ID

43593

Beschrijving

Epirubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab in Treating Women With HER2-Positive Stage III or Stage IV Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00379015

Link

https://clinicaltrials.gov/show/NCT00379015

Trefwoorden

  1. 13-01-17 13-01-17 -
  2. 20-09-21 20-09-21 -
Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00379015

Eligibility Breast Cancer NCT00379015

Criteria
Beschrijving

Criteria

diagnosis of primary breast cancer
Beschrijving

Breast Carcinoma Primary

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205225
stage iiib, iiic, or iv disease
Beschrijving

Disease TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
no inflammatory disease
Beschrijving

Inflammatory disorder

Datatype

boolean

Alias
UMLS CUI [1]
C1290884
her2 over-expressing tumor as assessed by immunohistochemistry and/or fluorescent in situ hybridization
Beschrijving

Malignant Neoplasm ERBB2 Protein Overexpression Immunohistochemistry | Fluorescent in Situ Hybridization

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1515560
UMLS CUI [1,3]
C0021044
UMLS CUI [2]
C0162789
hormone receptor status known
Beschrijving

Hormone Receptor Status Known

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0205309
patient characteristics:
Beschrijving

Client Characteristics

Datatype

boolean

Alias
UMLS CUI [1]
C0815172
female
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
menopausal status not specified
Beschrijving

Menopausal Status Unspecified

Datatype

boolean

Alias
UMLS CUI [1,1]
C3829127
UMLS CUI [1,2]
C0205370
performance status 0-1
Beschrijving

performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1518965
wbc ≤ 10,000/mm³
Beschrijving

White Blood Cell Count procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
absolute neutrophil count ≥ 2,000/mm³
Beschrijving

Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
platelet count ≥ 100,000/mm³
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin ≥ 9.5 g/dl
Beschrijving

Hemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
sgot/sgpt ≤ 60 iu/l
Beschrijving

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
bilirubin ≤ 1.5 mg/dl
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
creatinine ≤ 1.5 mg/dl
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
lvef ≥ 55%
Beschrijving

Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
no signs of pneumonitis
Beschrijving

Pneumonitis signs

Datatype

boolean

Alias
UMLS CUI [1,1]
C3714636
UMLS CUI [1,2]
C0220912
prior concurrent therapy:
Beschrijving

Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0087111
no prior surgery except for biopsy
Beschrijving

Operative Surgical Procedure | Biopsy

Datatype

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C0005558
no prior or concurrent chemotherapy and/or hormonal therapy
Beschrijving

Chemotherapy | Hormone Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0279025
no prior or concurrent biological therapy
Beschrijving

Biological treatment

Datatype

boolean

Alias
UMLS CUI [1]
C1531518
no prior or concurrent radiotherapy except postoperative radiotherapy
Beschrijving

Therapeutic radiology procedure | Postoperative course of radiotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0436206

Similar models

Eligibility Breast Cancer NCT00379015

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Breast Carcinoma Primary
Item
diagnosis of primary breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Disease TNM clinical staging
Item
stage iiib, iiic, or iv disease
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Inflammatory disorder
Item
no inflammatory disease
boolean
C1290884 (UMLS CUI [1])
Malignant Neoplasm ERBB2 Protein Overexpression Immunohistochemistry | Fluorescent in Situ Hybridization
Item
her2 over-expressing tumor as assessed by immunohistochemistry and/or fluorescent in situ hybridization
boolean
C0006826 (UMLS CUI [1,1])
C1515560 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C0162789 (UMLS CUI [2])
Hormone Receptor Status Known
Item
hormone receptor status known
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0205309 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Menopausal Status Unspecified
Item
menopausal status not specified
boolean
C3829127 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
performance status
Item
performance status 0-1
boolean
C1518965 (UMLS CUI [1])
White Blood Cell Count procedure
Item
wbc ≤ 10,000/mm³
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count ≥ 2,000/mm³
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 100,000/mm³
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin ≥ 9.5 g/dl
boolean
C0518015 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
sgot/sgpt ≤ 60 iu/l
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Serum total bilirubin measurement
Item
bilirubin ≤ 1.5 mg/dl
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine ≤ 1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Left ventricular ejection fraction
Item
lvef ≥ 55%
boolean
C0428772 (UMLS CUI [1])
Pneumonitis signs
Item
no signs of pneumonitis
boolean
C3714636 (UMLS CUI [1,1])
C0220912 (UMLS CUI [1,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Operative Surgical Procedure | Biopsy
Item
no prior surgery except for biopsy
boolean
C0543467 (UMLS CUI [1])
C0005558 (UMLS CUI [2])
Chemotherapy | Hormone Therapy
Item
no prior or concurrent chemotherapy and/or hormonal therapy
boolean
C0392920 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
Biological treatment
Item
no prior or concurrent biological therapy
boolean
C1531518 (UMLS CUI [1])
Therapeutic radiology procedure | Postoperative course of radiotherapy
Item
no prior or concurrent radiotherapy except postoperative radiotherapy
boolean
C1522449 (UMLS CUI [1])
C0436206 (UMLS CUI [2])

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