ID

15392

Beskrivning

A Notch Signalling Pathway Inhibitor for Patients With Advanced Breast Cancer (0752-014); ODM derived from: https://clinicaltrials.gov/show/NCT00106145

Länk

https://clinicaltrials.gov/show/NCT00106145

Nyckelord

  1. 2016-05-29 2016-05-29 -
Uppladdad den

29 maj 2016

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Advanced Breast Cancer NCT00106145

Eligibility Advanced Breast Cancer NCT00106145

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
women or men greater than or equal to 18 years of age
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog status less than or equal to 2 (a measurement to determine your ability to perform daily activities)
Beskrivning

ecog

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
in parts i, iii, and iv, patient must have a histologically confirmed, metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. there is no limit on the number of prior treatment regimens
Beskrivning

solid tumor

Datatyp

boolean

Alias
UMLS CUI [1]
C0280100
in part ii, only breast cancer patients are eligible
Beskrivning

breast cancer

Datatyp

boolean

Alias
UMLS CUI [1]
C0678222
in part v, only patients with numb negative breast cancer (i.e., tumor shows numb immunoreactivity in less than 10% of the neoplastic cells assessed) are eligible
Beskrivning

numb immunoreactivity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1417890
UMLS CUI [1,2]
C0597879
patient has recovered from and is at least 2 weeks from previous antineoplastic therapy, including chemotherapy, biological therapy (including herceptin), hormonal therapy, radiotherapy, or surgery
Beskrivning

antineoplastic therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C2346834
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has had an investigational treatment in the preceding 21 days
Beskrivning

investigational treatment

Datatyp

boolean

uncontrolled congestive heart failure or myocardial infarction (heart attack) within 3 months of study start
Beskrivning

congestive heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0018802
history of hepatitis b or c or hiv
Beskrivning

hepatitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0019158
patient has the presence of clinically apparent central nervous system metastases or carcinomatous meningitis. patients with cns metastases who have completed a course of radiotherapy and are clinically stable in the judgment of the investigator are eligible
Beskrivning

central nervous system metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0279130
patients with "currently active" second malignancy, other than non-melanoma skin cancer, should not be enrolled. patients are not considered to have a "currently active" malignancy if they have completed therapy for prior malignancy and are considered by their physician to be at <30% risk of relapse
Beskrivning

second malignancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0751623

Similar models

Eligibility Advanced Breast Cancer NCT00106145

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
women or men greater than or equal to 18 years of age
boolean
C0001779 (UMLS CUI [1])
ecog
Item
ecog status less than or equal to 2 (a measurement to determine your ability to perform daily activities)
boolean
C1520224 (UMLS CUI [1])
solid tumor
Item
in parts i, iii, and iv, patient must have a histologically confirmed, metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. there is no limit on the number of prior treatment regimens
boolean
C0280100 (UMLS CUI [1])
breast cancer
Item
in part ii, only breast cancer patients are eligible
boolean
C0678222 (UMLS CUI [1])
numb immunoreactivity
Item
in part v, only patients with numb negative breast cancer (i.e., tumor shows numb immunoreactivity in less than 10% of the neoplastic cells assessed) are eligible
boolean
C1417890 (UMLS CUI [1,1])
C0597879 (UMLS CUI [1,2])
antineoplastic therapy
Item
patient has recovered from and is at least 2 weeks from previous antineoplastic therapy, including chemotherapy, biological therapy (including herceptin), hormonal therapy, radiotherapy, or surgery
boolean
C2346834 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
investigational treatment
Item
patient has had an investigational treatment in the preceding 21 days
boolean
congestive heart failure
Item
uncontrolled congestive heart failure or myocardial infarction (heart attack) within 3 months of study start
boolean
C0018802 (UMLS CUI [1])
hepatitis
Item
history of hepatitis b or c or hiv
boolean
C0019158 (UMLS CUI [1])
central nervous system metastases
Item
patient has the presence of clinically apparent central nervous system metastases or carcinomatous meningitis. patients with cns metastases who have completed a course of radiotherapy and are clinically stable in the judgment of the investigator are eligible
boolean
C0279130 (UMLS CUI [1])
second malignancy
Item
patients with "currently active" second malignancy, other than non-melanoma skin cancer, should not be enrolled. patients are not considered to have a "currently active" malignancy if they have completed therapy for prior malignancy and are considered by their physician to be at <30% risk of relapse
boolean
C0751623 (UMLS CUI [1])

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