ID

13871

Descrição

BEZ235 Trial in Patients With HER2-(Human Epidermal Growth Factor Receptor 2 Negative) /HR+ (Hormonal Receptor Positive) Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01288092

Link

https://clinicaltrials.gov/show/NCT01288092

Palavras-chave

Versões (2)
  1. 13/03/2016 13/03/2016 -
  2. 20/09/2021 20/09/2021 -
Transferido a

13 de março de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT01288092

Inglês

Eligibility Metastatic Breast Cancer NCT01288092

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
female ≥ 18 years
Descrição

female; age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0015780
UMLS CUI [2]
C0001779
ecog performance status ≤ 2
Descrição

ecog performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
histologically and/or cytologically confirmed diagnosis of breast cancer presenting with metastatic disease (hormone receptor positive and her2 negative)
Descrição

Neoplasm Metastasis breast cancer; Hormone receptor positive tumor; her2 negative breast cancer

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0006142
UMLS CUI [2]
C1563119
UMLS CUI [3]
C2316304
known pi3k activation status (defined by pik3ca (phosphoinositide-3-kinase, catalytic, alpha polypeptide) mutation and pten pten (phosphatase and tensin homolog) mutation/expression)
Descrição

phosphoinositide-3-kinase, catalytic alpha; mutation PTEN gene

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1310696
UMLS CUI [2,1]
C0026882
UMLS CUI [2,2]
C0694888
prior treatment with at least one prior line of endocrine therapy and at least two and no more than three prior lines of chemotherapy for metastatic breast cancer
Descrição

endocrine therapy; chemotherapy metastatic breast cancer

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0278488
objective and radiologically confirmed progression of disease after prior treatment and at least one measurable lesion as per recist
Descrição

Measurable Disease; Cancer Progression

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1947901
adequate bone marrow and organ function
Descrição

organ function; bone marrow function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0412480
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with pi3k and/or mtor inhibitors
Descrição

mtor inhibitors; phosphoinositide-3-kinase

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1515672
UMLS CUI [2]
C1310696
symptomatic central nervous system (cns) metastases
Descrição

cns metastase

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0686377
concurrent malignancy or malignancy in the last 5 years prior to start of study treatment
Descrição

malignancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug
Descrição

field radiotherapy; palliation radiation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3826993
UMLS CUI [2]
C0475092
active cardiac disease (e.g. left ventricular ejection fraction (lvef) < 50%, qtcf > 480 msec on screening ecgelectrocardiogram (ecg), unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias)
Descrição

left ventricular ejection fraction; qtcf; electrocardiogram; Angina, Unstable; Cardiac Arrhythmia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C1882513
UMLS CUI [3]
C0013798
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
inadequately controlled hypertension
Descrição

hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020538
impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of bez235
Descrição

gastrointestinal disease; absorption bez235

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2,1]
C2698776
UMLS CUI [2,2]
C2347425
treatment at start of study treatment with drugs with a known risk to induce torsades de pointes, moderate and strong inhibitors or inducers of isoenzyme cyp3a4, warfarin and coumadin analogues, lhrh agonists
Descrição

torsades de pointes; cyp3a4 inhibitor; warfarin; coumadin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0040479
UMLS CUI [2]
C3830624
UMLS CUI [3]
C0043031
UMLS CUI [4]
C0699129
history of photosensitivity reactions to other drugs
Descrição

drug photosensitivity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0263586
pregnant or nursing (lactating) woman
Descrição

pregnancy; lactating

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
other protocol-defined inclusion/exclusion criteria may apply
Descrição

exclusion criteria

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0680251
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Similar models

Eligibility Metastatic Breast Cancer NCT01288092

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
female; age
Item
female ≥ 18 years
boolean
C0015780 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
ecog performance status
Item
ecog performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Neoplasm Metastasis breast cancer; Hormone receptor positive tumor; her2 negative breast cancer
Item
histologically and/or cytologically confirmed diagnosis of breast cancer presenting with metastatic disease (hormone receptor positive and her2 negative)
boolean
C0027627 (UMLS CUI [1,1])
C0006142 (UMLS CUI [1,2])
C1563119 (UMLS CUI [2])
C2316304 (UMLS CUI [3])
phosphoinositide-3-kinase, catalytic alpha; mutation PTEN gene
Item
known pi3k activation status (defined by pik3ca (phosphoinositide-3-kinase, catalytic, alpha polypeptide) mutation and pten pten (phosphatase and tensin homolog) mutation/expression)
boolean
C1310696 (UMLS CUI [1])
C0026882 (UMLS CUI [2,1])
C0694888 (UMLS CUI [2,2])
endocrine therapy; chemotherapy metastatic breast cancer
Item
prior treatment with at least one prior line of endocrine therapy and at least two and no more than three prior lines of chemotherapy for metastatic breast cancer
boolean
C0279025 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C0278488 (UMLS CUI [2,2])
Measurable Disease; Cancer Progression
Item
objective and radiologically confirmed progression of disease after prior treatment and at least one measurable lesion as per recist
boolean
C1513041 (UMLS CUI [1])
C1947901 (UMLS CUI [2])
organ function; bone marrow function
Item
adequate bone marrow and organ function
boolean
C0678852 (UMLS CUI [1])
C0412480 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
mtor inhibitors; phosphoinositide-3-kinase
Item
previous treatment with pi3k and/or mtor inhibitors
boolean
C1515672 (UMLS CUI [1])
C1310696 (UMLS CUI [2])
cns metastase
Item
symptomatic central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1])
malignancy
Item
concurrent malignancy or malignancy in the last 5 years prior to start of study treatment
boolean
C0006826 (UMLS CUI [1])
field radiotherapy; palliation radiation
Item
wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug
boolean
C3826993 (UMLS CUI [1])
C0475092 (UMLS CUI [2])
left ventricular ejection fraction; qtcf; electrocardiogram; Angina, Unstable; Cardiac Arrhythmia
Item
active cardiac disease (e.g. left ventricular ejection fraction (lvef) < 50%, qtcf > 480 msec on screening ecgelectrocardiogram (ecg), unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias)
boolean
C0428772 (UMLS CUI [1])
C1882513 (UMLS CUI [2])
C0013798 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
hypertension
Item
inadequately controlled hypertension
boolean
C0020538 (UMLS CUI [1])
gastrointestinal disease; absorption bez235
Item
impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of bez235
boolean
C0017178 (UMLS CUI [1])
C2698776 (UMLS CUI [2,1])
C2347425 (UMLS CUI [2,2])
torsades de pointes; cyp3a4 inhibitor; warfarin; coumadin
Item
treatment at start of study treatment with drugs with a known risk to induce torsades de pointes, moderate and strong inhibitors or inducers of isoenzyme cyp3a4, warfarin and coumadin analogues, lhrh agonists
boolean
C0040479 (UMLS CUI [1])
C3830624 (UMLS CUI [2])
C0043031 (UMLS CUI [3])
C0699129 (UMLS CUI [4])
drug photosensitivity
Item
history of photosensitivity reactions to other drugs
boolean
C0263586 (UMLS CUI [1])
pregnancy; lactating
Item
pregnant or nursing (lactating) woman
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
exclusion criteria
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C0680251 (UMLS CUI [1])
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