ID

26017

Description

Enzastaurin in Combination of Capecitabine to Treat Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00437294

Link

https://clinicaltrials.gov/show/NCT00437294

Keywords

Versions (2)
  1. 10/2/17 10/2/17 -
  2. 10/4/17 10/4/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 4, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00437294

English

Eligibility Breast Cancer NCT00437294

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have been diagnosed with metastatic or recurrent breast cancer.
Description

Secondary malignant neoplasm of female breast | Breast cancer recurrent

Data type

boolean

Alias
UMLS CUI [1]
C0346993
UMLS CUI [2]
C0278493
have been previously treated with both an anthracycline and a taxane.
Description

Anthracyclines | Taxane

Data type

boolean

Alias
UMLS CUI [1]
C0282564
UMLS CUI [2]
C0215136
have not received more than two prior chemotherapy treatment programs.
Description

Chemotherapy Regimen Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
have stopped any antitumoral hormonal treatment before you enroll in this study.
Description

Antineoplastic Hormonal Agents Discontinued

Data type

boolean

Alias
UMLS CUI [1,1]
C0282559
UMLS CUI [1,2]
C1444662
have a negative pregnancy blood test if menstruating or capable of becoming pregnant. you must use an approved birth control method during the study and for 3 months after stopping study treatment.
Description

Menstruation Serum pregnancy test negative | Childbearing Potential Serum pregnancy test negative | Menstruation Contraceptive methods | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0025344
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430061
UMLS CUI [3,1]
C0025344
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
cannot follow the study procedures (for example, you can not swallow tablets)
Description

Protocol Compliance Unable | Lacking Able to swallow Tablets

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C2712086
UMLS CUI [2,3]
C0039225
are receiving another treatment for your cancer.
Description

Cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0920425
have received another experimental drug in the last 4 weeks.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
have had serious heart disease within last 6 months.
Description

Heart Disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
are pregnant or breast-feeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Breast Cancer NCT00437294

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Secondary malignant neoplasm of female breast | Breast cancer recurrent
Item
have been diagnosed with metastatic or recurrent breast cancer.
boolean
C0346993 (UMLS CUI [1])
C0278493 (UMLS CUI [2])
Anthracyclines | Taxane
Item
have been previously treated with both an anthracycline and a taxane.
boolean
C0282564 (UMLS CUI [1])
C0215136 (UMLS CUI [2])
Chemotherapy Regimen Quantity
Item
have not received more than two prior chemotherapy treatment programs.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Antineoplastic Hormonal Agents Discontinued
Item
have stopped any antitumoral hormonal treatment before you enroll in this study.
boolean
C0282559 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
Menstruation Serum pregnancy test negative | Childbearing Potential Serum pregnancy test negative | Menstruation Contraceptive methods | Childbearing Potential Contraceptive methods
Item
have a negative pregnancy blood test if menstruating or capable of becoming pregnant. you must use an approved birth control method during the study and for 3 months after stopping study treatment.
boolean
C0025344 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
C0025344 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Protocol Compliance Unable | Lacking Able to swallow Tablets
Item
cannot follow the study procedures (for example, you can not swallow tablets)
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0332268 (UMLS CUI [2,1])
C2712086 (UMLS CUI [2,2])
C0039225 (UMLS CUI [2,3])
Cancer treatment
Item
are receiving another treatment for your cancer.
boolean
C0920425 (UMLS CUI [1])
Investigational New Drugs
Item
have received another experimental drug in the last 4 weeks.
boolean
C0013230 (UMLS CUI [1])
Heart Disease
Item
have had serious heart disease within last 6 months.
boolean
C0018799 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
are pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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