ID

37931

Description

Patterns of Care in Hormone-receptor Positive, Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01277926

Link

https://clinicaltrials.gov/show/NCT01277926

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 NCT01277926

English

Eligibility Breast Cancer NCT01277926

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological or cytological diagnosis of breast cancer
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
postmenopausal status at the time of enrolment, according to the following definitions:
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
history of bilateral oophorectomy at any age
Description

Bilateral oophorectomy | Age Any

Data type

boolean

Alias
UMLS CUI [1]
C0278321
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C1552551
proven hormonal menopause
Description

Menopause present

Data type

boolean

Alias
UMLS CUI [1]
C0567312
positive estrogen receptor (er) and/or progesterone receptor (pr) by immuno
Description

Estrogen receptor positive Immunohistochemistry | Progesterone receptor positive Immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1,1]
C0279754
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C0279759
UMLS CUI [2,2]
C0021044
failure of one previous endocrine therapy in the adjuvant or metastatic setting
Description

Hormone Therapy Quantity failed | Adjuvant therapy | Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0231175
UMLS CUI [2]
C0677850
UMLS CUI [3]
C0027627
use of no more than one previous chemotherapy regimen in the neoadjuvant or adjuvant setting
Description

Prior Chemotherapy Quantity | Neoadjuvant Therapy | Adjuvant therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0600558
UMLS CUI [3]
C0677850
indication to receive chemotherapy or endocrine therapy
Description

Indication Chemotherapy | Indication Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0392920
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0279025
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability to comply with the study protocol
Description

Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
use of more than one previous endocrine therapy, regardless of the setting; --
Description

Prior Hormone Therapy Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1514460
UMLS CUI [1,2]
C1265611
previous use of chemotherapy for metastatic disease
Description

Prior Chemotherapy Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0027627
use of neoadjuvant endocrine therapy as the only previous type of endocrine therapy
Description

Neoadjuvant Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C0279025
serious medical, surgical or psychiatric comorbidity that, upon investigator's discretion, should preclude participation in the study.
Description

Comorbidity Serious | Operative Surgical Procedure Serious | Serious mental illness | Study Subject Participation Status Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C3841614
UMLS CUI [4,1]
C2348568
UMLS CUI [4,2]
C0332196
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Similar models

Eligibility Breast Cancer NCT01277926

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma
Item
histological or cytological diagnosis of breast cancer
boolean
C0678222 (UMLS CUI [1])
Postmenopausal state
Item
postmenopausal status at the time of enrolment, according to the following definitions:
boolean
C0232970 (UMLS CUI [1])
Bilateral oophorectomy | Age Any
Item
history of bilateral oophorectomy at any age
boolean
C0278321 (UMLS CUI [1])
C0001779 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
Menopause present
Item
proven hormonal menopause
boolean
C0567312 (UMLS CUI [1])
Estrogen receptor positive Immunohistochemistry | Progesterone receptor positive Immunohistochemistry
Item
positive estrogen receptor (er) and/or progesterone receptor (pr) by immuno
boolean
C0279754 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0279759 (UMLS CUI [2,1])
C0021044 (UMLS CUI [2,2])
Hormone Therapy Quantity failed | Adjuvant therapy | Neoplasm Metastasis
Item
failure of one previous endocrine therapy in the adjuvant or metastatic setting
boolean
C0279025 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0677850 (UMLS CUI [2])
C0027627 (UMLS CUI [3])
Prior Chemotherapy Quantity | Neoadjuvant Therapy | Adjuvant therapy
Item
use of no more than one previous chemotherapy regimen in the neoadjuvant or adjuvant setting
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0600558 (UMLS CUI [2])
C0677850 (UMLS CUI [3])
Indication Chemotherapy | Indication Hormone Therapy
Item
indication to receive chemotherapy or endocrine therapy
boolean
C3146298 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Protocol Compliance Unable
Item
inability to comply with the study protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Prior Hormone Therapy Quantity
Item
use of more than one previous endocrine therapy, regardless of the setting; --
boolean
C1514460 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Prior Chemotherapy Neoplasm Metastasis
Item
previous use of chemotherapy for metastatic disease
boolean
C1514457 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Neoadjuvant Hormone Therapy
Item
use of neoadjuvant endocrine therapy as the only previous type of endocrine therapy
boolean
C0600558 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
Comorbidity Serious | Operative Surgical Procedure Serious | Serious mental illness | Study Subject Participation Status Excluded
Item
serious medical, surgical or psychiatric comorbidity that, upon investigator's discretion, should preclude participation in the study.
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C3841614 (UMLS CUI [3])
C2348568 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
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