ID

43618

Description

Trastuzumab in Treating Women With Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00896376

Link

https://clinicaltrials.gov/show/NCT00896376

Keywords

Versions (2)
  1. 1/18/17 1/18/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00896376

English

Eligibility Breast Cancer NCT00896376

1 forms  
Criteria
Description

Criteria

histologically confirmed breast cancer
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
metastatic disease, defined by the existence of a secondary tumor localization radiologically (i.e., by radiography, ct scan, mri scan, or ultrasound) or scintigraphically confrimed
Description

Neoplasm Metastasis | Secondary Neoplasm Localization Diagnostic radiologic examination | Radiography | CT scan | MRI Scan | Ultrasonography | Scintigraphy

Data type

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C2939419
UMLS CUI [2,2]
C0475264
UMLS CUI [2,3]
C0043299
UMLS CUI [3]
C0034571
UMLS CUI [4]
C0040405
UMLS CUI [5]
C0917711
UMLS CUI [6]
C0041618
UMLS CUI [7]
C0034606
evaluable disease
Description

Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1516986
beginning first-line metastatic treatment with trastuzumab (herceptin®) with or without chemotherapy
Description

First line treatment Neoplasm Metastasis | trastuzumab | Herceptin | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0027627
UMLS CUI [2]
C0728747
UMLS CUI [3]
C0338204
UMLS CUI [4]
C0392920
primary tumor must overexpress her2 (ihc 3+ or ihc 2+ and fish+ or fish+)
Description

primary tumor | ERBB2 Protein Overexpression Immunohistochemistry | Fluorescent in Situ Hybridization

Data type

boolean

Alias
UMLS CUI [1]
C0677930
UMLS CUI [2,1]
C1515560
UMLS CUI [2,2]
C0021044
UMLS CUI [3]
C0162789
hormone receptor status not specified
Description

Hormone Receptor Status Unspecified

Data type

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0205370
no brain metastasis
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
menopausal status not specified
Description

Menopausal Status Unspecified

Data type

boolean

Alias
UMLS CUI [1,1]
C3829127
UMLS CUI [1,2]
C0205370
life expectancy > 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
able to undergo cardiotoxicity evaluation every 4 months by measuring lvef via an isotopic method or ultrasound with systematic registration
Description

Cardiotoxicity Evaluation Frequency | Left ventricular ejection fraction Isotopic | Ultrasonography

Data type

boolean

Alias
UMLS CUI [1,1]
C0876994
UMLS CUI [1,2]
C1261322
UMLS CUI [1,3]
C0376249
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C4038403
UMLS CUI [3]
C0041618
no chronic uncontrolled disease
Description

Chronic disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0205318
no heart failure
Description

Heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018801
no respiratory failure or hypoxemia
Description

Respiratory Failure | Hypoxemia

Data type

boolean

Alias
UMLS CUI [1]
C1145670
UMLS CUI [2]
C0700292
no history of another primary cancer except for basal cell carcinoma of the skin
Description

Primary malignant neoplasm | Basal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C1306459
UMLS CUI [2]
C0007117
no severe uncontrolled infection
Description

Communicable Disease Uncontrolled Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0205082
no psychological incapacity
Description

Mental impairment

Data type

boolean

Alias
UMLS CUI [1]
C0683322
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Description

disease characteristic

Data type

boolean

Alias
UMLS CUI [1]
C0599878
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Similar models

Eligibility Breast Cancer NCT00896376

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Breast Carcinoma
Item
histologically confirmed breast cancer
boolean
C0678222 (UMLS CUI [1])
Neoplasm Metastasis | Secondary Neoplasm Localization Diagnostic radiologic examination | Radiography | CT scan | MRI Scan | Ultrasonography | Scintigraphy
Item
metastatic disease, defined by the existence of a secondary tumor localization radiologically (i.e., by radiography, ct scan, mri scan, or ultrasound) or scintigraphically confrimed
boolean
C0027627 (UMLS CUI [1])
C2939419 (UMLS CUI [2,1])
C0475264 (UMLS CUI [2,2])
C0043299 (UMLS CUI [2,3])
C0034571 (UMLS CUI [3])
C0040405 (UMLS CUI [4])
C0917711 (UMLS CUI [5])
C0041618 (UMLS CUI [6])
C0034606 (UMLS CUI [7])
Evaluable Disease
Item
evaluable disease
boolean
C1516986 (UMLS CUI [1])
First line treatment Neoplasm Metastasis | trastuzumab | Herceptin | Chemotherapy
Item
beginning first-line metastatic treatment with trastuzumab (herceptin®) with or without chemotherapy
boolean
C1708063 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0728747 (UMLS CUI [2])
C0338204 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
primary tumor | ERBB2 Protein Overexpression Immunohistochemistry | Fluorescent in Situ Hybridization
Item
primary tumor must overexpress her2 (ihc 3+ or ihc 2+ and fish+ or fish+)
boolean
C0677930 (UMLS CUI [1])
C1515560 (UMLS CUI [2,1])
C0021044 (UMLS CUI [2,2])
C0162789 (UMLS CUI [3])
Hormone Receptor Status Unspecified
Item
hormone receptor status not specified
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0205370 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain
Item
no brain metastasis
boolean
C0220650 (UMLS CUI [1])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Menopausal Status Unspecified
Item
menopausal status not specified
boolean
C3829127 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
Cardiotoxicity Evaluation Frequency | Left ventricular ejection fraction Isotopic | Ultrasonography
Item
able to undergo cardiotoxicity evaluation every 4 months by measuring lvef via an isotopic method or ultrasound with systematic registration
boolean
C0876994 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C0376249 (UMLS CUI [1,3])
C0428772 (UMLS CUI [2,1])
C4038403 (UMLS CUI [2,2])
C0041618 (UMLS CUI [3])
Chronic disease Uncontrolled
Item
no chronic uncontrolled disease
boolean
C0008679 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Heart failure
Item
no heart failure
boolean
C0018801 (UMLS CUI [1])
Respiratory Failure | Hypoxemia
Item
no respiratory failure or hypoxemia
boolean
C1145670 (UMLS CUI [1])
C0700292 (UMLS CUI [2])
Primary malignant neoplasm | Basal cell carcinoma
Item
no history of another primary cancer except for basal cell carcinoma of the skin
boolean
C1306459 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
Communicable Disease Uncontrolled Severe
Item
no severe uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Mental impairment
Item
no psychological incapacity
boolean
C0683322 (UMLS CUI [1])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
disease characteristic
Item
see disease characteristics
boolean
C0599878 (UMLS CUI [1])
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