ID

43777

Description

Study of ABI-007 and Taxol in Patients With Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00046527

Link

https://clinicaltrials.gov/show/NCT00046527

Keywords

  1. 5/1/16 5/1/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Neoplasms NCT00046527

Eligibility Breast Neoplasms NCT00046527

Criteria
Description

Criteria

female, non-pregnant, non-lactating, and, if of child-bearing potential, have a negative serum pregnancy test, and use approved contraception
Description

ID.1

Data type

boolean

Alias
UMLS CUI [1]
C0086287
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4]
C0015895
UMLS CUI [5]
C0700589
sixteen years of age or older
Description

ID.2

Data type

boolean

Alias
UMLS CUI [1]
C0001779
histologically or cytologically confirmed breast cancer (stage iii or iv) with evidence of inoperable local recurrence or metastasis, with measurable disease
Description

ID.3

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0019638
UMLS CUI [1,3]
C1300072
UMLS CUI [2]
C0205187
UMLS CUI [3]
C1513041
if patient has received taxane therapy as an adjuvant he/she has not relapsed within one year of completing adjuvant taxane
Description

ID.4

Data type

boolean

Alias
UMLS CUI [1,1]
C3541958
UMLS CUI [1,2]
C0277556
no other malignancy present within the past 5 years, except non-melanoma skin cancer, cervical intraepithelial neoplasia or in-situ cervical cancer
Description

ID.5

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
suitable candidate for paclitaxel therapy
Description

ID.6

Data type

boolean

Alias
UMLS CUI [1,1]
C0144576
UMLS CUI [1,2]
C0332149
hematology levels at baseline of: absolute neutrophil count of at least 1500 cells/mm3; platelet count of at least 100,000 cells/mm3; hemoglobin of at least 9 g/dl
Description

ID.7

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0005821
UMLS CUI [3]
C0019046
chemistry levels at baseline of: ast and alt of less than or equal to 2.5 x the upper limit of normal, if no evidence of liver metastasis; total bilirubin of less than or equal to 1.5 mg/dl; creatinine of less than or equal to 2 mg/dl; alkaline phosphatase of less than or equal to 5 x the upper limit of normal, unless there is bone metastasis but not liver metastasis
Description

ID.8

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201850
UMLS CUI [5]
C0201976
expected survival of at least 12 weeks
Description

ID.9

Data type

boolean

Alias
UMLS CUI [1]
C0023671
patient or his/her representative has signed an informed consent form
Description

ID.10

Data type

boolean

Alias
UMLS CUI [1]
C0021430

Similar models

Eligibility Breast Neoplasms NCT00046527

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
ID.1
Item
female, non-pregnant, non-lactating, and, if of child-bearing potential, have a negative serum pregnancy test, and use approved contraception
boolean
C0086287 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0015895 (UMLS CUI [4])
C0700589 (UMLS CUI [5])
ID.2
Item
sixteen years of age or older
boolean
C0001779 (UMLS CUI [1])
ID.3
Item
histologically or cytologically confirmed breast cancer (stage iii or iv) with evidence of inoperable local recurrence or metastasis, with measurable disease
boolean
C0678222 (UMLS CUI [1,1])
C0019638 (UMLS CUI [1,2])
C1300072 (UMLS CUI [1,3])
C0205187 (UMLS CUI [2])
C1513041 (UMLS CUI [3])
ID.4
Item
if patient has received taxane therapy as an adjuvant he/she has not relapsed within one year of completing adjuvant taxane
boolean
C3541958 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
ID.5
Item
no other malignancy present within the past 5 years, except non-melanoma skin cancer, cervical intraepithelial neoplasia or in-situ cervical cancer
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
ID.6
Item
suitable candidate for paclitaxel therapy
boolean
C0144576 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
ID.7
Item
hematology levels at baseline of: absolute neutrophil count of at least 1500 cells/mm3; platelet count of at least 100,000 cells/mm3; hemoglobin of at least 9 g/dl
boolean
C0948762 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
ID.8
Item
chemistry levels at baseline of: ast and alt of less than or equal to 2.5 x the upper limit of normal, if no evidence of liver metastasis; total bilirubin of less than or equal to 1.5 mg/dl; creatinine of less than or equal to 2 mg/dl; alkaline phosphatase of less than or equal to 5 x the upper limit of normal, unless there is bone metastasis but not liver metastasis
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
ID.9
Item
expected survival of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
ID.10
Item
patient or his/her representative has signed an informed consent form
boolean
C0021430 (UMLS CUI [1])

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