ID

43777

Description

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

Lien

https://clinicaltrials.gov/show/NCT00046527

Mots-clés

  1. 01/05/2016 01/05/2016 -
  2. 20/09/2021 20/09/2021 -
Téléchargé le

20 septembre 2021

DOI

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Licence

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

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

ID.6

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

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

ID.10

Type de données

boolean

Alias
UMLS CUI [1]
C0021430

Similar models

Eligibility Breast Neoplasms NCT00046527

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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