ID

16252

Beskrivning

Three Doses of TAS-108 to Treat Recurrent or Recurrent Inoperable Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00166543

Länk

https://clinicaltrials.gov/show/NCT00166543

Nyckelord

Versioner (1)
  1. 2016-07-07 2016-07-07 -
Uppladdad den

7 juli 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00166543

Engelsk

Eligibility Breast Cancer NCT00166543

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal females
Beskrivning

Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
histologically or cytologically confirmed diagnosis of breast carcinoma
Beskrivning

Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0678222
locally advanced or locally recurrent inoperable or metastatic breast carcinoma with documented disease progression
Beskrivning

Locally advanced breast cancer | Breast cancer recurrent Locally Inoperable | Carcinoma breast stage IV | Disease Progression

Datatyp

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2,1]
C0278493
UMLS CUI [2,2]
C1517927
UMLS CUI [2,3]
C0205187
UMLS CUI [3]
C0278488
UMLS CUI [4]
C0242656
has laboratory documentation of positive estrogen receptor (er) and/or progesterone receptor (pgr) status, and has responded to the standard first or second line hormonal anti-tumor therapy given
Beskrivning

Estrogen Receptor and/or Progesterone Receptor Positive | Response to Cancer hormonal therapy First line | Response to Cancer hormonal therapy Second line

Datatyp

boolean

Alias
UMLS CUI [1]
C3640067
UMLS CUI [2,1]
C0521982
UMLS CUI [2,2]
C0877050
UMLS CUI [2,3]
C1708063
UMLS CUI [3,1]
C0521982
UMLS CUI [3,2]
C0877050
UMLS CUI [3,3]
C1710038
has received and whose disease progressed after one or two prior systemic hormonal anti-tumor therapies
Beskrivning

Cancer hormonal therapy Systemic | Disease Progression

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877050
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C0242656
performance status of greater than or equal to 2 on the zubrod scale
Beskrivning

Zubrod Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C3714786
predicted life expectancy of greater than or equal to 12 weeks
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
must give written informed consent
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
measurable disease according to the response evaluation criteria in solid tumors (recist) criteria
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
absolute granulocyte count of greater than 1,500/meql, platelet count greater than 75,000/meql, and a hemoglobin of greater than 10 g/dl
Beskrivning

Absolute neutrophil count | Platelet Count measurement | Hemoglobin

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0019046
adequate liver and renal function as defined by a bilirubin of less than 1.5 times the upper limit of normal and a creatinine of less than 1.5 times the upper limit of normal
Beskrivning

Liver function | Renal function | Serum total bilirubin measurement | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201976
transaminases must be less than 2.5 times the upper limit of normal except for patients with liver metastases who may have transaminases less than 5 times the upper limit of normal.
Beskrivning

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver

Datatyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0494165
the patient has recovered from all previous anti-cancer treatment related to toxicities to at least grade 1.
Beskrivning

cancer treatment Due to Toxicities | Patient recovered

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0600688
UMLS CUI [2]
C1115804
all previous investigational drugs must be stopped at least four weeks before commencement of treatment with tas-108.
Beskrivning

Investigational New Drugs Previous Stop | TS 108 Start

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0850893
UMLS CUI [2,1]
C1435232
UMLS CUI [2,2]
C0439659
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Similar models

Eligibility Breast Cancer NCT00166543

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state
Item
postmenopausal females
boolean
C0232970 (UMLS CUI [1])
Breast Carcinoma
Item
histologically or cytologically confirmed diagnosis of breast carcinoma
boolean
C0678222 (UMLS CUI [1])
Locally advanced breast cancer | Breast cancer recurrent Locally Inoperable | Carcinoma breast stage IV | Disease Progression
Item
locally advanced or locally recurrent inoperable or metastatic breast carcinoma with documented disease progression
boolean
C3495949 (UMLS CUI [1])
C0278493 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
C0205187 (UMLS CUI [2,3])
C0278488 (UMLS CUI [3])
C0242656 (UMLS CUI [4])
Estrogen Receptor and/or Progesterone Receptor Positive | Response to Cancer hormonal therapy First line | Response to Cancer hormonal therapy Second line
Item
has laboratory documentation of positive estrogen receptor (er) and/or progesterone receptor (pgr) status, and has responded to the standard first or second line hormonal anti-tumor therapy given
boolean
C3640067 (UMLS CUI [1])
C0521982 (UMLS CUI [2,1])
C0877050 (UMLS CUI [2,2])
C1708063 (UMLS CUI [2,3])
C0521982 (UMLS CUI [3,1])
C0877050 (UMLS CUI [3,2])
C1710038 (UMLS CUI [3,3])
Cancer hormonal therapy Systemic | Disease Progression
Item
has received and whose disease progressed after one or two prior systemic hormonal anti-tumor therapies
boolean
C0877050 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
Zubrod Performance Status
Item
performance status of greater than or equal to 2 on the zubrod scale
boolean
C3714786 (UMLS CUI [1])
Life Expectancy
Item
predicted life expectancy of greater than or equal to 12 weeks
boolean
C0023671 (UMLS CUI [1])
Informed consent
Item
must give written informed consent
boolean
C0021430 (UMLS CUI [1])
Measurable Disease
Item
measurable disease according to the response evaluation criteria in solid tumors (recist) criteria
boolean
C1513041 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement | Hemoglobin
Item
absolute granulocyte count of greater than 1,500/meql, platelet count greater than 75,000/meql, and a hemoglobin of greater than 10 g/dl
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
Liver function | Renal function | Serum total bilirubin measurement | Creatinine measurement, serum
Item
adequate liver and renal function as defined by a bilirubin of less than 1.5 times the upper limit of normal and a creatinine of less than 1.5 times the upper limit of normal
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver
Item
transaminases must be less than 2.5 times the upper limit of normal except for patients with liver metastases who may have transaminases less than 5 times the upper limit of normal.
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
cancer treatment Due to Toxicities | Patient recovered
Item
the patient has recovered from all previous anti-cancer treatment related to toxicities to at least grade 1.
boolean
C0920425 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0600688 (UMLS CUI [1,3])
C1115804 (UMLS CUI [2])
Investigational New Drugs Previous Stop | TS 108 Start
Item
all previous investigational drugs must be stopped at least four weeks before commencement of treatment with tas-108.
boolean
C0013230 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0850893 (UMLS CUI [1,3])
C1435232 (UMLS CUI [2,1])
C0439659 (UMLS CUI [2,2])
Tillbaka till toppen 

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