ID

4925

Description

ODM derived from http://clinicaltrials.gov/show/NCT00545077

Link

http://clinicaltrials.gov/show/NCT00545077

Keywords

Versions (2)
  1. 12/10/13 12/10/13 - Martin Dugas
  2. 4/14/14 4/14/14 - Julian Varghese
Uploaded on

April 14, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00545077 Breast Cancer

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 80 Years
Description

age 18 Years to 80 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Before starting the specific protocol procedures, the written informed consent must be obtained and documented.
Description

Before starting the specific protocol procedures, the written informed consent must be obtained and documented.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Women >=18 years.
Description

Women >=18 years.

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Capacity to comply with all the protocol requirements.
Description

Capacity to comply with all the protocol requirements.

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C1709747
Functional ECOG status <= 1.
Description

Functional ECOG status <= 1.

Data type

boolean

Alias
UMLS CUI 2011AA
C0598463
LOINC Version 232
MTHU027728
UMLS CUI 2011AA
C1828127
SNOMED CT 2011_0131
424122007
Life expectancy >= 24 weeks.
Description

Life expectancy >= 24 weeks.

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
Histologically confirmed breast adenocarcinoma, with measurable or non-measurable, locally advanced or metastatic (stage IV) disease. In the event that the patient only has locally advanced disease, she will not be able to undergo curative local treatment. Patients with metastasis confined to the bone can be chosen, but the disease must be confirmed by radiology, CT scan or NMR if there is any doubt after a single bone scan.
Description

Histologically confirmed breast adenocarcinoma, with measurable or non-measurable, locally advanced or metastatic (stage IV) disease. In the event that the patient only has locally advanced disease, she will not be able to undergo curative local treatment. Patients with metastasis confined to the bone can be chosen, but the disease must be confirmed by radiology, CT scan or NMR if there is any doubt after a single bone scan.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0858252
MedDRA 14.1
10006173
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1513041
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1513040
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0677984
UMLS CUI 2011AA
C0278488
UMLS CUI 2011AA
C0153690
SNOMED CT 2011_0131
94222008
MedDRA 14.1
10055101
ICD-10-CM Version 2010
C79.51
ICD-9-CM Version 2011
198.5
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C1405978
UMLS CUI 2011AA
C0040405
MedDRA 14.1
10011603
UMLS CUI 2011AA
C0028580
Patients with HER2-negative disease evaluated by IHC and FISH/CISH (IHC 0 or 1+, or 2+ and negative FISH). Patients with 3+ by IHC cannot be chosen regardless of the FISH/CISH status and those with positive FISH/CISH (> 2 amplifications) cannot be chosen either, regardless of the IHC findings.
Description

Patients with HER2-negative disease evaluated by IHC and FISH/CISH (IHC 0 or 1+, or 2+ and negative FISH). Patients with 3+ by IHC cannot be chosen regardless of the FISH/CISH status and those with positive FISH/CISH (> 2 amplifications) cannot be chosen either, regardless of the IHC findings.

Data type

boolean

Alias
UMLS CUI 2011AA
CL412283
UMLS CUI 2011AA
C0220825
UMLS CUI 2011AA
C0021044
SNOMED CT 2011_0131
117617002
MedDRA 14.1
10059656
UMLS CUI 2011AA
C0162789
SNOMED CT 2011_0131
426329006
MedDRA 14.1
10066931
UMLS CUI 2011AA
C1516514
Positive hormone receptors (estrogen receptor [ER] and/or progesterone receptor [PgR]) evaluated by a local or central laboratory, according to the criteria of the participating institution.
Description

Positive hormone receptors (estrogen receptor [ER] and/or progesterone receptor [PgR]) evaluated by a local or central laboratory, according to the criteria of the participating institution.

Data type

boolean

Alias
UMLS CUI 2011AA
CL415097
UMLS CUI 2011AA
C0019929
UMLS CUI 2011AA
C1521863
UMLS CUI 2011AA
C0034833
SNOMED CT 2011_0131
61078009
LOINC Version 232
MTHU002145
UMLS CUI 2011AA
C0220825
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
Patients who are candidates for receiving first-line treatment with letrozole.
Description

Patients who are candidates for receiving first-line treatment with letrozole.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086960
UMLS CUI 2011AA
C1708063
UMLS CUI 2011AA
C0701348
SNOMED CT 2011_0131
386911004
Patients may have received (neo)adjuvant chemotherapy, provided that the last dose of the latter was received at least 12 months before randomization . Patients must be recovered from toxicity.
Description

Patients may have received (neo)adjuvant chemotherapy, provided that the last dose of the latter was received at least 12 months before randomization . Patients must be recovered from toxicity.

Data type

boolean

Alias
UMLS CUI 2011AA
C0085533
UMLS CUI 2011AA
C0600558
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
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
C1115804
LOINC Version 232
MTHU014522
UMLS CUI 2011AA
C0040539
The patients are allowed to have received adjuvant radiotherapy, provided that it was completed at least 6 weeks before randomization and the patient has recovered from the reversible acute effects of the radiation. The previous administration of radiotherapy to palliate the pain of bone metastases is authorized, provided that:
Description

The patients are allowed to have received adjuvant radiotherapy, provided that it was completed at least 6 weeks before randomization and the patient has recovered from the reversible acute effects of the radiation. The previous administration of radiotherapy to palliate the pain of bone metastases is authorized, provided that:

Data type

boolean

Alias
UMLS CUI 2011AA
C1524004
UMLS CUI 2011AA
C0242939
UMLS CUI 2011AA
C0580352
SNOMED CT 2011_0131
182992009
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
C1115804
LOINC Version 232
MTHU014522
UMLS CUI 2011AA
C0392615
UMLS CUI 2011AA
C1524004
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
CL421682
UMLS CUI 2011AA
C0153690
SNOMED CT 2011_0131
94222008
MedDRA 14.1
10055101
ICD-10-CM Version 2010
C79.51
ICD-9-CM Version 2011
198.5
UMLS CUI 2011AA
C1709632
Not more than 30% of bone marrow has been irradiated.
Description

Not more than 30% of bone marrow has been irradiated.

Data type

boolean

Alias
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
CL419326
UMLS CUI 2011AA
C1522449
SNOMED CT 2011_0131
108290001
MedDRA 14.1
10037794
The patient has recovered from the reversible acute effects of the radiation.
Description

The patient has recovered from the reversible acute effects of the radiation.

Data type

boolean

Alias
UMLS CUI 2011AA
C1115804
LOINC Version 232
MTHU014522
UMLS CUI 2011AA
C0392615
The patient has at least one metastatic location which has not been irradiated and which may be evaluated for progression, or a clear progression of the bone disease has been objectified after the end of the palliative radiotherapy.
Description

The patient has at least one metastatic location which has not been irradiated and which may be evaluated for progression, or a clear progression of the bone disease has been objectified after the end of the palliative radiotherapy.

Data type

boolean

Alias
UMLS CUI 2011AA
C0547040
SNOMED CT 2011_0131
255605001
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0036525
SNOMED CT 2011_0131
77879006
MedDRA 14.1
10027474
UMLS CUI 2011AA
C0450429
SNOMED CT 2011_0131
246267002
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1522449
SNOMED CT 2011_0131
108290001
MedDRA 14.1
10037794
UMLS CUI 2011AA
C0220825
UMLS CUI 2011AA
C0242656
SNOMED CT 2011_0131
246453008
MedDRA 14.1
10061818
UMLS CUI 2011AA
CL414906
UMLS CUI 2011AA
C0242656
SNOMED CT 2011_0131
246453008
MedDRA 14.1
10061818
UMLS CUI 2011AA
C0005940
SNOMED CT 2011_0131
76069003
MedDRA 14.1
10005956
ICD-10-CM Version 2010
M89.9
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
CL421682
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Evolutionary disease requiring an immediate treatment with cytotoxic chemotherapy according to the investigator's judgment.
Description

Evolutionary disease requiring an immediate treatment with cytotoxic chemotherapy according to the investigator's judgment.

Data type

boolean

Alias
UMLS CUI 2011AA
C0015219
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0205253
SNOMED CT 2011_0131
88694003
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0677881
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
Patients with locally advanced breast cancer who are expected to undergo surgery or curative radiotherapy.
Description

Patients with locally advanced breast cancer who are expected to undergo surgery or curative radiotherapy.

Data type

boolean

Alias
UMLS CUI 2011AA
C0677984
UMLS CUI 2011AA
C0678222
SNOMED CT 2011_0131
254838004
MedDRA 14.1
10006204
UMLS CUI 2011AA
C1517001
UMLS CUI 2011AA
C0038895
UMLS CUI 2011AA
C1880198
UMLS CUI 2011AA
C1522449
SNOMED CT 2011_0131
302505005
Previous chemotherapy or hormonotherapy for the metastatic disease. Patients may have received neoadjuvant chemotherapy or neoadjuvant hormonotherapy with curative intention as a part or as an alternative to an adjuvant treatment. For the previous neoadjuvant hormonotherapy the same premises than for the adjuvant hormonotherapy are valid.
Description

Previous chemotherapy or hormonotherapy for the metastatic disease. Patients may have received neoadjuvant chemotherapy or neoadjuvant hormonotherapy with curative intention as a part or as an alternative to an adjuvant treatment. For the previous neoadjuvant hormonotherapy the same premises than for the adjuvant hormonotherapy are valid.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0279025
SNOMED CT 2011_0131
309542002, 169413002
MedDRA 14.1
10065646
UMLS CUI 2011AA
C0036525
SNOMED CT 2011_0131
77879006
MedDRA 14.1
10027474
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0600558
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0279025
SNOMED CT 2011_0131
309542002, 169413002
MedDRA 14.1
10065646
UMLS CUI 2011AA
C1880198
UMLS CUI 2011AA
C0162425
UMLS CUI 2011AA
C0677850
MedDRA 14.1
10068969
Previous therapy with anti-VEGF or VEGFR tyrosine-kinase inhibitors.
Description

Previous therapy with anti-VEGF or VEGFR tyrosine-kinase inhibitors.

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
CL318109
UMLS CUI 2011AA
C1268567
SNOMED CT 2011_0131
372917005
UMLS CUI 2011AA
CL425146
History of another pathology that may affect the development of the protocol or the interpretation of results. It is considered that patients who have suffered from a skin carcinoma that is not melanoma, cervical carcinoma in situ or another neoplasia treated with a curative intention and with a disease-free interval exceeding 5 years can be chosen.
Description

History of another pathology that may affect the development of the protocol or the interpretation of results. It is considered that patients who have suffered from a skin carcinoma that is not melanoma, cervical carcinoma in situ or another neoplasia treated with a curative intention and with a disease-free interval exceeding 5 years can be chosen.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0677042
UMLS CUI 2011AA
C0392760
SNOMED CT 2011_0131
247591002
UMLS CUI 2011AA
C2348563
UMLS CUI 2011AA
C0459471
SNOMED CT 2011_0131
280452008
LOINC Version 232
MTHU003869
UMLS CUI 2011AA
C1274040
SNOMED CT 2011_0131
79409006
UMLS CUI 2011AA
C0699893
MedDRA 14.1
10040810
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
C0205394
SNOMED CT 2011_0131
74964007
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
CL415147
UMLS CUI 2011AA
C1880198
UMLS CUI 2011AA
C0332296
SNOMED CT 2011_0131
37837009
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C1272706
SNOMED CT 2011_0131
385673002
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
Evidence of CNS metastasis. A CT scan or brain NMR must be done within the 4 weeks before the randomization in case of suspecting brain metastasis.
Description

Evidence of CNS metastasis. A CT scan or brain NMR must be done within the 4 weeks before the randomization in case of suspecting brain metastasis.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0279130
SNOMED CT 2011_0131
261731003
UMLS CUI 2011AA
C0040405
MedDRA 14.1
10011603
UMLS CUI 2011AA
C1269537
SNOMED CT 2011_0131
258335003
UMLS CUI 2011AA
C0028580
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
C0750491
SNOMED CT 2011_0131
415684004
UMLS CUI 2011AA
C0220650
MedDRA 14.1
10006128
History or evidence in the physical or neurological examination of CNS pathology unrelated to cancer unless it is suitable treated with standard therapy (e.g. uncontrolled convulsions).
Description

History or evidence in the physical or neurological examination of CNS pathology unrelated to cancer unless it is suitable treated with standard therapy (e.g. uncontrolled convulsions).

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C1269563
SNOMED CT 2011_0131
278199004
UMLS CUI 2011AA
C0677042
UMLS CUI 2011AA
C1554961
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
CL426127
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0036572
SNOMED CT 2011_0131
91175000
MedDRA 14.1
10039910
ICD-9-CM Version 2011
780.39
History of peripheral neuropathy NCI CTCAE grade >2 at the time of randomization.
Description

History of peripheral neuropathy NCI CTCAE grade >2 at the time of randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0031117
MedDRA 14.1
10029331
ICD-10-CM Version 2010
G64
ICD-9-CM Version 2011
350-359.99
UMLS CUI 2011AA
C1140168
UMLS CUI 2011AA
C1516728
UMLS CUI 2011AA
C0441800
SNOMED CT 2011_0131
258349007
LOINC Version 232
MTHU003112
UMLS CUI 2011AA
C0439547
SNOMED CT 2011_0131
272105005
UMLS CUI 2011AA
C0034656
Patients subjected to major surgical procedures, open biopsies or those having significant trauma injuries within the 28 days prior to randomization, or patients who are expected to undergo a major surgical procedure that must necessarily be performed within the course of the study.
Description

Patients subjected to major surgical procedures, open biopsies or those having significant trauma injuries within the 28 days prior to randomization, or patients who are expected to undergo a major surgical procedure that must necessarily be performed within the course of the study.

Data type

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
C0034656
UMLS CUI 2011AA
CL414906
UMLS CUI 2011AA
C1517001
UMLS CUI 2011AA
C0679637
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0750729
SNOMED CT 2011_0131
288524001
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 18 Years to 80 Years
Item
age 18 Years to 80 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Before starting the specific protocol procedures, the written informed consent must be obtained and documented.
Item
Before starting the specific protocol procedures, the written informed consent must be obtained and documented.
boolean
C0021430 (UMLS CUI 2011AA)
Women >=18 years.
Item
Women >=18 years.
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Capacity to comply with all the protocol requirements.
Item
Capacity to comply with all the protocol requirements.
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C1709747 (UMLS CUI 2011AA)
Functional ECOG status <= 1.
Item
Functional ECOG status <= 1.
boolean
C0598463 (UMLS CUI 2011AA)
MTHU027728 (LOINC Version 232)
C1828127 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
Life expectancy >= 24 weeks.
Item
Life expectancy >= 24 weeks.
boolean
C0023671 (UMLS CUI 2011AA)
Histologically confirmed breast adenocarcinoma, with measurable or non-measurable, locally advanced or metastatic (stage IV) disease. In the event that the patient only has locally advanced disease, she will not be able to undergo curative local treatment. Patients with metastasis confined to the bone can be chosen, but the disease must be confirmed by radiology, CT scan or NMR if there is any doubt after a single bone scan.
Item
Histologically confirmed breast adenocarcinoma, with measurable or non-measurable, locally advanced or metastatic (stage IV) disease. In the event that the patient only has locally advanced disease, she will not be able to undergo curative local treatment. Patients with metastasis confined to the bone can be chosen, but the disease must be confirmed by radiology, CT scan or NMR if there is any doubt after a single bone scan.
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0858252 (UMLS CUI 2011AA)
10006173 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1513041 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C1513040 (UMLS CUI 2011AA)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0677984 (UMLS CUI 2011AA)
C0278488 (UMLS CUI 2011AA)
C0153690 (UMLS CUI 2011AA)
94222008 (SNOMED CT 2011_0131)
10055101 (MedDRA 14.1)
C79.51 (ICD-10-CM Version 2010)
198.5 (ICD-9-CM Version 2011)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C1405978 (UMLS CUI 2011AA)
C0040405 (UMLS CUI 2011AA)
10011603 (MedDRA 14.1)
C0028580 (UMLS CUI 2011AA)
Patients with HER2-negative disease evaluated by IHC and FISH/CISH (IHC 0 or 1+, or 2+ and negative FISH). Patients with 3+ by IHC cannot be chosen regardless of the FISH/CISH status and those with positive FISH/CISH (> 2 amplifications) cannot be chosen either, regardless of the IHC findings.
Item
Patients with HER2-negative disease evaluated by IHC and FISH/CISH (IHC 0 or 1+, or 2+ and negative FISH). Patients with 3+ by IHC cannot be chosen regardless of the FISH/CISH status and those with positive FISH/CISH (> 2 amplifications) cannot be chosen either, regardless of the IHC findings.
boolean
CL412283 (UMLS CUI 2011AA)
C0220825 (UMLS CUI 2011AA)
C0021044 (UMLS CUI 2011AA)
117617002 (SNOMED CT 2011_0131)
10059656 (MedDRA 14.1)
C0162789 (UMLS CUI 2011AA)
426329006 (SNOMED CT 2011_0131)
10066931 (MedDRA 14.1)
C1516514 (UMLS CUI 2011AA)
Positive hormone receptors (estrogen receptor [ER] and/or progesterone receptor [PgR]) evaluated by a local or central laboratory, according to the criteria of the participating institution.
Item
Positive hormone receptors (estrogen receptor [ER] and/or progesterone receptor [PgR]) evaluated by a local or central laboratory, according to the criteria of the participating institution.
boolean
CL415097 (UMLS CUI 2011AA)
C0019929 (UMLS CUI 2011AA)
C1521863 (UMLS CUI 2011AA)
C0034833 (UMLS CUI 2011AA)
61078009 (SNOMED CT 2011_0131)
MTHU002145 (LOINC Version 232)
C0220825 (UMLS CUI 2011AA)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
Patients who are candidates for receiving first-line treatment with letrozole.
Item
Patients who are candidates for receiving first-line treatment with letrozole.
boolean
C0086960 (UMLS CUI 2011AA)
C1708063 (UMLS CUI 2011AA)
C0701348 (UMLS CUI 2011AA)
386911004 (SNOMED CT 2011_0131)
Patients may have received (neo)adjuvant chemotherapy, provided that the last dose of the latter was received at least 12 months before randomization . Patients must be recovered from toxicity.
Item
Patients may have received (neo)adjuvant chemotherapy, provided that the last dose of the latter was received at least 12 months before randomization . Patients must be recovered from toxicity.
boolean
C0085533 (UMLS CUI 2011AA)
C0600558 (UMLS CUI 2011AA)
C1517741 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (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)
C0034656 (UMLS CUI 2011AA)
C1115804 (UMLS CUI 2011AA)
MTHU014522 (LOINC Version 232)
C0040539 (UMLS CUI 2011AA)
The patients are allowed to have received adjuvant radiotherapy, provided that it was completed at least 6 weeks before randomization and the patient has recovered from the reversible acute effects of the radiation. The previous administration of radiotherapy to palliate the pain of bone metastases is authorized, provided that:
Item
The patients are allowed to have received adjuvant radiotherapy, provided that it was completed at least 6 weeks before randomization and the patient has recovered from the reversible acute effects of the radiation. The previous administration of radiotherapy to palliate the pain of bone metastases is authorized, provided that:
boolean
C1524004 (UMLS CUI 2011AA)
C0242939 (UMLS CUI 2011AA)
C0580352 (UMLS CUI 2011AA)
182992009 (SNOMED CT 2011_0131)
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)
C1115804 (UMLS CUI 2011AA)
MTHU014522 (LOINC Version 232)
C0392615 (UMLS CUI 2011AA)
C1524004 (UMLS CUI 2011AA)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
CL421682 (UMLS CUI 2011AA)
C0153690 (UMLS CUI 2011AA)
94222008 (SNOMED CT 2011_0131)
10055101 (MedDRA 14.1)
C79.51 (ICD-10-CM Version 2010)
198.5 (ICD-9-CM Version 2011)
C1709632 (UMLS CUI 2011AA)
Not more than 30% of bone marrow has been irradiated.
Item
Not more than 30% of bone marrow has been irradiated.
boolean
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
CL419326 (UMLS CUI 2011AA)
C1522449 (UMLS CUI 2011AA)
108290001 (SNOMED CT 2011_0131)
10037794 (MedDRA 14.1)
The patient has recovered from the reversible acute effects of the radiation.
Item
The patient has recovered from the reversible acute effects of the radiation.
boolean
C1115804 (UMLS CUI 2011AA)
MTHU014522 (LOINC Version 232)
C0392615 (UMLS CUI 2011AA)
The patient has at least one metastatic location which has not been irradiated and which may be evaluated for progression, or a clear progression of the bone disease has been objectified after the end of the palliative radiotherapy.
Item
The patient has at least one metastatic location which has not been irradiated and which may be evaluated for progression, or a clear progression of the bone disease has been objectified after the end of the palliative radiotherapy.
boolean
C0547040 (UMLS CUI 2011AA)
255605001 (SNOMED CT 2011_0131)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0036525 (UMLS CUI 2011AA)
77879006 (SNOMED CT 2011_0131)
10027474 (MedDRA 14.1)
C0450429 (UMLS CUI 2011AA)
246267002 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C1522449 (UMLS CUI 2011AA)
108290001 (SNOMED CT 2011_0131)
10037794 (MedDRA 14.1)
C0220825 (UMLS CUI 2011AA)
C0242656 (UMLS CUI 2011AA)
246453008 (SNOMED CT 2011_0131)
10061818 (MedDRA 14.1)
CL414906 (UMLS CUI 2011AA)
C0242656 (UMLS CUI 2011AA)
246453008 (SNOMED CT 2011_0131)
10061818 (MedDRA 14.1)
C0005940 (UMLS CUI 2011AA)
76069003 (SNOMED CT 2011_0131)
10005956 (MedDRA 14.1)
M89.9 (ICD-10-CM Version 2010)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
CL421682 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Evolutionary disease requiring an immediate treatment with cytotoxic chemotherapy according to the investigator's judgment.
Item
Evolutionary disease requiring an immediate treatment with cytotoxic chemotherapy according to the investigator's judgment.
boolean
C0015219 (UMLS CUI 2011AA)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
C0205253 (UMLS CUI 2011AA)
88694003 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0677881 (UMLS CUI 2011AA)
CL102947 (UMLS CUI 2011AA)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
Patients with locally advanced breast cancer who are expected to undergo surgery or curative radiotherapy.
Item
Patients with locally advanced breast cancer who are expected to undergo surgery or curative radiotherapy.
boolean
C0677984 (UMLS CUI 2011AA)
C0678222 (UMLS CUI 2011AA)
254838004 (SNOMED CT 2011_0131)
10006204 (MedDRA 14.1)
C1517001 (UMLS CUI 2011AA)
C0038895 (UMLS CUI 2011AA)
C1880198 (UMLS CUI 2011AA)
C1522449 (UMLS CUI 2011AA)
302505005 (SNOMED CT 2011_0131)
Previous chemotherapy or hormonotherapy for the metastatic disease. Patients may have received neoadjuvant chemotherapy or neoadjuvant hormonotherapy with curative intention as a part or as an alternative to an adjuvant treatment. For the previous neoadjuvant hormonotherapy the same premises than for the adjuvant hormonotherapy are valid.
Item
Previous chemotherapy or hormonotherapy for the metastatic disease. Patients may have received neoadjuvant chemotherapy or neoadjuvant hormonotherapy with curative intention as a part or as an alternative to an adjuvant treatment. For the previous neoadjuvant hormonotherapy the same premises than for the adjuvant hormonotherapy are valid.
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0279025 (UMLS CUI 2011AA)
309542002, 169413002 (SNOMED CT 2011_0131)
10065646 (MedDRA 14.1)
C0036525 (UMLS CUI 2011AA)
77879006 (SNOMED CT 2011_0131)
10027474 (MedDRA 14.1)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0600558 (UMLS CUI 2011AA)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0279025 (UMLS CUI 2011AA)
309542002, 169413002 (SNOMED CT 2011_0131)
10065646 (MedDRA 14.1)
C1880198 (UMLS CUI 2011AA)
C0162425 (UMLS CUI 2011AA)
C0677850 (UMLS CUI 2011AA)
10068969 (MedDRA 14.1)
Previous therapy with anti-VEGF or VEGFR tyrosine-kinase inhibitors.
Item
Previous therapy with anti-VEGF or VEGFR tyrosine-kinase inhibitors.
boolean
C1514463 (UMLS CUI 2011AA)
CL318109 (UMLS CUI 2011AA)
C1268567 (UMLS CUI 2011AA)
372917005 (SNOMED CT 2011_0131)
CL425146 (UMLS CUI 2011AA)
History of another pathology that may affect the development of the protocol or the interpretation of results. It is considered that patients who have suffered from a skin carcinoma that is not melanoma, cervical carcinoma in situ or another neoplasia treated with a curative intention and with a disease-free interval exceeding 5 years can be chosen.
Item
History of another pathology that may affect the development of the protocol or the interpretation of results. It is considered that patients who have suffered from a skin carcinoma that is not melanoma, cervical carcinoma in situ or another neoplasia treated with a curative intention and with a disease-free interval exceeding 5 years can be chosen.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0677042 (UMLS CUI 2011AA)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C2348563 (UMLS CUI 2011AA)
C0459471 (UMLS CUI 2011AA)
280452008 (SNOMED CT 2011_0131)
MTHU003869 (LOINC Version 232)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
C0699893 (UMLS CUI 2011AA)
10040810 (MedDRA 14.1)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
CL415147 (UMLS CUI 2011AA)
C1880198 (UMLS CUI 2011AA)
C0332296 (UMLS CUI 2011AA)
37837009 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C1272706 (UMLS CUI 2011AA)
385673002 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
Evidence of CNS metastasis. A CT scan or brain NMR must be done within the 4 weeks before the randomization in case of suspecting brain metastasis.
Item
Evidence of CNS metastasis. A CT scan or brain NMR must be done within the 4 weeks before the randomization in case of suspecting brain metastasis.
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0279130 (UMLS CUI 2011AA)
261731003 (SNOMED CT 2011_0131)
C0040405 (UMLS CUI 2011AA)
10011603 (MedDRA 14.1)
C1269537 (UMLS CUI 2011AA)
258335003 (SNOMED CT 2011_0131)
C0028580 (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)
C0750491 (UMLS CUI 2011AA)
415684004 (SNOMED CT 2011_0131)
C0220650 (UMLS CUI 2011AA)
10006128 (MedDRA 14.1)
History or evidence in the physical or neurological examination of CNS pathology unrelated to cancer unless it is suitable treated with standard therapy (e.g. uncontrolled convulsions).
Item
History or evidence in the physical or neurological examination of CNS pathology unrelated to cancer unless it is suitable treated with standard therapy (e.g. uncontrolled convulsions).
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C1269563 (UMLS CUI 2011AA)
278199004 (SNOMED CT 2011_0131)
C0677042 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
CL415147 (UMLS CUI 2011AA)
CL426127 (UMLS CUI 2011AA)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0036572 (UMLS CUI 2011AA)
91175000 (SNOMED CT 2011_0131)
10039910 (MedDRA 14.1)
780.39 (ICD-9-CM Version 2011)
History of peripheral neuropathy NCI CTCAE grade >2 at the time of randomization.
Item
History of peripheral neuropathy NCI CTCAE grade >2 at the time of randomization.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0031117 (UMLS CUI 2011AA)
10029331 (MedDRA 14.1)
G64 (ICD-10-CM Version 2010)
350-359.99 (ICD-9-CM Version 2011)
C1140168 (UMLS CUI 2011AA)
C1516728 (UMLS CUI 2011AA)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Patients subjected to major surgical procedures, open biopsies or those having significant trauma injuries within the 28 days prior to randomization, or patients who are expected to undergo a major surgical procedure that must necessarily be performed within the course of the study.
Item
Patients subjected to major surgical procedures, open biopsies or those having significant trauma injuries within the 28 days prior to randomization, or patients who are expected to undergo a major surgical procedure that must necessarily be performed within the course of the study.
boolean
C0679637 (UMLS CUI 2011AA)
C0184922 (UMLS CUI 2011AA)
119283008 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
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)
CL414906 (UMLS CUI 2011AA)
C1517001 (UMLS CUI 2011AA)
C0679637 (UMLS CUI 2011AA)
C1514873 (UMLS CUI 2011AA)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0750729 (UMLS CUI 2011AA)
288524001 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
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