ID

26053

Descrição

A Study of Herceptin (Trastuzumab) in Combination With 2nd-Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.; ODM derived from: https://clinicaltrials.gov/show/NCT00444587

Link

https://clinicaltrials.gov/show/NCT00444587

Palavras-chave

  1. 05/10/2017 05/10/2017 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

5 de outubro de 2017

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00444587

Eligibility Breast Cancer NCT00444587

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
her2 overexpression (ihc 3+ and/or fish positive);
Descrição

HER2 Overexpression Immunohistochemistry Positive | HER2 Overexpression FISH Positive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0069515
UMLS CUI [1,2]
C1514559
UMLS CUI [1,3]
C0021044
UMLS CUI [1,4]
C1514241
UMLS CUI [2,1]
C0069515
UMLS CUI [2,2]
C1514559
UMLS CUI [2,3]
C0162789
UMLS CUI [2,4]
C1514241
disease progression during or after previous 1st line chemotherapy + herceptin;
Descrição

Disease Progression | First line Chemotherapy | Herceptin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C0392920
UMLS CUI [3]
C0338204
scheduled to receive 2nd line chemotherapy.
Descrição

Second line Chemotherapy Scheduled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1710038
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0205539
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
concurrent immunotherapy or hormonal therapy;
Descrição

Immunotherapy | Hormone Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021083
UMLS CUI [2]
C0279025
anthracyclines as part of previous 1st line chemotherapy or planned 2nd line chemotherapy;
Descrição

Anthracyclines | Part First line Chemotherapy | Second line Chemotherapy Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0282564
UMLS CUI [2,1]
C0449719
UMLS CUI [2,2]
C1708063
UMLS CUI [2,3]
C0392920
UMLS CUI [3,1]
C1710038
UMLS CUI [3,2]
C0392920
UMLS CUI [3,3]
C1301732
cardiac toxicity during previous 1st line chemotherapy + herceptin;
Descrição

Cardiotoxicity | First line Chemotherapy | Herceptin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0876994
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C0392920
UMLS CUI [3]
C0338204
history of other malignancy within last 5 years.
Descrição

Malignant Neoplasms

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826

Similar models

Eligibility Breast Cancer NCT00444587

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])
HER2 Overexpression Immunohistochemistry Positive | HER2 Overexpression FISH Positive
Item
her2 overexpression (ihc 3+ and/or fish positive);
boolean
C0069515 (UMLS CUI [1,1])
C1514559 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C1514241 (UMLS CUI [1,4])
C0069515 (UMLS CUI [2,1])
C1514559 (UMLS CUI [2,2])
C0162789 (UMLS CUI [2,3])
C1514241 (UMLS CUI [2,4])
Disease Progression | First line Chemotherapy | Herceptin
Item
disease progression during or after previous 1st line chemotherapy + herceptin;
boolean
C0242656 (UMLS CUI [1])
C1708063 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0338204 (UMLS CUI [3])
Second line Chemotherapy Scheduled
Item
scheduled to receive 2nd line chemotherapy.
boolean
C1710038 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Immunotherapy | Hormone Therapy
Item
concurrent immunotherapy or hormonal therapy;
boolean
C0021083 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
Anthracyclines | Part First line Chemotherapy | Second line Chemotherapy Planned
Item
anthracyclines as part of previous 1st line chemotherapy or planned 2nd line chemotherapy;
boolean
C0282564 (UMLS CUI [1])
C0449719 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
C1710038 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C1301732 (UMLS CUI [3,3])
Cardiotoxicity | First line Chemotherapy | Herceptin
Item
cardiac toxicity during previous 1st line chemotherapy + herceptin;
boolean
C0876994 (UMLS CUI [1])
C1708063 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0338204 (UMLS CUI [3])
Malignant Neoplasms
Item
history of other malignancy within last 5 years.
boolean
C0006826 (UMLS CUI [1])

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