ID

16387

Description

Randomized Phase II Study of Epirubicin vs Caelyx in Pretreated Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00431795

Link

https://clinicaltrials.gov/show/NCT00431795

Keywords

Versions (1)
  1. 7/14/16 7/14/16 -
Uploaded on

July 14, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00431795

English

Eligibility Breast Cancer NCT00431795

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog) performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow function (absolute neutrophil count >1000/mm^3, platelet count>100000/mm^3, hemoglobin>9gr/mm^3)
Description

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

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]
C0019046
histologically- or cytologically- confirmed breast adenocarcinoma
Description

Breast adenocarcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0858252
no prior anthracycline-based chemotherapy as treatment of advanced breast cancer
Description

Anthracycline Antibiotics | Therapeutic procedure Advanced breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0003234
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C3495917
no prior chemotherapy with ≥ 300mg/m2 doxorubicin or ≥ 540mg/m2 epirubicin as adjuvant setting
Description

Prior Chemotherapy | Doxorubicin Adjuvant | Epirubicin Adjuvant

Data type

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C0013089
UMLS CUI [2,2]
C1522673
UMLS CUI [3,1]
C0014582
UMLS CUI [3,2]
C1522673
at least 4 weeks interval since prior anticancer treatment
Description

Interval Minimum Since cancer treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1272706
UMLS CUI [1,2]
C1524031
UMLS CUI [1,3]
C1711239
UMLS CUI [1,4]
C0920425
measurable disease as defined by the presence of at least one measurable lesion(except bone metastases, ascites or pleural effusions)
Description

Measurable lesion Quantity | Secondary malignant neoplasm of bone | Ascites | Pleural effusion

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0153690
UMLS CUI [3]
C0003962
UMLS CUI [4]
C0032227
life expectancy > 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
written informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
documented history of congestive heart failure (chf), serious arrhythmia, or myocardial infarction (within 6 months)
Description

Congestive heart failure | Cardiac Arrhythmia Serious | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C0027051
other invasive malignancy except nonmelanoma skin cancer or acute infection.
Description

invasive cancer | Skin carcinoma | Acute infection

Data type

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0275518
radiation of measurable disease (except brain metastases)
Description

Radiation Measurable Disease | Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1,1]
C0851346
UMLS CUI [1,2]
C1513041
UMLS CUI [2]
C0220650
progressive brain metastases according to clinical or radiological criteria.
Description

Metastatic malignant neoplasm to brain Progressive

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0205329
brain metastases without prior radiation therapy
Description

Metastatic malignant neoplasm to brain Without prior radiation therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0279134
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Similar models

Eligibility Breast Cancer NCT00431795

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18-75 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin
Item
adequate bone marrow function (absolute neutrophil count >1000/mm^3, platelet count>100000/mm^3, hemoglobin>9gr/mm^3)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0019046 (UMLS CUI [4])
Breast adenocarcinoma
Item
histologically- or cytologically- confirmed breast adenocarcinoma
boolean
C0858252 (UMLS CUI [1])
Anthracycline Antibiotics | Therapeutic procedure Advanced breast cancer
Item
no prior anthracycline-based chemotherapy as treatment of advanced breast cancer
boolean
C0003234 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C3495917 (UMLS CUI [2,2])
Prior Chemotherapy | Doxorubicin Adjuvant | Epirubicin Adjuvant
Item
no prior chemotherapy with ≥ 300mg/m2 doxorubicin or ≥ 540mg/m2 epirubicin as adjuvant setting
boolean
C1514457 (UMLS CUI [1])
C0013089 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
C0014582 (UMLS CUI [3,1])
C1522673 (UMLS CUI [3,2])
Interval Minimum Since cancer treatment
Item
at least 4 weeks interval since prior anticancer treatment
boolean
C1272706 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
C1711239 (UMLS CUI [1,3])
C0920425 (UMLS CUI [1,4])
Measurable lesion Quantity | Secondary malignant neoplasm of bone | Ascites | Pleural effusion
Item
measurable disease as defined by the presence of at least one measurable lesion(except bone metastases, ascites or pleural effusions)
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0153690 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
C0032227 (UMLS CUI [4])
Life Expectancy
Item
life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
Informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnancy or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Congestive heart failure | Cardiac Arrhythmia Serious | Myocardial Infarction
Item
documented history of congestive heart failure (chf), serious arrhythmia, or myocardial infarction (within 6 months)
boolean
C0018802 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
invasive cancer | Skin carcinoma | Acute infection
Item
other invasive malignancy except nonmelanoma skin cancer or acute infection.
boolean
C0677898 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0275518 (UMLS CUI [3])
Radiation Measurable Disease | Metastatic malignant neoplasm to brain
Item
radiation of measurable disease (except brain metastases)
boolean
C0851346 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2])
Metastatic malignant neoplasm to brain Progressive
Item
progressive brain metastases according to clinical or radiological criteria.
boolean
C0220650 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain Without prior radiation therapy
Item
brain metastases without prior radiation therapy
boolean
C0220650 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0279134 (UMLS CUI [1,3])
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