ID

18111

Description

Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00225056

Link

https://clinicaltrials.gov/show/NCT00225056

Keywords

Versions (1)
  1. 10/20/16 10/20/16 -
Uploaded on

October 20, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00225056

English

Eligibility Metastatic Breast Cancer NCT00225056

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have metastatic breast cancer
Description

Carcinoma breast stage IV

Data type

boolean

Alias
UMLS CUI [1]
C0278488
must have cytologically or pathologically confirmed invasive ductal or lobular carcinoma
Description

Invasive Ductal Breast Carcinoma | Carcinoma, Lobular

Data type

boolean

Alias
UMLS CUI [1]
C1134719
UMLS CUI [2]
C0206692
must have measurable or evaluable disease
Description

Measurable Disease | Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
ecog of 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patients may have received 0, 1. or 2 prior treatments for metastatic breast cancer
Description

Prior Therapy Quantity Carcinoma breast stage IV

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0278488
must have adequate organ function
Description

organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
must be at least 19 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
peripheral neuropathy less than or equal to grade 1
Description

Peripheral Neuropathy | CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2]
C1516728
must have voluntarily signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients with brain metastases are eligible provided that other measurable disease exists and brain lesions are controlled
Description

Metastatic malignant neoplasm to brain | Measurable Disease | Lesion of brain Controlled

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C1513041
UMLS CUI [3,1]
C0221505
UMLS CUI [3,2]
C2911690
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with other malignancies, except non melanoma of the skin, who have had any evidence of cancer within the last 5 years
Description

Malignant Neoplasms | Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
patients with psychiatric illness or other concurrent severe co-morbid medical condition that would preclude study completion
Description

Mental disorder Excludes Clinical Trial Completion | Comorbidity Severe Excludes Clinical Trial Completion

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0205197
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0332196
UMLS CUI [2,4]
C0008976
UMLS CUI [2,5]
C0205197
known uncontrolled existing coagulopathy
Description

Blood Coagulation Disorder Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C0205318
patients with a history of severe hypersensitivity reaction to docetaxel, medications formulated with polysorbate 80 or 5-fluorouracil
Description

severe allergy docetaxel | severe allergy Polysorbate 80 Formulation | severe allergy Fluorouracil Formulation

Data type

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0246415
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C0032601
UMLS CUI [2,3]
C1705957
UMLS CUI [3,1]
C2945656
UMLS CUI [3,2]
C0016360
UMLS CUI [3,3]
C1705957
use of other investigational agents in the last 28 days
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients who are known hiv positive
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
patients with life expectancy of less than 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
sexually active patients unwilling to practice reliable contraception during the study
Description

Sex Behavior Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0036864
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
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Similar models

Eligibility Metastatic Breast Cancer NCT00225056

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Carcinoma breast stage IV
Item
must have metastatic breast cancer
boolean
C0278488 (UMLS CUI [1])
Invasive Ductal Breast Carcinoma | Carcinoma, Lobular
Item
must have cytologically or pathologically confirmed invasive ductal or lobular carcinoma
boolean
C1134719 (UMLS CUI [1])
C0206692 (UMLS CUI [2])
Measurable Disease | Evaluable Disease
Item
must have measurable or evaluable disease
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
ECOG performance status
Item
ecog of 0-1
boolean
C1520224 (UMLS CUI [1])
Prior Therapy Quantity Carcinoma breast stage IV
Item
patients may have received 0, 1. or 2 prior treatments for metastatic breast cancer
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0278488 (UMLS CUI [1,3])
organ function
Item
must have adequate organ function
boolean
C0678852 (UMLS CUI [1])
Age
Item
must be at least 19 years of age
boolean
C0001779 (UMLS CUI [1])
Peripheral Neuropathy | CTCAE Grades
Item
peripheral neuropathy less than or equal to grade 1
boolean
C0031117 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
Informed Consent
Item
must have voluntarily signed informed consent
boolean
C0021430 (UMLS CUI [1])
Metastatic malignant neoplasm to brain | Measurable Disease | Lesion of brain Controlled
Item
patients with brain metastases are eligible provided that other measurable disease exists and brain lesions are controlled
boolean
C0220650 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
C0221505 (UMLS CUI [3,1])
C2911690 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Skin carcinoma
Item
patients with other malignancies, except non melanoma of the skin, who have had any evidence of cancer within the last 5 years
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
Mental disorder Excludes Clinical Trial Completion | Comorbidity Severe Excludes Clinical Trial Completion
Item
patients with psychiatric illness or other concurrent severe co-morbid medical condition that would preclude study completion
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
C0205197 (UMLS CUI [2,5])
Blood Coagulation Disorder Uncontrolled
Item
known uncontrolled existing coagulopathy
boolean
C0005779 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
severe allergy docetaxel | severe allergy Polysorbate 80 Formulation | severe allergy Fluorouracil Formulation
Item
patients with a history of severe hypersensitivity reaction to docetaxel, medications formulated with polysorbate 80 or 5-fluorouracil
boolean
C2945656 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2,1])
C0032601 (UMLS CUI [2,2])
C1705957 (UMLS CUI [2,3])
C2945656 (UMLS CUI [3,1])
C0016360 (UMLS CUI [3,2])
C1705957 (UMLS CUI [3,3])
Investigational New Drugs
Item
use of other investigational agents in the last 28 days
boolean
C0013230 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity
Item
patients who are known hiv positive
boolean
C0019699 (UMLS CUI [1])
Life Expectancy
Item
patients with life expectancy of less than 3 months
boolean
C0023671 (UMLS CUI [1])
Sex Behavior Contraceptive methods Unwilling
Item
sexually active patients unwilling to practice reliable contraception during the study
boolean
C0036864 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
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