ID

21861

Description

Study of Cipterbin®, Used Alone or With Vinorelbine in Patients With HER2/Neu-overexpressed Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01439191

Link

https://clinicaltrials.gov/show/NCT01439191

Keywords

Versions (1)
  1. 5/4/17 5/4/17 -
Uploaded on

May 4, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT01439191

English

Eligibility Metastatic Breast Cancer NCT01439191

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologic diagnosis breast cancer
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
her2+ status defined as ihc3+ staining or in situ hybridization positive at least 1 measurable lesion as per recist criteria
Description

HER2/Neu Positive | Immunohistochemistry Score | In Situ Hybridization Positive | Measurable Disease Quantity

Data type

boolean

Alias
UMLS CUI [1]
C2348909
UMLS CUI [2,1]
C0021044
UMLS CUI [2,2]
C0449820
UMLS CUI [3,1]
C0162788
UMLS CUI [3,2]
C1514241
UMLS CUI [4,1]
C1513041
UMLS CUI [4,2]
C1265611
adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)
Description

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
adequate liver (bilirubin <1.0 times upper limit of normal and sgot/sgpt <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)
Description

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0232804
UMLS CUI [6]
C0201976
adequate cardiac function (lvef>50%). normal electrocardiogram and absence of significant heart disease
Description

Cardiac function | Left ventricular ejection fraction | ECG normal | Heart Disease Absent

Data type

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0428772
UMLS CUI [3]
C0522054
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0332197
age from 18 to 70y
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
karnofsky performance score ≥ 60
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
life expectancy of greater than 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
negative hcg pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause.
Description

Childbearing Potential Hcg pregnancy test Negative | Premenopausal state | Postmenopausal state Duration Hcg pregnancy test Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0546577
UMLS CUI [1,3]
C1513916
UMLS CUI [2]
C0232969
UMLS CUI [3,1]
C0232970
UMLS CUI [3,2]
C0449238
UMLS CUI [3,3]
C0546577
UMLS CUI [3,4]
C1513916
signed icf
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior exposure vinorelbine for breast cancer
Description

Vinorelbine Exposure | Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0078257
UMLS CUI [1,2]
C0332157
UMLS CUI [2]
C0678222
prior exposure trastuzumab for breast cancer
Description

Trastuzumab Exposure | Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0728747
UMLS CUI [1,2]
C0332157
UMLS CUI [2]
C0678222
prior chemotherapy and radiation therapy within the last 4 weeks before enrollment
Description

Chemotherapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
use of any other investigational agents within the last 4 weeks before enrollment
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
symptomatic, central nervous system metastases
Description

CNS metastases Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
hypersensitivity to trial medications
Description

Hypersensitivity Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
breastfeeding or pregnant
Description

Breast Feeding | Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
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Similar models

Eligibility Metastatic Breast Cancer NCT01439191

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma
Item
pathologic diagnosis breast cancer
boolean
C0678222 (UMLS CUI [1])
HER2/Neu Positive | Immunohistochemistry Score | In Situ Hybridization Positive | Measurable Disease Quantity
Item
her2+ status defined as ihc3+ staining or in situ hybridization positive at least 1 measurable lesion as per recist criteria
boolean
C2348909 (UMLS CUI [1])
C0021044 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
C0162788 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C1513041 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
adequate liver (bilirubin <1.0 times upper limit of normal and sgot/sgpt <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Cardiac function | Left ventricular ejection fraction | ECG normal | Heart Disease Absent
Item
adequate cardiac function (lvef>50%). normal electrocardiogram and absence of significant heart disease
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
C0522054 (UMLS CUI [3])
C0018799 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Age
Item
age from 18 to 70y
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky performance score ≥ 60
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of greater than 3 months
boolean
C0023671 (UMLS CUI [1])
Childbearing Potential Hcg pregnancy test Negative | Premenopausal state | Postmenopausal state Duration Hcg pregnancy test Negative
Item
negative hcg pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause.
boolean
C3831118 (UMLS CUI [1,1])
C0546577 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C0232969 (UMLS CUI [2])
C0232970 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C0546577 (UMLS CUI [3,3])
C1513916 (UMLS CUI [3,4])
Informed Consent
Item
signed icf
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Vinorelbine Exposure | Breast Carcinoma
Item
prior exposure vinorelbine for breast cancer
boolean
C0078257 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
Trastuzumab Exposure | Breast Carcinoma
Item
prior exposure trastuzumab for breast cancer
boolean
C0728747 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
Chemotherapy | Therapeutic radiology procedure
Item
prior chemotherapy and radiation therapy within the last 4 weeks before enrollment
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Investigational New Drugs
Item
use of any other investigational agents within the last 4 weeks before enrollment
boolean
C0013230 (UMLS CUI [1])
CNS metastases Symptomatic
Item
symptomatic, central nervous system metastases
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Hypersensitivity Investigational New Drugs
Item
hypersensitivity to trial medications
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Breast Feeding | Pregnancy
Item
breastfeeding or pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
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