ID

16292

Description

Neoadjuvant GW572016 to Treat Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00206427

Link

https://clinicaltrials.gov/show/NCT00206427

Keywords

Versions (1)
  1. 7/10/16 7/10/16 -
Uploaded on

July 10, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00206427

English

Eligibility Breast Cancer NCT00206427

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. all patients must be female.
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
2. signed informed consent.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
3. 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 >/- 5 cm, and/or are deemed surgically inoperable, with stage iiib, iiic, or iv disease.
Description

Locally advanced breast cancer | malignant neoplasm of breast TNM staging primary tumor | Metastatic Neoplasm Gross | Locally Advanced Malignant Neoplasm size | Locally Advanced Malignant Neoplasm Inoperable | TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2]
C2216708
UMLS CUI [3,1]
C2939420
UMLS CUI [3,2]
C0439806
UMLS CUI [4,1]
C0677984
UMLS CUI [4,2]
C0456389
UMLS CUI [5,1]
C0677984
UMLS CUI [5,2]
C0205187
UMLS CUI [6]
C3258246
4. her2 overexpressing tumors defined as herceptest score of 3+, or >/- 10% cells moderately or strongly her2 positive by other methods, or semi-quantitative score of >/- 5 (in dr. allred's laboratory) or gene amplified.
Description

HER2-positive carcinoma of breast | Score | HER2-positive carcinoma of breast Moderate | HER2-positive carcinoma of breast Strong | Allred score Semi-quantitative | Gene Amplification

Data type

boolean

Alias
UMLS CUI [1]
C1960398
UMLS CUI [2]
C0449820
UMLS CUI [3,1]
C1960398
UMLS CUI [3,2]
C0205081
UMLS CUI [4,1]
C1960398
UMLS CUI [4,2]
C0442821
UMLS CUI [5,1]
C2919519
UMLS CUI [5,2]
C0522525
UMLS CUI [6]
C0017256
5. negative serum pregnancy test (bhcg) within 7 days of starting study, if of child-bearing potential.
Description

Childbearing Potential Serum pregnancy test negative | Chorionic Gonadotropin, beta Subunit, Human

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2]
C0106132
6. kidney and liver function tests - all within 1.5 times the institution's upper limit of normal.
Description

Kidney Function Tests | Liver Function Tests

Data type

boolean

Alias
UMLS CUI [1]
C0022662
UMLS CUI [2]
C0023901
7. performance status (who scale) less than 2 and life expectancy greater than 6 months.
Description

WHO performance status scale | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C1298650
UMLS CUI [2]
C0023671
8. age greater than 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
9. no brain or leptomeningeal disease.
Description

Brain Diseases | Leptomeningeal disease

Data type

boolean

Alias
UMLS CUI [1]
C0006111
UMLS CUI [2]
C3160796
10. no previous or current malignancies at other sites within the last 5 years, with exception of adequately treated core-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
Description

Malignant Neoplasms Site | Therapeutic procedure Core biopsy Carcinoma in situ of uterine cervix | Therapeutic procedure Core biopsy Basal cell carcinoma | Therapeutic procedure Core biopsy Squamous cell carcinoma of skin

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1515974
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1318309
UMLS CUI [2,3]
C0851140
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1318309
UMLS CUI [3,3]
C0007117
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C1318309
UMLS CUI [4,3]
C0553723
Exclusion Criteria
Description

Exclusion Criteria

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

Pregnancy | Childbearing Potential Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
2. severe underlying chronic illness or disease.
Description

Chronic disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0205082
3. cardiomyopathy or baseline lvef <50%.
Description

Cardiomyopathies | Left ventricular ejection fraction

Data type

boolean

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

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
5. severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease.
Description

Hypertension, severe | Uncontrolled hypertension | Congestive heart failure | Coronary heart disease Severe

Data type

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0018802
UMLS CUI [4,1]
C0010068
UMLS CUI [4,2]
C0205082
6. malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. subjects with ulcerative colitis are also excluded.
Description

Malabsorption Syndrome | Disease Affecting gastrointestinal function | Gastrectomy | Small intestine excision | Ulcerative Colitis

Data type

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0516983
UMLS CUI [3]
C0017118
UMLS CUI [4]
C0192601
UMLS CUI [5]
C0009324
7. taking any gw572016-prohibited medication (see gw572016 prohibited medications list in protocol) within 7 days of first dose of study medications.
Description

GW572016 Illicit Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C1384663
UMLS CUI [1,2]
C0086190
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Similar models

Eligibility Breast Cancer NCT00206427

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
1. all patients must be female.
boolean
C0079399 (UMLS CUI [1])
Informed consent
Item
2. signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Locally advanced breast cancer | malignant neoplasm of breast TNM staging primary tumor | Metastatic Neoplasm Gross | Locally Advanced Malignant Neoplasm size | Locally Advanced Malignant Neoplasm Inoperable | TNM clinical staging
Item
3. 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 >/- 5 cm, and/or are deemed surgically inoperable, with stage iiib, iiic, or iv disease.
boolean
C3495949 (UMLS CUI [1])
C2216708 (UMLS CUI [2])
C2939420 (UMLS CUI [3,1])
C0439806 (UMLS CUI [3,2])
C0677984 (UMLS CUI [4,1])
C0456389 (UMLS CUI [4,2])
C0677984 (UMLS CUI [5,1])
C0205187 (UMLS CUI [5,2])
C3258246 (UMLS CUI [6])
HER2-positive carcinoma of breast | Score | HER2-positive carcinoma of breast Moderate | HER2-positive carcinoma of breast Strong | Allred score Semi-quantitative | Gene Amplification
Item
4. her2 overexpressing tumors defined as herceptest score of 3+, or >/- 10% cells moderately or strongly her2 positive by other methods, or semi-quantitative score of >/- 5 (in dr. allred's laboratory) or gene amplified.
boolean
C1960398 (UMLS CUI [1])
C0449820 (UMLS CUI [2])
C1960398 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C1960398 (UMLS CUI [4,1])
C0442821 (UMLS CUI [4,2])
C2919519 (UMLS CUI [5,1])
C0522525 (UMLS CUI [5,2])
C0017256 (UMLS CUI [6])
Childbearing Potential Serum pregnancy test negative | Chorionic Gonadotropin, beta Subunit, Human
Item
5. negative serum pregnancy test (bhcg) within 7 days of starting study, if of child-bearing potential.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0106132 (UMLS CUI [2])
Kidney Function Tests | Liver Function Tests
Item
6. kidney and liver function tests - all within 1.5 times the institution's upper limit of normal.
boolean
C0022662 (UMLS CUI [1])
C0023901 (UMLS CUI [2])
WHO performance status scale | Life Expectancy
Item
7. performance status (who scale) less than 2 and life expectancy greater than 6 months.
boolean
C1298650 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Age
Item
8. age greater than 18 years.
boolean
C0001779 (UMLS CUI [1])
Brain Diseases | Leptomeningeal disease
Item
9. no brain or leptomeningeal disease.
boolean
C0006111 (UMLS CUI [1])
C3160796 (UMLS CUI [2])
Malignant Neoplasms Site | Therapeutic procedure Core biopsy Carcinoma in situ of uterine cervix | Therapeutic procedure Core biopsy Basal cell carcinoma | Therapeutic procedure Core biopsy Squamous cell carcinoma of skin
Item
10. no previous or current malignancies at other sites within the last 5 years, with exception of adequately treated core-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1318309 (UMLS CUI [2,2])
C0851140 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C1318309 (UMLS CUI [3,2])
C0007117 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C1318309 (UMLS CUI [4,2])
C0553723 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Childbearing Potential Contraceptive methods Unwilling
Item
1. pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Chronic disease Severe
Item
2. severe underlying chronic illness or disease.
boolean
C0008679 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Cardiomyopathies | Left ventricular ejection fraction
Item
3. cardiomyopathy or baseline lvef <50%.
boolean
C0878544 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Investigational New Drugs
Item
4. other investigational drugs while on study.
boolean
C0013230 (UMLS CUI [1])
Hypertension, severe | Uncontrolled hypertension | Congestive heart failure | Coronary heart disease Severe
Item
5. severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease.
boolean
C4013784 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0010068 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Malabsorption Syndrome | Disease Affecting gastrointestinal function | Gastrectomy | Small intestine excision | Ulcerative Colitis
Item
6. malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. subjects with ulcerative colitis are also excluded.
boolean
C0024523 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0516983 (UMLS CUI [2,3])
C0017118 (UMLS CUI [3])
C0192601 (UMLS CUI [4])
C0009324 (UMLS CUI [5])
GW572016 Illicit Drugs
Item
7. taking any gw572016-prohibited medication (see gw572016 prohibited medications list in protocol) within 7 days of first dose of study medications.
boolean
C1384663 (UMLS CUI [1,1])
C0086190 (UMLS CUI [1,2])
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