ID

43391

Beskrivning

ODM derived from http://clinicaltrials.gov/show/NCT00625898

Länk

http://clinicaltrials.gov/show/NCT00625898

Nyckelord

Versioner (2)
  1. 2014-04-15 2014-04-15 - Julian Varghese
  2. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility NCT00625898 Breast Cancer

Tysk Engelsk

Eligibility

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beskrivning

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter mindestens 18 Jahre
Beskrivning

age at least 18 Years

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Life expectancy of at least 10 years, excluding their diagnosis of breast cancer.
Beskrivning

Life expectancy of at least 10 years, excluding their diagnosis of breast cancer.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0023671
LOINC Version 232
LP75025-4
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0678222
SNOMED CT 2011_0131
254838004
MedDRA 14.1
10006204
Women who have had breast reconstruction utilizing tissue expanders must be in agreement with delaying surgery to replace the tissue expanders with permanent implants until 3 months following the last dose of bevacizumab
Beskrivning

Women who have had breast reconstruction utilizing tissue expanders must be in agreement with delaying surgery to replace the tissue expanders with permanent implants until 3 months following the last dose of bevacizumab

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0085076
SNOMED CT 2011_0131
33496007
MedDRA 14.1
10006305
UMLS CUI 2011AA
C0588162
SNOMED CT 2011_0131
310630001
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C1710256
UMLS CUI 2011AA
C0559956
SNOMED CT 2011_0131
282089006
UMLS CUI 2011AA
C0205355
SNOMED CT 2011_0131
6934004
UMLS CUI 2011AA
C0021102
SNOMED CT 2011_0131
40388003
UMLS CUI 2011AA
C2825406
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0796392
SNOMED CT 2011_0131
409406007
Women of reproductive potential must agree to use an effective non-hormonal method of contraception (for example condoms, some intrauterine devices, diaphragms, vasectomized partner, or abstinence) during therapy and for at least 6 months after the last dose of bevacizumab and/or trastuzumab.
Beskrivning

Women of reproductive potential must agree to use an effective non-hormonal method of contraception (for example condoms, some intrauterine devices, diaphragms, vasectomized partner, or abstinence) during therapy and for at least 6 months after the last dose of bevacizumab and/or trastuzumab.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0035150
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL424941
UMLS CUI 2011AA
C0677582
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
UMLS CUI 2011AA
C0042241
SNOMED CT 2011_0131
20359006
UMLS CUI 2011AA
C0420842
SNOMED CT 2011_0131
268457007
UMLS CUI 2011AA
CL068143
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C2825407
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0796392
SNOMED CT 2011_0131
409406007
UMLS CUI 2011AA
C0728747
SNOMED CT 2011_0131
387003001
Submission of tumor samples from the breast surgery for central HER2 testing is required for all patients prior to enrollment in the BETH Trial
Beskrivning

Submission of tumor samples from the breast surgery for central HER2 testing is required for all patients prior to enrollment in the BETH Trial

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1515022
LOINC Version 232
MTHU032338
UMLS CUI 2011AA
C0475358
SNOMED CT 2011_0131
258435002
UMLS CUI 2011AA
C0851312
SNOMED CT 2011_0131
408469009, 392090004
MedDRA 14.1
10061734
ICD-9-CM Version 2011
85
UMLS CUI 2011AA
C0069515
SNOMED CT 2011_0131
44368005
LOINC Version 232
MTHU014669
UMLS CUI 2011AA
C0039593
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Signed and dated IRB/EC-approved consent
Beskrivning

Signed and dated IRB/EC-approved consent

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1561610
HL7 V3 2006_05
S
UMLS CUI 2011AA
C0011008
SNOMED CT 2011_0131
410671006
LOINC Version 232
MTHU021546
UMLS CUI 2011AA
C1511481
LOINC Version 232
MTHU035862
UMLS CUI 2011AA
C1706842
UMLS CUI 2011AA
C0086911
ECOG Status <= 1
Beskrivning

ECOG performance status <= 1

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1520224
SNOMED CT 2011_0131
424122007
The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
Beskrivning

The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.

Datatyp

boolean

Alias
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
C0205092
SNOMED CT 2011_0131
66459002
UMLS CUI 2011AA
C0205281
SNOMED CT 2011_0131
10179008
UMLS CUI 2011AA
C0858252
MedDRA 14.1
10006173
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0582103
SNOMED CT 2011_0131
225886003
The breast cancer must be HER2-positive based on test results as follows: Local testing (if available) should demonstrate that the tumor is IHC 2+ or 3+ or is considered to be HER2-positive for gene amplification by FISH, CISH, or other in situ hybridization (ISH) method. If local ISH test results are considered equivocal, the tumor can be submitted for central HER2 testing. (If local testing is not possible, the tumor can be submitted for central HER2 testing.) Central testing (a requirement for ALL patients) must demonstrate that the tumor is HER2-positive which is defined as FISH-positive and/or IHC 3+.
Beskrivning

The breast cancer must be HER2-positive based on test results as follows: Local testing (if available) should demonstrate that the tumor is IHC 2+ or 3+ or is considered to be HER2-positive for gene amplification by FISH, CISH, or other in situ hybridization (ISH) method. If local ISH test results are considered equivocal, the tumor can be submitted for central HER2 testing. (If local testing is not possible, the tumor can be submitted for central HER2 testing.) Central testing (a requirement for ALL patients) must demonstrate that the tumor is HER2-positive which is defined as FISH-positive and/or IHC 3+.

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL412284
UMLS CUI 2011AA
CL415116
UMLS CUI 2011AA
C0039593
UMLS CUI 2011AA
C0021044
SNOMED CT 2011_0131
117617002
MedDRA 14.1
10059656
UMLS CUI 2011AA
C0017256
SNOMED CT 2011_0131
12645001
UMLS CUI 2011AA
C0162789
SNOMED CT 2011_0131
426329006
MedDRA 14.1
10066931
UMLS CUI 2011AA
C1516514
UMLS CUI 2011AA
C0162788
HL7 V3 2006_05
123
UMLS CUI 2011AA
C0023449
SNOMED CT 2011_0131
91857003, 128822004
MedDRA 14.1
10060390
ICD-10-CM Version 2010
C91.0
ICD-9-CM Version 2011
204.0
All of the following staging criteria (according to the 6th edition of the AJCC Cancer Staging Manual) must be met: By pathologic evaluation, primary tumor must be pT1-3. By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b. If pN0, at least one of the following criteria must be met: Pathologic tumor size > 2.0 cm. ER negative and PgR negative. Histologic and/or nuclear grade 2 (intermediate) or 3 (high). Or Age < 35 years.
Beskrivning

All of the following staging criteria (according to the 6th edition of the AJCC Cancer Staging Manual) must be met: By pathologic evaluation, primary tumor must be pT1-3. By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b. If pN0, at least one of the following criteria must be met: Pathologic tumor size > 2.0 cm. ER negative and PgR negative. Histologic and/or nuclear grade 2 (intermediate) or 3 (high). Or Age < 35 years.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0027646
UMLS CUI 2011AA
CL414621
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0441915
SNOMED CT 2011_0131
258236004
UMLS CUI 2011AA
C1521733
SNOMED CT 2011_0131
29458008
UMLS CUI 2011AA
C0220825
UMLS CUI 2011AA
C1306459
SNOMED CT 2011_0131
372087000
UMLS CUI 2011AA
C0332391
SNOMED CT 2011_0131
53786006
UMLS CUI 2011AA
C0332392
SNOMED CT 2011_0131
80898003
UMLS CUI 2011AA
C0332393
SNOMED CT 2011_0131
90402004
UMLS CUI 2011AA
C0441989
SNOMED CT 2011_0131
255208005
UMLS CUI 2011AA
C0024204
SNOMED CT 2011_0131
59441001
LOINC Version 232
MTHU015050
UMLS CUI 2011AA
C0332396
UMLS CUI 2011AA
C0332397
UMLS CUI 2011AA
C2732831
SNOMED CT 2011_0131
443824009
UMLS CUI 2011AA
C1711118
UMLS CUI 2011AA
C1711119
UMLS CUI 2011AA
C1711120
UMLS CUI 2011AA
C1711121
UMLS CUI 2011AA
C1711124
UMLS CUI 2011AA
C1711125
UMLS CUI 2011AA
CL414621
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C1521733
SNOMED CT 2011_0131
29458008
UMLS CUI 2011AA
C0475440
SNOMED CT 2011_0131
263605001
UMLS CUI 2011AA
C0279756
UMLS CUI 2011AA
C0279766
UMLS CUI 2011AA
C0919553
SNOMED CT 2011_0131
371469007
UMLS CUI 2011AA
C1518435
UMLS CUI 2011AA
C1333838
UMLS CUI 2011AA
C1333843
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Patients must have undergone either a total mastectomy or breast conserving surgery (lumpectomy).
Beskrivning

Patients must have undergone either a total mastectomy or breast conserving surgery (lumpectomy).

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0024886
SNOMED CT 2011_0131
172043006
MedDRA 14.1
10040700
ICD-9-CM Version 2011
85.41
UMLS CUI 2011AA
C0917927
UMLS CUI 2011AA
C0851238
SNOMED CT 2011_0131
392021009
MedDRA 14.1
10061733
For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection.)
Beskrivning

For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection.)

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0851238
SNOMED CT 2011_0131
392021009
MedDRA 14.1
10061733
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0332296
SNOMED CT 2011_0131
37837009
UMLS CUI 2011AA
C0677898
UMLS CUI 2011AA
C0007124
SNOMED CT 2011_0131
86616005
MedDRA 14.1
10013806
ICD-10-CM Version 2010
D05.1
UMLS CUI 2011AA
C0728940
SNOMED CT 2011_0131
65801008
UMLS CUI 2011AA
C0229985
SNOMED CT 2011_0131
82868003
UMLS CUI 2011AA
C1706711
UMLS CUI 2011AA
C0184913
SNOMED CT 2011_0131
65854006
UMLS CUI 2011AA
C0024886
SNOMED CT 2011_0131
172043006
MedDRA 14.1
10040700
ICD-9-CM Version 2011
85.41
UMLS CUI 2011AA
C1548635
HL7 V3 2006_05
ELG
UMLS CUI 2011AA
C0279563
SNOMED CT 2011_0131
109888004
MedDRA 14.1
10024744
ICD-10-CM Version 2010
D05.0
For patients who undergo mastectomy, margins must be free of gross residual tumor. Patients with microscopic positive margins are eligible.
Beskrivning

For patients who undergo mastectomy, margins must be free of gross residual tumor. Patients with microscopic positive margins are eligible.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0024881
MedDRA 14.1
10026878
ICD-9-CM Version 2011
85.4
UMLS CUI 2011AA
C0229985
SNOMED CT 2011_0131
82868003
UMLS CUI 2011AA
C0332296
SNOMED CT 2011_0131
37837009
UMLS CUI 2011AA
C0439806
SNOMED CT 2011_0131
255344003
UMLS CUI 2011AA
C0242596
UMLS CUI 2011AA
C0205288
SNOMED CT 2011_0131
84496004
UMLS CUI 2011AA
CL415097
UMLS CUI 2011AA
C0229985
SNOMED CT 2011_0131
82868003
UMLS CUI 2011AA
C1548635
HL7 V3 2006_05
ELG
Patients must have completed one of the following procedures for evaluation of pathologic nodal status: Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive. Sentinel lymphadenectomy alone if pathologic nodal staging based on sentinel lymphadenectomy is pN0, pN1mi or pN1b. Or Axillary lymphadenectomy without SN isolation procedure.
Beskrivning

Patients must have completed one of the following procedures for evaluation of pathologic nodal status: Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive. Sentinel lymphadenectomy alone if pathologic nodal staging based on sentinel lymphadenectomy is pN0, pN1mi or pN1b. Or Axillary lymphadenectomy without SN isolation procedure.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1556116
HL7 V3 2006_05
completed
UMLS CUI 2011AA
C2700391
UMLS CUI 2011AA
C0220825
UMLS CUI 2011AA
C1521733
SNOMED CT 2011_0131
29458008
UMLS CUI 2011AA
C0449927
SNOMED CT 2011_0131
260918007
UMLS CUI 2011AA
C2363825
MedDRA 14.1
10068478
UMLS CUI 2011AA
C0728940
SNOMED CT 2011_0131
65801008
UMLS CUI 2011AA
C1524062
LOINC Version 232
MTHU013802
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0677944
SNOMED CT 2011_0131
330469005
UMLS CUI 2011AA
CL415097
UMLS CUI 2011AA
C2363825
MedDRA 14.1
10068478
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0332396
UMLS CUI 2011AA
C2732831
SNOMED CT 2011_0131
443824009
UMLS CUI 2011AA
C1711119
UMLS CUI 2011AA
CL414906
UMLS CUI 2011AA
C0193867
SNOMED CT 2011_0131
234262008
MedDRA 14.1
10068477
ICD-9-CM Version 2011
40.23
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0677944
SNOMED CT 2011_0131
330469005
UMLS CUI 2011AA
C0204727
SNOMED CT 2011_0131
40174006
ICD-9-CM Version 2011
99.84
The interval between the last surgery for breast cancer (treatment or staging) and randomization must be at least 28 days but no more than 84 days.
Beskrivning

The interval between the last surgery for breast cancer (treatment or staging) and randomization must be at least 28 days but no more than 84 days.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1272706
SNOMED CT 2011_0131
385673002
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0038895
UMLS CUI 2011AA
C0678222
SNOMED CT 2011_0131
254838004
MedDRA 14.1
10006204
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0027646
SNOMED CT 2011_0131
254292007
LOINC Version 232
LP78422-0
UMLS CUI 2011AA
C0034656
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then PgR analysis must also be performed.
Beskrivning

Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then PgR analysis must also be performed.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1521863
UMLS CUI 2011AA
C0002778
SNOMED CT 2011_0131
272389005
UMLS CUI 2011AA
C0884358
SNOMED CT 2011_0131
398166005
UMLS CUI 2011AA
C1306459
SNOMED CT 2011_0131
372087000
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0279756
UMLS CUI 2011AA
C0034833
SNOMED CT 2011_0131
61078009
LOINC Version 232
MTHU002145
UMLS CUI 2011AA
C0002778
SNOMED CT 2011_0131
272389005
UMLS CUI 2011AA
C1882330
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
The most recent postoperative blood counts, performed within 6 weeks prior to randomization, must meet the following criteria: ANC must be >= 1200/mm3. Platelet count must be >= 100,000/mm3. And Hemoglobin must be >= 10 g/dL.
Beskrivning

The most recent postoperative blood counts, performed within 6 weeks prior to randomization, must meet the following criteria: ANC must be >= 1200/mm3. Platelet count must be >= 100,000/mm3. And Hemoglobin must be >= 10 g/dL.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0332185
SNOMED CT 2011_0131
6493001
UMLS CUI 2011AA
C0241311
UMLS CUI 2011AA
C0005771
SNOMED CT 2011_0131
88308000
MedDRA 14.1
10064196
UMLS CUI 2011AA
C0884358
SNOMED CT 2011_0131
398166005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
CL414621
UMLS CUI 2011AA
C0948762
MedDRA 14.1
10052033
UMLS CUI 2011AA
C1287267
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
UMLS CUI 2011AA
C0019046
SNOMED CT 2011_0131
38082009
MedDRA 14.1
10019481
LOINC Version 232
LP14449-0
and AST must be less than or equal to 1.5 x ULN for the lab. Alkaline phosphatase and AST may not both be > the ULN.
Beskrivning

The following criteria for evidence of adequate hepatic function must be met based on the results of the most recent postoperative tests performed within 6 weeks prior to randomization: total bilirubin must be <= upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL414621
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0232741
SNOMED CT 2011_0131
79036002
UMLS CUI 2011AA
C0332185
SNOMED CT 2011_0131
6493001
UMLS CUI 2011AA
C0241311
UMLS CUI 2011AA
C0392366
SNOMED CT 2011_0131
272393004
UMLS CUI 2011AA
C0884358
SNOMED CT 2011_0131
398166005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
UMLS CUI 2011AA
C0201913
SNOMED CT 2011_0131
359986008
MedDRA 14.1
10004696
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
UMLS CUI 2011AA
C0311468
SNOMED CT 2011_0131
26165005
MedDRA 14.1
10005364
CTCAE 1105E
E12096
UMLS CUI 2011AA
C0017551
SNOMED CT 2011_0131
27503000
MedDRA 14.1
10018267
ICD-10-CM Version 2010
E80.4
UMLS CUI 2011AA
C2348205
UMLS CUI 2011AA
C0039082
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0439834
SNOMED CT 2011_0131
255361000
UMLS CUI 2011AA
C1160466
UMLS CUI 2011AA
C0011221
SNOMED CT 2011_0131
79706000
LOINC Version 232
1975-2
Patients with AST or alkaline phosphatase > ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET scan, or PET-CT scan performed within 3 months prior to randomization) does not demonstrate metastatic disease and the requirements for evidence of adequate hepatic function are met.
Beskrivning

Patients with AST or alkaline phosphatase > ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET scan, or PET-CT scan performed within 3 months prior to randomization) does not demonstrate metastatic disease and the requirements for evidence of adequate hepatic function are met.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C0002059
SNOMED CT 2011_0131
57056007
LOINC Version 232
MTHU005195
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C1302261
SNOMED CT 2011_0131
399223003
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0920364
UMLS CUI 2011AA
C0040405
SNOMED CT 2011_0131
77477000
MedDRA 14.1
10010234
HL7 V3 2006_05
0002
UMLS CUI 2011AA
C0024485
SNOMED CT 2011_0131
113091000
MedDRA 14.1
10028049
UMLS CUI 2011AA
C0032743
SNOMED CT 2011_0131
82918005
MedDRA 14.1
10036220
HL7 V3 2006_05
0007
UMLS CUI 2011AA
CL381767
UMLS CUI 2011AA
C0441633
UMLS CUI 2011AA
C2825406
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
UMLS CUI 2011AA
C0445092
SNOMED CT 2011_0131
261985008
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0232741
SNOMED CT 2011_0131
79036002
Patients with alkaline phosphatase that is > ULN but <= 2.5 x ULN are eligible for inclusion in the study if a bone scan,PET scan, or PET-CT scan (performed within 3 months prior to randomization) does not demonstrate metastatic disease.
Beskrivning

Patients with alkaline phosphatase that is > ULN but <= 2.5 x ULN are eligible for inclusion in the study if a bone scan,PET scan, or PET-CT scan (performed within 3 months prior to randomization) does not demonstrate metastatic disease.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0002059
SNOMED CT 2011_0131
57056007
LOINC Version 232
MTHU005195
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C1302261
SNOMED CT 2011_0131
399223003
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0203668
SNOMED CT 2011_0131
41747008
MedDRA 14.1
10006009
ICD-9-CM Version 2011
92.14
UMLS CUI 2011AA
C0032743
SNOMED CT 2011_0131
82918005
MedDRA 14.1
10036220
HL7 V3 2006_05
0007
UMLS CUI 2011AA
CL381767
UMLS CUI 2011AA
C0441633
UMLS CUI 2011AA
C2825406
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
UMLS CUI 2011AA
C0445092
SNOMED CT 2011_0131
261985008
The following criteria for renal function must be met based on the results of the most recent postoperative tests performed within 6 weeks prior to randomization: Serum creatinine must be <= ULN for the lab. Measured or calculated creatinine clearance must be > 60 mL/min.
Beskrivning

The following criteria for renal function must be met based on the results of the most recent postoperative tests performed within 6 weeks prior to randomization: Serum creatinine must be <= ULN for the lab. Measured or calculated creatinine clearance must be > 60 mL/min.

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL414621
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
UMLS CUI 2011AA
C0332185
SNOMED CT 2011_0131
6493001
UMLS CUI 2011AA
C0241311
UMLS CUI 2011AA
C0392366
SNOMED CT 2011_0131
272393004
UMLS CUI 2011AA
C0884358
SNOMED CT 2011_0131
398166005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
UMLS CUI 2011AA
C0373595
SNOMED CT 2011_0131
167181009
MedDRA 14.1
10011371
UMLS CUI 2011AA
C0444686
SNOMED CT 2011_0131
258090004
A urine sample must be tested for protein by determination of the urine protein/creatinine (UPC) ratio or by urine dipstick. UPC ratio must be < 1.0. Urine dipstick must indicate 0-1+ protein. If dipstick reading is >= 2+, determine the UPC ratio, which must be < 1.0, or collect a 24-hour urine specimen, which must demonstrate < 1.0 g of protein per 24 hours.
Beskrivning

A urine sample must be tested for protein by determination of the urine protein/creatinine (UPC) ratio or by urine dipstick. UPC ratio must be < 1.0. Urine dipstick must indicate 0-1+ protein. If dipstick reading is >= 2+, determine the UPC ratio, which must be < 1.0, or collect a 24-hour urine specimen, which must demonstrate < 1.0 g of protein per 24 hours.

Datatyp

boolean

LVEF assessment must be performed within 3 months prior to randomization. The LVEF must be >= 55% regardless of the cardiac imaging facility's lower limit of normal (LLN).
Beskrivning

LVEF assessment must be performed within 3 months prior to randomization. The LVEF must be >= 55% regardless of the cardiac imaging facility's lower limit of normal (LLN).

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0428772
SNOMED CT 2011_0131
250908004
MedDRA 14.1
10069170
UMLS CUI 2011AA
C2825406
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
UMLS CUI 2011AA
C0851587
MedDRA 14.1
10007574
UMLS CUI 2011AA
C1547538
LOINC Version 232
MTHU020558
UMLS CUI 2011AA
C1518030
and conduction abnormality requiring a pacemaker.
Beskrivning

The ECG (performed within 3 months prior to randomization) must not have demonstrated any of the following conditions: ventricular arrhythmias except for benign premature ventricular contractions

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1623258
SNOMED CT 2011_0131
46825001
MedDRA 14.1
10014084
UMLS CUI 2011AA
C2825406
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL414352
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0085612
SNOMED CT 2011_0131
44103008
MedDRA 14.1
10047281
ICD-10-CM Version 2010
I49.01
CTCAE 1105E
E10230
UMLS CUI 2011AA
C1554961
UMLS CUI 2011AA
C0205183
SNOMED CT 2011_0131
30807003
UMLS CUI 2011AA
C0151636
SNOMED CT 2011_0131
17338001
MedDRA 14.1
10047289
LOINC Version 232
MTHU024512
ICD-10-CM Version 2010
I49.3
Ausschlusskriterien
Beskrivning

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
Inflammatory Breast Carcinoma, Mastitis carcinomatosa
Beskrivning

Inflammatory breast cancer.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0278601
SNOMED CT 2011_0131
254840009
MedDRA 14.1
10021980
Definitive clinical or radiologic evidence of metastatic disease. (Chest imaging [mandatory for all patients] and other imaging [if required] must have been performed within 3 months prior to randomization.)
Beskrivning

Definitive clinical or radiologic evidence of metastatic disease. (Chest imaging [mandatory for all patients] and other imaging [if required] must have been performed within 3 months prior to randomization.)

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0205483
SNOMED CT 2011_0131
5526005
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0027627
MedDRA 14.1
10027478
UMLS CUI 2011AA
C1531652
SNOMED CT 2011_0131
413815006
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0011923
SNOMED CT 2011_0131
363679005
UMLS CUI 2011AA
C0884358
SNOMED CT 2011_0131
398166005
UMLS CUI 2011AA
C2825406
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
Synchronous or previous contralateral invasive breast cancer (Patients with synchronous or previous contralateral DCIS or LCIS are eligible).
Beskrivning

Synchronous or previous contralateral invasive breast cancer (Patients with synchronous or previous contralateral DCIS or LCIS are eligible).

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0439580
SNOMED CT 2011_0131
255237009
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0441988
SNOMED CT 2011_0131
255209002
UMLS CUI 2011AA
C0853879
MedDRA 14.1
10006190
UMLS CUI 2011AA
C0439580
SNOMED CT 2011_0131
255237009
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0441988
SNOMED CT 2011_0131
255209002
UMLS CUI 2011AA
C0007124
SNOMED CT 2011_0131
86616005
MedDRA 14.1
10013806
ICD-10-CM Version 2010
D05.1
UMLS CUI 2011AA
C0279563
SNOMED CT 2011_0131
109888004
MedDRA 14.1
10024744
ICD-10-CM Version 2010
D05.0
UMLS CUI 2011AA
C1548635
HL7 V3 2006_05
ELG
History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with excision and RT. (Patients with history of ipsilateral LCIS are eligible.)
Beskrivning

History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with excision and RT. (Patients with history of ipsilateral LCIS are eligible.)

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0441989
SNOMED CT 2011_0131
255208005
UMLS CUI 2011AA
C0853879
MedDRA 14.1
10006190
UMLS CUI 2011AA
C1554079
HL7 V3 2006_05
I
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0441989
SNOMED CT 2011_0131
255208005
UMLS CUI 2011AA
C0007124
SNOMED CT 2011_0131
86616005
MedDRA 14.1
10013806
ICD-10-CM Version 2010
D05.1
UMLS CUI 2011AA
C0728940
SNOMED CT 2011_0131
65801008
UMLS CUI 2011AA
C0034619
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0441989
SNOMED CT 2011_0131
255208005
UMLS CUI 2011AA
C0279563
SNOMED CT 2011_0131
109888004
MedDRA 14.1
10024744
ICD-10-CM Version 2010
D05.0
UMLS CUI 2011AA
C1548635
HL7 V3 2006_05
ELG
History of non-breast malignancies within the 5 years prior to study entry, except for the following: 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.
Beskrivning

History of non-breast malignancies within the 5 years prior to study entry, except for the following: 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.

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0678222
SNOMED CT 2011_0131
254838004
MedDRA 14.1
10006204
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
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
MedDRA 14.1
10004146
UMLS CUI 2011AA
C0553723
SNOMED CT 2011_0131
254651007
MedDRA 14.1
10041834
Previous therapy with anthracyclines, taxanes, carboplatin, trastuzumab, or bevacizumab for any malignancy.
Beskrivning

Previous therapy with anthracyclines, taxanes, carboplatin, trastuzumab, or bevacizumab for any malignancy.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0282564
SNOMED CT 2011_0131
372540003
UMLS CUI 2011AA
C0215136
UMLS CUI 2011AA
C0079083
SNOMED CT 2011_0131
386905002
UMLS CUI 2011AA
C0728747
SNOMED CT 2011_0131
387003001
UMLS CUI 2011AA
C0796392
SNOMED CT 2011_0131
409406007
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to randomization.
Beskrivning

RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to randomization.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0034619
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
CL421608
UMLS CUI 2011AA
C1521801
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0678222
SNOMED CT 2011_0131
254838004
MedDRA 14.1
10006204
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
Continued therapy with any hormonal agent such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor. (Patients are eligible if these medications are discontinued prior to randomization.)
Beskrivning

Continued therapy with any hormonal agent such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor. (Patients are eligible if these medications are discontinued prior to randomization.)

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0549178
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0458083
SNOMED CT 2011_0131
278994005
UMLS CUI 2011AA
C1254351
UMLS CUI 2011AA
C0244404
SNOMED CT 2011_0131
109029006
UMLS CUI 2011AA
C0039286
SNOMED CT 2011_0131
373345002
LOINC Version 232
MTHU003102
UMLS CUI 2011AA
C0732611
SNOMED CT 2011_0131
415515000
UMLS CUI 2011AA
C0593802
SNOMED CT 2011_0131
413575009
UMLS CUI 2011AA
C1548635
HL7 V3 2006_05
ELG
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C1444662
SNOMED CT 2011_0131
410546004
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. Patients are eligible if these medications are discontinued prior to randomization.
Beskrivning

Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. Patients are eligible if these medications are discontinued prior to randomization.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0036884
SNOMED CT 2011_0131
312263009
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0009905
SNOMED CT 2011_0131
59261009
UMLS CUI 2011AA
C0729511
SNOMED CT 2011_0131
43171004
UMLS CUI 2011AA
C0559956
SNOMED CT 2011_0131
282089006
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1302261
SNOMED CT 2011_0131
399223003
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C1444662
SNOMED CT 2011_0131
410546004
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens. This includes but is not confined to: Active cardiac disease - angina pectoris that requires the use of anti-anginal medication. Ventricular arrhythmias except for benign premature ventricular contractions. Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication. Conduction abnormality requiring a pacemaker. Valvular disease with documented compromise in cardiac function. And symptomatic pericarditis. History of cardiac disease - myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function. History of documented CHF. And documented cardiomyopathy.
Beskrivning

Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens. This includes but is not confined to: Active cardiac disease - angina pectoris that requires the use of anti-anginal medication. Ventricular arrhythmias except for benign premature ventricular contractions. Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication. Conduction abnormality requiring a pacemaker. Valvular disease with documented compromise in cardiac function. And symptomatic pericarditis. History of cardiac disease - myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function. History of documented CHF. And documented cardiomyopathy.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C2707252
LOINC Version 232
MTHU031865
UMLS CUI 2011AA
C0332196
SNOMED CT 2011_0131
77765009
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
CL031856
UMLS CUI 2011AA
C2707252
LOINC Version 232
MTHU031865
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
UMLS CUI 2011AA
C0002962
SNOMED CT 2011_0131
194828000
MedDRA 14.1
10002383
ICD-10-CM Version 2010
I20
ICD-9-CM Version 2011
413
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C1874267
UMLS CUI 2011AA
C0085612
SNOMED CT 2011_0131
44103008
MedDRA 14.1
10047281
ICD-10-CM Version 2010
I49.01
CTCAE 1105E
E10230
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0205183
SNOMED CT 2011_0131
30807003
UMLS CUI 2011AA
C0151636
SNOMED CT 2011_0131
17338001
MedDRA 14.1
10047289
LOINC Version 232
MTHU024512
ICD-10-CM Version 2010
I49.3
UMLS CUI 2011AA
C0428974
SNOMED CT 2011_0131
72654001
MedDRA 14.1
10003130
UMLS CUI 2011AA
C0264893
SNOMED CT 2011_0131
71792006
MedDRA 14.1
10029458
ICD-10-CM Version 2010
I49.8
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0030163
SNOMED CT 2011_0131
14106009
LOINC Version 232
MTHU024521
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C1842820
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0030163
SNOMED CT 2011_0131
14106009
LOINC Version 232
MTHU024521
UMLS CUI 2011AA
C0026265
SNOMED CT 2011_0131
11851006
MedDRA 14.1
10061532
ICD-9-CM Version 2011
424.0
CTCAE 1105E
E10134
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C0232166
UMLS CUI 2011AA
C0231220
SNOMED CT 2011_0131
264931009
UMLS CUI 2011AA
C0031046
SNOMED CT 2011_0131
3238004
MedDRA 14.1
10034484
CTCAE 1105E
E10180
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C1707297
UMLS CUI 2011AA
C0205322
UMLS CUI 2011AA
C0205147
SNOMED CT 2011_0131
410673009
LOINC Version 232
MTHU009053
UMLS CUI 2011AA
C0504053
UMLS CUI 2011AA
C1704258
UMLS CUI 2011AA
C1516048
UMLS CUI 2011AA
C0080310
SNOMED CT 2011_0131
250907009
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C0018802
SNOMED CT 2011_0131
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
CL411823
SNOMED CT 2011_0131
85898001
MedDRA 14.1
10007636
ICD-10-CM Version 2010
I42.9
ICD-9-CM Version 2011
425
Uncontrolled hypertension defined as systolic blood pressure (BP) > 150 mmHg or diastolic BP > 90 mmHg, with or without anti-hypertensive medication. (BP must be assessed within 28 days prior to randomization.) Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.
Beskrivning

Uncontrolled hypertension defined as systolic blood pressure (BP) > 150 mmHg or diastolic BP > 90 mmHg, with or without anti-hypertensive medication. (BP must be assessed within 28 days prior to randomization.) Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1868885
MedDRA 14.1
10066860
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0871470
SNOMED CT 2011_0131
271649006
UMLS CUI 2011AA
C0428883
SNOMED CT 2011_0131
271650006
UMLS CUI 2011AA
C0003364
SNOMED CT 2011_0131
372586001
UMLS CUI 2011AA
C0005823
SNOMED CT 2011_0131
75367002
LOINC Version 232
MTHU008342
UMLS CUI 2011AA
C1516048
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
UMLS CUI 2011AA
C0205265
SNOMED CT 2011_0131
884001
UMLS CUI 2011AA
C0497247
SNOMED CT 2011_0131
24184005
MedDRA 14.1
10005750
UMLS CUI 2011AA
C1302261
SNOMED CT 2011_0131
399223003
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C1704686
UMLS CUI 2011AA
C0456081
SNOMED CT 2011_0131
410617001
UMLS CUI 2011AA
C0003364
SNOMED CT 2011_0131
372586001
UMLS CUI 2011AA
C2003888
UMLS CUI 2011AA
C0005823
SNOMED CT 2011_0131
75367002
LOINC Version 232
MTHU008342
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
CL425202
History of hypertensive crisis or hypertensive encephalopathy.
Beskrivning

History of hypertensive crisis or hypertensive encephalopathy.

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0020546
SNOMED CT 2011_0131
50490005
MedDRA 14.1
10020802
UMLS CUI 2011AA
C0151620
SNOMED CT 2011_0131
50490005
MedDRA 14.1
10020803
ICD-10-CM Version 2010
I67.4
ICD-9-CM Version 2011
437.2
History of TIA or CVA.
Beskrivning

History of TIA or CVA.

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0007787
SNOMED CT 2011_0131
266257000
MedDRA 14.1
10044390
LOINC Version 232
MTHU020810
ICD-10-CM Version 2010
G45.9
ICD-9-CM Version 2011
435.9
CTCAE 1105E
E12834
UMLS CUI 2011AA
C0038454
SNOMED CT 2011_0131
230690007
MedDRA 14.1
10042244
ICD-10-CM Version 2010
I63.9
CTCAE 1105E
E12826
History of any arterial thrombotic event within 12 months before randomization.
Beskrivning

History of any arterial thrombotic event within 12 months before randomization.

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0151942
SNOMED CT 2011_0131
65198009
MedDRA 14.1
10003178
UMLS CUI 2011AA
C0441471
SNOMED CT 2011_0131
272379006
LOINC Version 232
MTHU019184
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
Symptomatic peripheral vascular disease
Beskrivning

Symptomatic peripheral vascular disease

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0231220
SNOMED CT 2011_0131
264931009
UMLS CUI 2011AA
C0085096
SNOMED CT 2011_0131
400047006
MedDRA 14.1
10034636
LOINC Version 232
MTHU020791
ICD-10-CM Version 2010
I73.9
ICD-9-CM Version 2011
443.9
Intrinsic lung disease resulting in dyspnea
Beskrivning

Intrinsic lung disease resulting in dyspnea

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205102
SNOMED CT 2011_0131
260521003
UMLS CUI 2011AA
C0024115
SNOMED CT 2011_0131
19829001
MedDRA 14.1
10025082
ICD-10-CM Version 2010
J98.4
UMLS CUI 2011AA
C1274040
SNOMED CT 2011_0131
79409006
UMLS CUI 2011AA
C0013404
SNOMED CT 2011_0131
139201002
MedDRA 14.1
10013968
LOINC Version 232
MTHU020850
ICD-10-CM Version 2010
R06.0
ICD-9-CM Version 2011
786.05
CTCAE 1105E
E13368
labiler Diabetes mellitus Typ I
Beskrivning

Unstable diabetes mellitus

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0342302
SNOMED CT 2011_0131
11530004
MedDRA 14.1
10006372
Active infection or chronic infection requiring chronic suppressive antibiotics.
Beskrivning

Active infection or chronic infection requiring chronic suppressive antibiotics.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0205367
SNOMED CT 2011_0131
244840000
UMLS CUI 2011AA
C0003232
SNOMED CT 2011_0131
255631004
Any significant bleeding within 6 months before randomization, exclusive of menorrhagia in premenopausal women.
Beskrivning

Any significant bleeding within 6 months before randomization, exclusive of menorrhagia in premenopausal women.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0019080
SNOMED CT 2011_0131
50960005
MedDRA 14.1
10055798
ICD-10-CM Version 2010
R58
ICD-9-CM Version 2011
459.0
UMLS CUI 2011AA
C2825407
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0025323
SNOMED CT 2011_0131
386692008
MedDRA 14.1
10027313
ICD-10-CM Version 2010
N92.0
CTCAE 1105E
E13132
UMLS CUI 2011AA
C0279752
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
Non-healing wound, skin ulcers, or incompletely healed bone fracture.
Beskrivning

Non-healing wound, skin ulcers, or incompletely healed bone fracture.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0750433
SNOMED CT 2011_0131
125192008
UMLS CUI 2011AA
C0748826
ICD-10-CM Version 2010
L97
UMLS CUI 2011AA
C0205257
SNOMED CT 2011_0131
255599008
UMLS CUI 2011AA
C0205249
SNOMED CT 2011_0131
90910008
UMLS CUI 2011AA
C0016658
SNOMED CT 2011_0131
125605004
MedDRA 14.1
10017076
ICD-10-CM Version 2010
T14.8
ICD-9-CM Version 2011
800-829.99
CTCAE 1105E
E11703
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to planned start of study therapy.
Beskrivning

Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to planned start of study therapy.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0679637
UMLS CUI 2011AA
C0184922
SNOMED CT 2011_0131
119283008
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0175677
SNOMED CT 2011_0131
417746004
MedDRA 14.1
10022116
ICD-10-CM Version 2010
T14.9
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1301732
SNOMED CT 2011_0131
397943006
UMLS CUI 2011AA
C2348558
UMLS CUI 2011AA
C0039798
Anticipation of need for major surgical procedures during study therapy and for at least 3 months following completion of bevacizumab.
Beskrivning

Anticipation of need for major surgical procedures during study therapy and for at least 3 months following completion of bevacizumab.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0679106
UMLS CUI 2011AA
C0686904
SNOMED CT 2011_0131
103325001
UMLS CUI 2011AA
C0679637
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C2825406
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C1554962
HL7 V3 2006_05
C
UMLS CUI 2011AA
C0796392
SNOMED CT 2011_0131
409406007
Gastroduodenal ulcer(s) documented by endoscopy to be active within 6 months before randomization.
Beskrivning

Gastroduodenal ulcer(s) documented by endoscopy to be active within 6 months before randomization.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0030920
SNOMED CT 2011_0131
13200003
MedDRA 14.1
10034341
ICD-10-CM Version 2010
K27
ICD-9-CM Version 2011
533
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C0014245
SNOMED CT 2011_0131
423827005
MedDRA 14.1
10014805
LOINC Version 232
MTHU008659
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C2825407
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
History of GI perforation, abdominal fistulae, or intra-abdominal abscess.
Beskrivning

History of GI perforation, abdominal fistulae, or intra-abdominal abscess.

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0151664
SNOMED CT 2011_0131
51875005
MedDRA 14.1
10018001
UMLS CUI 2011AA
C1879311
UMLS CUI 2011AA
CL031631
UMLS CUI 2011AA
C0000833
SNOMED CT 2011_0131
128477000
MedDRA 14.1
10000269
LOINC Version 232
MTHU022414
Known bleeding diathesis or coagulopathy.
Beskrivning

Known bleeding diathesis or coagulopathy.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C1458140
SNOMED CT 2011_0131
248250000
MedDRA 14.1
10005134
UMLS CUI 2011AA
C0005779
SNOMED CT 2011_0131
64779008
MedDRA 14.1
10009802
ICD-10-CM Version 2010
D68.9
Requirement for therapeutic doses of coumadin or equivalent.
Beskrivning

Requirement for therapeutic doses of coumadin or equivalent.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C1564394
UMLS CUI 2011AA
CL415123
Sensory/motor neuropathy >= grade 2, as defined by the NCI CTCAE v3.0.
Beskrivning

Sensory/motor neuropathy >= grade 2, as defined by the NCI CTCAE v3.0.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0151313
SNOMED CT 2011_0131
95662005
MedDRA 14.1
10034620
CTCAE 1105E
E12768
UMLS CUI 2011AA
C1557259
CTCAE 1105E
MTHU113783
UMLS CUI 2011AA
C1557260
CTCAE 1105E
MTHU114803
UMLS CUI 2011AA
C1557261
CTCAE 1105E
MTHU115776
UMLS CUI 2011AA
C1557262
CTCAE 1105E
MTHU116556
UMLS CUI 2011AA
C0235025
SNOMED CT 2011_0131
95663000
MedDRA 14.1
10034580
CTCAE 1105E
E12762
UMLS CUI 2011AA
C1557254
CTCAE 1105E
MTHU113523
UMLS CUI 2011AA
C1557255
CTCAE 1105E
MTHU114539
UMLS CUI 2011AA
C1557256
CTCAE 1105E
MTHU115527
UMLS CUI 2011AA
C1557257
CTCAE 1105E
MTHU116371
Conditions that would prohibit administration of corticosteroids.
Beskrivning

Conditions that would prohibit administration of corticosteroids.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0683610
UMLS CUI 2011AA
C1533734
SNOMED CT 2011_0131
416118004
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
Chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids).
Beskrivning

Chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids).

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C2348070
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0025815
SNOMED CT 2011_0131
116593003
LOINC Version 232
MTHU004699
UMLS CUI 2011AA
CL415123
UMLS CUI 2011AA
C0586794
SNOMED CT 2011_0131
170660006
History of hypersensitivity reaction to drugs formulated with polysorbate 80.
Beskrivning

History of hypersensitivity reaction to drugs formulated with polysorbate 80.

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C1705957
UMLS CUI 2011AA
C0032601
SNOMED CT 2011_0131
255899003
Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing must be performed within 14 days prior to randomization according to institutional standards for women of child-bearing potential.)
Beskrivning

Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing must be performed within 14 days prior to randomization according to institutional standards for women of child-bearing potential.)

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C2348558
UMLS CUI 2011AA
C0032976
SNOMED CT 2011_0131
74036000
MedDRA 14.1
10036572
UMLS CUI 2011AA
C2825407
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0021622
UMLS CUI 2011AA
C2828392
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.
Beskrivning

Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1518371
UMLS CUI 2011AA
C0442893
SNOMED CT 2011_0131
56019007, 264578000
UMLS CUI 2011AA
C0332196
SNOMED CT 2011_0131
77765009
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C2700409
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C1522577
Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
Beskrivning

Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0004936
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
UMLS CUI 2011AA
C0085281
SNOMED CT 2011_0131
32709003
MedDRA 14.1
10001125
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C0332196
SNOMED CT 2011_0131
77765009
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1514873
Use of any investigational product within 4 weeks prior to enrollment in the study.
Beskrivning

Use of any investigational product within 4 weeks prior to enrollment in the study.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C1517586
UMLS CUI 2011AA
C1514468
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Tillbaka till toppen

Similar models

Eligibility

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
Alter mindestens 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Life expectancy of at least 10 years, excluding their diagnosis of breast cancer.
Item
Life expectancy of at least 10 years, excluding their diagnosis of breast cancer.
boolean
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
CL411789 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0678222 (UMLS CUI 2011AA)
254838004 (SNOMED CT 2011_0131)
10006204 (MedDRA 14.1)
Women who have had breast reconstruction utilizing tissue expanders must be in agreement with delaying surgery to replace the tissue expanders with permanent implants until 3 months following the last dose of bevacizumab
Item
Women who have had breast reconstruction utilizing tissue expanders must be in agreement with delaying surgery to replace the tissue expanders with permanent implants until 3 months following the last dose of bevacizumab
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0085076 (UMLS CUI 2011AA)
33496007 (SNOMED CT 2011_0131)
10006305 (MedDRA 14.1)
C0588162 (UMLS CUI 2011AA)
310630001 (SNOMED CT 2011_0131)
C0680240 (UMLS CUI 2011AA)
C1710256 (UMLS CUI 2011AA)
C0559956 (UMLS CUI 2011AA)
282089006 (SNOMED CT 2011_0131)
C0205355 (UMLS CUI 2011AA)
6934004 (SNOMED CT 2011_0131)
C0021102 (UMLS CUI 2011AA)
40388003 (SNOMED CT 2011_0131)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C1517741 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0796392 (UMLS CUI 2011AA)
409406007 (SNOMED CT 2011_0131)
Women of reproductive potential must agree to use an effective non-hormonal method of contraception (for example condoms, some intrauterine devices, diaphragms, vasectomized partner, or abstinence) during therapy and for at least 6 months after the last dose of bevacizumab and/or trastuzumab.
Item
Women of reproductive potential must agree to use an effective non-hormonal method of contraception (for example condoms, some intrauterine devices, diaphragms, vasectomized partner, or abstinence) during therapy and for at least 6 months after the last dose of bevacizumab and/or trastuzumab.
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0035150 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
CL424941 (UMLS CUI 2011AA)
C0677582 (UMLS CUI 2011AA)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0042241 (UMLS CUI 2011AA)
20359006 (SNOMED CT 2011_0131)
C0420842 (UMLS CUI 2011AA)
268457007 (SNOMED CT 2011_0131)
CL068143 (UMLS CUI 2011AA)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C2825407 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C1517741 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0796392 (UMLS CUI 2011AA)
409406007 (SNOMED CT 2011_0131)
C0728747 (UMLS CUI 2011AA)
387003001 (SNOMED CT 2011_0131)
Submission of tumor samples from the breast surgery for central HER2 testing is required for all patients prior to enrollment in the BETH Trial
Item
Submission of tumor samples from the breast surgery for central HER2 testing is required for all patients prior to enrollment in the BETH Trial
boolean
C1515022 (UMLS CUI 2011AA)
MTHU032338 (LOINC Version 232)
C0475358 (UMLS CUI 2011AA)
258435002 (SNOMED CT 2011_0131)
C0851312 (UMLS CUI 2011AA)
408469009, 392090004 (SNOMED CT 2011_0131)
10061734 (MedDRA 14.1)
85 (ICD-9-CM Version 2011)
C0069515 (UMLS CUI 2011AA)
44368005 (SNOMED CT 2011_0131)
MTHU014669 (LOINC Version 232)
C0039593 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Signed and dated IRB/EC-approved consent
Item
Signed and dated IRB/EC-approved consent
boolean
C1561610 (UMLS CUI 2011AA)
S (HL7 V3 2006_05)
C0011008 (UMLS CUI 2011AA)
410671006 (SNOMED CT 2011_0131)
MTHU021546 (LOINC Version 232)
C1511481 (UMLS CUI 2011AA)
MTHU035862 (LOINC Version 232)
C1706842 (UMLS CUI 2011AA)
C0086911 (UMLS CUI 2011AA)
ECOG performance status <= 1
Item
ECOG Status <= 1
boolean
C1520224 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
Item
The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0205092 (UMLS CUI 2011AA)
66459002 (SNOMED CT 2011_0131)
C0205281 (UMLS CUI 2011AA)
10179008 (SNOMED CT 2011_0131)
C0858252 (UMLS CUI 2011AA)
10006173 (MedDRA 14.1)
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
The breast cancer must be HER2-positive based on test results as follows: Local testing (if available) should demonstrate that the tumor is IHC 2+ or 3+ or is considered to be HER2-positive for gene amplification by FISH, CISH, or other in situ hybridization (ISH) method. If local ISH test results are considered equivocal, the tumor can be submitted for central HER2 testing. (If local testing is not possible, the tumor can be submitted for central HER2 testing.) Central testing (a requirement for ALL patients) must demonstrate that the tumor is HER2-positive which is defined as FISH-positive and/or IHC 3+.
Item
The breast cancer must be HER2-positive based on test results as follows: Local testing (if available) should demonstrate that the tumor is IHC 2+ or 3+ or is considered to be HER2-positive for gene amplification by FISH, CISH, or other in situ hybridization (ISH) method. If local ISH test results are considered equivocal, the tumor can be submitted for central HER2 testing. (If local testing is not possible, the tumor can be submitted for central HER2 testing.) Central testing (a requirement for ALL patients) must demonstrate that the tumor is HER2-positive which is defined as FISH-positive and/or IHC 3+.
boolean
CL412284 (UMLS CUI 2011AA)
CL415116 (UMLS CUI 2011AA)
C0039593 (UMLS CUI 2011AA)
C0021044 (UMLS CUI 2011AA)
117617002 (SNOMED CT 2011_0131)
10059656 (MedDRA 14.1)
C0017256 (UMLS CUI 2011AA)
12645001 (SNOMED CT 2011_0131)
C0162789 (UMLS CUI 2011AA)
426329006 (SNOMED CT 2011_0131)
10066931 (MedDRA 14.1)
C1516514 (UMLS CUI 2011AA)
C0162788 (UMLS CUI 2011AA)
123 (HL7 V3 2006_05)
C0023449 (UMLS CUI 2011AA)
91857003, 128822004 (SNOMED CT 2011_0131)
10060390 (MedDRA 14.1)
C91.0 (ICD-10-CM Version 2010)
204.0 (ICD-9-CM Version 2011)
All of the following staging criteria (according to the 6th edition of the AJCC Cancer Staging Manual) must be met: By pathologic evaluation, primary tumor must be pT1-3. By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b. If pN0, at least one of the following criteria must be met: Pathologic tumor size > 2.0 cm. ER negative and PgR negative. Histologic and/or nuclear grade 2 (intermediate) or 3 (high). Or Age < 35 years.
Item
All of the following staging criteria (according to the 6th edition of the AJCC Cancer Staging Manual) must be met: By pathologic evaluation, primary tumor must be pT1-3. By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b. If pN0, at least one of the following criteria must be met: Pathologic tumor size > 2.0 cm. ER negative and PgR negative. Histologic and/or nuclear grade 2 (intermediate) or 3 (high). Or Age < 35 years.
boolean
C0027646 (UMLS CUI 2011AA)
CL414621 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0441915 (UMLS CUI 2011AA)
258236004 (SNOMED CT 2011_0131)
C1521733 (UMLS CUI 2011AA)
29458008 (SNOMED CT 2011_0131)
C0220825 (UMLS CUI 2011AA)
C1306459 (UMLS CUI 2011AA)
372087000 (SNOMED CT 2011_0131)
C0332391 (UMLS CUI 2011AA)
53786006 (SNOMED CT 2011_0131)
C0332392 (UMLS CUI 2011AA)
80898003 (SNOMED CT 2011_0131)
C0332393 (UMLS CUI 2011AA)
90402004 (SNOMED CT 2011_0131)
C0441989 (UMLS CUI 2011AA)
255208005 (SNOMED CT 2011_0131)
C0024204 (UMLS CUI 2011AA)
59441001 (SNOMED CT 2011_0131)
MTHU015050 (LOINC Version 232)
C0332396 (UMLS CUI 2011AA)
C0332397 (UMLS CUI 2011AA)
C2732831 (UMLS CUI 2011AA)
443824009 (SNOMED CT 2011_0131)
C1711118 (UMLS CUI 2011AA)
C1711119 (UMLS CUI 2011AA)
C1711120 (UMLS CUI 2011AA)
C1711121 (UMLS CUI 2011AA)
C1711124 (UMLS CUI 2011AA)
C1711125 (UMLS CUI 2011AA)
CL414621 (UMLS CUI 2011AA)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C1521733 (UMLS CUI 2011AA)
29458008 (SNOMED CT 2011_0131)
C0475440 (UMLS CUI 2011AA)
263605001 (SNOMED CT 2011_0131)
C0279756 (UMLS CUI 2011AA)
C0279766 (UMLS CUI 2011AA)
C0919553 (UMLS CUI 2011AA)
371469007 (SNOMED CT 2011_0131)
C1518435 (UMLS CUI 2011AA)
C1333838 (UMLS CUI 2011AA)
C1333843 (UMLS CUI 2011AA)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patients must have undergone either a total mastectomy or breast conserving surgery (lumpectomy).
Item
Patients must have undergone either a total mastectomy or breast conserving surgery (lumpectomy).
boolean
C0024886 (UMLS CUI 2011AA)
172043006 (SNOMED CT 2011_0131)
10040700 (MedDRA 14.1)
85.41 (ICD-9-CM Version 2011)
C0917927 (UMLS CUI 2011AA)
C0851238 (UMLS CUI 2011AA)
392021009 (SNOMED CT 2011_0131)
10061733 (MedDRA 14.1)
For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection.)
Item
For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection.)
boolean
C0851238 (UMLS CUI 2011AA)
392021009 (SNOMED CT 2011_0131)
10061733 (MedDRA 14.1)
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0332296 (UMLS CUI 2011AA)
37837009 (SNOMED CT 2011_0131)
C0677898 (UMLS CUI 2011AA)
C0007124 (UMLS CUI 2011AA)
86616005 (SNOMED CT 2011_0131)
10013806 (MedDRA 14.1)
D05.1 (ICD-10-CM Version 2010)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C0229985 (UMLS CUI 2011AA)
82868003 (SNOMED CT 2011_0131)
C1706711 (UMLS CUI 2011AA)
C0184913 (UMLS CUI 2011AA)
65854006 (SNOMED CT 2011_0131)
C0024886 (UMLS CUI 2011AA)
172043006 (SNOMED CT 2011_0131)
10040700 (MedDRA 14.1)
85.41 (ICD-9-CM Version 2011)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C0279563 (UMLS CUI 2011AA)
109888004 (SNOMED CT 2011_0131)
10024744 (MedDRA 14.1)
D05.0 (ICD-10-CM Version 2010)
For patients who undergo mastectomy, margins must be free of gross residual tumor. Patients with microscopic positive margins are eligible.
Item
For patients who undergo mastectomy, margins must be free of gross residual tumor. Patients with microscopic positive margins are eligible.
boolean
C0024881 (UMLS CUI 2011AA)
10026878 (MedDRA 14.1)
85.4 (ICD-9-CM Version 2011)
C0229985 (UMLS CUI 2011AA)
82868003 (SNOMED CT 2011_0131)
C0332296 (UMLS CUI 2011AA)
37837009 (SNOMED CT 2011_0131)
C0439806 (UMLS CUI 2011AA)
255344003 (SNOMED CT 2011_0131)
C0242596 (UMLS CUI 2011AA)
C0205288 (UMLS CUI 2011AA)
84496004 (SNOMED CT 2011_0131)
CL415097 (UMLS CUI 2011AA)
C0229985 (UMLS CUI 2011AA)
82868003 (SNOMED CT 2011_0131)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
Patients must have completed one of the following procedures for evaluation of pathologic nodal status: Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive. Sentinel lymphadenectomy alone if pathologic nodal staging based on sentinel lymphadenectomy is pN0, pN1mi or pN1b. Or Axillary lymphadenectomy without SN isolation procedure.
Item
Patients must have completed one of the following procedures for evaluation of pathologic nodal status: Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive. Sentinel lymphadenectomy alone if pathologic nodal staging based on sentinel lymphadenectomy is pN0, pN1mi or pN1b. Or Axillary lymphadenectomy without SN isolation procedure.
boolean
C1556116 (UMLS CUI 2011AA)
completed (HL7 V3 2006_05)
C2700391 (UMLS CUI 2011AA)
C0220825 (UMLS CUI 2011AA)
C1521733 (UMLS CUI 2011AA)
29458008 (SNOMED CT 2011_0131)
C0449927 (UMLS CUI 2011AA)
260918007 (SNOMED CT 2011_0131)
C2363825 (UMLS CUI 2011AA)
10068478 (MedDRA 14.1)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C1518422 (UMLS CUI 2011AA)
C0677944 (UMLS CUI 2011AA)
330469005 (SNOMED CT 2011_0131)
CL415097 (UMLS CUI 2011AA)
C2363825 (UMLS CUI 2011AA)
10068478 (MedDRA 14.1)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0750557 (UMLS CUI 2011AA)
C0332396 (UMLS CUI 2011AA)
C2732831 (UMLS CUI 2011AA)
443824009 (SNOMED CT 2011_0131)
C1711119 (UMLS CUI 2011AA)
CL414906 (UMLS CUI 2011AA)
C0193867 (UMLS CUI 2011AA)
234262008 (SNOMED CT 2011_0131)
10068477 (MedDRA 14.1)
40.23 (ICD-9-CM Version 2011)
CL411789 (UMLS CUI 2011AA)
C0677944 (UMLS CUI 2011AA)
330469005 (SNOMED CT 2011_0131)
C0204727 (UMLS CUI 2011AA)
40174006 (SNOMED CT 2011_0131)
99.84 (ICD-9-CM Version 2011)
The interval between the last surgery for breast cancer (treatment or staging) and randomization must be at least 28 days but no more than 84 days.
Item
The interval between the last surgery for breast cancer (treatment or staging) and randomization must be at least 28 days but no more than 84 days.
boolean
C1272706 (UMLS CUI 2011AA)
385673002 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C0038895 (UMLS CUI 2011AA)
C0678222 (UMLS CUI 2011AA)
254838004 (SNOMED CT 2011_0131)
10006204 (MedDRA 14.1)
C0039798 (UMLS CUI 2011AA)
C0027646 (UMLS CUI 2011AA)
254292007 (SNOMED CT 2011_0131)
LP78422-0 (LOINC Version 232)
C0034656 (UMLS CUI 2011AA)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then PgR analysis must also be performed.
Item
Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then PgR analysis must also be performed.
boolean
C1521863 (UMLS CUI 2011AA)
C0002778 (UMLS CUI 2011AA)
272389005 (SNOMED CT 2011_0131)
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C1306459 (UMLS CUI 2011AA)
372087000 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0750557 (UMLS CUI 2011AA)
C0279756 (UMLS CUI 2011AA)
C0034833 (UMLS CUI 2011AA)
61078009 (SNOMED CT 2011_0131)
MTHU002145 (LOINC Version 232)
C0002778 (UMLS CUI 2011AA)
272389005 (SNOMED CT 2011_0131)
C1882330 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
The most recent postoperative blood counts, performed within 6 weeks prior to randomization, must meet the following criteria: ANC must be >= 1200/mm3. Platelet count must be >= 100,000/mm3. And Hemoglobin must be >= 10 g/dL.
Item
The most recent postoperative blood counts, performed within 6 weeks prior to randomization, must meet the following criteria: ANC must be >= 1200/mm3. Platelet count must be >= 100,000/mm3. And Hemoglobin must be >= 10 g/dL.
boolean
C0332185 (UMLS CUI 2011AA)
6493001 (SNOMED CT 2011_0131)
C0241311 (UMLS CUI 2011AA)
C0005771 (UMLS CUI 2011AA)
88308000 (SNOMED CT 2011_0131)
10064196 (MedDRA 14.1)
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
CL414621 (UMLS CUI 2011AA)
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
C0019046 (UMLS CUI 2011AA)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
The following criteria for evidence of adequate hepatic function must be met based on the results of the most recent postoperative tests performed within 6 weeks prior to randomization: total bilirubin must be <= upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin
Item
and AST must be less than or equal to 1.5 x ULN for the lab. Alkaline phosphatase and AST may not both be > the ULN.
boolean
CL414621 (UMLS CUI 2011AA)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
C0332185 (UMLS CUI 2011AA)
6493001 (SNOMED CT 2011_0131)
C0241311 (UMLS CUI 2011AA)
C0392366 (UMLS CUI 2011AA)
272393004 (SNOMED CT 2011_0131)
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0201913 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C0311468 (UMLS CUI 2011AA)
26165005 (SNOMED CT 2011_0131)
10005364 (MedDRA 14.1)
E12096 (CTCAE 1105E)
C0017551 (UMLS CUI 2011AA)
27503000 (SNOMED CT 2011_0131)
10018267 (MedDRA 14.1)
E80.4 (ICD-10-CM Version 2010)
C2348205 (UMLS CUI 2011AA)
C0039082 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0439834 (UMLS CUI 2011AA)
255361000 (SNOMED CT 2011_0131)
C1160466 (UMLS CUI 2011AA)
C0011221 (UMLS CUI 2011AA)
79706000 (SNOMED CT 2011_0131)
1975-2 (LOINC Version 232)
Patients with AST or alkaline phosphatase > ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET scan, or PET-CT scan performed within 3 months prior to randomization) does not demonstrate metastatic disease and the requirements for evidence of adequate hepatic function are met.
Item
Patients with AST or alkaline phosphatase > ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET scan, or PET-CT scan performed within 3 months prior to randomization) does not demonstrate metastatic disease and the requirements for evidence of adequate hepatic function are met.
boolean
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0002059 (UMLS CUI 2011AA)
57056007 (SNOMED CT 2011_0131)
MTHU005195 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C1302261 (UMLS CUI 2011AA)
399223003 (SNOMED CT 2011_0131)
C0750557 (UMLS CUI 2011AA)
C0920364 (UMLS CUI 2011AA)
C0040405 (UMLS CUI 2011AA)
77477000 (SNOMED CT 2011_0131)
10010234 (MedDRA 14.1)
0002 (HL7 V3 2006_05)
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
C0032743 (UMLS CUI 2011AA)
82918005 (SNOMED CT 2011_0131)
10036220 (MedDRA 14.1)
0007 (HL7 V3 2006_05)
CL381767 (UMLS CUI 2011AA)
C0441633 (UMLS CUI 2011AA)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0445092 (UMLS CUI 2011AA)
261985008 (SNOMED CT 2011_0131)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C1514873 (UMLS CUI 2011AA)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
Patients with alkaline phosphatase that is > ULN but <= 2.5 x ULN are eligible for inclusion in the study if a bone scan,PET scan, or PET-CT scan (performed within 3 months prior to randomization) does not demonstrate metastatic disease.
Item
Patients with alkaline phosphatase that is > ULN but <= 2.5 x ULN are eligible for inclusion in the study if a bone scan,PET scan, or PET-CT scan (performed within 3 months prior to randomization) does not demonstrate metastatic disease.
boolean
C0002059 (UMLS CUI 2011AA)
57056007 (SNOMED CT 2011_0131)
MTHU005195 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C1302261 (UMLS CUI 2011AA)
399223003 (SNOMED CT 2011_0131)
C0750557 (UMLS CUI 2011AA)
C0203668 (UMLS CUI 2011AA)
41747008 (SNOMED CT 2011_0131)
10006009 (MedDRA 14.1)
92.14 (ICD-9-CM Version 2011)
C0032743 (UMLS CUI 2011AA)
82918005 (SNOMED CT 2011_0131)
10036220 (MedDRA 14.1)
0007 (HL7 V3 2006_05)
CL381767 (UMLS CUI 2011AA)
C0441633 (UMLS CUI 2011AA)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0445092 (UMLS CUI 2011AA)
261985008 (SNOMED CT 2011_0131)
The following criteria for renal function must be met based on the results of the most recent postoperative tests performed within 6 weeks prior to randomization: Serum creatinine must be <= ULN for the lab. Measured or calculated creatinine clearance must be > 60 mL/min.
Item
The following criteria for renal function must be met based on the results of the most recent postoperative tests performed within 6 weeks prior to randomization: Serum creatinine must be <= ULN for the lab. Measured or calculated creatinine clearance must be > 60 mL/min.
boolean
CL414621 (UMLS CUI 2011AA)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C0332185 (UMLS CUI 2011AA)
6493001 (SNOMED CT 2011_0131)
C0241311 (UMLS CUI 2011AA)
C0392366 (UMLS CUI 2011AA)
272393004 (SNOMED CT 2011_0131)
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
C0444686 (UMLS CUI 2011AA)
258090004 (SNOMED CT 2011_0131)
A urine sample must be tested for protein by determination of the urine protein/creatinine (UPC) ratio or by urine dipstick. UPC ratio must be < 1.0. Urine dipstick must indicate 0-1+ protein. If dipstick reading is >= 2+, determine the UPC ratio, which must be < 1.0, or collect a 24-hour urine specimen, which must demonstrate < 1.0 g of protein per 24 hours.
Item
A urine sample must be tested for protein by determination of the urine protein/creatinine (UPC) ratio or by urine dipstick. UPC ratio must be < 1.0. Urine dipstick must indicate 0-1+ protein. If dipstick reading is >= 2+, determine the UPC ratio, which must be < 1.0, or collect a 24-hour urine specimen, which must demonstrate < 1.0 g of protein per 24 hours.
boolean
LVEF assessment must be performed within 3 months prior to randomization. The LVEF must be >= 55% regardless of the cardiac imaging facility's lower limit of normal (LLN).
Item
LVEF assessment must be performed within 3 months prior to randomization. The LVEF must be >= 55% regardless of the cardiac imaging facility's lower limit of normal (LLN).
boolean
C0428772 (UMLS CUI 2011AA)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0851587 (UMLS CUI 2011AA)
10007574 (MedDRA 14.1)
C1547538 (UMLS CUI 2011AA)
MTHU020558 (LOINC Version 232)
C1518030 (UMLS CUI 2011AA)
The ECG (performed within 3 months prior to randomization) must not have demonstrated any of the following conditions: ventricular arrhythmias except for benign premature ventricular contractions
Item
and conduction abnormality requiring a pacemaker.
boolean
C1623258 (UMLS CUI 2011AA)
46825001 (SNOMED CT 2011_0131)
10014084 (MedDRA 14.1)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
CL414352 (UMLS CUI 2011AA)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0085612 (UMLS CUI 2011AA)
44103008 (SNOMED CT 2011_0131)
10047281 (MedDRA 14.1)
I49.01 (ICD-10-CM Version 2010)
E10230 (CTCAE 1105E)
C1554961 (UMLS CUI 2011AA)
C0205183 (UMLS CUI 2011AA)
30807003 (SNOMED CT 2011_0131)
C0151636 (UMLS CUI 2011AA)
17338001 (SNOMED CT 2011_0131)
10047289 (MedDRA 14.1)
MTHU024512 (LOINC Version 232)
I49.3 (ICD-10-CM Version 2010)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Inflammatory breast cancer.
Item
Inflammatory Breast Carcinoma, Mastitis carcinomatosa
boolean
C0278601 (UMLS CUI 2011AA)
254840009 (SNOMED CT 2011_0131)
10021980 (MedDRA 14.1)
Definitive clinical or radiologic evidence of metastatic disease. (Chest imaging [mandatory for all patients] and other imaging [if required] must have been performed within 3 months prior to randomization.)
Item
Definitive clinical or radiologic evidence of metastatic disease. (Chest imaging [mandatory for all patients] and other imaging [if required] must have been performed within 3 months prior to randomization.)
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0205483 (UMLS CUI 2011AA)
5526005 (SNOMED CT 2011_0131)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0027627 (UMLS CUI 2011AA)
10027478 (MedDRA 14.1)
C1531652 (UMLS CUI 2011AA)
413815006 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0011923 (UMLS CUI 2011AA)
363679005 (SNOMED CT 2011_0131)
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Synchronous or previous contralateral invasive breast cancer (Patients with synchronous or previous contralateral DCIS or LCIS are eligible).
Item
Synchronous or previous contralateral invasive breast cancer (Patients with synchronous or previous contralateral DCIS or LCIS are eligible).
boolean
C0439580 (UMLS CUI 2011AA)
255237009 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0441988 (UMLS CUI 2011AA)
255209002 (SNOMED CT 2011_0131)
C0853879 (UMLS CUI 2011AA)
10006190 (MedDRA 14.1)
C0439580 (UMLS CUI 2011AA)
255237009 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0441988 (UMLS CUI 2011AA)
255209002 (SNOMED CT 2011_0131)
C0007124 (UMLS CUI 2011AA)
86616005 (SNOMED CT 2011_0131)
10013806 (MedDRA 14.1)
D05.1 (ICD-10-CM Version 2010)
C0279563 (UMLS CUI 2011AA)
109888004 (SNOMED CT 2011_0131)
10024744 (MedDRA 14.1)
D05.0 (ICD-10-CM Version 2010)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with excision and RT. (Patients with history of ipsilateral LCIS are eligible.)
Item
History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with excision and RT. (Patients with history of ipsilateral LCIS are eligible.)
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0441989 (UMLS CUI 2011AA)
255208005 (SNOMED CT 2011_0131)
C0853879 (UMLS CUI 2011AA)
10006190 (MedDRA 14.1)
C1554079 (UMLS CUI 2011AA)
I (HL7 V3 2006_05)
C0039798 (UMLS CUI 2011AA)
C0441989 (UMLS CUI 2011AA)
255208005 (SNOMED CT 2011_0131)
C0007124 (UMLS CUI 2011AA)
86616005 (SNOMED CT 2011_0131)
10013806 (MedDRA 14.1)
D05.1 (ICD-10-CM Version 2010)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI 2011AA)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0441989 (UMLS CUI 2011AA)
255208005 (SNOMED CT 2011_0131)
C0279563 (UMLS CUI 2011AA)
109888004 (SNOMED CT 2011_0131)
10024744 (MedDRA 14.1)
D05.0 (ICD-10-CM Version 2010)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
History of non-breast malignancies within the 5 years prior to study entry, except for the following: 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 the following: 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)
C0678222 (UMLS CUI 2011AA)
254838004 (SNOMED CT 2011_0131)
10006204 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
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 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
Previous therapy with anthracyclines, taxanes, carboplatin, trastuzumab, or bevacizumab for any malignancy.
Item
Previous therapy with anthracyclines, taxanes, carboplatin, trastuzumab, or bevacizumab for any malignancy.
boolean
C1514463 (UMLS CUI 2011AA)
C0282564 (UMLS CUI 2011AA)
372540003 (SNOMED CT 2011_0131)
C0215136 (UMLS CUI 2011AA)
C0079083 (UMLS CUI 2011AA)
386905002 (SNOMED CT 2011_0131)
C0728747 (UMLS CUI 2011AA)
387003001 (SNOMED CT 2011_0131)
C0796392 (UMLS CUI 2011AA)
409406007 (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)
RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to randomization.
Item
RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to randomization.
boolean
C0034619 (UMLS CUI 2011AA)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
CL421608 (UMLS CUI 2011AA)
C1521801 (UMLS CUI 2011AA)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0678222 (UMLS CUI 2011AA)
254838004 (SNOMED CT 2011_0131)
10006204 (MedDRA 14.1)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Continued therapy with any hormonal agent such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor. (Patients are eligible if these medications are discontinued prior to randomization.)
Item
Continued therapy with any hormonal agent such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor. (Patients are eligible if these medications are discontinued prior to randomization.)
boolean
C0549178 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0458083 (UMLS CUI 2011AA)
278994005 (SNOMED CT 2011_0131)
C1254351 (UMLS CUI 2011AA)
C0244404 (UMLS CUI 2011AA)
109029006 (SNOMED CT 2011_0131)
C0039286 (UMLS CUI 2011AA)
373345002 (SNOMED CT 2011_0131)
MTHU003102 (LOINC Version 232)
C0732611 (UMLS CUI 2011AA)
415515000 (SNOMED CT 2011_0131)
C0593802 (UMLS CUI 2011AA)
413575009 (SNOMED CT 2011_0131)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C0750557 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C1444662 (UMLS CUI 2011AA)
410546004 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. Patients are eligible if these medications are discontinued prior to randomization.
Item
Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. Patients are eligible if these medications are discontinued prior to randomization.
boolean
C0036884 (UMLS CUI 2011AA)
312263009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0009905 (UMLS CUI 2011AA)
59261009 (SNOMED CT 2011_0131)
C0729511 (UMLS CUI 2011AA)
43171004 (SNOMED CT 2011_0131)
C0559956 (UMLS CUI 2011AA)
282089006 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C1302261 (UMLS CUI 2011AA)
399223003 (SNOMED CT 2011_0131)
C0750557 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C1444662 (UMLS CUI 2011AA)
410546004 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens. This includes but is not confined to: Active cardiac disease - angina pectoris that requires the use of anti-anginal medication. Ventricular arrhythmias except for benign premature ventricular contractions. Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication. Conduction abnormality requiring a pacemaker. Valvular disease with documented compromise in cardiac function. And symptomatic pericarditis. History of cardiac disease - myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function. History of documented CHF. And documented cardiomyopathy.
Item
Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens. This includes but is not confined to: Active cardiac disease - angina pectoris that requires the use of anti-anginal medication. Ventricular arrhythmias except for benign premature ventricular contractions. Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication. Conduction abnormality requiring a pacemaker. Valvular disease with documented compromise in cardiac function. And symptomatic pericarditis. History of cardiac disease - myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function. History of documented CHF. And documented cardiomyopathy.
boolean
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C2707252 (UMLS CUI 2011AA)
MTHU031865 (LOINC Version 232)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
CL031856 (UMLS CUI 2011AA)
C2707252 (UMLS CUI 2011AA)
MTHU031865 (LOINC Version 232)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0002962 (UMLS CUI 2011AA)
194828000 (SNOMED CT 2011_0131)
10002383 (MedDRA 14.1)
I20 (ICD-10-CM Version 2010)
413 (ICD-9-CM Version 2011)
C1514873 (UMLS CUI 2011AA)
C1874267 (UMLS CUI 2011AA)
C0085612 (UMLS CUI 2011AA)
44103008 (SNOMED CT 2011_0131)
10047281 (MedDRA 14.1)
I49.01 (ICD-10-CM Version 2010)
E10230 (CTCAE 1105E)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0205183 (UMLS CUI 2011AA)
30807003 (SNOMED CT 2011_0131)
C0151636 (UMLS CUI 2011AA)
17338001 (SNOMED CT 2011_0131)
10047289 (MedDRA 14.1)
MTHU024512 (LOINC Version 232)
I49.3 (ICD-10-CM Version 2010)
C0428974 (UMLS CUI 2011AA)
72654001 (SNOMED CT 2011_0131)
10003130 (MedDRA 14.1)
C0264893 (UMLS CUI 2011AA)
71792006 (SNOMED CT 2011_0131)
10029458 (MedDRA 14.1)
I49.8 (ICD-10-CM Version 2010)
C1514873 (UMLS CUI 2011AA)
C0030163 (UMLS CUI 2011AA)
14106009 (SNOMED CT 2011_0131)
MTHU024521 (LOINC Version 232)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C1842820 (UMLS CUI 2011AA)
C1514873 (UMLS CUI 2011AA)
C0030163 (UMLS CUI 2011AA)
14106009 (SNOMED CT 2011_0131)
MTHU024521 (LOINC Version 232)
C0026265 (UMLS CUI 2011AA)
11851006 (SNOMED CT 2011_0131)
10061532 (MedDRA 14.1)
424.0 (ICD-9-CM Version 2011)
E10134 (CTCAE 1105E)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0232166 (UMLS CUI 2011AA)
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0031046 (UMLS CUI 2011AA)
3238004 (SNOMED CT 2011_0131)
10034484 (MedDRA 14.1)
E10180 (CTCAE 1105E)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C1707297 (UMLS CUI 2011AA)
C0205322 (UMLS CUI 2011AA)
C0205147 (UMLS CUI 2011AA)
410673009 (SNOMED CT 2011_0131)
MTHU009053 (LOINC Version 232)
C0504053 (UMLS CUI 2011AA)
C1704258 (UMLS CUI 2011AA)
C1516048 (UMLS CUI 2011AA)
C0080310 (UMLS CUI 2011AA)
250907009 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
CL411823 (UMLS CUI 2011AA)
85898001 (SNOMED CT 2011_0131)
10007636 (MedDRA 14.1)
I42.9 (ICD-10-CM Version 2010)
425 (ICD-9-CM Version 2011)
Uncontrolled hypertension defined as systolic blood pressure (BP) > 150 mmHg or diastolic BP > 90 mmHg, with or without anti-hypertensive medication. (BP must be assessed within 28 days prior to randomization.) Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.
Item
Uncontrolled hypertension defined as systolic blood pressure (BP) > 150 mmHg or diastolic BP > 90 mmHg, with or without anti-hypertensive medication. (BP must be assessed within 28 days prior to randomization.) Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.
boolean
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
C1704788 (UMLS CUI 2011AA)
C0871470 (UMLS CUI 2011AA)
271649006 (SNOMED CT 2011_0131)
C0428883 (UMLS CUI 2011AA)
271650006 (SNOMED CT 2011_0131)
C0003364 (UMLS CUI 2011AA)
372586001 (SNOMED CT 2011_0131)
C0005823 (UMLS CUI 2011AA)
75367002 (SNOMED CT 2011_0131)
MTHU008342 (LOINC Version 232)
C1516048 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0205265 (UMLS CUI 2011AA)
884001 (SNOMED CT 2011_0131)
C0497247 (UMLS CUI 2011AA)
24184005 (SNOMED CT 2011_0131)
10005750 (MedDRA 14.1)
C1302261 (UMLS CUI 2011AA)
399223003 (SNOMED CT 2011_0131)
C0750557 (UMLS CUI 2011AA)
C1704686 (UMLS CUI 2011AA)
C0456081 (UMLS CUI 2011AA)
410617001 (SNOMED CT 2011_0131)
C0003364 (UMLS CUI 2011AA)
372586001 (SNOMED CT 2011_0131)
C2003888 (UMLS CUI 2011AA)
C0005823 (UMLS CUI 2011AA)
75367002 (SNOMED CT 2011_0131)
MTHU008342 (LOINC Version 232)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
CL425202 (UMLS CUI 2011AA)
History of hypertensive crisis or hypertensive encephalopathy.
Item
History of hypertensive crisis or hypertensive encephalopathy.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0020546 (UMLS CUI 2011AA)
50490005 (SNOMED CT 2011_0131)
10020802 (MedDRA 14.1)
C0151620 (UMLS CUI 2011AA)
50490005 (SNOMED CT 2011_0131)
10020803 (MedDRA 14.1)
I67.4 (ICD-10-CM Version 2010)
437.2 (ICD-9-CM Version 2011)
History of TIA or CVA.
Item
History of TIA or CVA.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0007787 (UMLS CUI 2011AA)
266257000 (SNOMED CT 2011_0131)
10044390 (MedDRA 14.1)
MTHU020810 (LOINC Version 232)
G45.9 (ICD-10-CM Version 2010)
435.9 (ICD-9-CM Version 2011)
E12834 (CTCAE 1105E)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
History of any arterial thrombotic event within 12 months before randomization.
Item
History of any arterial thrombotic event within 12 months before randomization.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0151942 (UMLS CUI 2011AA)
65198009 (SNOMED CT 2011_0131)
10003178 (MedDRA 14.1)
C0441471 (UMLS CUI 2011AA)
272379006 (SNOMED CT 2011_0131)
MTHU019184 (LOINC Version 232)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Symptomatic peripheral vascular disease
Item
Symptomatic peripheral vascular disease
boolean
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0085096 (UMLS CUI 2011AA)
400047006 (SNOMED CT 2011_0131)
10034636 (MedDRA 14.1)
MTHU020791 (LOINC Version 232)
I73.9 (ICD-10-CM Version 2010)
443.9 (ICD-9-CM Version 2011)
Intrinsic lung disease resulting in dyspnea
Item
Intrinsic lung disease resulting in dyspnea
boolean
C0205102 (UMLS CUI 2011AA)
260521003 (SNOMED CT 2011_0131)
C0024115 (UMLS CUI 2011AA)
19829001 (SNOMED CT 2011_0131)
10025082 (MedDRA 14.1)
J98.4 (ICD-10-CM Version 2010)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
C0013404 (UMLS CUI 2011AA)
139201002 (SNOMED CT 2011_0131)
10013968 (MedDRA 14.1)
MTHU020850 (LOINC Version 232)
R06.0 (ICD-10-CM Version 2010)
786.05 (ICD-9-CM Version 2011)
E13368 (CTCAE 1105E)
Unstable diabetes mellitus
Item
labiler Diabetes mellitus Typ I
boolean
C0342302 (UMLS CUI 2011AA)
11530004 (SNOMED CT 2011_0131)
10006372 (MedDRA 14.1)
Active infection or chronic infection requiring chronic suppressive antibiotics.
Item
Active infection or chronic infection requiring chronic suppressive antibiotics.
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C1514873 (UMLS CUI 2011AA)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0205367 (UMLS CUI 2011AA)
244840000 (SNOMED CT 2011_0131)
C0003232 (UMLS CUI 2011AA)
255631004 (SNOMED CT 2011_0131)
Any significant bleeding within 6 months before randomization, exclusive of menorrhagia in premenopausal women.
Item
Any significant bleeding within 6 months before randomization, exclusive of menorrhagia in premenopausal women.
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0019080 (UMLS CUI 2011AA)
50960005 (SNOMED CT 2011_0131)
10055798 (MedDRA 14.1)
R58 (ICD-10-CM Version 2010)
459.0 (ICD-9-CM Version 2011)
C2825407 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C0025323 (UMLS CUI 2011AA)
386692008 (SNOMED CT 2011_0131)
10027313 (MedDRA 14.1)
N92.0 (ICD-10-CM Version 2010)
E13132 (CTCAE 1105E)
C0279752 (UMLS CUI 2011AA)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
Non-healing wound, skin ulcers, or incompletely healed bone fracture.
Item
Non-healing wound, skin ulcers, or incompletely healed bone fracture.
boolean
C0750433 (UMLS CUI 2011AA)
125192008 (SNOMED CT 2011_0131)
C0748826 (UMLS CUI 2011AA)
L97 (ICD-10-CM Version 2010)
C0205257 (UMLS CUI 2011AA)
255599008 (SNOMED CT 2011_0131)
C0205249 (UMLS CUI 2011AA)
90910008 (SNOMED CT 2011_0131)
C0016658 (UMLS CUI 2011AA)
125605004 (SNOMED CT 2011_0131)
10017076 (MedDRA 14.1)
T14.8 (ICD-10-CM Version 2010)
800-829.99 (ICD-9-CM Version 2011)
E11703 (CTCAE 1105E)
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to planned start of study therapy.
Item
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to planned start of study therapy.
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)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Anticipation of need for major surgical procedures during study therapy and for at least 3 months following completion of bevacizumab.
Item
Anticipation of need for major surgical procedures during study therapy and for at least 3 months following completion of bevacizumab.
boolean
C0679106 (UMLS CUI 2011AA)
C0686904 (UMLS CUI 2011AA)
103325001 (SNOMED CT 2011_0131)
C0679637 (UMLS CUI 2011AA)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0796392 (UMLS CUI 2011AA)
409406007 (SNOMED CT 2011_0131)
Gastroduodenal ulcer(s) documented by endoscopy to be active within 6 months before randomization.
Item
Gastroduodenal ulcer(s) documented by endoscopy to be active within 6 months before randomization.
boolean
C0030920 (UMLS CUI 2011AA)
13200003 (SNOMED CT 2011_0131)
10034341 (MedDRA 14.1)
K27 (ICD-10-CM Version 2010)
533 (ICD-9-CM Version 2011)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0014245 (UMLS CUI 2011AA)
423827005 (SNOMED CT 2011_0131)
10014805 (MedDRA 14.1)
MTHU008659 (LOINC Version 232)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C2825407 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
History of GI perforation, abdominal fistulae, or intra-abdominal abscess.
Item
History of GI perforation, abdominal fistulae, or intra-abdominal abscess.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0151664 (UMLS CUI 2011AA)
51875005 (SNOMED CT 2011_0131)
10018001 (MedDRA 14.1)
C1879311 (UMLS CUI 2011AA)
CL031631 (UMLS CUI 2011AA)
C0000833 (UMLS CUI 2011AA)
128477000 (SNOMED CT 2011_0131)
10000269 (MedDRA 14.1)
MTHU022414 (LOINC Version 232)
Known bleeding diathesis or coagulopathy.
Item
Known bleeding diathesis or coagulopathy.
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C1458140 (UMLS CUI 2011AA)
248250000 (SNOMED CT 2011_0131)
10005134 (MedDRA 14.1)
C0005779 (UMLS CUI 2011AA)
64779008 (SNOMED CT 2011_0131)
10009802 (MedDRA 14.1)
D68.9 (ICD-10-CM Version 2010)
Requirement for therapeutic doses of coumadin or equivalent.
Item
Requirement for therapeutic doses of coumadin or equivalent.
boolean
C1514873 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C1564394 (UMLS CUI 2011AA)
CL415123 (UMLS CUI 2011AA)
Sensory/motor neuropathy >= grade 2, as defined by the NCI CTCAE v3.0.
Item
Sensory/motor neuropathy >= grade 2, as defined by the NCI CTCAE v3.0.
boolean
C0151313 (UMLS CUI 2011AA)
95662005 (SNOMED CT 2011_0131)
10034620 (MedDRA 14.1)
E12768 (CTCAE 1105E)
C1557259 (UMLS CUI 2011AA)
MTHU113783 (CTCAE 1105E)
C1557260 (UMLS CUI 2011AA)
MTHU114803 (CTCAE 1105E)
C1557261 (UMLS CUI 2011AA)
MTHU115776 (CTCAE 1105E)
C1557262 (UMLS CUI 2011AA)
MTHU116556 (CTCAE 1105E)
C0235025 (UMLS CUI 2011AA)
95663000 (SNOMED CT 2011_0131)
10034580 (MedDRA 14.1)
E12762 (CTCAE 1105E)
C1557254 (UMLS CUI 2011AA)
MTHU113523 (CTCAE 1105E)
C1557255 (UMLS CUI 2011AA)
MTHU114539 (CTCAE 1105E)
C1557256 (UMLS CUI 2011AA)
MTHU115527 (CTCAE 1105E)
C1557257 (UMLS CUI 2011AA)
MTHU116371 (CTCAE 1105E)
Conditions that would prohibit administration of corticosteroids.
Item
Conditions that would prohibit administration of corticosteroids.
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0683610 (UMLS CUI 2011AA)
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
Chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids).
Item
Chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids).
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C2348070 (UMLS CUI 2011AA)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0025815 (UMLS CUI 2011AA)
116593003 (SNOMED CT 2011_0131)
MTHU004699 (LOINC Version 232)
CL415123 (UMLS CUI 2011AA)
C0586794 (UMLS CUI 2011AA)
170660006 (SNOMED CT 2011_0131)
History of hypersensitivity reaction to drugs formulated with polysorbate 80.
Item
History of hypersensitivity reaction to drugs formulated with polysorbate 80.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C1705957 (UMLS CUI 2011AA)
C0032601 (UMLS CUI 2011AA)
255899003 (SNOMED CT 2011_0131)
Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing must be performed within 14 days prior to randomization according to institutional standards for women of child-bearing potential.)
Item
Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing must be performed within 14 days prior to randomization according to institutional standards for women of child-bearing potential.)
boolean
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C2348558 (UMLS CUI 2011AA)
C0032976 (UMLS CUI 2011AA)
74036000 (SNOMED CT 2011_0131)
10036572 (MedDRA 14.1)
C2825407 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0021622 (UMLS CUI 2011AA)
C2828392 (UMLS CUI 2011AA)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.
Item
Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.
boolean
C1518371 (UMLS CUI 2011AA)
C0442893 (UMLS CUI 2011AA)
56019007, 264578000 (SNOMED CT 2011_0131)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C2700409 (UMLS CUI 2011AA)
C1514873 (UMLS CUI 2011AA)
C1522577 (UMLS CUI 2011AA)
Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
Item
Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
boolean
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0085281 (UMLS CUI 2011AA)
32709003 (SNOMED CT 2011_0131)
10001125 (MedDRA 14.1)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
Use of any investigational product within 4 weeks prior to enrollment in the study.
Item
Use of any investigational product within 4 weeks prior to enrollment in the study.
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C1517586 (UMLS CUI 2011AA)
C1514468 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
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