ID

37941

Description

Comparing the Efficacy and Tolerability of Fulvestrant 500 mg Versus 250 mg in Advanced Breast Cancer Women; ODM derived from: https://clinicaltrials.gov/show/NCT01300351

Link

https://clinicaltrials.gov/show/NCT01300351

Keywords

Versions (1)
  1. 9/1/19 9/1/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 1, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01300351

English

Eligibility Breast Cancer NCT01300351

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal women defined as a woman who has stopped having menstrual periods
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
breast cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor
Description

Breast Carcinoma | Disease Progression | Status post Antioestrogen therapy | Tamoxifen | Aromatase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0854638
UMLS CUI [4]
C0039286
UMLS CUI [5]
C0593802
requiring hormonal treatment
Description

Requirement Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0279025
oestrogen-receptor positive tumour
Description

Estrogen receptor positive tumor

Data type

boolean

Alias
UMLS CUI [1]
C1562312
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
treatment with an investigational or non-approved drug within one month
Description

Investigational New Drugs | Drugs, Non-Prescription

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0013231
an existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
Description

Illness Serious Study Subject Participation Status Excluded | Condition Serious Study Subject Participation Status Excluded | Illness Serious Preventing Protocol Compliance | Condition Serious Preventing Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C0332196
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C0332196
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C1292733
UMLS CUI [3,4]
C0525058
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C1292733
UMLS CUI [4,4]
C0525058
a history of allergies to any active or inactive ingredients of fulvestrant (i.e. castor oil)
Description

Hypersensitivity Fulvestrant Ingredient | Castor oil allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0935916
UMLS CUI [1,3]
C1550600
UMLS CUI [2]
C0571232
treatment with more than one regimen of chemotherapy for advanced breast cancer
Description

Chemotherapy Regimen Quantity Advanced breast cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C3495917
treatment with more than one regimen of hormonal treatment for advanced breast cancer
Description

Hormone Therapy Quantity Advanced breast cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C3495917
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Similar models

Eligibility Breast Cancer NCT01300351

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state
Item
postmenopausal women defined as a woman who has stopped having menstrual periods
boolean
C0232970 (UMLS CUI [1])
Breast Carcinoma | Disease Progression | Status post Antioestrogen therapy | Tamoxifen | Aromatase Inhibitors
Item
breast cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor
boolean
C0678222 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0854638 (UMLS CUI [3,2])
C0039286 (UMLS CUI [4])
C0593802 (UMLS CUI [5])
Requirement Hormone Therapy
Item
requiring hormonal treatment
boolean
C1514873 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
Estrogen receptor positive tumor
Item
oestrogen-receptor positive tumour
boolean
C1562312 (UMLS CUI [1])
Informed Consent
Item
written informed consent to participate in the trial
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs | Drugs, Non-Prescription
Item
treatment with an investigational or non-approved drug within one month
boolean
C0013230 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
Illness Serious Study Subject Participation Status Excluded | Condition Serious Study Subject Participation Status Excluded | Illness Serious Preventing Protocol Compliance | Condition Serious Preventing Protocol Compliance
Item
an existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0332196 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0332196 (UMLS CUI [2,4])
C0221423 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C1292733 (UMLS CUI [3,3])
C0525058 (UMLS CUI [3,4])
C0348080 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C1292733 (UMLS CUI [4,3])
C0525058 (UMLS CUI [4,4])
Hypersensitivity Fulvestrant Ingredient | Castor oil allergy
Item
a history of allergies to any active or inactive ingredients of fulvestrant (i.e. castor oil)
boolean
C0020517 (UMLS CUI [1,1])
C0935916 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
C0571232 (UMLS CUI [2])
Chemotherapy Regimen Quantity Advanced breast cancer
Item
treatment with more than one regimen of chemotherapy for advanced breast cancer
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3495917 (UMLS CUI [1,3])
Hormone Therapy Quantity Advanced breast cancer
Item
treatment with more than one regimen of hormonal treatment for advanced breast cancer
boolean
C0279025 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3495917 (UMLS CUI [1,3])
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