ID

44597

Description

ODM derived from http://clinicaltrials.gov/show/NCT01026142

Link

http://clinicaltrials.gov/show/NCT01026142

Keywords

Versions (3)
  1. 12/7/13 12/7/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility DRKS00007744 NCT01026142 Breast Cancer

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Adult (person)
Description

Adult patients >/=18 years of age

Data type

boolean

Alias
UMLS CUI 2011AA
C0001675
SNOMED CT 2011_0131
133936004
Metastatic HER2 positive breast cancer
Description

Metastatic HER2 positive breast cancer

Data type

boolean

Alias
UMLS CUI 2011AA
C0036525
SNOMED CT 2011_0131
77879006
MedDRA 14.1
10027474
UMLS CUI 2011AA
CL412284
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
ECOG performance status 0 or 1
Description

ECOG performance status 0 or 1

Data type

boolean

Alias
UMLS CUI 2011AA
C1520224
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)
Description

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)

Data type

boolean

Alias
UMLS CUI 2011AA
C0242656
SNOMED CT 2011_0131
246453008
MedDRA 14.1
10061818
UMLS CUI 2011AA
C0728747
SNOMED CT 2011_0131
387003001
UMLS CUI 2011AA
C1705938
UMLS CUI 2011AA
C1708063
UMLS CUI 2011AA
C0278488
Prior treatment with taxane-containing regimen
Description

Prior treatment with taxane-containing regimen

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0215136
UMLS CUI 2011AA
C0332256
SNOMED CT 2011_0131
42504009
UMLS CUI 2011AA
CL031856
LVEF - Left ventricular ejection fraction
Description

LVEF >/=50 percent

Data type

boolean

Alias
UMLS CUI 2011AA
C0428772
SNOMED CT 2011_0131
250908004
MedDRA 14.1
10069170
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
Description

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

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0682323
SNOMED CT 2011_0131
262043009
HL7 V3 2006_05
SIGOTHR
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL424941
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Prior treatment with pertuzumab or capecitabine
Description

Prior treatment with pertuzumab or capecitabine

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C1328025
UMLS CUI 2011AA
C0671970
SNOMED CT 2011_0131
108761006
Concurrent treatment with other experimental drug
Description

Concurrent treatment with other experimental drug

Data type

boolean

Alias
UMLS CUI 2011AA
C0009429
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
Concurrent immunotherapy or anticancer hormonal therapy
Description

Concurrent immunotherapy or anticancer hormonal therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
UMLS CUI 2011AA
C0021083
SNOMED CT 2011_0131
146638005
UMLS CUI 2011AA
C0279025
SNOMED CT 2011_0131
309542002, 169413002
MedDRA 14.1
10065646
UMLS CUI 2011AA
C0521124
SNOMED CT 2011_0131
65897001
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
Serious concurrent disease (e.g. active infection, uncontrolled hypertension, cardiovascular disease)
Description

Serious concurrent disease (e.g. active infection, uncontrolled hypertension, cardiovascular disease)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205404
SNOMED CT 2011_0131
42745003
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C1868885
MedDRA 14.1
10066860
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
CNS metastases, which are not well controlled
Description

CNS metastases, which are not well controlled

Data type

boolean

Alias
UMLS CUI 2011AA
C0279130
SNOMED CT 2011_0131
261731003
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
History of exposure to anthracycline cumulative dose equivalent to 360mg/m2 doxorubicin
Description

History of exposure to anthracycline cumulative dose equivalent to 360mg/m2 doxorubicin

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0332157
SNOMED CT 2011_0131
24932003
UMLS CUI 2011AA
C0282564
SNOMED CT 2011_0131
372540003
UMLS CUI 2011AA
CL426125
UMLS CUI 2011AA
CL415123
UMLS CUI 2011AA
C0013089
SNOMED CT 2011_0131
68444001
LOINC Version 232
MTHU004184
History of congestive heart failure of any New York Heart Association criteria, or serious cardiac arrhythmia requiring treatment
Description

History of congestive heart failure of any New York Heart Association criteria, or serious cardiac arrhythmia requiring treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C0264722
SNOMED CT 2011_0131
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50
ICD-9-CM Version 2011
428
UMLS CUI 2011AA
C1275491
SNOMED CT 2011_0131
420816009
UMLS CUI 2011AA
CL414621
UMLS CUI 2011AA
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0039798
Past history of myocardial infarction
Description

History of myocardial infarction within 6 months prior to randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C1275835
SNOMED CT 2011_0131
399211009
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
Description

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

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C1096403
MedDRA 14.1
10053222
UMLS CUI 2011AA
C0876994
MedDRA 14.1
10048610
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0728747
SNOMED CT 2011_0131
387003001
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Adult patients >/=18 years of age
Item
Adult (person)
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)
Item Group
Exclusion Criteria
CL425201 (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)
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