ID

12935

Description

Primary Chemotherapy With Docetaxel-Capecitabine and Doxorubicin-Cyclophosphamide in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00005908

Link

https://clinicaltrials.gov/show/NCT00005908

Keywords

  1. 1/6/16 1/6/16 -
Uploaded on

January 6, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00005908

Eligibility Breast Cancer NCT00005908

Criteria
Description

Criteria

stage ii or iii breast cancer with a tumor size of greater than 2 cm. patients with a previous biopsy are eligible provided adequate tumor tissue remains for biopsy in this study.
Description

breast cancer stage

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0027646
UMLS CUI [2]
C0005558
at least 18 years of age.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
adequate hematopoietic function as defined by absolute neutrophil count greater than 1200/mm^3 and platelet count greater than 100,000/mm^3.
Description

Hematopoiesis

Data type

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
adequate renal function as defined by creatinine less than 1.6 mg/dl.
Description

creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
adequate hepatic function as defined by total (t.) bilirubin less than 1.4 mg/dl and serum glutamic oxaloacetic transaminase (sgot)/serum glutamic pyruvic transaminase (sgpt) less than 1.5 times the upper limit of normal and alkaline phosphatase less than 2.5 times upper limit of normal
Description

liver function

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201850
zubrod performance status 0-2.
Description

zubrod

Data type

boolean

Alias
UMLS CUI [1,1]
C1518965
UMLS CUI [1,2]
C0449820
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
medical or psychiatric condition that, in the opinion of the principal investigator, would preclude chemotherapy administration. patients may be evaluated by psychiatry or medical subspecialties as appropriate.
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
pregnant or lactating women
Description

pregnancy, lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C2828358
known bleeding disorders
Description

bleeding disorders

Data type

boolean

Alias
UMLS CUI [1]
C0005779
hypersensitivity to tween 80 (polysorbate)
Description

hypersensitivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0041417
cardiac ejection fraction below normal limits, myocardial infarction within the past 12 months, or symptomatic arrhythmia requiring medical intervention.
Description

heart disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
prior chemotherapy or hormonal therapy for breast cancer. patients treated with hormonal chemoprevention (tamoxifen or raloxifene) will be eligible.
Description

chemotherapy, hormone therapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0279025
active malignancy diagnosed within the last 5 years. (cervical cancer or non-melanomatous skin cancer that has been treated with curative intent will be eligible).
Description

malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826

Similar models

Eligibility Breast Cancer NCT00005908

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
breast cancer stage
Item
stage ii or iii breast cancer with a tumor size of greater than 2 cm. patients with a previous biopsy are eligible provided adequate tumor tissue remains for biopsy in this study.
boolean
C0678222 (UMLS CUI [1,1])
C0027646 (UMLS CUI [1,2])
C0005558 (UMLS CUI [2])
age
Item
at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Hematopoiesis
Item
adequate hematopoietic function as defined by absolute neutrophil count greater than 1200/mm^3 and platelet count greater than 100,000/mm^3.
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
creatinine
Item
adequate renal function as defined by creatinine less than 1.6 mg/dl.
boolean
C0201976 (UMLS CUI [1])
liver function
Item
adequate hepatic function as defined by total (t.) bilirubin less than 1.4 mg/dl and serum glutamic oxaloacetic transaminase (sgot)/serum glutamic pyruvic transaminase (sgpt) less than 1.5 times the upper limit of normal and alkaline phosphatase less than 2.5 times upper limit of normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
zubrod
Item
zubrod performance status 0-2.
boolean
C1518965 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
comorbidity
Item
medical or psychiatric condition that, in the opinion of the principal investigator, would preclude chemotherapy administration. patients may be evaluated by psychiatry or medical subspecialties as appropriate.
boolean
C0009488 (UMLS CUI [1])
pregnancy, lactating
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
bleeding disorders
Item
known bleeding disorders
boolean
C0005779 (UMLS CUI [1])
hypersensitivity
Item
hypersensitivity to tween 80 (polysorbate)
boolean
C0020517 (UMLS CUI [1,1])
C0041417 (UMLS CUI [1,2])
heart disease
Item
cardiac ejection fraction below normal limits, myocardial infarction within the past 12 months, or symptomatic arrhythmia requiring medical intervention.
boolean
C0018799 (UMLS CUI [1])
chemotherapy, hormone therapy
Item
prior chemotherapy or hormonal therapy for breast cancer. patients treated with hormonal chemoprevention (tamoxifen or raloxifene) will be eligible.
boolean
C0392920 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
malignancy
Item
active malignancy diagnosed within the last 5 years. (cervical cancer or non-melanomatous skin cancer that has been treated with curative intent will be eligible).
boolean
C0006826 (UMLS CUI [1])

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