age at least 18 Years
Item
Alter mindestens 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Adult patients >/=18 years of age
Item
Erwachsener, erwachsen
boolean
C0001675 (UMLS CUI 2011AA)
133936004 (SNOMED CT 2011_0131)
Metastatic HER2 positive breast cancer
Item
Metastatic HER2 positive breast cancer
boolean
C0036525 (UMLS CUI 2011AA)
77879006 (SNOMED CT 2011_0131)
10027474 (MedDRA 14.1)
CL412284 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
ECOG performance status 0 or 1
Item
ECOG performance status 0 or 1
boolean
C1520224 (UMLS CUI 2011AA)
Disease progression during or following trastuzumab-based therapy for 1st line metastatic breast cancer (trastuzumab must have been part of the last prior treatment regimen)
Item
Disease progression during or following trastuzumab-based therapy for 1st line metastatic breast cancer (trastuzumab must have been part of the last prior treatment regimen)
boolean
C0242656 (UMLS CUI 2011AA)
246453008 (SNOMED CT 2011_0131)
10061818 (MedDRA 14.1)
C0728747 (UMLS CUI 2011AA)
387003001 (SNOMED CT 2011_0131)
C1705938 (UMLS CUI 2011AA)
C1708063 (UMLS CUI 2011AA)
C0278488 (UMLS CUI 2011AA)
Prior treatment with taxane-containing regimen
Item
Prior treatment with taxane-containing regimen
boolean
C1514463 (UMLS CUI 2011AA)
C0215136 (UMLS CUI 2011AA)
C0332256 (UMLS CUI 2011AA)
42504009 (SNOMED CT 2011_0131)
CL031856 (UMLS CUI 2011AA)
LVEF >/=50 percent
Item
LVEF - Left ventricular ejection fraction
boolean
C0428772 (UMLS CUI 2011AA)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
For women of childbearing potential agreement to use highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by patient and/or partner. Contraception must continue for duration of study treatment and for at least 6 months after last dose of study drug treatment
Item
For women of childbearing potential agreement to use highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by patient and/or partner. Contraception must continue for duration of study treatment and for at least 6 months after last dose of study drug treatment
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0682323 (UMLS CUI 2011AA)
262043009 (SNOMED CT 2011_0131)
SIGOTHR (HL7 V3 2006_05)
C0680240 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
CL424941 (UMLS CUI 2011AA)
Prior treatment with pertuzumab or capecitabine
Item
Prior treatment with pertuzumab or capecitabine
boolean
C1514463 (UMLS CUI 2011AA)
C1328025 (UMLS CUI 2011AA)
C0671970 (UMLS CUI 2011AA)
108761006 (SNOMED CT 2011_0131)
Concurrent treatment with other experimental drug
Item
Concurrent treatment with other experimental drug
boolean
C0009429 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
Concurrent immunotherapy or anticancer hormonal therapy
Item
Concurrent immunotherapy or anticancer hormonal therapy
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C0021083 (UMLS CUI 2011AA)
146638005 (SNOMED CT 2011_0131)
C0279025 (UMLS CUI 2011AA)
309542002, 169413002 (SNOMED CT 2011_0131)
10065646 (MedDRA 14.1)
C0521124 (UMLS CUI 2011AA)
65897001 (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)
Serious concurrent disease (e.g. active infection, uncontrolled hypertension, cardiovascular disease)
Item
Serious concurrent disease (e.g. active infection, uncontrolled hypertension, cardiovascular disease)
boolean
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
CNS metastases, which are not well controlled
Item
CNS metastases, which are not well controlled
boolean
C0279130 (UMLS CUI 2011AA)
261731003 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
History of exposure to anthracycline cumulative dose equivalent to 360mg/m2 doxorubicin
Item
History of exposure to anthracycline cumulative dose equivalent to 360mg/m2 doxorubicin
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
C0282564 (UMLS CUI 2011AA)
372540003 (SNOMED CT 2011_0131)
CL426125 (UMLS CUI 2011AA)
CL415123 (UMLS CUI 2011AA)
C0013089 (UMLS CUI 2011AA)
68444001 (SNOMED CT 2011_0131)
MTHU004184 (LOINC Version 232)
History of congestive heart failure of any New York Heart Association criteria, or serious cardiac arrhythmia requiring treatment
Item
History of congestive heart failure of any New York Heart Association criteria, or serious cardiac arrhythmia requiring treatment
boolean
C0264722 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50 (ICD-10-CM Version 2010)
428 (ICD-9-CM Version 2011)
C1275491 (UMLS CUI 2011AA)
420816009 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
C1514873 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
History of myocardial infarction within 6 months prior to randomization
Item
Past history of myocardial infarction
boolean
C1275835 (UMLS CUI 2011AA)
399211009 (SNOMED CT 2011_0131)
History of LVEF decline to below 50% during or after prior trastuzumab therapy or other cardiac toxicity during previous trastuzumab treatment that necessitated discontinuation of trastuzumab
Item
History of LVEF decline to below 50% during or after prior trastuzumab therapy or other cardiac toxicity during previous trastuzumab treatment that necessitated discontinuation of trastuzumab
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1096403 (UMLS CUI 2011AA)
10053222 (MedDRA 14.1)
C0876994 (UMLS CUI 2011AA)
10048610 (MedDRA 14.1)
C1514463 (UMLS CUI 2011AA)
C0728747 (UMLS CUI 2011AA)
387003001 (SNOMED CT 2011_0131)