ID

26017

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00437294

Trefwoorden

  1. 02-10-17 02-10-17 -
  2. 04-10-17 04-10-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

4 oktober 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00437294

Eligibility Breast Cancer NCT00437294

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Secondary malignant neoplasm of female breast | Breast cancer recurrent

Datatype

boolean

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

Anthracyclines | Taxane

Datatype

boolean

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

Chemotherapy Regimen Quantity

Datatype

boolean

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

Antineoplastic Hormonal Agents Discontinued

Datatype

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.
Beschrijving

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

Datatype

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
Beschrijving

Exclusion Criteria

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

Protocol Compliance Unable | Lacking Able to swallow Tablets

Datatype

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.
Beschrijving

Cancer treatment

Datatype

boolean

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

Investigational New Drugs

Datatype

boolean

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

Heart Disease

Datatype

boolean

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

Pregnancy | Breast Feeding

Datatype

boolean

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

Similar models

Eligibility Breast Cancer NCT00437294

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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