ID

27353

Beschrijving

Everolimus in Breast Cancer Patients After Pre-operative Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT01088893

Link

https://clinicaltrials.gov/show/NCT01088893

Trefwoorden

Versies (1)
  1. 09-11-17 09-11-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

9 november 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01088893

Engels

Eligibility Breast Neoplasms NCT01088893

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
women aged ≥ 18 years;
Beschrijving

Gender | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
histologically and/or cytologically confirmed invasive ductal or lobular breast cancer;
Beschrijving

Invasive Ductal Breast Carcinoma | Breast cancer, lobular

Datatype

boolean

Alias
UMLS CUI [1]
C1134719
UMLS CUI [2]
C3549742
tumor of 3 cm or greater at time of diagnosis
Beschrijving

Tumor size

Datatype

boolean

Alias
UMLS CUI [1]
C0475440
measurable primary tumor after neoadjuvant treatment before randomization
Beschrijving

Neoadjuvant Therapy Primary tumor Measurable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C0677930
UMLS CUI [1,3]
C1513040
no prior chemotherapy for breast cancer;
Beschrijving

Absence Prior Chemotherapy Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1514457
UMLS CUI [1,3]
C0678222
ecog performance status ≤1 or karnofsky performace status ≥ 70%
Beschrijving

ECOG performance status | Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
adequate liver/renal function
Beschrijving

Liver function | Renal function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
able to swallow whole tablets.
Beschrijving

Able to swallow Tablets

Datatype

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0039225
able to give written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
able to follow prescription instructions reasonably well
Beschrijving

Compliance behavior Prescription Instructions

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0033081
UMLS CUI [1,3]
C1442085
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
male patient
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
prior history of other malignancy within 5 years of study entry, aside from contralateral breast carcinoma, appropriately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin
Beschrijving

Cancer Other | Exception Contralateral Breast Carcinoma | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C3274709
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0553723
UMLS CUI [5,3]
C1522326
distant metastasis, including skin involvement beyond the breast area
Beschrijving

Distant metastasis | Skin Involvement outside Breast

Datatype

boolean

Alias
UMLS CUI [1]
C1269798
UMLS CUI [2,1]
C1123023
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0205101
UMLS CUI [2,4]
C0006141
other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
Beschrijving

Medical condition Severe High risk Study Subject Participation Status | Medical condition Severe High risk Investigational New Drugs | Medical condition Severe Study Subject Participation Status Inappropriate | Medical condition chronic High risk Study Subject Participation Status | Medical condition chronic High risk Investigational New Drugs | Medical condition chronic Study Subject Participation Status Inappropriate | Mental disorders Severe High risk Study Subject Participation Status | Mental disorders Severe High risk Investigational New Drugs | Mental disorders Severe Study Subject Participation Status Inappropriate | Mental disorders chronic High risk Study Subject Participation Status | Mental disorders chronic High risk Investigational New Drugs | Mental disorders chronic Study Subject Participation Status Inappropriate | Laboratory test result abnormal High risk Study Subject Participation Status | Laboratory test result abnormal High risk Investigational New Drugs | Laboratory test result abnormal Study Subject Participation Status Inappropriate

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332167
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0332167
UMLS CUI [2,4]
C0013230
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C2348568
UMLS CUI [3,4]
C1548788
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0205191
UMLS CUI [4,3]
C0332167
UMLS CUI [4,4]
C2348568
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0205191
UMLS CUI [5,3]
C0332167
UMLS CUI [5,4]
C0013230
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0205191
UMLS CUI [6,3]
C2348568
UMLS CUI [6,4]
C1548788
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C0205082
UMLS CUI [7,3]
C0332167
UMLS CUI [7,4]
C2348568
UMLS CUI [8,1]
C0004936
UMLS CUI [8,2]
C0205082
UMLS CUI [8,3]
C0332167
UMLS CUI [8,4]
C0013230
UMLS CUI [9,1]
C0004936
UMLS CUI [9,2]
C0205082
UMLS CUI [9,3]
C2348568
UMLS CUI [9,4]
C1548788
UMLS CUI [10,1]
C0004936
UMLS CUI [10,2]
C0205191
UMLS CUI [10,3]
C0332167
UMLS CUI [10,4]
C2348568
UMLS CUI [11,1]
C0004936
UMLS CUI [11,2]
C0205191
UMLS CUI [11,3]
C0332167
UMLS CUI [11,4]
C0013230
UMLS CUI [12,1]
C0004936
UMLS CUI [12,2]
C0205191
UMLS CUI [12,3]
C2348568
UMLS CUI [12,4]
C1548788
UMLS CUI [13,1]
C0438215
UMLS CUI [13,2]
C0332167
UMLS CUI [13,3]
C2348568
UMLS CUI [14,1]
C0438215
UMLS CUI [14,2]
C0332167
UMLS CUI [14,3]
C0013230
UMLS CUI [15,1]
C0438215
UMLS CUI [15,2]
C2348568
UMLS CUI [15,3]
C1548788
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Similar models

Eligibility Breast Neoplasms NCT01088893

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women aged ≥ 18 years;
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Invasive Ductal Breast Carcinoma | Breast cancer, lobular
Item
histologically and/or cytologically confirmed invasive ductal or lobular breast cancer;
boolean
C1134719 (UMLS CUI [1])
C3549742 (UMLS CUI [2])
Tumor size
Item
tumor of 3 cm or greater at time of diagnosis
boolean
C0475440 (UMLS CUI [1])
Neoadjuvant Therapy Primary tumor Measurable
Item
measurable primary tumor after neoadjuvant treatment before randomization
boolean
C0600558 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C1513040 (UMLS CUI [1,3])
Absence Prior Chemotherapy Breast Carcinoma
Item
no prior chemotherapy for breast cancer;
boolean
C0332197 (UMLS CUI [1,1])
C1514457 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
ECOG performance status | Karnofsky Performance Status
Item
ecog performance status ≤1 or karnofsky performace status ≥ 70%
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Liver function | Renal function
Item
adequate liver/renal function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Able to swallow Tablets
Item
able to swallow whole tablets.
boolean
C2712086 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Informed Consent
Item
able to give written informed consent
boolean
C0021430 (UMLS CUI [1])
Compliance behavior Prescription Instructions
Item
able to follow prescription instructions reasonably well
boolean
C1321605 (UMLS CUI [1,1])
C0033081 (UMLS CUI [1,2])
C1442085 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Gender
Item
male patient
boolean
C0079399 (UMLS CUI [1])
Cancer Other | Exception Contralateral Breast Carcinoma | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
prior history of other malignancy within 5 years of study entry, aside from contralateral breast carcinoma, appropriately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C3274709 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0553723 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
Distant metastasis | Skin Involvement outside Breast
Item
distant metastasis, including skin involvement beyond the breast area
boolean
C1269798 (UMLS CUI [1])
C1123023 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0205101 (UMLS CUI [2,3])
C0006141 (UMLS CUI [2,4])
Medical condition Severe High risk Study Subject Participation Status | Medical condition Severe High risk Investigational New Drugs | Medical condition Severe Study Subject Participation Status Inappropriate | Medical condition chronic High risk Study Subject Participation Status | Medical condition chronic High risk Investigational New Drugs | Medical condition chronic Study Subject Participation Status Inappropriate | Mental disorders Severe High risk Study Subject Participation Status | Mental disorders Severe High risk Investigational New Drugs | Mental disorders Severe Study Subject Participation Status Inappropriate | Mental disorders chronic High risk Study Subject Participation Status | Mental disorders chronic High risk Investigational New Drugs | Mental disorders chronic Study Subject Participation Status Inappropriate | Laboratory test result abnormal High risk Study Subject Participation Status | Laboratory test result abnormal High risk Investigational New Drugs | Laboratory test result abnormal Study Subject Participation Status Inappropriate
Item
other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332167 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332167 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C1548788 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0332167 (UMLS CUI [4,3])
C2348568 (UMLS CUI [4,4])
C3843040 (UMLS CUI [5,1])
C0205191 (UMLS CUI [5,2])
C0332167 (UMLS CUI [5,3])
C0013230 (UMLS CUI [5,4])
C3843040 (UMLS CUI [6,1])
C0205191 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
C1548788 (UMLS CUI [6,4])
C0004936 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0332167 (UMLS CUI [7,3])
C2348568 (UMLS CUI [7,4])
C0004936 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0332167 (UMLS CUI [8,3])
C0013230 (UMLS CUI [8,4])
C0004936 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C2348568 (UMLS CUI [9,3])
C1548788 (UMLS CUI [9,4])
C0004936 (UMLS CUI [10,1])
C0205191 (UMLS CUI [10,2])
C0332167 (UMLS CUI [10,3])
C2348568 (UMLS CUI [10,4])
C0004936 (UMLS CUI [11,1])
C0205191 (UMLS CUI [11,2])
C0332167 (UMLS CUI [11,3])
C0013230 (UMLS CUI [11,4])
C0004936 (UMLS CUI [12,1])
C0205191 (UMLS CUI [12,2])
C2348568 (UMLS CUI [12,3])
C1548788 (UMLS CUI [12,4])
C0438215 (UMLS CUI [13,1])
C0332167 (UMLS CUI [13,2])
C2348568 (UMLS CUI [13,3])
C0438215 (UMLS CUI [14,1])
C0332167 (UMLS CUI [14,2])
C0013230 (UMLS CUI [14,3])
C0438215 (UMLS CUI [15,1])
C2348568 (UMLS CUI [15,2])
C1548788 (UMLS CUI [15,3])
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