ID

33896

Beskrivning

Retrospective Study Assessment Treatment Response Faslodex®( 500 mg); ODM derived from: https://clinicaltrials.gov/show/NCT01509625

Länk

https://clinicaltrials.gov/show/NCT01509625

Nyckelord

Versioner (1)
  1. 2019-01-06 2019-01-06 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

6 januari 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Malignant Neoplasm of Breast Stage IV NCT01509625

Engelsk

Eligibility Malignant Neoplasm of Breast Stage IV NCT01509625

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent from patients when possible.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
in the event of patients who are deceased at the time of inclusion, no signed informed consent will be available; thus, the investigator assumes the responsibility of data protection and confidentiality and of safeguarding the processing of the data.
Beskrivning

Patient Deceased | Informed Consent Unavailable | Data Protection | Confidential patient data held | Protection Data Processing

Datatyp

boolean

Alias
UMLS CUI [1]
C1555024
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0686905
UMLS CUI [3]
C0086099
UMLS CUI [4]
C0422743
UMLS CUI [5,1]
C1545588
UMLS CUI [5,2]
C0868941
post-menopausal women.
Beskrivning

Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
diagnosed with locally advanced or metastatic breast cancer with histological/cytological confirmation.
Beskrivning

Locally advanced breast cancer | Secondary malignant neoplasm of female breast

Datatyp

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2]
C0346993
documented estrogen receptor positive status for the primary tumour.
Beskrivning

Primary tumor Estrogen receptor positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0279754
patient who, after progression with a previous anti-estrogen treatment, received treatment at some time with fulvestrant (faslodex®) at the 500 mg/month and ld-500 dose during the study period.
Beskrivning

Prior antiestrogen therapy | Disease Progression | Fulvestrant Dose per month | Faslodex Dose per month | Fulvestrant Loading dose | Faslodex Loading dose

Datatyp

boolean

Alias
UMLS CUI [1]
C0279797
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C0935916
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0332177
UMLS CUI [4,1]
C0701491
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0332177
UMLS CUI [5,1]
C0935916
UMLS CUI [5,2]
C3714444
UMLS CUI [6,1]
C0701491
UMLS CUI [6,2]
C3714444
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
having received treatment with unapproved or experimental drugs during the study period.
Beskrivning

Drugs, Non-Prescription | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2]
C0013230
presenting another concomitant cancer other than stage i cervical cancer or cutaneous tumours without lymph node or distant involvement.
Beskrivning

Cancer Other | Exception Cervical cancer Stage | Exception Skin Neoplasms Without Lymph Node Involvement | Exception Skin Neoplasms Without Distant metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C4048328
UMLS CUI [2,3]
C1306673
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0037286
UMLS CUI [3,3]
C0332288
UMLS CUI [3,4]
C0806692
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0037286
UMLS CUI [4,3]
C0332288
UMLS CUI [4,4]
C1269798
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Similar models

Eligibility Malignant Neoplasm of Breast Stage IV NCT01509625

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed informed consent from patients when possible.
boolean
C0021430 (UMLS CUI [1])
Patient Deceased | Informed Consent Unavailable | Data Protection | Confidential patient data held | Protection Data Processing
Item
in the event of patients who are deceased at the time of inclusion, no signed informed consent will be available; thus, the investigator assumes the responsibility of data protection and confidentiality and of safeguarding the processing of the data.
boolean
C1555024 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0686905 (UMLS CUI [2,2])
C0086099 (UMLS CUI [3])
C0422743 (UMLS CUI [4])
C1545588 (UMLS CUI [5,1])
C0868941 (UMLS CUI [5,2])
Postmenopausal state
Item
post-menopausal women.
boolean
C0232970 (UMLS CUI [1])
Locally advanced breast cancer | Secondary malignant neoplasm of female breast
Item
diagnosed with locally advanced or metastatic breast cancer with histological/cytological confirmation.
boolean
C3495949 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
Primary tumor Estrogen receptor positive
Item
documented estrogen receptor positive status for the primary tumour.
boolean
C0677930 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
Prior antiestrogen therapy | Disease Progression | Fulvestrant Dose per month | Faslodex Dose per month | Fulvestrant Loading dose | Faslodex Loading dose
Item
patient who, after progression with a previous anti-estrogen treatment, received treatment at some time with fulvestrant (faslodex®) at the 500 mg/month and ld-500 dose during the study period.
boolean
C0279797 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
C0935916 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0332177 (UMLS CUI [3,3])
C0701491 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0332177 (UMLS CUI [4,3])
C0935916 (UMLS CUI [5,1])
C3714444 (UMLS CUI [5,2])
C0701491 (UMLS CUI [6,1])
C3714444 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Drugs, Non-Prescription | Investigational New Drugs
Item
having received treatment with unapproved or experimental drugs during the study period.
boolean
C0013231 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Cancer Other | Exception Cervical cancer Stage | Exception Skin Neoplasms Without Lymph Node Involvement | Exception Skin Neoplasms Without Distant metastasis
Item
presenting another concomitant cancer other than stage i cervical cancer or cutaneous tumours without lymph node or distant involvement.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C4048328 (UMLS CUI [2,2])
C1306673 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0037286 (UMLS CUI [3,2])
C0332288 (UMLS CUI [3,3])
C0806692 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0037286 (UMLS CUI [4,2])
C0332288 (UMLS CUI [4,3])
C1269798 (UMLS CUI [4,4])
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