ID

16009

Description

Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00153907

Link

https://clinicaltrials.gov/show/NCT00153907

Keywords

  1. 5/2/16 5/2/16 -
  2. 6/26/16 6/26/16 -
Uploaded on

June 26, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Breast Cancer NCT00153907

Eligibility Breast Cancer NCT00153907

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed breast cancer with evidence of locally advanced or metastatic disease
Description

locally advanced breast cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0027627
female patients age 18 or older
Description

female and aged over 18

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0001779
no more than three prior chemotherapeutic regimens in the metastatic setting
Description

prior chemotherapeutic regimens

Data type

boolean

Alias
UMLS CUI [1]
C0392920
anc > 1,500/mm3
Description

neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelet count > 100,000/mm3
Description

platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0005821
sgot < 3 x uln
Description

GOT

Data type

boolean

Alias
UMLS CUI [1]
C0201899
bilirubin < 1.5 x uln
Description

bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
performance status of 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
at least 3 weeks since prior chemotherapy or 2 weeks since prior radiation, surgery or any anticancer investigational agent
Description

interval since prior anticancer treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C3541383
UMLS CUI [1,2]
C0920425
able to swallow and retain oral medications
Description

dysphagia

Data type

boolean

Alias
UMLS CUI [1]
C0500456
measurable disease
Description

measurable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior vinca alkaloids
Description

prior therapy with vinca-alkaloids

Data type

boolean

Alias
UMLS CUI [1,1]
C0042672
UMLS CUI [1,2]
C0392920
active gastrointestinal disease or disorder
Description

gastrointestinal disease

Data type

boolean

Alias
UMLS CUI [1]
C0017178
pregnant or lactating
Description

pregnant or lactating

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
serious co-morbid medical or psychological condition
Description

serious comorbidities

Data type

boolean

Alias
UMLS CUI [1]
C0009488
prior bone marrow or stem cell transplant
Description

prior bone marrow or stem cell transplant

Data type

boolean

Alias
UMLS CUI [1]
C1504389
prior documented severe sensitivity to 5-fu
Description

hypersensitivity to fluorouracil

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0016360

Similar models

Eligibility Breast Cancer NCT00153907

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
locally advanced breast cancer
Item
histologically confirmed breast cancer with evidence of locally advanced or metastatic disease
boolean
C0678222 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
female and aged over 18
Item
female patients age 18 or older
boolean
C0079399 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
prior chemotherapeutic regimens
Item
no more than three prior chemotherapeutic regimens in the metastatic setting
boolean
C0392920 (UMLS CUI [1])
neutrophil count
Item
anc > 1,500/mm3
boolean
C0948762 (UMLS CUI [1])
platelet count
Item
platelet count > 100,000/mm3
boolean
C0005821 (UMLS CUI [1])
GOT
Item
sgot < 3 x uln
boolean
C0201899 (UMLS CUI [1])
bilirubin
Item
bilirubin < 1.5 x uln
boolean
C1278039 (UMLS CUI [1])
ECOG performance status
Item
performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
interval since prior anticancer treatment
Item
at least 3 weeks since prior chemotherapy or 2 weeks since prior radiation, surgery or any anticancer investigational agent
boolean
C3541383 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
dysphagia
Item
able to swallow and retain oral medications
boolean
C0500456 (UMLS CUI [1])
measurable disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
prior therapy with vinca-alkaloids
Item
prior vinca alkaloids
boolean
C0042672 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
gastrointestinal disease
Item
active gastrointestinal disease or disorder
boolean
C0017178 (UMLS CUI [1])
pregnant or lactating
Item
pregnant or lactating
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
serious comorbidities
Item
serious co-morbid medical or psychological condition
boolean
C0009488 (UMLS CUI [1])
prior bone marrow or stem cell transplant
Item
prior bone marrow or stem cell transplant
boolean
C1504389 (UMLS CUI [1])
hypersensitivity to fluorouracil
Item
prior documented severe sensitivity to 5-fu
boolean
C0020517 (UMLS CUI [1,1])
C0016360 (UMLS CUI [1,2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial