ID

30607

Beschrijving

Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00930475

Link

https://clinicaltrials.gov/show/NCT00930475

Trefwoorden

Versies (1)
  1. 17-06-18 17-06-18 -
Houder van rechten

see clinicaltrials.gov

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17 juni 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00930475

Engels

Eligibility Breast Cancer NCT00930475

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult female patients
Beschrijving

Gender; Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
at least two prior chemotherapies due to metastatic or inoperable breast cancer
Beschrijving

Prior Chemotherapy Due to Carcinoma breast stage IV; Prior Chemotherapy Due to Breast Carcinoma, Inoperable

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0278488
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0678222
UMLS CUI [2,4]
C0205187
karnofsky performance status of at least 60%
Beschrijving

Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
pretreatment with at least one taxane and one anthracycline
Beschrijving

Pretreatment taxane; Pretreatment Anthracyclines

Datatype

boolean

Alias
UMLS CUI [1,1]
C3539076
UMLS CUI [1,2]
C0215136
UMLS CUI [2,1]
C3539076
UMLS CUI [2,2]
C0282564
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with mtor-inhibitors, carboplatin, cisplatin or oxaliplatin
Beschrijving

mTOR Inhibitor, Therapeutic procedure, Previous; Carboplatin, Therapeutic procedure, Previous; Cisplatin, Therapeutic procedure, Previous; oxaliplatin, Therapeutic procedure, Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C2746052
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205156
UMLS CUI [2,1]
C0079083
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0205156
UMLS CUI [3,1]
C0008838
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0205156
UMLS CUI [4,1]
C0069717
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C0205156
inadequate organ function including bone marrow function
Beschrijving

body system or organ function, Inadequate

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0205412
bleeding tumours
Beschrijving

Malignant Neoplasms, Hemorrhage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0019080
known uncontrolled metastases in cns or carcinomatous meningosis
Beschrijving

CNS metastases, Uncontrolled; Meningeal Carcinomatosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0220654
patients who have been treated during the last five days with inhibitors or inducers of cyp3a
Beschrijving

Cytochrome P450 3A4 Inhibitor, Therapeutic procedure, Previous; Cytochrome P450 3A4 Inducer, Therapeutic procedure, Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C3830624
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205156
UMLS CUI [2,1]
C3830625
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0205156
serious pulmonary, neurological, endocrinological or other disorders interfering with this study medication, especially patients with known lung fibrosis, emphysema or severe copd
Beschrijving

Bronchopulmonary disease, Serious, Interferes with clinical trial drug; nervous system disorder, Serious, Interferes with, clinical trial drug; Endocrine System Diseases, Serious, Interferes with clinical trial drug; Disease, Other, Interferes with clinical trial drug

Datatype

boolean

Alias
UMLS CUI [1,1]
C1096000
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C3854006
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C3854006
UMLS CUI [3,1]
C0014130
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C3854006
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205394
UMLS CUI [4,3]
C0521102
UMLS CUI [4,4]
C3854006
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Similar models

Eligibility Breast Cancer NCT00930475

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender; Age
Item
adult female patients
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Prior Chemotherapy Due to Carcinoma breast stage IV; Prior Chemotherapy Due to Breast Carcinoma, Inoperable
Item
at least two prior chemotherapies due to metastatic or inoperable breast cancer
boolean
C1514457 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0278488 (UMLS CUI [1,3])
C1514457 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
C0205187 (UMLS CUI [2,4])
Karnofsky Performance Status
Item
karnofsky performance status of at least 60%
boolean
C0206065 (UMLS CUI [1])
Pretreatment taxane; Pretreatment Anthracyclines
Item
pretreatment with at least one taxane and one anthracycline
boolean
C3539076 (UMLS CUI [1,1])
C0215136 (UMLS CUI [1,2])
C3539076 (UMLS CUI [2,1])
C0282564 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
mTOR Inhibitor, Therapeutic procedure, Previous; Carboplatin, Therapeutic procedure, Previous; Cisplatin, Therapeutic procedure, Previous; oxaliplatin, Therapeutic procedure, Previous
Item
previous treatment with mtor-inhibitors, carboplatin, cisplatin or oxaliplatin
boolean
C2746052 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0079083 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
C0008838 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0205156 (UMLS CUI [3,3])
C0069717 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0205156 (UMLS CUI [4,3])
body system or organ function, Inadequate
Item
inadequate organ function including bone marrow function
boolean
C0678852 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
Malignant Neoplasms, Hemorrhage
Item
bleeding tumours
boolean
C0006826 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
CNS metastases, Uncontrolled; Meningeal Carcinomatosis
Item
known uncontrolled metastases in cns or carcinomatous meningosis
boolean
C0686377 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0220654 (UMLS CUI [2])
Cytochrome P450 3A4 Inhibitor, Therapeutic procedure, Previous; Cytochrome P450 3A4 Inducer, Therapeutic procedure, Previous
Item
patients who have been treated during the last five days with inhibitors or inducers of cyp3a
boolean
C3830624 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C3830625 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
Bronchopulmonary disease, Serious, Interferes with clinical trial drug; nervous system disorder, Serious, Interferes with, clinical trial drug; Endocrine System Diseases, Serious, Interferes with clinical trial drug; Disease, Other, Interferes with clinical trial drug
Item
serious pulmonary, neurological, endocrinological or other disorders interfering with this study medication, especially patients with known lung fibrosis, emphysema or severe copd
boolean
C1096000 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C3854006 (UMLS CUI [1,4])
C0027765 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C3854006 (UMLS CUI [2,4])
C0014130 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C3854006 (UMLS CUI [3,4])
C0012634 (UMLS CUI [4,1])
C0205394 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C3854006 (UMLS CUI [4,4])
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