ID

12982

Description

Perioperative Chemotherapy After Primary Chemotherapy for Locally Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00301548

Link

https://clinicaltrials.gov/show/NCT00301548

Keywords

Versions (1)
  1. 1/9/16 1/9/16 -
Uploaded on

January 9, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00301548

English

Eligibility Breast Neoplasms NCT00301548

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with breast cancer histologically proven > 2 cm, er and pgr <20% or any er and pgr absent (t2,t3 n0-2, m0)
Description

histology, tumor size, er, pgr

Data type

boolean

Alias
UMLS CUI [1]
C0019638
UMLS CUI [2]
C0475440
UMLS CUI [3]
C2919271
UMLS CUI [4]
C2919590
no treatment with previous chemotherapy/hormonotherapy
Description

chemotherapy, hormone therapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0279025
performance status 0-2 (ecog scale, appendix 2)
Description

ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
measurable or evaluable lesions
Description

measurable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
age between 18-70 years
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
no significant intercurrent illness such as diabetes, cardiovascular, renal or neurologic impairments
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
absence of psychiatric illness
Description

psychiatric illness

Data type

boolean

Alias
UMLS CUI [1]
C0004936
wbc > 4,000/mm3; plts > 100,000/mm3
Description

wbc, platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0032181
ast, alt, ldh, gamma-gt < 2.5 x upper limit of normal and bilirubin < 3 mg/100 ml
Description

ast, alt, ldh, gamm-gt, bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0202113
UMLS CUI [4]
C0202035
UMLS CUI [5]
C1278039
informed consent obtained
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
pregnancy test (in fertile women). an effective contraceptive method must be utilized by fertile women.
Description

pregnancy test, contraception

Data type

boolean

Alias
UMLS CUI [1]
C0032976
UMLS CUI [2]
C0700589
baseline examinations (chest x ray, ct scan, ecg etc) performed within one month prior initiation to therapy
Description

diagnostic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0430022
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled infection and metabolite disease
Description

infection, metabolic diseases

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0025517
distant metastases
Description

metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
active peripheric and/or central neurological disease
Description

neurological disease

Data type

boolean

Alias
UMLS CUI [1]
C0027765
active cardiac disease defined as chf (nyha iii-iv) significant arrhytmias, bilateral bundle branch block or recent (less than 3 months) history of myocardial infarction
Description

cardiac disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
history of second malignancy (exception in situ carcinoma of the uterine cervix and basal or squamous cell carcinoma of the skin)
Description

malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
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Similar models

Eligibility Breast Neoplasms NCT00301548

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
histology, tumor size, er, pgr
Item
patients with breast cancer histologically proven > 2 cm, er and pgr <20% or any er and pgr absent (t2,t3 n0-2, m0)
boolean
C0019638 (UMLS CUI [1])
C0475440 (UMLS CUI [2])
C2919271 (UMLS CUI [3])
C2919590 (UMLS CUI [4])
chemotherapy, hormone therapy
Item
no treatment with previous chemotherapy/hormonotherapy
boolean
C0392920 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
ecog
Item
performance status 0-2 (ecog scale, appendix 2)
boolean
C1520224 (UMLS CUI [1])
measurable disease
Item
measurable or evaluable lesions
boolean
C1513041 (UMLS CUI [1])
age
Item
age between 18-70 years
boolean
C0001779 (UMLS CUI [1])
comorbidity
Item
no significant intercurrent illness such as diabetes, cardiovascular, renal or neurologic impairments
boolean
C0009488 (UMLS CUI [1])
psychiatric illness
Item
absence of psychiatric illness
boolean
C0004936 (UMLS CUI [1])
wbc, platelet count
Item
wbc > 4,000/mm3; plts > 100,000/mm3
boolean
C0023508 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
ast, alt, ldh, gamm-gt, bilirubin
Item
ast, alt, ldh, gamma-gt < 2.5 x upper limit of normal and bilirubin < 3 mg/100 ml
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0202113 (UMLS CUI [3])
C0202035 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
informed consent
Item
informed consent obtained
boolean
C0021430 (UMLS CUI [1])
pregnancy test, contraception
Item
pregnancy test (in fertile women). an effective contraceptive method must be utilized by fertile women.
boolean
C0032976 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
diagnostic procedure
Item
baseline examinations (chest x ray, ct scan, ecg etc) performed within one month prior initiation to therapy
boolean
C0430022 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
infection, metabolic diseases
Item
uncontrolled infection and metabolite disease
boolean
C0009450 (UMLS CUI [1])
C0025517 (UMLS CUI [2])
metastasis
Item
distant metastases
boolean
C0027627 (UMLS CUI [1])
neurological disease
Item
active peripheric and/or central neurological disease
boolean
C0027765 (UMLS CUI [1])
cardiac disease
Item
active cardiac disease defined as chf (nyha iii-iv) significant arrhytmias, bilateral bundle branch block or recent (less than 3 months) history of myocardial infarction
boolean
C0018799 (UMLS CUI [1])
malignancy
Item
history of second malignancy (exception in situ carcinoma of the uterine cervix and basal or squamous cell carcinoma of the skin)
boolean
C0006826 (UMLS CUI [1])
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