ID

26302

Beskrivning

Study of CR011-vcMMAE to Treat Locally Advanced or Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00704158

Länk

https://clinicaltrials.gov/show/NCT00704158

Nyckelord

Versioner (1)
  1. 2017-10-16 2017-10-16 -
Rättsinnehavare

See clinicaltrials.gov

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16 oktober 2017

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00704158

Engelsk

Eligibility Breast Cancer NCT00704158

1 Formulär  
Criteria
Beskrivning

Criteria

females with confirmed breast cancer
Beskrivning

Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0678222
age ≥ 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog) performance status 0 to 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
locally advanced or metastatic disease who have received at least two prior chemotherapeutic regimens for breast cancer, as follows:
Beskrivning

Advanced disease Locally | Neoplasm Metastasis | Chemotherapy Regimen Quantity Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679246
UMLS CUI [1,2]
C1517927
UMLS CUI [2]
C0027627
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0678222
at least one regimen must have been for locally advanced or metastatic disease
Beskrivning

Chemotherapy Regimen Quantity Advanced disease Locally | Chemotherapy Regimen Quantity Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0679246
UMLS CUI [1,4]
C1517927
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0027627
subject must have received an anthracycline, a taxane, and capecitabine in any combination unless the subject was intolerant to or not a candidate for any of these agents
Beskrivning

Anthracycline | taxane | capecitabine | Combined Modality Therapy | Exception Intolerance to substance | Exception Patient Inappropriate Medication

Datatyp

boolean

Alias
UMLS CUI [1]
C0282564
UMLS CUI [2]
C0215136
UMLS CUI [3]
C0671970
UMLS CUI [4]
C0009429
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1744706
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0030705
UMLS CUI [6,3]
C1548788
UMLS CUI [6,4]
C0013227
hormonal therapy, biologic therapy (such as trastuzumab or bevacizumab), or immunotherapy do not count as one of the 2 regimens
Beskrivning

Hormone Therapy Excluded | Biological treatment Excluded | trastuzumab | bevacizumab | Immunotherapy Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C1531518
UMLS CUI [2,2]
C2828389
UMLS CUI [3]
C0728747
UMLS CUI [4]
C0796392
UMLS CUI [5,1]
C0021083
UMLS CUI [5,2]
C2828389
subjects with her2/neu overexpressing tumors must have been treated with trastuzumab except in situations where the subject was intolerant to or not a candidate for trastuzumab
Beskrivning

Neoplasm HER2/neu Overexpression | trastuzumab | Exception Intolerance to trastuzumab | Exception Patient Inappropriate trastuzumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1702024
UMLS CUI [1,3]
C1514559
UMLS CUI [2]
C0728747
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1744706
UMLS CUI [3,3]
C0728747
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0030705
UMLS CUI [4,3]
C1548788
UMLS CUI [4,4]
C0728747
documented progressive disease within 6 months of the last regimen
Beskrivning

Progressive Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1335499
adequate bone marrow, renal and liver function
Beskrivning

Bone Marrow function | Renal function | Liver function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
signed informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
main exclusion criteria:
Beskrivning

Exclusion Criteria Main

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
chemotherapy, radiation, hormonal therapy, or bevacizumab within two weeks, or trastuzumab or investigational therapy within three weeks before treatment start
Beskrivning

Chemotherapy | Therapeutic radiology procedure | Hormone Therapy | bevacizumab | trastuzumab | Therapy, Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0279025
UMLS CUI [4]
C0796392
UMLS CUI [5]
C0728747
UMLS CUI [6]
C0949266
neuropathy > nci-ctcae grade 1
Beskrivning

Neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
active brain metastases.
Beskrivning

Metastatic malignant neoplasm to brain

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
new york heart association class iii or iv heart disease
Beskrivning

Heart Disease New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
unstable angina
Beskrivning

Angina, Unstable

Datatyp

boolean

Alias
UMLS CUI [1]
C0002965
uncontrolled arrhythmia
Beskrivning

Cardiac Arrhythmia Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0205318
a marked baseline prolongation of qt/qtc interval
Beskrivning

Prolonged QT interval | Prolonged QTc interval

Datatyp

boolean

Alias
UMLS CUI [1]
C0151878
UMLS CUI [2]
C1560305
pregnant or breast-feeding women, and women of childbearing age and potential who are not willing to use effective contraception
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
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Similar models

Eligibility Breast Cancer NCT00704158

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Breast Carcinoma
Item
females with confirmed breast cancer
boolean
C0678222 (UMLS CUI [1])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0 to 2
boolean
C1520224 (UMLS CUI [1])
Advanced disease Locally | Neoplasm Metastasis | Chemotherapy Regimen Quantity Breast Carcinoma
Item
locally advanced or metastatic disease who have received at least two prior chemotherapeutic regimens for breast cancer, as follows:
boolean
C0679246 (UMLS CUI [1,1])
C1517927 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0678222 (UMLS CUI [3,3])
Chemotherapy Regimen Quantity Advanced disease Locally | Chemotherapy Regimen Quantity Neoplasm Metastasis
Item
at least one regimen must have been for locally advanced or metastatic disease
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0679246 (UMLS CUI [1,3])
C1517927 (UMLS CUI [1,4])
C0392920 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
Anthracycline | taxane | capecitabine | Combined Modality Therapy | Exception Intolerance to substance | Exception Patient Inappropriate Medication
Item
subject must have received an anthracycline, a taxane, and capecitabine in any combination unless the subject was intolerant to or not a candidate for any of these agents
boolean
C0282564 (UMLS CUI [1])
C0215136 (UMLS CUI [2])
C0671970 (UMLS CUI [3])
C0009429 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C1744706 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0030705 (UMLS CUI [6,2])
C1548788 (UMLS CUI [6,3])
C0013227 (UMLS CUI [6,4])
Hormone Therapy Excluded | Biological treatment Excluded | trastuzumab | bevacizumab | Immunotherapy Excluded
Item
hormonal therapy, biologic therapy (such as trastuzumab or bevacizumab), or immunotherapy do not count as one of the 2 regimens
boolean
C0279025 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C1531518 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0728747 (UMLS CUI [3])
C0796392 (UMLS CUI [4])
C0021083 (UMLS CUI [5,1])
C2828389 (UMLS CUI [5,2])
Neoplasm HER2/neu Overexpression | trastuzumab | Exception Intolerance to trastuzumab | Exception Patient Inappropriate trastuzumab
Item
subjects with her2/neu overexpressing tumors must have been treated with trastuzumab except in situations where the subject was intolerant to or not a candidate for trastuzumab
boolean
C0027651 (UMLS CUI [1,1])
C1702024 (UMLS CUI [1,2])
C1514559 (UMLS CUI [1,3])
C0728747 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1744706 (UMLS CUI [3,2])
C0728747 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0030705 (UMLS CUI [4,2])
C1548788 (UMLS CUI [4,3])
C0728747 (UMLS CUI [4,4])
Progressive Disease
Item
documented progressive disease within 6 months of the last regimen
boolean
C1335499 (UMLS CUI [1])
Bone Marrow function | Renal function | Liver function
Item
adequate bone marrow, renal and liver function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Chemotherapy | Therapeutic radiology procedure | Hormone Therapy | bevacizumab | trastuzumab | Therapy, Investigational
Item
chemotherapy, radiation, hormonal therapy, or bevacizumab within two weeks, or trastuzumab or investigational therapy within three weeks before treatment start
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C0796392 (UMLS CUI [4])
C0728747 (UMLS CUI [5])
C0949266 (UMLS CUI [6])
Neuropathy CTCAE Grades
Item
neuropathy > nci-ctcae grade 1
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain
Item
active brain metastases.
boolean
C0220650 (UMLS CUI [1])
Heart Disease New York Heart Association Classification
Item
new york heart association class iii or iv heart disease
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Angina, Unstable
Item
unstable angina
boolean
C0002965 (UMLS CUI [1])
Cardiac Arrhythmia Uncontrolled
Item
uncontrolled arrhythmia
boolean
C0003811 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Prolonged QT interval | Prolonged QTc interval
Item
a marked baseline prolongation of qt/qtc interval
boolean
C0151878 (UMLS CUI [1])
C1560305 (UMLS CUI [2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling
Item
pregnant or breast-feeding women, and women of childbearing age and potential who are not willing to use effective contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
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