ID

43085

Description

ODM derived from http://clinicaltrials.gov/show/NCT01358877

Link

http://clinicaltrials.gov/show/NCT01358877

Keywords

Versions (3)
  1. 4/11/13 4/11/13 - Martin Dugas
  2. 4/20/14 4/20/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01358877 Breast Cancer

German English

Eligibility

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

Inclusion Criteria

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
Non-metastatic primary invasive HER2-positive carcinoma of the breast that is adequately excised, and that is either node-positive (except T0) or node-negative but with presence of at least one risk factor as defined by the protocol
Description

Non-metastatic primary invasive HER2-positive carcinoma of the breast that is adequately excised, and that is either node-positive (except T0) or node-negative but with presence of at least one risk factor as defined by the protocol

Data type

boolean

Alias
UMLS CUI 2011AA
C1518409
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
C0205281
SNOMED CT 2011_0131
10179008
UMLS CUI 2011AA
C1960398
SNOMED CT 2011_0131
427685000
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0728940
SNOMED CT 2011_0131
65801008
UMLS CUI 2011AA
C3160887
MedDRA 14.1
10071113
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0475371
SNOMED CT 2011_0131
58790005
UMLS CUI 2011AA
C3160889
MedDRA 14.1
10071115
UMLS CUI 2011AA
C0035648
SNOMED CT 2011_0131
80943009
LOINC Version 232
MTHU028018
ECOG performance status finding <= 1
Description

Eastern Cooperative Oncology Group (ECOG) performance status </=1

Data type

boolean

Alias
UMLS CUI 2011AA
C1520224
SNOMED CT 2011_0131
424122007
The interval between definitive surgery for breast cancer and randomization must be at least 3 weeks but no more than 7 weeks and the patient must be willing and able to start treatment within 1 week of randomization
Description

The interval between definitive surgery for breast cancer and randomization must be at least 3 weeks but no more than 7 weeks and the patient must be willing and able to start treatment within 1 week of randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C1272706
SNOMED CT 2011_0131
385673002
UMLS CUI 2011AA
C1628561
LOINC Version 232
MTHU019327
UMLS CUI 2011AA
C0678222
SNOMED CT 2011_0131
254838004
MedDRA 14.1
10006204
UMLS CUI 2011AA
C0034656
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
Known hormone receptor status (estrogen receptor and progesterone receptor)
Description

Known hormone receptor status (estrogen receptor and progesterone receptor)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0019929
UMLS CUI 2011AA
C0449438
SNOMED CT 2011_0131
263490005
LOINC Version 232
MTHU015827
UMLS CUI 2011AA
C1516974
UMLS CUI 2011AA
C1514471
Baseline LVEF >/= 55%
Description

Baseline LVEF >/= 55%

Data type

boolean

Alias
UMLS CUI 2011AA
C1442488
UMLS CUI 2011AA
C0428772
SNOMED CT 2011_0131
250908004
MedDRA 14.1
10069170
Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the patient and/or partner for the duration of the study treatment and for at least 6 months after the last dose of study drug
Description

Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the patient and/or partner for the duration of the study treatment and for at least 6 months after the last dose of study drug

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0682323
SNOMED CT 2011_0131
262043009
HL7 V3 2006_05
SIGOTHR
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Exclusion Criteria
Description

Exclusion Criteria

History of any prior (ipsi- and/or contralateral) invasive breast cancer
Description

History of any prior (ipsi- and/or contralateral) invasive breast cancer

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0441989
SNOMED CT 2011_0131
255208005
UMLS CUI 2011AA
C0441988
SNOMED CT 2011_0131
255209002
UMLS CUI 2011AA
C0853879
MedDRA 14.1
10006190
History of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin
Description

History of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0006141
SNOMED CT 2011_0131
76752008
LOINC Version 232
MTHU011382
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0851140
SNOMED CT 2011_0131
92564006
MedDRA 14.1
10061809
ICD-10-CM Version 2010
D06.9
ICD-9-CM Version 2011
233.1
UMLS CUI 2011AA
C0154061
SNOMED CT 2011_0131
92568009
MedDRA 14.1
10063523
ICD-10-CM Version 2010
D01.0
ICD-9-CM Version 2011
230.3
UMLS CUI 2011AA
C0346040
SNOMED CT 2011_0131
77986002
MedDRA 14.1
10027148
ICD-10-CM Version 2010
D03
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007, 254701007
MedDRA 14.1
10004146
UMLS CUI 2011AA
C0553723
SNOMED CT 2011_0131
254651007
MedDRA 14.1
10041834
Any clinical T4 tumor as defined by TNM, including inflammatory breast cancer
Description

Any clinical T4 tumor as defined by TNM, including inflammatory breast cancer

Data type

boolean

Alias
UMLS CUI 2011AA
C0475751
SNOMED CT 2011_0131
65565005
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0809869
SNOMED CT 2011_0131
399566009
LOINC Version 232
MTHU010377
UMLS CUI 2011AA
C0278601
SNOMED CT 2011_0131
254840009
MedDRA 14.1
10021980
Any previous systemic chemotherapy for cancer or radiotherapy for cancer
Description

Any previous systemic chemotherapy for cancer or radiotherapy for cancer

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C1883256
UMLS CUI 2011AA
CL414551
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
Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer
Description

Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0521124
SNOMED CT 2011_0131
65897001
UMLS CUI 2011AA
C0069515
SNOMED CT 2011_0131
44368005
LOINC Version 232
MTHU014669
UMLS CUI 2011AA
C0005527
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
UMLS CUI 2011AA
C0864561
Concurrent anti-cancer treatment in another investigational trial
Description

Concurrent anti-cancer treatment in another investigational trial

Data type

boolean

Alias
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
UMLS CUI 2011AA
C0920425
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0681814
Serious cardiac or cardiovascular disease or condition
Description

Serious cardiac or cardiovascular disease or condition

Data type

boolean

Alias
UMLS CUI 2011AA
C0205404
SNOMED CT 2011_0131
42745003
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
Pregnant or lactating women
Description

Pregnant or lactating women

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C2828358
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
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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
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)
Non-metastatic primary invasive HER2-positive carcinoma of the breast that is adequately excised, and that is either node-positive (except T0) or node-negative but with presence of at least one risk factor as defined by the protocol
Item
Non-metastatic primary invasive HER2-positive carcinoma of the breast that is adequately excised, and that is either node-positive (except T0) or node-negative but with presence of at least one risk factor as defined by the protocol
boolean
C1518409 (UMLS CUI 2011AA)
CL414904 (UMLS CUI 2011AA)
C0205281 (UMLS CUI 2011AA)
10179008 (SNOMED CT 2011_0131)
C1960398 (UMLS CUI 2011AA)
427685000 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C3160887 (UMLS CUI 2011AA)
10071113 (MedDRA 14.1)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0475371 (UMLS CUI 2011AA)
58790005 (SNOMED CT 2011_0131)
C3160889 (UMLS CUI 2011AA)
10071115 (MedDRA 14.1)
C0035648 (UMLS CUI 2011AA)
80943009 (SNOMED CT 2011_0131)
MTHU028018 (LOINC Version 232)
Eastern Cooperative Oncology Group (ECOG) performance status </=1
Item
ECOG performance status finding <= 1
boolean
C1520224 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
The interval between definitive surgery for breast cancer and randomization must be at least 3 weeks but no more than 7 weeks and the patient must be willing and able to start treatment within 1 week of randomization
Item
The interval between definitive surgery for breast cancer and randomization must be at least 3 weeks but no more than 7 weeks and the patient must be willing and able to start treatment within 1 week of randomization
boolean
C1272706 (UMLS CUI 2011AA)
385673002 (SNOMED CT 2011_0131)
C1628561 (UMLS CUI 2011AA)
MTHU019327 (LOINC Version 232)
C0678222 (UMLS CUI 2011AA)
254838004 (SNOMED CT 2011_0131)
10006204 (MedDRA 14.1)
C0034656 (UMLS CUI 2011AA)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
Known hormone receptor status (estrogen receptor and progesterone receptor)
Item
Known hormone receptor status (estrogen receptor and progesterone receptor)
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0019929 (UMLS CUI 2011AA)
C0449438 (UMLS CUI 2011AA)
263490005 (SNOMED CT 2011_0131)
MTHU015827 (LOINC Version 232)
C1516974 (UMLS CUI 2011AA)
C1514471 (UMLS CUI 2011AA)
Baseline LVEF >/= 55%
Item
Baseline LVEF >/= 55%
boolean
C1442488 (UMLS CUI 2011AA)
C0428772 (UMLS CUI 2011AA)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the patient and/or partner for the duration of the study treatment and for at least 6 months after the last dose of study drug
Item
Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the patient and/or partner for the duration of the study treatment and for at least 6 months after the last dose of study drug
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0682323 (UMLS CUI 2011AA)
262043009 (SNOMED CT 2011_0131)
SIGOTHR (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Item Group
Exclusion Criteria
History of any prior (ipsi- and/or contralateral) invasive breast cancer
Item
History of any prior (ipsi- and/or contralateral) invasive breast cancer
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0441989 (UMLS CUI 2011AA)
255208005 (SNOMED CT 2011_0131)
C0441988 (UMLS CUI 2011AA)
255209002 (SNOMED CT 2011_0131)
C0853879 (UMLS CUI 2011AA)
10006190 (MedDRA 14.1)
History of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin
Item
History of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0006141 (UMLS CUI 2011AA)
76752008 (SNOMED CT 2011_0131)
MTHU011382 (LOINC Version 232)
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)
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)
C0154061 (UMLS CUI 2011AA)
92568009 (SNOMED CT 2011_0131)
10063523 (MedDRA 14.1)
D01.0 (ICD-10-CM Version 2010)
230.3 (ICD-9-CM Version 2011)
C0346040 (UMLS CUI 2011AA)
77986002 (SNOMED CT 2011_0131)
10027148 (MedDRA 14.1)
D03 (ICD-10-CM Version 2010)
C0007117 (UMLS CUI 2011AA)
1338007, 254701007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
Any clinical T4 tumor as defined by TNM, including inflammatory breast cancer
Item
Any clinical T4 tumor as defined by TNM, including inflammatory breast cancer
boolean
C0475751 (UMLS CUI 2011AA)
65565005 (SNOMED CT 2011_0131)
C1704788 (UMLS CUI 2011AA)
C0809869 (UMLS CUI 2011AA)
399566009 (SNOMED CT 2011_0131)
MTHU010377 (LOINC Version 232)
C0278601 (UMLS CUI 2011AA)
254840009 (SNOMED CT 2011_0131)
10021980 (MedDRA 14.1)
Any previous systemic chemotherapy for cancer or radiotherapy for cancer
Item
Any previous systemic chemotherapy for cancer or radiotherapy for cancer
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1883256 (UMLS CUI 2011AA)
CL414551 (UMLS CUI 2011AA)
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)
Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer
Item
Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer
boolean
C1514463 (UMLS CUI 2011AA)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
C0069515 (UMLS CUI 2011AA)
44368005 (SNOMED CT 2011_0131)
MTHU014669 (LOINC Version 232)
C0005527 (UMLS CUI 2011AA)
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)
C0864561 (UMLS CUI 2011AA)
Concurrent anti-cancer treatment in another investigational trial
Item
Concurrent anti-cancer treatment in another investigational trial
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C0920425 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0681814 (UMLS CUI 2011AA)
Serious cardiac or cardiovascular disease or condition
Item
Serious cardiac or cardiovascular disease or condition
boolean
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
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)
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