ID

33349

Descrição

Combination Study of BMS-754807 and Herceptin® in Patients With Advanced or Metastatic Her-2-positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00788333

Link

https://clinicaltrials.gov/show/NCT00788333

Palavras-chave

  1. 06/12/2018 06/12/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

6 de dezembro de 2018

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00788333

Eligibility Breast Cancer NCT00788333

Criteria
Descrição

Criteria

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with locally advanced or metastatic her-2-positive breast cancer who have failed at least one trastuzumab containing regimen. prior treatment with other her-2-targeted agents (e.g. lapatinib, pertuzumab, trastuzumab dm-1 etc.) is allowed
Descrição

HER2-positive carcinoma of breast Advanced Locally | HER2-positive carcinoma of breast metastatic | Tuzumab Regimen Quantity failed | Pharmaceutical Preparations HER2 Targeted | lapatinib | pertuzumab | Trastuzumab-DM1

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2,1]
C1960398
UMLS CUI [2,2]
C1522484
UMLS CUI [3,1]
C0728747
UMLS CUI [3,2]
C0040808
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C0231175
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0069515
UMLS CUI [4,3]
C1521840
UMLS CUI [5]
C1506770
UMLS CUI [6]
C1328025
UMLS CUI [7]
C2935436
histologic or cytologic diagnosis of her-2-positive breast cancer
Descrição

HER2-positive carcinoma of breast

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1960398
ecog status 0 - 1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
symptomatic brain metastasis
Descrição

Metastatic malignant neoplasm to brain Symptomatic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
any condition requiring chronic use of steroids
Descrição

Condition Requirement Steroids chronic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0038317
UMLS CUI [1,4]
C0205191
any disorder with dysregulation of glucose homeostasis (history of type 1 or 2 diabetes mellitus or prediabetic symptoms
Descrição

Abnormal glucose homeostasis | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Symptoms Prediabetic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4023598
UMLS CUI [2]
C0011854
UMLS CUI [3]
C0011860
UMLS CUI [4,1]
C1457887
UMLS CUI [4,2]
C0362046
history of glucose intolerance
Descrição

Glucose intolerance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0271650
women of child-bearing potential unwilling or unable to use acceptable contraception methods
Descrição

Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Contraceptive methods Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1299582

Similar models

Eligibility Breast Cancer NCT00788333

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
HER2-positive carcinoma of breast Advanced Locally | HER2-positive carcinoma of breast metastatic | Tuzumab Regimen Quantity failed | Pharmaceutical Preparations HER2 Targeted | lapatinib | pertuzumab | Trastuzumab-DM1
Item
subjects with locally advanced or metastatic her-2-positive breast cancer who have failed at least one trastuzumab containing regimen. prior treatment with other her-2-targeted agents (e.g. lapatinib, pertuzumab, trastuzumab dm-1 etc.) is allowed
boolean
C1960398 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C1960398 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C0728747 (UMLS CUI [3,1])
C0040808 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0231175 (UMLS CUI [3,4])
C0013227 (UMLS CUI [4,1])
C0069515 (UMLS CUI [4,2])
C1521840 (UMLS CUI [4,3])
C1506770 (UMLS CUI [5])
C1328025 (UMLS CUI [6])
C2935436 (UMLS CUI [7])
HER2-positive carcinoma of breast
Item
histologic or cytologic diagnosis of her-2-positive breast cancer
boolean
C1960398 (UMLS CUI [1])
ECOG performance status
Item
ecog status 0 - 1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain Symptomatic
Item
symptomatic brain metastasis
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Condition Requirement Steroids chronic
Item
any condition requiring chronic use of steroids
boolean
C0348080 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0038317 (UMLS CUI [1,3])
C0205191 (UMLS CUI [1,4])
Abnormal glucose homeostasis | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Symptoms Prediabetic
Item
any disorder with dysregulation of glucose homeostasis (history of type 1 or 2 diabetes mellitus or prediabetic symptoms
boolean
C4023598 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
C1457887 (UMLS CUI [4,1])
C0362046 (UMLS CUI [4,2])
Glucose intolerance
Item
history of glucose intolerance
boolean
C0271650 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Contraceptive methods Unable
Item
women of child-bearing potential unwilling or unable to use acceptable contraception methods
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])

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