ID

38105

Descrição

A Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Patients With Locally Recurrent or Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01740336

Link

https://clinicaltrials.gov/show/NCT01740336

Palavras-chave

Versões (1)
  1. 17/09/2019 17/09/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

17 de setembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01740336

Inglês

Eligibility Breast Cancer NCT01740336

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
female adult patients
Descrição

Gender | Adult

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001675
histologically or cytologically confirmed adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease
Descrição

Breast adenocarcinoma | Recurrent disease Locally Measurable | Neoplasm Metastasis Measurable | Recurrent disease Locally | Neoplasm Metastasis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0858252
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C1517927
UMLS CUI [2,3]
C1513040
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C1513040
UMLS CUI [4,1]
C0277556
UMLS CUI [4,2]
C1517927
UMLS CUI [5]
C0027627
human epidermal growth factor receptor 2 (her2)-negative and hr (estrogen receptor and/or progesterone receptor)-positive disease as defined by local guidelines
Descrição

Disease HER2 Negative | Disease Hormone Receptor Positive | Disease Estrogen receptor positive | Disease Progesterone receptor positive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348908
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0019929
UMLS CUI [2,3]
C1514241
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0279754
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0279759
eastern cooperative oncology group (ecog) performance status 0 or 1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematologic and end organ function
Descrição

Hematologic function | Organ function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0678852
women of childbearing potential must agree to remain abstinent or to use two adequate methods of contraception, including at least one method with a failure rate of < 1% per year, during the treatment period and for at least 30 days after the last dose of study treatment or 6 months after discontinuation of paclitaxel, whichever is longer
Descrição

Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0036899
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1265611
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior non-capecitabine chemotherapy for locally recurrent or metastatic disease
Descrição

Prior Chemotherapy Recurrent disease Locally | Prior Chemotherapy Neoplasm Metastasis | Exception Capecitabine

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0277556
UMLS CUI [1,3]
C1517927
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0027627
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0671970
prior treatment with a pi3k inhibitor for advanced or metastatic breast cancer
Descrição

Prior Therapy Advanced breast cancer | Prior Therapy Secondary malignant neoplasm of female breast | PI3K Inhibitor

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C3495917
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0346993
UMLS CUI [3]
C1519050
history of intolerance to a taxane-containing therapy
Descrição

Intolerance to Therapy Containing Taxane

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0332256
UMLS CUI [1,4]
C0215136
history of clinically significant cardiac or pulmonary dysfunction
Descrição

Cardiac dysfunction | Pulmonary Dysfunction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3277906
UMLS CUI [2]
C1709770
history of malabsorption syndrome or other condition that would interfere with enteral absorption
Descrição

Malabsorption Syndrome | Condition Interferes with Absorption Enteral

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C1304890
clinically significant history of liver disease
Descrição

Liver disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023895
active autoimmune disease or active inflammatory disease
Descrição

Autoimmune Disease | Inflammatory disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C1290884
immunocompromised status
Descrição

Immunocompromised patient

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085393
need for current chronic corticosteroid therapy
Descrição

Patient need for Steroid therapy chronic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0149783
UMLS CUI [1,3]
C0205191
pregnancy, lactation, or breastfeeding
Descrição

Pregnancy | Lactation | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0022925
UMLS CUI [3]
C0006147
current severe, uncontrolled systemic disease
Descrição

Systemic disease Severe Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205318
known untreated or active central nervous system (cns) metastases
Descrição

CNS metastases Untreated | CNS metastases

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0686377
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Similar models

Eligibility Breast Cancer NCT01740336

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Adult
Item
female adult patients
boolean
C0079399 (UMLS CUI [1])
C0001675 (UMLS CUI [2])
Breast adenocarcinoma | Recurrent disease Locally Measurable | Neoplasm Metastasis Measurable | Recurrent disease Locally | Neoplasm Metastasis
Item
histologically or cytologically confirmed adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease
boolean
C0858252 (UMLS CUI [1])
C0277556 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
C1513040 (UMLS CUI [2,3])
C0027627 (UMLS CUI [3,1])
C1513040 (UMLS CUI [3,2])
C0277556 (UMLS CUI [4,1])
C1517927 (UMLS CUI [4,2])
C0027627 (UMLS CUI [5])
Disease HER2 Negative | Disease Hormone Receptor Positive | Disease Estrogen receptor positive | Disease Progesterone receptor positive
Item
human epidermal growth factor receptor 2 (her2)-negative and hr (estrogen receptor and/or progesterone receptor)-positive disease as defined by local guidelines
boolean
C0012634 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0019929 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0279754 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C0279759 (UMLS CUI [4,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Organ function
Item
adequate hematologic and end organ function
boolean
C0221130 (UMLS CUI [1])
C0678852 (UMLS CUI [2])
Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods Quantity
Item
women of childbearing potential must agree to remain abstinent or to use two adequate methods of contraception, including at least one method with a failure rate of < 1% per year, during the treatment period and for at least 30 days after the last dose of study treatment or 6 months after discontinuation of paclitaxel, whichever is longer
boolean
C3831118 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Recurrent disease Locally | Prior Chemotherapy Neoplasm Metastasis | Exception Capecitabine
Item
prior non-capecitabine chemotherapy for locally recurrent or metastatic disease
boolean
C1514457 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C1514457 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0671970 (UMLS CUI [3,2])
Prior Therapy Advanced breast cancer | Prior Therapy Secondary malignant neoplasm of female breast | PI3K Inhibitor
Item
prior treatment with a pi3k inhibitor for advanced or metastatic breast cancer
boolean
C1514463 (UMLS CUI [1,1])
C3495917 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
C1519050 (UMLS CUI [3])
Intolerance to Therapy Containing Taxane
Item
history of intolerance to a taxane-containing therapy
boolean
C1744706 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
C0215136 (UMLS CUI [1,4])
Cardiac dysfunction | Pulmonary Dysfunction
Item
history of clinically significant cardiac or pulmonary dysfunction
boolean
C3277906 (UMLS CUI [1])
C1709770 (UMLS CUI [2])
Malabsorption Syndrome | Condition Interferes with Absorption Enteral
Item
history of malabsorption syndrome or other condition that would interfere with enteral absorption
boolean
C0024523 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C1304890 (UMLS CUI [2,4])
Liver disease
Item
clinically significant history of liver disease
boolean
C0023895 (UMLS CUI [1])
Autoimmune Disease | Inflammatory disorder
Item
active autoimmune disease or active inflammatory disease
boolean
C0004364 (UMLS CUI [1])
C1290884 (UMLS CUI [2])
Immunocompromised patient
Item
immunocompromised status
boolean
C0085393 (UMLS CUI [1])
Patient need for Steroid therapy chronic
Item
need for current chronic corticosteroid therapy
boolean
C0686904 (UMLS CUI [1,1])
C0149783 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
Pregnancy | Lactation | Breast Feeding
Item
pregnancy, lactation, or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0022925 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Systemic disease Severe Uncontrolled
Item
current severe, uncontrolled systemic disease
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
CNS metastases Untreated | CNS metastases
Item
known untreated or active central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2])
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