ID

26567

Beschrijving

ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00752986

Link

https://clinicaltrials.gov/show/NCT00752986

Trefwoorden

Versies (1)
  1. 19-10-17 19-10-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

19 oktober 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00752986

Engels

Eligibility Breast Cancer NCT00752986

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
post menopausal women with locally advanced or metastatic breast cancer
Beschrijving

Postmenopausal state | Locally advanced breast cancer | Secondary malignant neoplasm of female breast

Datatype

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C3495949
UMLS CUI [3]
C0346993
patients may have either measurable or non-measurable disease, as defined by recist criteria
Beschrijving

Measurable Disease | Non-Measurable Lesion

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1334988
one previous hormone therapy or one previous chemotherapy for advanced disease are allowed (patients who have stable but evident disease after chemotherapy are eligible)
Beschrijving

Hormone Therapy Quantity Advanced disease | Chemotherapy Quantity Advanced disease | Stable Disease Post Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0679246
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0679246
UMLS CUI [3,1]
C0677946
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C0392920
estrogen receptor positive er+ and/or progesterone receptor positive pr+ on primary or secondary tumour
Beschrijving

Primary tumor Estrogen receptor positive | Primary tumor Progesterone receptor positive | Secondary Neoplasm Estrogen receptor positive | Secondary Neoplasm Progesterone receptor positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0279754
UMLS CUI [2,1]
C0677930
UMLS CUI [2,2]
C0279759
UMLS CUI [3,1]
C2939419
UMLS CUI [3,2]
C0279754
UMLS CUI [4,1]
C2939419
UMLS CUI [4,2]
C0279759
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
hormone receptor negative tumours (er and pr negative)
Beschrijving

Hormone receptor negative tumor | Estrogen receptor negative neoplasm | Progesterone receptor negative neoplasm

Datatype

boolean

Alias
UMLS CUI [1]
C4272834
UMLS CUI [2]
C2584629
UMLS CUI [3]
C2584628
presence of life-threatening metastatic visceral disease
Beschrijving

Neoplasm Metastasis Visceral Life Threatening

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0442045
UMLS CUI [1,3]
C2826244
significant cardiovascular event (e.g. myocardial infarction, superior vena cava [svc] syndrome, new york heart association [nyha] classification of heart disease ³2) within 3 months before entry, or presence of cardiac disease that in the opinion of
Beschrijving

Cardiovascular event | Myocardial Infarction | Superior Vena Cava Syndrome | Heart Disease New York Heart Association Classification | Heart Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C1320716
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0038833
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C1275491
UMLS CUI [5]
C0018799
history of arrhythmia or qtc with bazett's correction unmeasurable or ≥ 480 msec on screening ecg
Beschrijving

Cardiac Arrhythmia | QTc interval Bazett formula Non-Measurable | QTc interval Bazett formula Electrocardiography

Datatype

boolean

Alias
UMLS CUI [1]
C0003811
UMLS CUI [2,1]
C4036473
UMLS CUI [2,2]
C1518373
UMLS CUI [3,1]
C4036473
UMLS CUI [3,2]
C1623258
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Similar models

Eligibility Breast Cancer NCT00752986

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state | Locally advanced breast cancer | Secondary malignant neoplasm of female breast
Item
post menopausal women with locally advanced or metastatic breast cancer
boolean
C0232970 (UMLS CUI [1])
C3495949 (UMLS CUI [2])
C0346993 (UMLS CUI [3])
Measurable Disease | Non-Measurable Lesion
Item
patients may have either measurable or non-measurable disease, as defined by recist criteria
boolean
C1513041 (UMLS CUI [1])
C1334988 (UMLS CUI [2])
Hormone Therapy Quantity Advanced disease | Chemotherapy Quantity Advanced disease | Stable Disease Post Chemotherapy
Item
one previous hormone therapy or one previous chemotherapy for advanced disease are allowed (patients who have stable but evident disease after chemotherapy are eligible)
boolean
C0279025 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0679246 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0679246 (UMLS CUI [2,3])
C0677946 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0392920 (UMLS CUI [3,3])
Primary tumor Estrogen receptor positive | Primary tumor Progesterone receptor positive | Secondary Neoplasm Estrogen receptor positive | Secondary Neoplasm Progesterone receptor positive
Item
estrogen receptor positive er+ and/or progesterone receptor positive pr+ on primary or secondary tumour
boolean
C0677930 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0677930 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
C2939419 (UMLS CUI [3,1])
C0279754 (UMLS CUI [3,2])
C2939419 (UMLS CUI [4,1])
C0279759 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Hormone receptor negative tumor | Estrogen receptor negative neoplasm | Progesterone receptor negative neoplasm
Item
hormone receptor negative tumours (er and pr negative)
boolean
C4272834 (UMLS CUI [1])
C2584629 (UMLS CUI [2])
C2584628 (UMLS CUI [3])
Neoplasm Metastasis Visceral Life Threatening
Item
presence of life-threatening metastatic visceral disease
boolean
C0027627 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
C2826244 (UMLS CUI [1,3])
Cardiovascular event | Myocardial Infarction | Superior Vena Cava Syndrome | Heart Disease New York Heart Association Classification | Heart Diseases
Item
significant cardiovascular event (e.g. myocardial infarction, superior vena cava [svc] syndrome, new york heart association [nyha] classification of heart disease ³2) within 3 months before entry, or presence of cardiac disease that in the opinion of
boolean
C1320716 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0038833 (UMLS CUI [3])
C0018799 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C0018799 (UMLS CUI [5])
Cardiac Arrhythmia | QTc interval Bazett formula Non-Measurable | QTc interval Bazett formula Electrocardiography
Item
history of arrhythmia or qtc with bazett's correction unmeasurable or ≥ 480 msec on screening ecg
boolean
C0003811 (UMLS CUI [1])
C4036473 (UMLS CUI [2,1])
C1518373 (UMLS CUI [2,2])
C4036473 (UMLS CUI [3,1])
C1623258 (UMLS CUI [3,2])
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