ID

35067

Description

Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02491697

Link

https://clinicaltrials.gov/show/NCT02491697

Keywords

Versions (1)
  1. 2/13/19 2/13/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 13, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02491697

English

Eligibility Breast Cancer NCT02491697

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed with advanced breast cancer.
Description

Advanced breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C3495917
eastern cooperative oncology group (ecog) performance status was 0 - 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
hemoglobin≥10.0g/dl, neutrophil count≥1.5×10^9/l, platelet count≥75×10^9/l; total bilirubin(tbil)≤1.5×uln; alkaline phosphatase(akp), aspartate aminotransferase(ast),alt≤2.5×uln(without metastasis of the liver), akp,ast,alt≤5×uln(with metastasis of the liver); bun≤1.5×uln, cr≤1.5×uln.
Description

Hemoglobin measurement | Neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver | Blood urea nitrogen measurement | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0032181
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201850
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201836
UMLS CUI [8,1]
C0494165
UMLS CUI [8,2]
C0332197
UMLS CUI [9]
C0494165
UMLS CUI [10]
C0005845
UMLS CUI [11]
C0201976
patient received 1-2 kinds of cytotoxic chemotherapy previously.
Description

Cytotoxic Chemotherapy Kind Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1265611
patient never received capecitabine or other oral fluorouracil.
Description

Capecitabine Absent | Fluorouracil Oral Product Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0671970
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C3215189
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are suffering from serious organ dysfunction.
Description

Organ dysfunction Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0349410
UMLS CUI [1,2]
C0205404
hiv positive or other immunodeficiency disease.
Description

HIV Seropositivity | Immunodeficiency

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0021051
patients who had used long time or are using immunosuppressant drugs.
Description

Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0021081
patients who had active infection.
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
patients who were allergic to fluorouracil.
Description

Fluorouracil allergy

Data type

boolean

Alias
UMLS CUI [1]
C0570698
pregnant or lactating women.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of other malignancies.
Description

Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C1707251
other situations that the researchers considered unsuitable for this study.
Description

Social situation Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0748872
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
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Similar models

Eligibility Breast Cancer NCT02491697

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Advanced breast cancer
Item
histologically confirmed with advanced breast cancer.
boolean
C3495917 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status was 0 - 2.
boolean
C1520224 (UMLS CUI [1])
Hemoglobin measurement | Neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver | Blood urea nitrogen measurement | Creatinine measurement, serum
Item
hemoglobin≥10.0g/dl, neutrophil count≥1.5×10^9/l, platelet count≥75×10^9/l; total bilirubin(tbil)≤1.5×uln; alkaline phosphatase(akp), aspartate aminotransferase(ast),alt≤2.5×uln(without metastasis of the liver), akp,ast,alt≤5×uln(with metastasis of the liver); bun≤1.5×uln, cr≤1.5×uln.
boolean
C0518015 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
C0494165 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
C0494165 (UMLS CUI [9])
C0005845 (UMLS CUI [10])
C0201976 (UMLS CUI [11])
Cytotoxic Chemotherapy Kind Quantity
Item
patient received 1-2 kinds of cytotoxic chemotherapy previously.
boolean
C0677881 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Capecitabine Absent | Fluorouracil Oral Product Absent
Item
patient never received capecitabine or other oral fluorouracil.
boolean
C0671970 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3215189 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Organ dysfunction Serious
Item
patients who are suffering from serious organ dysfunction.
boolean
C0349410 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
HIV Seropositivity | Immunodeficiency
Item
hiv positive or other immunodeficiency disease.
boolean
C0019699 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
Immunosuppressive Agents
Item
patients who had used long time or are using immunosuppressant drugs.
boolean
C0021081 (UMLS CUI [1])
Communicable Disease
Item
patients who had active infection.
boolean
C0009450 (UMLS CUI [1])
Fluorouracil allergy
Item
patients who were allergic to fluorouracil.
boolean
C0570698 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cancer Other
Item
history of other malignancies.
boolean
C1707251 (UMLS CUI [1])
Social situation Study Subject Participation Status Inappropriate
Item
other situations that the researchers considered unsuitable for this study.
boolean
C0748872 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
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