ID

19637

Description

An All-Oral Combination of Capecitabine and Cyclophosphamide in Patients With Metastatic Breast Cancer (MBC); ODM derived from: https://clinicaltrials.gov/show/NCT00589901

Link

https://clinicaltrials.gov/show/NCT00589901

Keywords

Versions (1)
  1. 1/17/17 1/17/17 -
Uploaded on

January 17, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00589901

English

Eligibility Breast Cancer NCT00589901

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed breast cancer
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
anthracycline and taxane pretreated metastatic breast cancer
Description

Anthracyclines Pretreatment Secondary malignant neoplasm of female breast | Taxane Pretreatment Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0282564
UMLS CUI [1,2]
C3539076
UMLS CUI [1,3]
C0346993
UMLS CUI [2,1]
C0215136
UMLS CUI [2,2]
C3539076
UMLS CUI [2,3]
C0346993
have not been previously treated with capecitabine
Description

capecitabine

Data type

boolean

Alias
UMLS CUI [1]
C0671970
ecog performance status of ≤ 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
are female and ≥ 18 and ≤ 70 years of age
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
have at least one target lesion according to the recist criteria
Description

Target Lesion Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1265611
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
ecog ≥ 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
have been treated with capecitabine
Description

capecitabine

Data type

boolean

Alias
UMLS CUI [1]
C0671970
evidence of cns metastasis
Description

CNS metastases Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0332120
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
Description

Malignant Neoplasm | Basal cell carcinoma Cured disease | Carcinoma in situ of uterine cervix Cured disease | Contralateral breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C0679252
UMLS CUI [3,1]
C0851140
UMLS CUI [3,2]
C0679252
UMLS CUI [4]
C1096616
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
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0700225
UMLS CUI [6]
C0859062
UMLS CUI [7]
C0151905
UMLS CUI [8]
C0151904
UMLS CUI [9]
C0151849
serious uncontrolled intercurrent infection
Description

Communicable Disease Uncontrolled Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0205404
life expectancy of less than 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
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Similar models

Eligibility Breast Cancer NCT00589901

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
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])
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])
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])
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])
Life Expectancy
Item
life expectancy of less than 3 months
boolean
C0023671 (UMLS CUI [1])
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