ID

19601

Description

Preoperative Bevacizumab and Trastuzumab With ABI-007 and Carboplatin in HER2+ Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00392392

Link

https://clinicaltrials.gov/show/NCT00392392

Keywords

Versions (1)
  1. 1/14/17 1/14/17 -
Uploaded on

January 14, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00392392

English

Eligibility Breast Cancer NCT00392392

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients with histologically confirmed adenocarcinoma of the breast or inflammatory breast cancer
Description

Gender | Breast adenocarcinoma | Inflammatory Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0858252
UMLS CUI [3]
C0278601
clinical stage t 1-4, n 0-3, m0
Description

TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3258246
fish+ her2 gene amplified breast cancer
Description

Fluorescent in Situ Hybridization Positive | Breast Carcinoma HER2 gene amplification

Data type

boolean

Alias
UMLS CUI [1,1]
C0162789
UMLS CUI [1,2]
C1514241
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C1512127
18 years or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
normal cardiac function
Description

Cardiac function

Data type

boolean

Alias
UMLS CUI [1]
C0232164
performance status 0-2
Description

performance status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
cannot have received any prior chemotherapy for this disease or cannot have received chemotherapy for any other cancer in the past 5 years.
Description

Chemotherapy Disease | Chemotherapy Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0012634
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0006826
previous diagnosis of noninvasive breast cancer is ok.
Description

Breast Carcinoma Non-invasive

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205303
must have adequate bone marrow, renal and liver function.
Description

Bone Marrow function | Renal function | Liver function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
pregnant or lactating females not allowed.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
preexisting peripheral neuropathy must be equal to or less than grade 1
Description

Peripheral Neuropathy Pre-existing CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
must have archived tumor tissue for tissue testing.
Description

Tumor tissue sample Available Tissue analysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C3161513
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
you cannot be in this study if you any of the following:
Description

Study Subject Participation Status Exclusion

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C2828389
history of cardiac disease, with new york heart association class ii or greater with congestive heart failure
Description

Heart Diseases | Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1275491
any heart attack, stroke or tias within the last 6 months or serious arrhythmias needing medication; no bleeding diathesis or coagulopathy.
Description

Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack | Cardiac Arrhythmia Serious Requirement Pharmaceutical Preparations | Bleeding tendency | Blood Coagulation Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C1514873
UMLS CUI [4,4]
C0013227
UMLS CUI [5]
C1458140
UMLS CUI [6]
C0005779
no prior investigational drug within the last 30 days
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
no prior trastuzumab or bevacizumab therapy
Description

trastuzumab | bevacizumab

Data type

boolean

Alias
UMLS CUI [1]
C0728747
UMLS CUI [2]
C0796392
there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons.
Description

Clinical Trial Eligibility Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Breast Cancer NCT00392392

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast adenocarcinoma | Inflammatory Breast Carcinoma
Item
female patients with histologically confirmed adenocarcinoma of the breast or inflammatory breast cancer
boolean
C0079399 (UMLS CUI [1])
C0858252 (UMLS CUI [2])
C0278601 (UMLS CUI [3])
TNM clinical staging
Item
clinical stage t 1-4, n 0-3, m0
boolean
C3258246 (UMLS CUI [1])
Fluorescent in Situ Hybridization Positive | Breast Carcinoma HER2 gene amplification
Item
fish+ her2 gene amplified breast cancer
boolean
C0162789 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C1512127 (UMLS CUI [2,2])
Age
Item
18 years or older
boolean
C0001779 (UMLS CUI [1])
Cardiac function
Item
normal cardiac function
boolean
C0232164 (UMLS CUI [1])
performance status
Item
performance status 0-2
boolean
C1518965 (UMLS CUI [1])
Chemotherapy Disease | Chemotherapy Malignant Neoplasms
Item
cannot have received any prior chemotherapy for this disease or cannot have received chemotherapy for any other cancer in the past 5 years.
boolean
C0392920 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
Breast Carcinoma Non-invasive
Item
previous diagnosis of noninvasive breast cancer is ok.
boolean
C0678222 (UMLS CUI [1,1])
C0205303 (UMLS CUI [1,2])
Bone Marrow function | Renal function | Liver function
Item
must have adequate bone marrow, renal and liver function.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or lactating females not allowed.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Peripheral Neuropathy Pre-existing CTCAE Grades
Item
preexisting peripheral neuropathy must be equal to or less than grade 1
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Tumor tissue sample Available Tissue analysis
Item
must have archived tumor tissue for tissue testing.
boolean
C0475358 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C3161513 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status Exclusion
Item
you cannot be in this study if you any of the following:
boolean
C2348568 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Heart Diseases | Congestive heart failure New York Heart Association Classification
Item
history of cardiac disease, with new york heart association class ii or greater with congestive heart failure
boolean
C0018799 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack | Cardiac Arrhythmia Serious Requirement Pharmaceutical Preparations | Bleeding tendency | Blood Coagulation Disorders
Item
any heart attack, stroke or tias within the last 6 months or serious arrhythmias needing medication; no bleeding diathesis or coagulopathy.
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0003811 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C1514873 (UMLS CUI [4,3])
C0013227 (UMLS CUI [4,4])
C1458140 (UMLS CUI [5])
C0005779 (UMLS CUI [6])
Investigational New Drugs
Item
no prior investigational drug within the last 30 days
boolean
C0013230 (UMLS CUI [1])
trastuzumab | bevacizumab
Item
no prior trastuzumab or bevacizumab therapy
boolean
C0728747 (UMLS CUI [1])
C0796392 (UMLS CUI [2])
Clinical Trial Eligibility Criteria Additional
Item
there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons.
boolean
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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