ID

18327

Beschreibung

Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00075270

Link

https://clinicaltrials.gov/show/NCT00075270

Stichworte

Versionen (2)
  1. 31.10.16 31.10.16 -
  2. 31.10.16 31.10.16 -
Hochgeladen am

31. Oktober 2016

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Eligibility Neoplasms, Breast NCT00075270

Englisch

Eligibility Neoplasms, Breast NCT00075270

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
able to swallow an oral medication
Beschreibung

Able to swallow oral medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
cardiac ejection fraction within the institutional range of normal as measured by echocardiogram
Beschreibung

Cardiac ejection fraction | Echocardiography

Datentyp

boolean

Alias
UMLS CUI [1]
C0232174
UMLS CUI [2]
C0013516
adequate kidney and liver function
Beschreibung

Renal function | Liver function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
adequate bone marrow function
Beschreibung

Bone Marrow function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
tumor tissue available for testing
Beschreibung

Tumor tissue Available Testing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0039593
prior adjuvant or neoadjuvant therapy is permitted with an anthracycline or anthracenedione-containing regimen however, subjects must have had cumulative doses of less than 360 mg/m2 of doxorubicin, 720 mg/m2 of epirubicin, or 72 mg/m2 of mitoxantrone
Beschreibung

Adjuvant therapy | Neoadjuvant Therapy | Anthracycline Antibiotics | Anthraquinones | Doxorubicin Cumulative Dose | Epirubicin Cumulative Dose | Mitoxantrone Cumulative Dose

Datentyp

boolean

Alias
UMLS CUI [1]
C0677850
UMLS CUI [2]
C0600558
UMLS CUI [3]
C0003234
UMLS CUI [4]
C0003174
UMLS CUI [5,1]
C0013089
UMLS CUI [5,2]
C2986497
UMLS CUI [6,1]
C0014582
UMLS CUI [6,2]
C2986497
UMLS CUI [7,1]
C0026259
UMLS CUI [7,2]
C2986497
no her2/neu overexpression in tumor tissue tested or status unknown if tissue has never been tested
Beschreibung

HER2/NEU Overexpression Tumor tissue | HER2/Neu Status Unknown

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3810543
UMLS CUI [1,2]
C1514559
UMLS CUI [1,3]
C0475358
UMLS CUI [2]
C2348910
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment regimens for advanced or metastatic breast cancer.
Beschreibung

Prior Therapy Advanced breast cancer | Prior Therapy Breast Carcinoma Metastatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C3495917
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0678222
UMLS CUI [2,3]
C0036525
pregnant or lactating
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
conditions that would effect the absorption of an oral drug
Beschreibung

Condition Affecting drug absorption

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0678745
active infection
Beschreibung

Communicable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
brain metastases
Beschreibung

Metastatic malignant neoplasm to brain

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
treatment with egfr (endothelial growth factor receptor) inhibitor.
Beschreibung

Endothelial Growth Factor Receptor Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C2267120
known hypersensitivity to taxol or excipients of taxol
Beschreibung

HypersensitivityTaxol | Hypersensitivity Taxol Excipient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0678133
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0678133
UMLS CUI [2,3]
C0015237
peripheral neuropathy of grade 2 or greater is not permitted
Beschreibung

Peripheral Neuropathy | CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2]
C1516728
severe cardiovascular disease or cardiac disease requiring a device.
Beschreibung

Cardiovascular Disease Severe | Cardiovascular Disease Requirement Medical Device

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0025080
serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.
Beschreibung

Disease Serious Interferes with patient safety | Disease Serious Interferes with Informed Consent | Mental disorder Interferes with patient safety | Mental disorder Interferes with Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C1113679
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C1113679
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0021430
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Ähnliche Modelle

Eligibility Neoplasms, Breast NCT00075270

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Able to swallow oral medication
Item
able to swallow an oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Cardiac ejection fraction | Echocardiography
Item
cardiac ejection fraction within the institutional range of normal as measured by echocardiogram
boolean
C0232174 (UMLS CUI [1])
C0013516 (UMLS CUI [2])
Renal function | Liver function
Item
adequate kidney and liver function
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
Bone Marrow function
Item
adequate bone marrow function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
Tumor tissue Available Testing
Item
tumor tissue available for testing
boolean
C0475358 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
Adjuvant therapy | Neoadjuvant Therapy | Anthracycline Antibiotics | Anthraquinones | Doxorubicin Cumulative Dose | Epirubicin Cumulative Dose | Mitoxantrone Cumulative Dose
Item
prior adjuvant or neoadjuvant therapy is permitted with an anthracycline or anthracenedione-containing regimen however, subjects must have had cumulative doses of less than 360 mg/m2 of doxorubicin, 720 mg/m2 of epirubicin, or 72 mg/m2 of mitoxantrone
boolean
C0677850 (UMLS CUI [1])
C0600558 (UMLS CUI [2])
C0003234 (UMLS CUI [3])
C0003174 (UMLS CUI [4])
C0013089 (UMLS CUI [5,1])
C2986497 (UMLS CUI [5,2])
C0014582 (UMLS CUI [6,1])
C2986497 (UMLS CUI [6,2])
C0026259 (UMLS CUI [7,1])
C2986497 (UMLS CUI [7,2])
HER2/NEU Overexpression Tumor tissue | HER2/Neu Status Unknown
Item
no her2/neu overexpression in tumor tissue tested or status unknown if tissue has never been tested
boolean
C3810543 (UMLS CUI [1,1])
C1514559 (UMLS CUI [1,2])
C0475358 (UMLS CUI [1,3])
C2348910 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Advanced breast cancer | Prior Therapy Breast Carcinoma Metastatic
Item
prior treatment regimens for advanced or metastatic breast cancer.
boolean
C1514463 (UMLS CUI [1,1])
C3495917 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0036525 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Condition Affecting drug absorption
Item
conditions that would effect the absorption of an oral drug
boolean
C0348080 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
Communicable Disease
Item
active infection
boolean
C0009450 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
brain metastases
boolean
C0220650 (UMLS CUI [1])
Endothelial Growth Factor Receptor Inhibitors
Item
treatment with egfr (endothelial growth factor receptor) inhibitor.
boolean
C2267120 (UMLS CUI [1])
HypersensitivityTaxol | Hypersensitivity Taxol Excipient
Item
known hypersensitivity to taxol or excipients of taxol
boolean
C0020517 (UMLS CUI [1,1])
C0678133 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0678133 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Peripheral Neuropathy | CTCAE Grades
Item
peripheral neuropathy of grade 2 or greater is not permitted
boolean
C0031117 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
Cardiovascular Disease Severe | Cardiovascular Disease Requirement Medical Device
Item
severe cardiovascular disease or cardiac disease requiring a device.
boolean
C0007222 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0025080 (UMLS CUI [2,3])
Disease Serious Interferes with patient safety | Disease Serious Interferes with Informed Consent | Mental disorder Interferes with patient safety | Mental disorder Interferes with Informed Consent
Item
serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0021430 (UMLS CUI [2,4])
C0004936 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0021430 (UMLS CUI [4,3])
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