ID

26061

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00548184

Trefwoorden

Versies (1)
  1. 05-10-17 05-10-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

5 oktober 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Breast Cancer NCT00548184

Engels

Eligibility Breast Cancer NCT00548184

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients must be female.
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
signed informed consent.
Beschrijving

Informed Consent

Datatype

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).
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Childbearing Potential Serum pregnancy test (B-HCG) Negative

Datatype

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.
Beschrijving

Kidney Function Tests | Liver Function Tests

Datatype

boolean

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

WHO performance status scale | Life Expectancy

Datatype

boolean

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

Age

Datatype

boolean

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

Brain Disease Absent | Disease Leptomeningeal Absent

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Axillary Lymph Node Involvement

Datatype

boolean

Alias
UMLS CUI [1]
C0741343
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Pregnancy | Childbearing Potential Contraceptive methods Unwilling

Datatype

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.
Beschrijving

Comorbidity chronic severe

Datatype

boolean

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

Cardiomyopathy | Left ventricular ejection fraction

Datatype

boolean

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

Investigational New Drugs

Datatype

boolean

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

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

Datatype

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
Beschrijving

Malabsorption Syndrome | Disease Affecting Gastrointestinal function | Stomach Excision | Small intestine excision | Ulcerative Colitis

Datatype

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.)
Beschrijving

Pharmaceutical Preparation Illicit | Relationship Lapatinib

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332266
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C1506770
Terug naar het begin van de pagina

Similar models

Eligibility Breast Cancer NCT00548184

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial