ID

26601

Description

A Study of Circulating Endothelial Cell as Marker for Avastin (Bevacizumab) in Combination With Docetaxel Plus Xeloda (Capecitabine) as First Line Treatment for Patients With Locally Recurrent and Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00845910

Link

https://clinicaltrials.gov/show/NCT00845910

Keywords

  1. 10/21/17 10/21/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 21, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00845910

Eligibility Breast Cancer NCT00845910

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients, 18-65 years of age;
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
locally recurrent and metastatic breast cancer;
Description

Breast cancer recurrent Local | Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0278493
UMLS CUI [1,2]
C0205276
UMLS CUI [2]
C0346993
measurable or evaluable disease;
Description

Measurable Disease | Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
ecog performance status of 0-2;
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
lvef >=50% without clinical symptoms or signs of heart failure.
Description

Left ventricular ejection fraction | Sign or Symptom Absent Heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2,1]
C3540840
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0018801
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
unknown her2 status, or known her2-positive status;
Description

HER2/Neu Status Unknown | HER2/Neu Positive

Data type

boolean

Alias
UMLS CUI [1]
C2348910
UMLS CUI [2]
C2348909
prior chemotherapy for locally recurrent or metastatic disease;
Description

Chemotherapy Recurrent disease Local | Chemotherapy Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0277556
UMLS CUI [1,3]
C0205276
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0027627
prior adjuvant or neoadjuvant taxane therapy within 12 months prior to start of treatment;
Description

Taxane Adjuvant therapy | Taxane Neoadjuvant Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0215136
UMLS CUI [1,2]
C0677850
UMLS CUI [2,1]
C0215136
UMLS CUI [2,2]
C0600558
clinical or radiological evidence of cns metastases;
Description

CNS metastases Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0332120
clinically significant cardiovascular disease.
Description

Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222

Similar models

Eligibility Breast Cancer NCT00845910

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
female patients, 18-65 years of age;
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast cancer recurrent Local | Secondary malignant neoplasm of female breast
Item
locally recurrent and metastatic breast cancer;
boolean
C0278493 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0346993 (UMLS CUI [2])
Measurable Disease | Evaluable Disease
Item
measurable or evaluable disease;
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status of 0-2;
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction | Sign or Symptom Absent Heart failure
Item
lvef >=50% without clinical symptoms or signs of heart failure.
boolean
C0428772 (UMLS CUI [1])
C3540840 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0018801 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
HER2/Neu Status Unknown | HER2/Neu Positive
Item
unknown her2 status, or known her2-positive status;
boolean
C2348910 (UMLS CUI [1])
C2348909 (UMLS CUI [2])
Chemotherapy Recurrent disease Local | Chemotherapy Neoplasm Metastasis
Item
prior chemotherapy for locally recurrent or metastatic disease;
boolean
C0392920 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
Taxane Adjuvant therapy | Taxane Neoadjuvant Therapy
Item
prior adjuvant or neoadjuvant taxane therapy within 12 months prior to start of treatment;
boolean
C0215136 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C0215136 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
CNS metastases Evidence of
Item
clinical or radiological evidence of cns metastases;
boolean
C0686377 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Cardiovascular Disease
Item
clinically significant cardiovascular disease.
boolean
C0007222 (UMLS CUI [1])

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