ID

26061

Description

Lapatinib and Trastuzumab With or Without Endocrine Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00548184

Link

https://clinicaltrials.gov/show/NCT00548184

Keywords

Versions (1)
  1. 10/5/17 10/5/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 5, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00548184

English

Eligibility Breast Cancer NCT00548184

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
signed informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
locally advanced breast cancers or primary breast cancers are eligible. locally advanced cancers must be of clinical and/or radiologic size >3 cm, or >2 cm with clinical evidence of axillary nodal involvement. (if tumors are less than 3 cm, we will use radiologically measured tumor size to determine the minimal tumor size for eligibility and in assessing tumor size during follow-up).
Description

Locally advanced breast cancer Size | Breast Carcinoma Primary | Locally advanced breast cancer Size Axillary Lymph Node Involvement | Tumor size Measured Radiologic

Data type

boolean

Alias
UMLS CUI [1,1]
C3495949
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0205225
UMLS CUI [3,1]
C3495949
UMLS CUI [3,2]
C0456389
UMLS CUI [3,3]
C0741343
UMLS CUI [4,1]
C0475440
UMLS CUI [4,2]
C0444706
UMLS CUI [4,3]
C0205483
her2 overexpressing tumors defined as herceptest score of 3+, or > 10% cells moderately or strongly her2 positive by other methods, or allred semi-quantitative score of >5, or gene amplified.
Description

HER2-positive carcinoma of breast | HercepTest Score Positive | Cells Percentage HER2/Neu Positive Moderate | Cells Percentage HER2/Neu Positive Strong | Allred score Semi-quantitative | Gene Amplification

Data type

boolean

Alias
UMLS CUI [1]
C1960398
UMLS CUI [2,1]
C1512416
UMLS CUI [2,2]
C0449820
UMLS CUI [2,3]
C1514241
UMLS CUI [3,1]
C0007634
UMLS CUI [3,2]
C0439165
UMLS CUI [3,3]
C2348909
UMLS CUI [3,4]
C0205081
UMLS CUI [4,1]
C0007634
UMLS CUI [4,2]
C0439165
UMLS CUI [4,3]
C2348909
UMLS CUI [4,4]
C0442821
UMLS CUI [5,1]
C2919519
UMLS CUI [5,2]
C0522525
UMLS CUI [6]
C0017256
negative serum pregnancy test (hcg) within 7 days of starting study, if of child-bearing potential.
Description

Childbearing Potential Serum pregnancy test (B-HCG) Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430060
UMLS CUI [1,3]
C1513916
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
performance status (who scale) less than 2 and life expectancy more than 6 months.
Description

WHO performance status scale | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C1298650
UMLS CUI [2]
C0023671
age at least 18 years.
Description

Age

Data type

boolean

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

Brain Disease Absent | Disease Leptomeningeal Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0006111
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0521401
UMLS CUI [2,3]
C0332197
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

Exclusion Malignant Neoplasms Site Other | Exception Carcinoma in situ of uterine cervix Treated Conization | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C1515974
UMLS CUI [1,4]
C0205394
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [2,4]
C0195324
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
note: the presence of pathological involvement of axillary nodes will be assessed and agreed upon by two investigators.
Description

Axillary Lymph Node Involvement

Data type

boolean

Alias
UMLS CUI [1]
C0741343
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 | 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
severe underlying chronic illness or disease.
Description

Comorbidity chronic severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0205082
cardiomyopathy or baseline lvef less than 50%.
Description

Cardiomyopathy | Left ventricular ejection fraction

Data type

boolean

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

Investigational New Drugs

Data type

boolean

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

Hypertension, severe | Uncontrolled hypertension | Congestive heart failure | Coronary Artery Disease Severe

Data type

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0018802
UMLS CUI [4,1]
C1956346
UMLS CUI [4,2]
C0205082
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 | Stomach Excision | 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]
C1304699
UMLS CUI [4]
C0192601
UMLS CUI [5]
C0009324
taking any lapatinib-prohibited medication within 7 days of first dose of study medications. (see prohibited medications list in protocol.)
Description

Pharmaceutical Preparation Illicit | Relationship Lapatinib

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332266
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C1506770
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Similar models

Eligibility Breast Cancer NCT00548184

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
signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Locally advanced breast cancer Size | Breast Carcinoma Primary | Locally advanced breast cancer Size Axillary Lymph Node Involvement | Tumor size Measured Radiologic
Item
locally advanced breast cancers or primary breast cancers are eligible. locally advanced cancers must be of clinical and/or radiologic size >3 cm, or >2 cm with clinical evidence of axillary nodal involvement. (if tumors are less than 3 cm, we will use radiologically measured tumor size to determine the minimal tumor size for eligibility and in assessing tumor size during follow-up).
boolean
C3495949 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C3495949 (UMLS CUI [3,1])
C0456389 (UMLS CUI [3,2])
C0741343 (UMLS CUI [3,3])
C0475440 (UMLS CUI [4,1])
C0444706 (UMLS CUI [4,2])
C0205483 (UMLS CUI [4,3])
HER2-positive carcinoma of breast | HercepTest Score Positive | Cells Percentage HER2/Neu Positive Moderate | Cells Percentage HER2/Neu Positive Strong | Allred score Semi-quantitative | Gene Amplification
Item
her2 overexpressing tumors defined as herceptest score of 3+, or > 10% cells moderately or strongly her2 positive by other methods, or allred semi-quantitative score of >5, or gene amplified.
boolean
C1960398 (UMLS CUI [1])
C1512416 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C0007634 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C2348909 (UMLS CUI [3,3])
C0205081 (UMLS CUI [3,4])
C0007634 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
C2348909 (UMLS CUI [4,3])
C0442821 (UMLS CUI [4,4])
C2919519 (UMLS CUI [5,1])
C0522525 (UMLS CUI [5,2])
C0017256 (UMLS CUI [6])
Childbearing Potential Serum pregnancy test (B-HCG) Negative
Item
negative serum pregnancy test (hcg) within 7 days of starting study, if of child-bearing potential.
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Kidney Function Tests | Liver Function Tests
Item
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
performance status (who scale) less than 2 and life expectancy more than 6 months.
boolean
C1298650 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Age
Item
age at least 18 years.
boolean
C0001779 (UMLS CUI [1])
Brain Disease Absent | Disease Leptomeningeal Absent
Item
no brain or leptomeningeal disease.
boolean
C0006111 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0521401 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Exclusion Malignant Neoplasms Site Other | Exception Carcinoma in situ of uterine cervix Treated Conization | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
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
C2828389 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C0195324 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
Axillary Lymph Node Involvement
Item
note: the presence of pathological involvement of axillary nodes will be assessed and agreed upon by two investigators.
boolean
C0741343 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Childbearing Potential Contraceptive methods Unwilling
Item
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])
Comorbidity chronic severe
Item
severe underlying chronic illness or disease.
boolean
C0009488 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Cardiomyopathy | Left ventricular ejection fraction
Item
cardiomyopathy or baseline lvef less than 50%.
boolean
C0878544 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Investigational New Drugs
Item
other investigational drugs while on study.
boolean
C0013230 (UMLS CUI [1])
Hypertension, severe | Uncontrolled hypertension | Congestive heart failure | Coronary Artery Disease Severe
Item
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])
C1956346 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Malabsorption Syndrome | Disease Affecting Gastrointestinal function | Stomach Excision | Small intestine excision | Ulcerative Colitis
Item
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])
C1304699 (UMLS CUI [3])
C0192601 (UMLS CUI [4])
C0009324 (UMLS CUI [5])
Pharmaceutical Preparation Illicit | Relationship Lapatinib
Item
taking any lapatinib-prohibited medication within 7 days of first dose of study medications. (see prohibited medications list in protocol.)
boolean
C0013227 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
C0439849 (UMLS CUI [2,1])
C1506770 (UMLS CUI [2,2])
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