ID

30578

Description

Gemcitabine Plus Bevacizumab in Locally Recurrent or Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00623233

Link

https://clinicaltrials.gov/show/NCT00623233

Keywords

Versions (1)
  1. 6/16/18 6/16/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 16, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00623233

English

Eligibility Metastatic Breast Cancer NCT00623233

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
must be female and greater than or equal to 18 yrs of age
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
participants must have confirmed cancer with measurable or evaluable, locally recurrent or metastatic disease.
Description

Malignant Neoplasms | Measurable Disease | Evaluable Disease | Locally Recurrent Malignant Neoplasm | Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C1513041
UMLS CUI [3]
C1516986
UMLS CUI [4]
C2986682
UMLS CUI [5]
C0027627
participants must have received a taxane as neo-adjuvant and/or adjuvant therapy
Description

Taxane Neoadjuvant Therapy | Taxane Adjuvant therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0215136
UMLS CUI [1,2]
C0600558
UMLS CUI [2,1]
C0215136
UMLS CUI [2,2]
C0677850
participants may have received prior hormone therapy for locally recurrent or metastatic disease
Description

Hormone Therapy Locally Recurrent Malignant Neoplasm | Hormone Therapy Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C2986682
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0027627
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants with breast cancer overexpressing human epidermal growth factor receptor 2 (her2) gene amplification
Description

HER2 Overexpressing Breast Carcinoma HER2 gene amplification

Data type

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C1512127
prior chemotherapy or targeted therapy for metastatic breast cancer
Description

Chemotherapy Secondary malignant neoplasm of female breast | Targeted Therapy Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0346993
UMLS CUI [2,1]
C2985566
UMLS CUI [2,2]
C0346993
prior treatment with gemcitabine, trastuzumab, lapatinib or bevacizumab in any setting
Description

gemcitabine | trastuzumab | lapatinib | bevacizumab

Data type

boolean

Alias
UMLS CUI [1]
C0045093
UMLS CUI [2]
C0728747
UMLS CUI [3]
C1506770
UMLS CUI [4]
C0796392
history of, or active brain mets
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment, or anticipation of need for major surgical procedure during course of study
Description

Major surgery | Incisional biopsy | Traumatic injury | Patient need for Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0184922
UMLS CUI [3]
C3263723
UMLS CUI [4,1]
C0686904
UMLS CUI [4,2]
C0679637
prior history of high blood pressure crisis
Description

Hypertensive crisis

Data type

boolean

Alias
UMLS CUI [1]
C0020546
have a serious, nonhealing wound, ulcer, or bone fracture
Description

Non-healing Wound Serious | Ulcer Serious | Bone Fracture Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0750433
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0041582
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C0016658
UMLS CUI [3,2]
C0205404
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Similar models

Eligibility Metastatic Breast Cancer NCT00623233

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
must be female and greater than or equal to 18 yrs of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Malignant Neoplasms | Measurable Disease | Evaluable Disease | Locally Recurrent Malignant Neoplasm | Neoplasm Metastasis
Item
participants must have confirmed cancer with measurable or evaluable, locally recurrent or metastatic disease.
boolean
C0006826 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
C1516986 (UMLS CUI [3])
C2986682 (UMLS CUI [4])
C0027627 (UMLS CUI [5])
Taxane Neoadjuvant Therapy | Taxane Adjuvant therapy
Item
participants must have received a taxane as neo-adjuvant and/or adjuvant therapy
boolean
C0215136 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0215136 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
Hormone Therapy Locally Recurrent Malignant Neoplasm | Hormone Therapy Neoplasm Metastasis
Item
participants may have received prior hormone therapy for locally recurrent or metastatic disease
boolean
C0279025 (UMLS CUI [1,1])
C2986682 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
HER2 Overexpressing Breast Carcinoma HER2 gene amplification
Item
participants with breast cancer overexpressing human epidermal growth factor receptor 2 (her2) gene amplification
boolean
C1960398 (UMLS CUI [1,1])
C1512127 (UMLS CUI [1,2])
Chemotherapy Secondary malignant neoplasm of female breast | Targeted Therapy Secondary malignant neoplasm of female breast
Item
prior chemotherapy or targeted therapy for metastatic breast cancer
boolean
C0392920 (UMLS CUI [1,1])
C0346993 (UMLS CUI [1,2])
C2985566 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
gemcitabine | trastuzumab | lapatinib | bevacizumab
Item
prior treatment with gemcitabine, trastuzumab, lapatinib or bevacizumab in any setting
boolean
C0045093 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
C1506770 (UMLS CUI [3])
C0796392 (UMLS CUI [4])
Metastatic malignant neoplasm to brain
Item
history of, or active brain mets
boolean
C0220650 (UMLS CUI [1])
Major surgery | Incisional biopsy | Traumatic injury | Patient need for Major surgery
Item
major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment, or anticipation of need for major surgical procedure during course of study
boolean
C0679637 (UMLS CUI [1])
C0184922 (UMLS CUI [2])
C3263723 (UMLS CUI [3])
C0686904 (UMLS CUI [4,1])
C0679637 (UMLS CUI [4,2])
Hypertensive crisis
Item
prior history of high blood pressure crisis
boolean
C0020546 (UMLS CUI [1])
Non-healing Wound Serious | Ulcer Serious | Bone Fracture Serious
Item
have a serious, nonhealing wound, ulcer, or bone fracture
boolean
C0750433 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0041582 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0016658 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
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