricular ejection fraction) at study start at least 55%
Item
No signs and symptoms of CHF (chronic heart failure), LVEF (left ventricular ejection fraction) at study start at least 55%
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0037088 (UMLS CUI 2011AA)
404684003 (SNOMED CT 2011_0131)
C0264716 (UMLS CUI 2011AA)
48447003 (SNOMED CT 2011_0131)
10008908 (MedDRA 14.1)
C0428772 (UMLS CUI 2011AA)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
C2348558 (UMLS CUI 2011AA)
Adequate hepatic and renal function value
Item
Adequate hepatic and renal function value
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C1522609 (UMLS CUI 2011AA)
Adequate hematologic function values
Item
Adequate hematologic function values
boolean
C0221130 (UMLS CUI 2011AA)
Pregnant or lactating women
Item
Pregnant or lactating women
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
Concurrent participation in another clinical trial. Prior participation is allowed if the last study medication was administered more than 4 weeks prior to randomization
Item
Concurrent participation in another clinical trial. Prior participation is allowed if the last study medication was administered more than 4 weeks prior to randomization
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Asymptomatic with regards to tumor illness
Item
Asymptomatic with regards to tumor illness
boolean
C0231221 (UMLS CUI 2011AA)
84387000 (SNOMED CT 2011_0131)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Previous treatment with lapatinib, capecitabine or vinorelbine
Item
Previous treatment with lapatinib, capecitabine or vinorelbine
boolean
C1514463 (UMLS CUI 2011AA)
C1506770 (UMLS CUI 2011AA)
425466009 (SNOMED CT 2011_0131)
C0671970 (UMLS CUI 2011AA)
108761006 (SNOMED CT 2011_0131)
C0078257 (UMLS CUI 2011AA)
108792008 (SNOMED CT 2011_0131)
Necessity of planned treatment with other chemotherapeutics oder anti-hormone therapy
Item
Necessity of planned treatment with other chemotherapeutics oder anti-hormone therapy
boolean
C1555447 (UMLS CUI 2011AA)
MEDNEC (HL7 V3 2006_05)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0729502 (UMLS CUI 2011AA)
312059006 (SNOMED CT 2011_0131)
C2986607 (UMLS CUI 2011AA)
Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study
Item
Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study
boolean
C0679637 (UMLS CUI 2011AA)
C0184922 (UMLS CUI 2011AA)
119283008 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
Evidence of cardiovascular disease, e.g. myocardial infection, unstable angina pectoris or arrhythmia
Item
Evidence of cardiovascular disease, e.g. myocardial infection, unstable angina pectoris or arrhythmia
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C1522564 (UMLS CUI 2011AA)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0002965 (UMLS CUI 2011AA)
4557003 (SNOMED CT 2011_0131)
10002388 (MedDRA 14.1)
I20.0 (ICD-10-CM Version 2010)
411.1 (ICD-9-CM Version 2011)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
History of vascular or cardiovascular disease within the past 6 months
Item
History of vascular or cardiovascular disease within the past 6 months
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0042373 (UMLS CUI 2011AA)
27550009 (SNOMED CT 2011_0131)
10047062 (MedDRA 14.1)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
All illnesses that result in malabsorption of oral medication or inability to take oral medication
Item
All illnesses that result in malabsorption of oral medication or inability to take oral medication
boolean
C0221423 (UMLS CUI 2011AA)
39104002 (SNOMED CT 2011_0131)
10040658 (MedDRA 14.1)
R69 (ICD-10-CM Version 2010)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
C0024523 (UMLS CUI 2011AA)
155841000 (SNOMED CT 2011_0131)
K90.4 (ICD-10-CM Version 2010)
CL436624 (UMLS CUI 2011AA)
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C1512806 (UMLS CUI 2011AA)
Concurrent treatment with anti-viral drugs based on sorivudine or with aminoglycosides
Item
Concurrent treatment with anti-viral drugs based on sorivudine or with aminoglycosides
boolean
C0009429 (UMLS CUI 2011AA)
C0003451 (UMLS CUI 2011AA)
372701006 (SNOMED CT 2011_0131)
C1527178 (UMLS CUI 2011AA)
C0207628 (UMLS CUI 2011AA)
C0002556 (UMLS CUI 2011AA)
324116004 (SNOMED CT 2011_0131)
Concurrent treatment with any drug interfering with study medication, especially, those that induce CYP3A
Item
Concurrent treatment with any drug interfering with study medication, especially, those that induce CYP3A
boolean
C0009429 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C0205263 (UMLS CUI 2011AA)
16404004 (SNOMED CT 2011_0131)
C1413881 (UMLS CUI 2011AA)
Concurrent treatment with allopurinol
Item
Concurrent treatment with allopurinol
boolean
C0009429 (UMLS CUI 2011AA)
C0002144 (UMLS CUI 2011AA)
25246002 (SNOMED CT 2011_0131)
MTHU024809 (LOINC Version 232)
Other malignancies (except for basal cell carcinoma of the skin and cervical carcinoma in situ). Patient can be included in the study if no recurrent disease has been observed for at least 5 years
Item
Other malignancies (except for basal cell carcinoma of the skin and cervical carcinoma in situ). Patient can be included in the study if no recurrent disease has been observed for at least 5 years
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0007117 (UMLS CUI 2011AA)
1338007, 254701007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
Concurrent illnesses or other circumstances that could interfere with trial participation, efficacy or safety of the patient
Item
Concurrent illnesses or other circumstances that could interfere with trial participation, efficacy or safety of the patient
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C0221423 (UMLS CUI 2011AA)
39104002 (SNOMED CT 2011_0131)
10040658 (MedDRA 14.1)
R69 (ICD-10-CM Version 2010)
C0683578 (UMLS CUI 2011AA)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C2348568 (UMLS CUI 2011AA)
C1113679 (UMLS CUI 2011AA)
C0235828 (UMLS CUI 2011AA)
10014291 (MedDRA 14.1)