ID

26057

Description

A Prospective, Single-Arm Study to Evaluate the Efficacy and Safety of Zoladex 3.6mg Combined With CEF Chemotherapy as Neo-Adjuvant Therapy in Hormone Responsive, Premenopausal, Operable Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00488722

Link

https://clinicaltrials.gov/show/NCT00488722

Keywords

Versions (1)
  1. 10/5/17 10/5/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 5, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00488722

English

Eligibility Breast Cancer NCT00488722

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provision of informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. pathological confirmation of breast cancer
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
3. tumor stage(tnm):t2-4bn0-3m0
Description

TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3258246
4. er(+) and/or pr(+).
Description

Estrogen receptor positive | Progesterone receptor positive

Data type

boolean

Alias
UMLS CUI [1]
C0279754
UMLS CUI [2]
C0279759
5. premenopausal woman.
Description

Premenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232969
6. age≥40 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
7. measurable disease as per recist criteria
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
8. karnofsky≥70
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
9. labratory criteria:
Description

Laboratory criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0243161
plt≥100*109/l
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
wbc≥4000/mm3
Description

White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1]
C0023508
hgb≥10g/dl
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
alt and ast<2*uln
Description

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. presence of metastatic disease.
Description

Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
2. inflammatory breast cancer.
Description

Inflammatory Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0278601
3. bilateral breast cancer.
Description

bilateral breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0281267
4. previous chemotherapy or hormonal therapyfor current breast neoplasm.
Description

Chemotherapy Breast Carcinoma | Hormone Therapy Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0678222
5. other malignant tumor (concurrent or previous).
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
6. pregnant woman.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
7. hypersensitive to any drug in cef regimen or any ingredient of zoladex.
Description

Hypersensitivity Pharmaceutical Preparations CEF regimen | Hypersensitivity Zoladex Ingredient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0248241
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0149473
UMLS CUI [2,3]
C1550600
8. any severe systemic disease contraindicating chemotherapy.
Description

Systemic disease Severe | Medical contraindication Chemotherapy Regimen

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0392920
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Similar models

Eligibility Breast Cancer NCT00488722

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. provision of informed consent
boolean
C0021430 (UMLS CUI [1])
Breast Carcinoma
Item
2. pathological confirmation of breast cancer
boolean
C0678222 (UMLS CUI [1])
TNM clinical staging
Item
3. tumor stage(tnm):t2-4bn0-3m0
boolean
C3258246 (UMLS CUI [1])
Estrogen receptor positive | Progesterone receptor positive
Item
4. er(+) and/or pr(+).
boolean
C0279754 (UMLS CUI [1])
C0279759 (UMLS CUI [2])
Premenopausal state
Item
5. premenopausal woman.
boolean
C0232969 (UMLS CUI [1])
Age
Item
6. age≥40 years
boolean
C0001779 (UMLS CUI [1])
Measurable Disease
Item
7. measurable disease as per recist criteria
boolean
C1513041 (UMLS CUI [1])
Karnofsky Performance Status
Item
8. karnofsky≥70
boolean
C0206065 (UMLS CUI [1])
Laboratory criteria
Item
9. labratory criteria:
boolean
C0022877 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Platelet Count measurement
Item
plt≥100*109/l
boolean
C0032181 (UMLS CUI [1])
White Blood Cell Count procedure
Item
wbc≥4000/mm3
boolean
C0023508 (UMLS CUI [1])
Hemoglobin measurement
Item
hgb≥10g/dl
boolean
C0518015 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
alt and ast<2*uln
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis
Item
1. presence of metastatic disease.
boolean
C0027627 (UMLS CUI [1])
Inflammatory Breast Carcinoma
Item
2. inflammatory breast cancer.
boolean
C0278601 (UMLS CUI [1])
bilateral breast cancer
Item
3. bilateral breast cancer.
boolean
C0281267 (UMLS CUI [1])
Chemotherapy Breast Carcinoma | Hormone Therapy Breast Carcinoma
Item
4. previous chemotherapy or hormonal therapyfor current breast neoplasm.
boolean
C0392920 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Malignant Neoplasms
Item
5. other malignant tumor (concurrent or previous).
boolean
C0006826 (UMLS CUI [1])
Pregnancy
Item
6. pregnant woman.
boolean
C0032961 (UMLS CUI [1])
Hypersensitivity Pharmaceutical Preparations CEF regimen | Hypersensitivity Zoladex Ingredient
Item
7. hypersensitive to any drug in cef regimen or any ingredient of zoladex.
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0248241 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0149473 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
Systemic disease Severe | Medical contraindication Chemotherapy Regimen
Item
8. any severe systemic disease contraindicating chemotherapy.
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
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