ID

37813

Beschreibung

Extension Study of Lapatinib Plus Herceptin With or Without Endocrine Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00999804

Link

https://clinicaltrials.gov/show/NCT00999804

Stichworte

Versionen (1)
  1. 25.08.19 25.08.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

25. August 2019

DOI

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Eligibility Breast Cancer NCT00999804

Englisch

Eligibility Breast Cancer NCT00999804

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. all patients must be female and at least 18 years of age.
Beschreibung

Gender | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. signed informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
3. locally advanced 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 the radiologically measured tumor size to determine if the tumor meets the minimal size requirements.)
Beschreibung

Locally advanced breast cancer | Locally Advanced Malignant Neoplasm Size | Axillary lymph nodes Involvement | Tumor size Radiology

Datentyp

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2,1]
C0677984
UMLS CUI [2,2]
C0456389
UMLS CUI [3,1]
C0729594
UMLS CUI [3,2]
C1314939
UMLS CUI [4,1]
C0475440
UMLS CUI [4,2]
C0043299
4. patients must have histologically confirmed invasive mammary carcinoma that is her2 overexpressing, defined as 3+ by immunohistochemistry, or a fish/cep ratio greater than 2.
Beschreibung

Invasive carcinoma of breast HER2 Protein Overexpression | Immunohistochemistry | Other Coding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C1515560
UMLS CUI [2]
C0021044
UMLS CUI [3]
C3846158
5. negative serum pregnancy test (hcg) within 7 days of starting study drug, if of child-bearing potential.
Beschreibung

Childbearing Potential Serum pregnancy test (B-HCG) Negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430060
UMLS CUI [1,3]
C1513916
6. kidney and liver function tests - all within 1.5 times the institutional upper limit of normal.
Beschreibung

Kidney Function Tests Quantity Times Upper Limit of Normal | Liver Function Tests Quantity Times Upper Limit of Normal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022662
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1632851
UMLS CUI [1,4]
C1519815
UMLS CUI [2,1]
C0023901
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1632851
UMLS CUI [2,4]
C1519815
7. performance status (who/ecog scale) 0-1 and life expectancy >6 months.
Beschreibung

WHO performance status scale | ECOG performance status | Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C1298650
UMLS CUI [2]
C1520224
UMLS CUI [3]
C0023671
8. no evidence of brain or leptomeningeal disease, or any other stage iv disease.
Beschreibung

Brain Disease Absent | Leptomeningeal disease Absent | Disease TNM clinical staging Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006111
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0751297
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C3258246
UMLS CUI [3,3]
C0332197
9. 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.
Beschreibung

Cancer Other Absent | Exception Carcinoma in situ of uterine cervix Treated Conization | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0332197
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 [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with bilateral breast cancer.
Beschreibung

Bilateral breast cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C0281267
2. pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
Beschreibung

Pregnancy | Childbearing Potential Contraceptive methods Unwilling

Datentyp

boolean

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

Chronic disease Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0205082
4. cardiomyopathy or baseline lvef less than 50%.
Beschreibung

Cardiomyopathy | Left ventricular ejection fraction

Datentyp

boolean

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

Investigational New Drugs

Datentyp

boolean

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

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

Datentyp

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0018802
UMLS CUI [4,1]
C1956346
UMLS CUI [4,2]
C0205082
7. malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. subjects with ulcerative colitis are also excluded
Beschreibung

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

Datentyp

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
8. taking any lapatinib prohibited medication(s)
Beschreibung

Lapatinib Illicit Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1506770
UMLS CUI [1,2]
C0086190
9. inability or unwillingness to comply with, or follow study procedures.
Beschreibung

Protocol Compliance Unable | Protocol Compliance Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
10. patients who have received any form of treatment for breast cancer within the past five years, including surgical resection, chemotherapy, endocrine therapy, or biologic therapy.
Beschreibung

Prior Therapy Breast Carcinoma | Excision | Chemotherapy | Hormone Therapy | Biological treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C0728940
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0279025
UMLS CUI [5]
C1531518
11. patients with a prior history of ipsilateral invasive breast cancer or carcinoma in situ who present with a new primary.
Beschreibung

Invasive carcinoma of breast Ipsilateral Previous | Carcinoma in Situ Ipsilateral Previous | Primary tumor New

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0441989
UMLS CUI [1,3]
C0205156
UMLS CUI [2,1]
C0007099
UMLS CUI [2,2]
C0441989
UMLS CUI [2,3]
C0205156
UMLS CUI [3,1]
C0677930
UMLS CUI [3,2]
C0205314
12. patients with known active, infectious hepatitis b, hepatitis c, or hiv.
Beschreibung

Hepatitis B | Hepatitis C | HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019693
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Ähnliche Modelle

Eligibility Breast Cancer NCT00999804

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
1. all patients must be female and at least 18 years of age.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed Consent
Item
2. signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Locally advanced breast cancer | Locally Advanced Malignant Neoplasm Size | Axillary lymph nodes Involvement | Tumor size Radiology
Item
3. locally advanced 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 the radiologically measured tumor size to determine if the tumor meets the minimal size requirements.)
boolean
C3495949 (UMLS CUI [1])
C0677984 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0729594 (UMLS CUI [3,1])
C1314939 (UMLS CUI [3,2])
C0475440 (UMLS CUI [4,1])
C0043299 (UMLS CUI [4,2])
Invasive carcinoma of breast HER2 Protein Overexpression | Immunohistochemistry | Other Coding
Item
4. patients must have histologically confirmed invasive mammary carcinoma that is her2 overexpressing, defined as 3+ by immunohistochemistry, or a fish/cep ratio greater than 2.
boolean
C0853879 (UMLS CUI [1,1])
C1515560 (UMLS CUI [1,2])
C0021044 (UMLS CUI [2])
C3846158 (UMLS CUI [3])
Childbearing Potential Serum pregnancy test (B-HCG) Negative
Item
5. negative serum pregnancy test (hcg) within 7 days of starting study drug, if of child-bearing potential.
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Kidney Function Tests Quantity Times Upper Limit of Normal | Liver Function Tests Quantity Times Upper Limit of Normal
Item
6. kidney and liver function tests - all within 1.5 times the institutional upper limit of normal.
boolean
C0022662 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1632851 (UMLS CUI [1,3])
C1519815 (UMLS CUI [1,4])
C0023901 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1632851 (UMLS CUI [2,3])
C1519815 (UMLS CUI [2,4])
WHO performance status scale | ECOG performance status | Life Expectancy
Item
7. performance status (who/ecog scale) 0-1 and life expectancy >6 months.
boolean
C1298650 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
C0023671 (UMLS CUI [3])
Brain Disease Absent | Leptomeningeal disease Absent | Disease TNM clinical staging Absent
Item
8. no evidence of brain or leptomeningeal disease, or any other stage iv disease.
boolean
C0006111 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0751297 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Cancer Other Absent | Exception Carcinoma in situ of uterine cervix Treated Conization | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
9. 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
C1707251 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
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])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Bilateral breast cancer
Item
1. patients with bilateral breast cancer.
boolean
C0281267 (UMLS CUI [1])
Pregnancy | Childbearing Potential Contraceptive methods Unwilling
Item
2. 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
3. severe underlying chronic illness or disease.
boolean
C0008679 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Cardiomyopathy | Left ventricular ejection fraction
Item
4. cardiomyopathy or baseline lvef less than 50%.
boolean
C0878544 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Investigational New Drugs
Item
5. other investigational drugs while on study.
boolean
C0013230 (UMLS CUI [1])
Hypertension, severe | Uncontrolled hypertension | Congestive heart failure | Coronary Artery Disease Severe
Item
6. 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 | Gastrectomy | Small intestine excision | Ulcerative Colitis
Item
7. 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])
Lapatinib Illicit Drugs
Item
8. taking any lapatinib prohibited medication(s)
boolean
C1506770 (UMLS CUI [1,1])
C0086190 (UMLS CUI [1,2])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
9. inability or unwillingness to comply with, or follow study procedures.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Prior Therapy Breast Carcinoma | Excision | Chemotherapy | Hormone Therapy | Biological treatment
Item
10. patients who have received any form of treatment for breast cancer within the past five years, including surgical resection, chemotherapy, endocrine therapy, or biologic therapy.
boolean
C1514463 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0728940 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
C1531518 (UMLS CUI [5])
Invasive carcinoma of breast Ipsilateral Previous | Carcinoma in Situ Ipsilateral Previous | Primary tumor New
Item
11. patients with a prior history of ipsilateral invasive breast cancer or carcinoma in situ who present with a new primary.
boolean
C0853879 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0007099 (UMLS CUI [2,1])
C0441989 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
C0677930 (UMLS CUI [3,1])
C0205314 (UMLS CUI [3,2])
Hepatitis B | Hepatitis C | HIV Infection
Item
12. patients with known active, infectious hepatitis b, hepatitis c, or hiv.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
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