ID

30257

Descrição

Phase I Study of Ixabepilone Plus Lapatinib With or Without Capecitabine in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00634088

Link

https://clinicaltrials.gov/show/NCT00634088

Palavras-chave

Versões (1)
  1. 25/05/2018 25/05/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

25 de maio de 2018

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Locally Advanced or Metastatic Breast Cancer NCT00634088

Inglês

Eligibility Locally Advanced or Metastatic Breast Cancer NCT00634088

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
females aged 18 years or older with histologic or cytologic diagnosis of adenocarcinoma originating in the breast
Descrição

Gender | Age | Breast adenocarcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0858252
radiologic or pathologic evidence that the cancer is metastatic or locally advanced (a t4 tumor and stage iiib/iiic disease) and not curable by local measures, such as radiation or surgery
Descrição

Neoplasm Metastasis TNM clinical staging | Locally Advanced Malignant Neoplasm TNM clinical staging | Incurable disease | Therapeutic radiology procedure Unsuccessful | Operative Surgical Procedures Unsuccessful

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0677984
UMLS CUI [2,2]
C3258246
UMLS CUI [3]
C0175969
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C1272705
UMLS CUI [5,1]
C0543467
UMLS CUI [5,2]
C1272705
positive status for human epidermal growth factor receptor 2
Descrição

HER2/Neu Positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348909
measurable disease as per response evaluation criteria in solid tumors guidelines
Descrição

Measurable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513041
karnofsky performance status of 70 to 100
Descrição

Karnofsky Performance Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0206065
life expectancy of at least 3 months
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior radiation must not have included 30% or more of major bone-marrow containing areas, such as the pelvis and lumbar spine
Descrição

Irradiation of pelvis Bone Marrow Percentage | Prior radiation therapy Lumbar spine Bone Marrow Percentage

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0747411
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0024091
UMLS CUI [2,3]
C0005953
UMLS CUI [2,4]
C0439165
common terminology criteria grade 2 or greater neuropathy
Descrição

Neuropathy CTCAE Grades

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
inadequate hematologic, hepatic, or renal function
Descrição

Hematologic function | Liver function | Renal function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
known prior severe hypersensitivity reactions to agents containing cremophor® el or known hypersensitivity or prior intolerance to fluoropyrimidine
Descrição

Severe allergy Cremophor EL Pharmaceutical Preparations | Hypersensitivity Fluoropyrimidine | Intolerance to Fluoropyrimidine

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0056476
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0596581
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0596581
known or suspected dihydropyrimidine dehydrogenase deficiency
Descrição

Dihydropyrimidine Dehydrogenase Deficiency | Dihydropyrimidine Dehydrogenase Deficiency Suspected

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1959620
UMLS CUI [2,1]
C1959620
UMLS CUI [2,2]
C0750491
more than 3 prior chemotherapy regimens in the metastatic setting
Descrição

Chemotherapy Regimen Quantity Neoplasm Metastasis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
prior treatment with an epothilone or lapatinib; prior treatment with capecitabine within the past 6 months
Descrição

Epothilone | lapatinib | capecitabine

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1136012
UMLS CUI [2]
C1506770
UMLS CUI [3]
C0671970
Voltar ao início da página

Similar models

Eligibility Locally Advanced or Metastatic Breast Cancer NCT00634088

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Breast adenocarcinoma
Item
females aged 18 years or older with histologic or cytologic diagnosis of adenocarcinoma originating in the breast
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0858252 (UMLS CUI [3])
Neoplasm Metastasis TNM clinical staging | Locally Advanced Malignant Neoplasm TNM clinical staging | Incurable disease | Therapeutic radiology procedure Unsuccessful | Operative Surgical Procedures Unsuccessful
Item
radiologic or pathologic evidence that the cancer is metastatic or locally advanced (a t4 tumor and stage iiib/iiic disease) and not curable by local measures, such as radiation or surgery
boolean
C0027627 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0677984 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0175969 (UMLS CUI [3])
C1522449 (UMLS CUI [4,1])
C1272705 (UMLS CUI [4,2])
C0543467 (UMLS CUI [5,1])
C1272705 (UMLS CUI [5,2])
HER2/Neu Positive
Item
positive status for human epidermal growth factor receptor 2
boolean
C2348909 (UMLS CUI [1])
Measurable Disease
Item
measurable disease as per response evaluation criteria in solid tumors guidelines
boolean
C1513041 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky performance status of 70 to 100
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Irradiation of pelvis Bone Marrow Percentage | Prior radiation therapy Lumbar spine Bone Marrow Percentage
Item
prior radiation must not have included 30% or more of major bone-marrow containing areas, such as the pelvis and lumbar spine
boolean
C0747411 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0279134 (UMLS CUI [2,1])
C0024091 (UMLS CUI [2,2])
C0005953 (UMLS CUI [2,3])
C0439165 (UMLS CUI [2,4])
Neuropathy CTCAE Grades
Item
common terminology criteria grade 2 or greater neuropathy
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Hematologic function | Liver function | Renal function
Item
inadequate hematologic, hepatic, or renal function
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Severe allergy Cremophor EL Pharmaceutical Preparations | Hypersensitivity Fluoropyrimidine | Intolerance to Fluoropyrimidine
Item
known prior severe hypersensitivity reactions to agents containing cremophor® el or known hypersensitivity or prior intolerance to fluoropyrimidine
boolean
C2945656 (UMLS CUI [1,1])
C0056476 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0596581 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0596581 (UMLS CUI [3,2])
Dihydropyrimidine Dehydrogenase Deficiency | Dihydropyrimidine Dehydrogenase Deficiency Suspected
Item
known or suspected dihydropyrimidine dehydrogenase deficiency
boolean
C1959620 (UMLS CUI [1])
C1959620 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Chemotherapy Regimen Quantity Neoplasm Metastasis
Item
more than 3 prior chemotherapy regimens in the metastatic setting
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Epothilone | lapatinib | capecitabine
Item
prior treatment with an epothilone or lapatinib; prior treatment with capecitabine within the past 6 months
boolean
C1136012 (UMLS CUI [1])
C1506770 (UMLS CUI [2])
C0671970 (UMLS CUI [3])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial