ID

15155

Description

A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers; ODM derived from: https://clinicaltrials.gov/show/NCT02238808

Link

https://clinicaltrials.gov/show/NCT02238808

Keywords

Versions (1)
  1. 5/19/16 5/19/16 -
Uploaded on

May 19, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Estrogen Receptor Positive Breast Cancer NCT02238808

English

Eligibility Estrogen Receptor Positive Breast Cancer NCT02238808

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female gender
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
estrogen receptor positive (er+) breast cancer
Description

Oestrogen receptor positive breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C2938924
her2 negative breast cancer
Description

Human epidermal growth factor 2 negative carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C2316304
post-menopausal by greater than 5 years
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
no previous hormonal replacement therapy
Description

H/O: hormone replacement (HRT)

Data type

boolean

Alias
UMLS CUI [1]
C0455631
low to intermediate histologic grade
Description

Low grade histologic differentiation | Intermediate grade histologic differentiation

Data type

boolean

Alias
UMLS CUI [1]
C1302385
UMLS CUI [2]
C1320484
ecog performance status of 0 of 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematological, renal and hepatic function is required
Description

Hematologic function Adequate | Normal renal function | Liver function Adequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0205411
UMLS CUI [2]
C0232805
UMLS CUI [3,1]
C0232741
UMLS CUI [3,2]
C0205411
ability to take oral medication
Description

Able to swallow oral medication

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
patient must have adequate tissue for diagnosis, biomarkers and ki67 assays
Description

Tissue specimen Adequate Diagnosis | Biological Markers | MKI67 gene

Data type

boolean

Alias
UMLS CUI [1,1]
C1292533
UMLS CUI [1,2]
C0205411
UMLS CUI [1,3]
C0011900
UMLS CUI [2]
C0005516
UMLS CUI [3]
C1334508
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pre-menopausal women
Description

Woman Premenopausal

Data type

boolean

Alias
UMLS CUI [1,1]
C0043210
UMLS CUI [1,2]
C0279752
locally advanced or metastatic breast cancer
Description

Locally advanced breast cancer | Carcinoma breast stage IV

Data type

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2]
C0278488
current, previous or planning for pre-operative treatment with chemotherapy, hormone therapy including corticosteroids, radiation therapy for malignancy or other condition
Description

Neoadjuvant Therapy | Chemotherapy Regimen | Hormone Therapy | Adrenal Cortex Hormones | Therapeutic radiology procedure | Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0600558
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0279025
UMLS CUI [4]
C0001617
UMLS CUI [5]
C1522449
UMLS CUI [6]
C0006826
known hypersensitivity or intolerance to estradiol
Description

Hypersensitivity Estradiol | Intolerance to substance Estradiol

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0014912
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0014912
ischemic changes on baseline electrocardiogram
Description

Ischemic Change Electrocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C2826576
UMLS CUI [1,2]
C1623258
symptomatic but untreated cholelithiasis
Description

Cholelithiasis Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0008350
UMLS CUI [1,2]
C0231220
history of deep vein thrombosis, pulmonary embolism, stroke, acute myocardial infarction, congestive cardiac failure, untreated hypertension or known inherited hypercoagulable disorder
Description

Deep Vein Thrombosis | Pulmonary Embolism | Cerebrovascular accident | Acute myocardial infarction | Congestive heart failure | Hypertensive disease | Thrombophilia, hereditary

Data type

boolean

Alias
UMLS CUI [1]
C0149871
UMLS CUI [2]
C0034065
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0155626
UMLS CUI [5]
C0018802
UMLS CUI [6]
C0020538
UMLS CUI [7]
C2584620
undiagnosed abnormal vaginal bleeding or prior history of endometrial cancer
Description

Vaginal Hemorrhage Abnormal | Malignant neoplasm of endometrium

Data type

boolean

Alias
UMLS CUI [1,1]
C2979982
UMLS CUI [1,2]
C0205161
UMLS CUI [2]
C0007103
untreated metabolic disturbances (glucose > 11.0 mmol/l and triglycerides > 400 mg/dl)
Description

metabolic disturbance | Glucose measurement | Triglycerides measurement

Data type

boolean

Alias
UMLS CUI [1]
C0746556
UMLS CUI [2]
C0337438
UMLS CUI [3]
C0202236
current treatment with drugs known to be moderate or strong inhibitors of inducers of isoenzyme cyp3a4
Description

Therapeutic procedure Pharmaceutical Preparations | Inhibitors Cytochrome P-450 CYP3A4 Inducers

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0013227
UMLS CUI [2,1]
C0243077
UMLS CUI [2,2]
C3850041
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Similar models

Eligibility Estrogen Receptor Positive Breast Cancer NCT02238808

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
female gender
boolean
C0079399 (UMLS CUI [1])
Oestrogen receptor positive breast cancer
Item
estrogen receptor positive (er+) breast cancer
boolean
C2938924 (UMLS CUI [1])
Human epidermal growth factor 2 negative carcinoma of breast
Item
her2 negative breast cancer
boolean
C2316304 (UMLS CUI [1])
Postmenopausal state
Item
post-menopausal by greater than 5 years
boolean
C0232970 (UMLS CUI [1])
H/O: hormone replacement (HRT)
Item
no previous hormonal replacement therapy
boolean
C0455631 (UMLS CUI [1])
Low grade histologic differentiation | Intermediate grade histologic differentiation
Item
low to intermediate histologic grade
boolean
C1302385 (UMLS CUI [1])
C1320484 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status of 0 of 1
boolean
C1520224 (UMLS CUI [1])
Hematologic function Adequate | Normal renal function | Liver function Adequate
Item
adequate hematological, renal and hepatic function is required
boolean
C0221130 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
C0232805 (UMLS CUI [2])
C0232741 (UMLS CUI [3,1])
C0205411 (UMLS CUI [3,2])
Able to swallow oral medication
Item
ability to take oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Tissue specimen Adequate Diagnosis | Biological Markers | MKI67 gene
Item
patient must have adequate tissue for diagnosis, biomarkers and ki67 assays
boolean
C1292533 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0005516 (UMLS CUI [2])
C1334508 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Woman Premenopausal
Item
pre-menopausal women
boolean
C0043210 (UMLS CUI [1,1])
C0279752 (UMLS CUI [1,2])
Locally advanced breast cancer | Carcinoma breast stage IV
Item
locally advanced or metastatic breast cancer
boolean
C3495949 (UMLS CUI [1])
C0278488 (UMLS CUI [2])
Neoadjuvant Therapy | Chemotherapy Regimen | Hormone Therapy | Adrenal Cortex Hormones | Therapeutic radiology procedure | Malignant Neoplasms
Item
current, previous or planning for pre-operative treatment with chemotherapy, hormone therapy including corticosteroids, radiation therapy for malignancy or other condition
boolean
C0600558 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C0001617 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
C0006826 (UMLS CUI [6])
Hypersensitivity Estradiol | Intolerance to substance Estradiol
Item
known hypersensitivity or intolerance to estradiol
boolean
C0020517 (UMLS CUI [1,1])
C0014912 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0014912 (UMLS CUI [2,2])
Ischemic Change Electrocardiography
Item
ischemic changes on baseline electrocardiogram
boolean
C2826576 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
Cholelithiasis Symptomatic
Item
symptomatic but untreated cholelithiasis
boolean
C0008350 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Deep Vein Thrombosis | Pulmonary Embolism | Cerebrovascular accident | Acute myocardial infarction | Congestive heart failure | Hypertensive disease | Thrombophilia, hereditary
Item
history of deep vein thrombosis, pulmonary embolism, stroke, acute myocardial infarction, congestive cardiac failure, untreated hypertension or known inherited hypercoagulable disorder
boolean
C0149871 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0155626 (UMLS CUI [4])
C0018802 (UMLS CUI [5])
C0020538 (UMLS CUI [6])
C2584620 (UMLS CUI [7])
Vaginal Hemorrhage Abnormal | Malignant neoplasm of endometrium
Item
undiagnosed abnormal vaginal bleeding or prior history of endometrial cancer
boolean
C2979982 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0007103 (UMLS CUI [2])
metabolic disturbance | Glucose measurement | Triglycerides measurement
Item
untreated metabolic disturbances (glucose > 11.0 mmol/l and triglycerides > 400 mg/dl)
boolean
C0746556 (UMLS CUI [1])
C0337438 (UMLS CUI [2])
C0202236 (UMLS CUI [3])
Therapeutic procedure Pharmaceutical Preparations | Inhibitors Cytochrome P-450 CYP3A4 Inducers
Item
current treatment with drugs known to be moderate or strong inhibitors of inducers of isoenzyme cyp3a4
boolean
C0087111 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0243077 (UMLS CUI [2,1])
C3850041 (UMLS CUI [2,2])
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