ID

37902

Descrição

A Study of Avastin (Bevacizumab) in Combination With Gemcitabine and Carboplatin as First Line Treatment in Patients With Triple Negative Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01201265

Link

https://clinicaltrials.gov/show/NCT01201265

Palavras-chave

Versões (1)
  1. 29/08/2019 29/08/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

29 de agosto de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01201265

Inglês

Eligibility Breast Cancer NCT01201265

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients, >/= 18 years of age
Descrição

Gender | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
metastatic breast cancer
Descrição

Secondary malignant neoplasm of female breast

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0346993
estrogen receptor- , progesterone- and her2-negative disease
Descrição

Disease Estrogen receptor negative Progesterone receptor negative HER2 Negative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0279756
UMLS CUI [1,3]
C0279766
UMLS CUI [1,4]
C2348908
treatment-naïve for metastatic breast cancer
Descrição

Therapy naive Secondary malignant neoplasm of female breast

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0346993
eastern cooperative oncology group (ecog) performance status 0-1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematological, renal and liver function
Descrição

Hematologic function | Renal function | Liver function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior first line treatment for metastatic breast cancer
Descrição

First line treatment Previous Secondary malignant neoplasm of female breast

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0346993
cns metastasis
Descrição

CNS metastases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0686377
uncontrolled hypertension (> 170/95 mmhg)
Descrição

Uncontrolled hypertension | Blood pressure determination

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0005824
evidence of bleeding diathesis, coagulopathy or hemorrhage at baseline
Descrição

Bleeding tendency | Blood Coagulation Disorder | Hemorrhage

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
UMLS CUI [3]
C0019080
history of other malignant disease within past 3 years, except for curatively treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
Descrição

Cancer Other | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0851140
prior therapy with gemcitabine or carboplatin in the metastatic setting. patients having received gemcitabine or carboplatin as part of adjuvant therapy are eligible, if recurrence was first documented >6 months after the last exposure to the drug(s)
Descrição

Prior Therapy | gemcitabine | Carboplatin | Neoplasm Metastasis | Adjuvant therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0045093
UMLS CUI [3]
C0079083
UMLS CUI [4]
C0027627
UMLS CUI [5]
C0677850
requirement of chronic use of immunosuppressive agents
Descrição

Requirement Immunosuppressive Agents chronic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0021081
UMLS CUI [1,3]
C0205191
hiv, hepatitis b or hepatitis c infection
Descrição

HIV Infection | Hepatitis B | Hepatitis C

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
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Similar models

Eligibility Breast Cancer NCT01201265

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
female patients, >/= 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Secondary malignant neoplasm of female breast
Item
metastatic breast cancer
boolean
C0346993 (UMLS CUI [1])
Disease Estrogen receptor negative Progesterone receptor negative HER2 Negative
Item
estrogen receptor- , progesterone- and her2-negative disease
boolean
C0012634 (UMLS CUI [1,1])
C0279756 (UMLS CUI [1,2])
C0279766 (UMLS CUI [1,3])
C2348908 (UMLS CUI [1,4])
Therapy naive Secondary malignant neoplasm of female breast
Item
treatment-naïve for metastatic breast cancer
boolean
C0919936 (UMLS CUI [1,1])
C0346993 (UMLS CUI [1,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Renal function | Liver function
Item
adequate hematological, renal and liver function
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
First line treatment Previous Secondary malignant neoplasm of female breast
Item
prior first line treatment for metastatic breast cancer
boolean
C1708063 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0346993 (UMLS CUI [1,3])
CNS metastases
Item
cns metastasis
boolean
C0686377 (UMLS CUI [1])
Uncontrolled hypertension | Blood pressure determination
Item
uncontrolled hypertension (> 170/95 mmhg)
boolean
C1868885 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
Bleeding tendency | Blood Coagulation Disorder | Hemorrhage
Item
evidence of bleeding diathesis, coagulopathy or hemorrhage at baseline
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
C0019080 (UMLS CUI [3])
Cancer Other | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix
Item
history of other malignant disease within past 3 years, except for curatively treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
Prior Therapy | gemcitabine | Carboplatin | Neoplasm Metastasis | Adjuvant therapy
Item
prior therapy with gemcitabine or carboplatin in the metastatic setting. patients having received gemcitabine or carboplatin as part of adjuvant therapy are eligible, if recurrence was first documented >6 months after the last exposure to the drug(s)
boolean
C1514463 (UMLS CUI [1])
C0045093 (UMLS CUI [2])
C0079083 (UMLS CUI [3])
C0027627 (UMLS CUI [4])
C0677850 (UMLS CUI [5])
Requirement Immunosuppressive Agents chronic
Item
requirement of chronic use of immunosuppressive agents
boolean
C1514873 (UMLS CUI [1,1])
C0021081 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
HIV Infection | Hepatitis B | Hepatitis C
Item
hiv, hepatitis b or hepatitis c infection
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
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