ID

17916

Description

The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00065325

Link

https://clinicaltrials.gov/show/NCT00065325

Keywords

Versions (1)
  1. 10/9/16 10/9/16 -
Uploaded on

October 9, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Locally Advanced Breast Cancer NCT00065325

English

Eligibility Locally Advanced Breast Cancer NCT00065325

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
biopsy confirmation of breast cancer
Description

Breast Carcinoma | Biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0005558
breast cancer has continued to grow after having received treatment with an aromatase inhibitor
Description

Therapeutic procedure Breast Carcinoma | Aromatase Inhibitor | Disease Progression

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C0593802
UMLS CUI [3]
C0242656
postmenopausal women defined as a women who has stopped having menstrual periods
Description

Postmenopausal state | Periods have stopped

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0425957
evidence of hormone sensitivity
Description

hormone sensitivity Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0920555
UMLS CUI [1,2]
C0332120
written informed consent to participate in the trial
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with faslodex (fulvestrant) or aromasin (exemestane)
Description

Faslodex | fulvestrant | Aromasin | exemestane

Data type

boolean

Alias
UMLS CUI [1]
C0701491
UMLS CUI [2]
C0935916
UMLS CUI [3]
C0876723
UMLS CUI [4]
C0851344
any hormonal therapy used to modify the course of an additional medical condition after prior treatment with a non-steroidal aromatase inhibitor
Description

Hormone Therapy Other medical condition Changing | Non-Steroidal Aromatase Inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C3843040
UMLS CUI [1,3]
C0392747
UMLS CUI [2]
C1518386
treatment with an investigational or non-approved drug within one month
Description

Investigational New Drugs | Illicit Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0086190
an existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
Description

Disease Serious Preventing participation | Disease Serious Preventing Protocol Compliance | Condition Preventing participation | Condition Preventing Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C0679823
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C1292733
UMLS CUI [2,4]
C0525058
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0679823
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C0525058
a history of allergies to any active or inactive ingredients of faslodex or exemestane (i.e. castor oil or mannitol)
Description

Hypersensitivity Faslodex Ingredient | Hypersensitivity exemestane Ingredient | Hypersensitivity Castor Oil | Hypersensitivity Mannitol

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0701491
UMLS CUI [1,3]
C1550600
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0851344
UMLS CUI [2,3]
C1550600
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0007343
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0024730
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Similar models

Eligibility Locally Advanced Breast Cancer NCT00065325

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | Biopsy
Item
biopsy confirmation of breast cancer
boolean
C0678222 (UMLS CUI [1])
C0005558 (UMLS CUI [2])
Therapeutic procedure Breast Carcinoma | Aromatase Inhibitor | Disease Progression
Item
breast cancer has continued to grow after having received treatment with an aromatase inhibitor
boolean
C0087111 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0593802 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
Postmenopausal state | Periods have stopped
Item
postmenopausal women defined as a women who has stopped having menstrual periods
boolean
C0232970 (UMLS CUI [1])
C0425957 (UMLS CUI [2])
hormone sensitivity Evidence of
Item
evidence of hormone sensitivity
boolean
C0920555 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Informed Consent
Item
written informed consent to participate in the trial
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Faslodex | fulvestrant | Aromasin | exemestane
Item
previous treatment with faslodex (fulvestrant) or aromasin (exemestane)
boolean
C0701491 (UMLS CUI [1])
C0935916 (UMLS CUI [2])
C0876723 (UMLS CUI [3])
C0851344 (UMLS CUI [4])
Hormone Therapy Other medical condition Changing | Non-Steroidal Aromatase Inhibitor
Item
any hormonal therapy used to modify the course of an additional medical condition after prior treatment with a non-steroidal aromatase inhibitor
boolean
C0279025 (UMLS CUI [1,1])
C3843040 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C1518386 (UMLS CUI [2])
Investigational New Drugs | Illicit Drugs
Item
treatment with an investigational or non-approved drug within one month
boolean
C0013230 (UMLS CUI [1])
C0086190 (UMLS CUI [2])
Disease Serious Preventing participation | Disease Serious Preventing Protocol Compliance | Condition Preventing participation | Condition Preventing Protocol Compliance
Item
an existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0679823 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0679823 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Hypersensitivity Faslodex Ingredient | Hypersensitivity exemestane Ingredient | Hypersensitivity Castor Oil | Hypersensitivity Mannitol
Item
a history of allergies to any active or inactive ingredients of faslodex or exemestane (i.e. castor oil or mannitol)
boolean
C0020517 (UMLS CUI [1,1])
C0701491 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0851344 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0007343 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0024730 (UMLS CUI [4,2])
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