ID

19583

Description

A Study of Avastin (Bevacizumab) in Women With HER2 Negative Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00333775

Lien

https://clinicaltrials.gov/show/NCT00333775

Mots-clés

Versions (1)
  1. 12/01/2017 12/01/2017 -
Téléchargé le

12 janvier 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00333775

Anglais

Eligibility Breast Cancer NCT00333775

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients >= 18 years of age;
Description

Gender | Age

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
her2 negative cancer of the breast with locally recurrent or metastatic disease, suitable for chemotherapy;
Description

Human epidermal growth factor 2 negative carcinoma of breast | Recurrent disease Locally | Neoplasm Metastasis Chemotherapy suitable

Type de données

boolean

Alias
UMLS CUI [1]
C2316304
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C1517927
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0392920
UMLS CUI [3,3]
C3900053
no adjuvant chemotherapy within 6 months before randomization, and no taxane-based chemotherapy within 12 months before randomization;
Description

Chemotherapy, Adjuvant | Chemotherapy Taxane Based

Type de données

boolean

Alias
UMLS CUI [1]
C0085533
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0215136
UMLS CUI [2,3]
C1705938
ecog performance status 0-1.
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous chemotherapy for metastatic or locally recurrent breast cancer;
Description

Chemotherapy Secondary malignant neoplasm of female breast | Chemotherapy Breast cancer recurrent Locally

Type de données

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0346993
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0278493
UMLS CUI [2,3]
C1517927
radiotherapy for treatment of metastatic disease;
Description

Therapeutic radiology procedure Neoplasm Metastasis

Type de données

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0027627
other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix;
Description

primary tumor | Basal cell carcinoma Limited Controlled | Squamous cell carcinoma of skin Limited Controlled | Carcinoma in situ of uterine cervix

Type de données

boolean

Alias
UMLS CUI [1]
C0677930
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C2587213
UMLS CUI [3,1]
C0553723
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C2587213
UMLS CUI [4]
C0851140
spinal cord compression or brain metastases;
Description

Compression of spinal cord | Metastatic malignant neoplasm to brain

Type de données

boolean

Alias
UMLS CUI [1]
C0037926
UMLS CUI [2]
C0220650
major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization;
Description

major surgery | open biopsy | Traumatic injury Significant

Type de données

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0184922
UMLS CUI [3,1]
C3263723
UMLS CUI [3,2]
C0750502
inadequate bone marrow, liver or renal function;
Description

Bone Marrow function | Liver function | Renal function

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
uncontrolled hypertension.
Description

Uncontrolled hypertension

Type de données

boolean

Alias
UMLS CUI [1]
C1868885
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Similar models

Eligibility Breast Cancer NCT00333775

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
female patients >= 18 years of age;
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Human epidermal growth factor 2 negative carcinoma of breast | Recurrent disease Locally | Neoplasm Metastasis Chemotherapy suitable
Item
her2 negative cancer of the breast with locally recurrent or metastatic disease, suitable for chemotherapy;
boolean
C2316304 (UMLS CUI [1])
C0277556 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C3900053 (UMLS CUI [3,3])
Chemotherapy, Adjuvant | Chemotherapy Taxane Based
Item
no adjuvant chemotherapy within 6 months before randomization, and no taxane-based chemotherapy within 12 months before randomization;
boolean
C0085533 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C0215136 (UMLS CUI [2,2])
C1705938 (UMLS CUI [2,3])
ECOG performance status
Item
ecog performance status 0-1.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Secondary malignant neoplasm of female breast | Chemotherapy Breast cancer recurrent Locally
Item
previous chemotherapy for metastatic or locally recurrent breast cancer;
boolean
C0392920 (UMLS CUI [1,1])
C0346993 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0278493 (UMLS CUI [2,2])
C1517927 (UMLS CUI [2,3])
Therapeutic radiology procedure Neoplasm Metastasis
Item
radiotherapy for treatment of metastatic disease;
boolean
C1522449 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
primary tumor | Basal cell carcinoma Limited Controlled | Squamous cell carcinoma of skin Limited Controlled | Carcinoma in situ of uterine cervix
Item
other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix;
boolean
C0677930 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C2587213 (UMLS CUI [2,3])
C0553723 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C2587213 (UMLS CUI [3,3])
C0851140 (UMLS CUI [4])
Compression of spinal cord | Metastatic malignant neoplasm to brain
Item
spinal cord compression or brain metastases;
boolean
C0037926 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
major surgery | open biopsy | Traumatic injury Significant
Item
major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization;
boolean
C0679637 (UMLS CUI [1])
C0184922 (UMLS CUI [2])
C3263723 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
Bone Marrow function | Liver function | Renal function
Item
inadequate bone marrow, liver or renal function;
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Uncontrolled hypertension
Item
uncontrolled hypertension.
boolean
C1868885 (UMLS CUI [1])
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