ID

19593

Beskrivning

Efficacy and Safety of Imatinib and Vinorelbine in Patients With Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00372476

Länk

https://clinicaltrials.gov/show/NCT00372476

Nyckelord

Versioner (1)
  1. 2017-01-13 2017-01-13 -
Uppladdad den

13 januari 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00372476

Engelsk

Eligibility Breast Cancer NCT00372476

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically documented diagnosis of invasive breast cancer that is locally advanced or metastatic
Beskrivning

Invasive carcinoma of breast Advanced Local | Invasive carcinoma of breast metastatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0205276
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C1522484
previous anthracycline containing chemotherapy
Beskrivning

Chemotherapy Anthracycline Containing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0282564
UMLS CUI [1,3]
C0332256
presence of a certain protein on the cell surface (c-kit (cd117) and /or pdgf-receptor)
Beskrivning

c-kit protein Cell surface | Platelet-Derived Growth Factor Receptor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0072470
UMLS CUI [1,2]
C0699040
UMLS CUI [2]
C0071253
preferably tumor samples should be taken within 6 weeks of study entry. most recent primary tumor tissue has to be available for analysis
Beskrivning

Tumor tissue sample Available Analysis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0002778
acceptable health status (eastern cooperative oncology group [ecog]-performance status 0,1, 2 or 3)
Beskrivning

Health Status Acceptable ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018759
UMLS CUI [1,2]
C1879533
UMLS CUI [1,3]
C1520224
exclusion criteria: (for the second-line therapy)
Beskrivning

Exclusion Criteria Second line treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1710038
patient with grade iii/iv cardiac problems (i.e., congestive heart failure, myocardial infarction within 6 months of study) and with severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
Beskrivning

cardiac problem New York Heart Association Classification | Congestive heart failure | Myocardial Infarction | Disease Severe | Disease Uncontrolled | Diabetic - poor control | Chronic Kidney Disease | Communicable Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262402
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0205318
UMLS CUI [6]
C0421258
UMLS CUI [7]
C1561643
UMLS CUI [8,1]
C0009450
UMLS CUI [8,2]
C0205318
patient has a known brain metastasis, chronic liver disease (i.e., chronic active hepatitis, and cirrhosis) and diagnosis of (hiv) infection.
Beskrivning

Metastatic malignant neoplasm to brain | Chronic liver disease | Hepatitis, Chronic | Liver Cirrhosis chronic | Communicable Disease | HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0341439
UMLS CUI [3]
C0019189
UMLS CUI [4,1]
C0023890
UMLS CUI [4,2]
C0205191
UMLS CUI [5]
C0009450
UMLS CUI [6]
C0019693
patient received chemotherapy within 4 weeks prior to study entry, unless the disease is rapidly progressing.
Beskrivning

Chemotherapy | Rapid disease progression

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1834700
patient previously received radiotherapy to ≥ 25 % of the bone marrow and had a major surgery within 2 weeks prior to study entry.
Beskrivning

Therapeutic radiology procedure Bone Marrow Percentage | major surgery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
UMLS CUI [2]
C0679637
patient received either vinorelbine or imatinib in previous treatment regimens
Beskrivning

vinorelbine | imatinib

Datatyp

boolean

Alias
UMLS CUI [1]
C0078257
UMLS CUI [2]
C0935989
other protocol-defined inclusion/exclusion criteria may apply
Beskrivning

Eligibility Criteria Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Breast Cancer NCT00372476

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast Advanced Local | Invasive carcinoma of breast metastatic
Item
histologically documented diagnosis of invasive breast cancer that is locally advanced or metastatic
boolean
C0853879 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0853879 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
Chemotherapy Anthracycline Containing
Item
previous anthracycline containing chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0282564 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
c-kit protein Cell surface | Platelet-Derived Growth Factor Receptor
Item
presence of a certain protein on the cell surface (c-kit (cd117) and /or pdgf-receptor)
boolean
C0072470 (UMLS CUI [1,1])
C0699040 (UMLS CUI [1,2])
C0071253 (UMLS CUI [2])
Tumor tissue sample Available Analysis
Item
preferably tumor samples should be taken within 6 weeks of study entry. most recent primary tumor tissue has to be available for analysis
boolean
C0475358 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0002778 (UMLS CUI [1,3])
Health Status Acceptable ECOG performance status
Item
acceptable health status (eastern cooperative oncology group [ecog]-performance status 0,1, 2 or 3)
boolean
C0018759 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C1520224 (UMLS CUI [1,3])
Exclusion Criteria Second line treatment
Item
exclusion criteria: (for the second-line therapy)
boolean
C0680251 (UMLS CUI [1,1])
C1710038 (UMLS CUI [1,2])
cardiac problem New York Heart Association Classification | Congestive heart failure | Myocardial Infarction | Disease Severe | Disease Uncontrolled | Diabetic - poor control | Chronic Kidney Disease | Communicable Disease Uncontrolled
Item
patient with grade iii/iv cardiac problems (i.e., congestive heart failure, myocardial infarction within 6 months of study) and with severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
boolean
C0262402 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0012634 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0421258 (UMLS CUI [6])
C1561643 (UMLS CUI [7])
C0009450 (UMLS CUI [8,1])
C0205318 (UMLS CUI [8,2])
Metastatic malignant neoplasm to brain | Chronic liver disease | Hepatitis, Chronic | Liver Cirrhosis chronic | Communicable Disease | HIV Infection
Item
patient has a known brain metastasis, chronic liver disease (i.e., chronic active hepatitis, and cirrhosis) and diagnosis of (hiv) infection.
boolean
C0220650 (UMLS CUI [1])
C0341439 (UMLS CUI [2])
C0019189 (UMLS CUI [3])
C0023890 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0009450 (UMLS CUI [5])
C0019693 (UMLS CUI [6])
Chemotherapy | Rapid disease progression
Item
patient received chemotherapy within 4 weeks prior to study entry, unless the disease is rapidly progressing.
boolean
C0392920 (UMLS CUI [1])
C1834700 (UMLS CUI [2])
Therapeutic radiology procedure Bone Marrow Percentage | major surgery
Item
patient previously received radiotherapy to ≥ 25 % of the bone marrow and had a major surgery within 2 weeks prior to study entry.
boolean
C1522449 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0679637 (UMLS CUI [2])
vinorelbine | imatinib
Item
patient received either vinorelbine or imatinib in previous treatment regimens
boolean
C0078257 (UMLS CUI [1])
C0935989 (UMLS CUI [2])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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