ID

13389

Description

Neoadjuvant Herceptin in Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00133796

Link

https://clinicaltrials.gov/show/NCT00133796

Keywords

Versions (1)
  1. 2/10/16 2/10/16 -
Uploaded on

February 10, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00133796

English

Eligibility Breast Cancer NCT00133796

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
All patients must be female.
Description

gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
Informed consent must be signed.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Women with locally advanced breast cancers or primary breast cancers with concomitant gross metastatic disease are eligible. locally advanced cancers must be of clinical and/or radiologic size > 4 cm, and/or are deemed surgically inoperable.
Description

locally advanced breast cancers

Data type

boolean

Alias
UMLS CUI [1,1]
C0677984
UMLS CUI [1,2]
C0006141
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0006141
UMLS CUI [2,3]
C0205225
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0027627
Her2/neu overexpressing tumors defined as herceptest score of 3+, or >/= one-third of invasive tumor showing membranous staining, or fluorescence in situ hybridization (fish) positive.
Description

Her2neu overexpressing tumors

Data type

boolean

Alias
UMLS CUI [1]
C1960398
Negative serum pregnancy test (bhcg) within 7 days of starting study, if of child-bearing potential.
Description

pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0430060
kidney and liver function tests - all within 1.5 times of the institution's upper limit of normal.
Description

kidney and liver function tests

Data type

boolean

Alias
UMLS CUI [1]
C0232805
UMLS CUI [2]
C0232741
Performance status (world health organization [who] scale) < 2 and life expectancy > 6 months.
Description

performance status and life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0023671
Age > 18.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
No metastatic disease without concomitant primary breast cancer.
Description

primary breast cancer and metastatic disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C0205225
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0027627
No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
Description

other malignancies

Data type

boolean

Alias
UMLS CUI [1]
C0006826
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
Description

pregnancy and contraceptive use

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C1999124
Severe underlying chronic illness or disease.
Description

severe comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
Cardiomyopathy or baseline left ventricular ejection fraction (lvef) < 50%.
Description

cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1]
C0878544
UMLS CUI [2]
C0428772
Patients on other investigational drugs while on study.
Description

participation in another trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Severe or uncontrolled hypertension defined as blood pressure (bp) > 180/100 on three separate occasions.
Description

hypertension

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0005823
History of congestive heart failure.
Description

history of CHF

Data type

boolean

Alias
UMLS CUI [1]
C0018802
History of coronary arterial disease.
Description

history of CAD

Data type

boolean

Alias
UMLS CUI [1]
C1956346
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Similar models

Eligibility Breast Cancer NCT00133796

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
gender
Item
All patients must be female.
boolean
C0079399 (UMLS CUI [1])
informed consent
Item
Informed consent must be signed.
boolean
C0021430 (UMLS CUI [1])
locally advanced breast cancers
Item
Women with locally advanced breast cancers or primary breast cancers with concomitant gross metastatic disease are eligible. locally advanced cancers must be of clinical and/or radiologic size > 4 cm, and/or are deemed surgically inoperable.
boolean
C0677984 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2,1])
C0006141 (UMLS CUI [2,2])
C0205225 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
Her2neu overexpressing tumors
Item
Her2/neu overexpressing tumors defined as herceptest score of 3+, or >/= one-third of invasive tumor showing membranous staining, or fluorescence in situ hybridization (fish) positive.
boolean
C1960398 (UMLS CUI [1])
pregnancy test
Item
Negative serum pregnancy test (bhcg) within 7 days of starting study, if of child-bearing potential.
boolean
C0430060 (UMLS CUI [1])
kidney and liver function tests
Item
kidney and liver function tests - all within 1.5 times of the institution's upper limit of normal.
boolean
C0232805 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
performance status and life expectancy
Item
Performance status (world health organization [who] scale) < 2 and life expectancy > 6 months.
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
age
Item
Age > 18.
boolean
C0001779 (UMLS CUI [1])
primary breast cancer and metastatic disease
Item
No metastatic disease without concomitant primary breast cancer.
boolean
C0006826 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
other malignancies
Item
No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnancy and contraceptive use
Item
Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C1999124 (UMLS CUI [3])
severe comorbidity
Item
Severe underlying chronic illness or disease.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
cardiomyopathy
Item
Cardiomyopathy or baseline left ventricular ejection fraction (lvef) < 50%.
boolean
C0878544 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
participation in another trial
Item
Patients on other investigational drugs while on study.
boolean
C2348568 (UMLS CUI [1])
hypertension
Item
Severe or uncontrolled hypertension defined as blood pressure (bp) > 180/100 on three separate occasions.
boolean
C0020538 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2])
C0005823 (UMLS CUI [3])
history of CHF
Item
History of congestive heart failure.
boolean
C0018802 (UMLS CUI [1])
history of CAD
Item
History of coronary arterial disease.
boolean
C1956346 (UMLS CUI [1])
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