Information:
Fel:
ID
19637
Beskrivning
An All-Oral Combination of Capecitabine and Cyclophosphamide in Patients With Metastatic Breast Cancer (MBC); ODM derived from: https://clinicaltrials.gov/show/NCT00589901
Länk
https://clinicaltrials.gov/show/NCT00589901
Nyckelord
Versioner (1)
- 2017-01-17 2017-01-17 -
Uppladdad den
17 januari 2017
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00589901
Eligibility Breast Cancer NCT00589901
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT00589901
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Breast Carcinoma
Item
histologically confirmed breast cancer
boolean
C0678222 (UMLS CUI [1])
Anthracyclines Pretreatment Secondary malignant neoplasm of female breast | Taxane Pretreatment Secondary malignant neoplasm of female breast
Item
anthracycline and taxane pretreated metastatic breast cancer
boolean
C0282564 (UMLS CUI [1,1])
C3539076 (UMLS CUI [1,2])
C0346993 (UMLS CUI [1,3])
C0215136 (UMLS CUI [2,1])
C3539076 (UMLS CUI [2,2])
C0346993 (UMLS CUI [2,3])
C3539076 (UMLS CUI [1,2])
C0346993 (UMLS CUI [1,3])
C0215136 (UMLS CUI [2,1])
C3539076 (UMLS CUI [2,2])
C0346993 (UMLS CUI [2,3])
capecitabine
Item
have not been previously treated with capecitabine
boolean
C0671970 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of ≤ 1
boolean
C1520224 (UMLS CUI [1])
Gender | Age
Item
are female and ≥ 18 and ≤ 70 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
Target Lesion Quantity
Item
have at least one target lesion according to the recist criteria
boolean
C2986546 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
ECOG performance status
Item
ecog ≥ 2
boolean
C1520224 (UMLS CUI [1])
capecitabine
Item
have been treated with capecitabine
boolean
C0671970 (UMLS CUI [1])
CNS metastases Evidence of
Item
evidence of cns metastasis
boolean
C0686377 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,2])
Malignant Neoplasm | Basal cell carcinoma Cured disease | Carcinoma in situ of uterine cervix Cured disease | Contralateral breast cancer
Item
history of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C0679252 (UMLS CUI [2,2])
C0851140 (UMLS CUI [3,1])
C0679252 (UMLS CUI [3,2])
C1096616 (UMLS CUI [4])
C0007117 (UMLS CUI [2,1])
C0679252 (UMLS CUI [2,2])
C0851140 (UMLS CUI [3,1])
C0679252 (UMLS CUI [3,2])
C1096616 (UMLS CUI [4])
Laboratory test result abnormal | Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement | Serum creatinine raised | Serum bilirubin increased | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised
Item
abnormal laboratory values: hemoglobin < 8.0 g/dl, neutrophils < 1.5×10^9/l, platelets < 100×10^9/l, serum creatinine > upper limit of normal (uln), serum bilirubin > uln, alt and ast > 5×uln, akp > 5×uln
boolean
C0438215 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0700225 (UMLS CUI [5])
C0859062 (UMLS CUI [6])
C0151905 (UMLS CUI [7])
C0151904 (UMLS CUI [8])
C0151849 (UMLS CUI [9])
C0518015 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0700225 (UMLS CUI [5])
C0859062 (UMLS CUI [6])
C0151905 (UMLS CUI [7])
C0151904 (UMLS CUI [8])
C0151849 (UMLS CUI [9])
Communicable Disease Uncontrolled Serious
Item
serious uncontrolled intercurrent infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0205318 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
Life Expectancy
Item
life expectancy of less than 3 months
boolean
C0023671 (UMLS CUI [1])