ID

14858

Beskrivning

Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score; ODM derived from: https://clinicaltrials.gov/show/NCT02476786

Länk

https://clinicaltrials.gov/show/NCT02476786

Nyckelord

Versioner (1)
  1. 2016-05-02 2016-05-02 -
Uppladdad den

2 maj 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02476786

Engelsk

Eligibility Breast Cancer NCT02476786

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed histologically or cytologically confirmed operable invasive breast cancer defined as ct1 or t2, n0-1, and m0.
Beskrivning

Invasive breast carcinoma Operable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205188
disease must be er+ (allred score ≥ 5) and her2-.
Beskrivning

Disease Estrogen receptor positive Human epidermal growth factor 2 negative carcinoma of breast | Allred score

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0279754
UMLS CUI [1,3]
C2316304
UMLS CUI [2]
C2919519
measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) by ultrasound or mammogram.
Beskrivning

Measurable Disease | Lesion | Ultrasonics (sound) | Mammography

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C0221198
UMLS CUI [3]
C1456803
UMLS CUI [4]
C0024671
75 years of age or older.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status ≤ 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
able to understand and willing to sign an irb approved written informed consent document (or that of legally authorized representative, if applicable).
Beskrivning

Comprehension Informed Consent Institutional Review Board Approval

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2346499
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior chemotherapy and/or hormone therapy for cancer.
Beskrivning

Prior Chemotherapy Malignant Neoplasms | Prior Hormone Therapy Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C1514460
UMLS CUI [2,2]
C0006826
a history of other malignancy ≤ 5 years previous which would preclude endocrine treatment of their cancer.
Beskrivning

Malignant Neoplasms | Hormone Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0279025
currently receiving any other investigational agents.
Beskrivning

Investigational New Drugs Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205394
a history of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents used in the study.
Beskrivning

Allergic Reaction Investigational New Drugs Compound (substance)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1706082
uncontrolled intercurrent illness as determined by their treating physician which would limit compliance with study requirements.
Beskrivning

Disease Uncontrolled | Compliance behavior Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0439801
known hiv-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with endocrine therapies. appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Beskrivning

HIV Seropositivity | Antiretroviral therapy | Pharmacokinetic interaction Hormone Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C1963724
UMLS CUI [3,1]
C1868980
UMLS CUI [3,2]
C0279025
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Similar models

Eligibility Breast Cancer NCT02476786

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Invasive breast carcinoma Operable
Item
newly diagnosed histologically or cytologically confirmed operable invasive breast cancer defined as ct1 or t2, n0-1, and m0.
boolean
C0853879 (UMLS CUI [1,1])
C0205188 (UMLS CUI [1,2])
Disease Estrogen receptor positive Human epidermal growth factor 2 negative carcinoma of breast | Allred score
Item
disease must be er+ (allred score ≥ 5) and her2-.
boolean
C0012634 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C2316304 (UMLS CUI [1,3])
C2919519 (UMLS CUI [2])
Measurable Disease | Lesion | Ultrasonics (sound) | Mammography
Item
measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) by ultrasound or mammogram.
boolean
C1513041 (UMLS CUI [1])
C0221198 (UMLS CUI [2])
C1456803 (UMLS CUI [3])
C0024671 (UMLS CUI [4])
Age
Item
75 years of age or older.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Comprehension Informed Consent Institutional Review Board Approval
Item
able to understand and willing to sign an irb approved written informed consent document (or that of legally authorized representative, if applicable).
boolean
C0162340 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2346499 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Malignant Neoplasms | Prior Hormone Therapy Malignant Neoplasms
Item
prior chemotherapy and/or hormone therapy for cancer.
boolean
C1514457 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C1514460 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
Malignant Neoplasms | Hormone Therapy
Item
a history of other malignancy ≤ 5 years previous which would preclude endocrine treatment of their cancer.
boolean
C0006826 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
Investigational New Drugs Other
Item
currently receiving any other investigational agents.
boolean
C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Allergic Reaction Investigational New Drugs Compound (substance)
Item
a history of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents used in the study.
boolean
C1527304 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1706082 (UMLS CUI [1,3])
Disease Uncontrolled | Compliance behavior Limited
Item
uncontrolled intercurrent illness as determined by their treating physician which would limit compliance with study requirements.
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
HIV Seropositivity | Antiretroviral therapy | Pharmacokinetic interaction Hormone Therapy
Item
known hiv-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with endocrine therapies. appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
boolean
C0019699 (UMLS CUI [1])
C1963724 (UMLS CUI [2])
C1868980 (UMLS CUI [3,1])
C0279025 (UMLS CUI [3,2])
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