ID

18113

Description

Myocet, Docetaxel & Trastuzumab as 1st Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00250874

Link

https://clinicaltrials.gov/show/NCT00250874

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 NCT00250874

English

Eligibility Metastatic Breast Cancer NCT00250874

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
her-2/neu overexpression assessed by fish test or with immunohistochemical methods: dako(the result must be 3+ with dakotest); if the immunohistochemical test results 2+
Description

HER2/Neu Overexpression | Fluorescent in Situ Hybridization | Immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1,1]
C1512413
UMLS CUI [1,2]
C1514559
UMLS CUI [2]
C0162789
UMLS CUI [3]
C0021044
it is needed a positive fish test
Description

Fluorescent in Situ Hybridization Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0162789
UMLS CUI [1,2]
C1514241
female < 70yrs
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
histologically or cytologically proven breast cancer.
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
metastatic or locally advanced breast cancer (clinical stage: iii-iv)
Description

Carcinoma breast stage IV | Locally advanced breast cancer | TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C0278488
UMLS CUI [2]
C3495949
UMLS CUI [3]
C3258246
adequate hematological, hepatic, renal and cardiac function, the latter confirmed by echocardiography with fevs ≥50%
Description

Hematologic function | Liver function | Renal function | Cardiac function | Echocardiography | FEV1

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
UMLS CUI [4]
C0232164
UMLS CUI [5]
C0013516
UMLS CUI [6]
C0429706
prior adjuvant chemotherapy if doxorubicin total dose ≤300 mg/m2, epirubicin total dose ≤450 mg/m2
Description

Chemotherapy, Adjuvant | Doxorubicin Cumulative Dose | Epirubicin Cumulative Dose

Data type

boolean

Alias
UMLS CUI [1]
C0085533
UMLS CUI [2,1]
C0013089
UMLS CUI [2,2]
C2986497
UMLS CUI [3,1]
C0014582
UMLS CUI [3,2]
C2986497
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of cardiopathy
Description

Heart Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0018799
severe hepatic and renal diseases
Description

Liver disease Severe | Kidney Disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205082
brain metastases as the only parameter of disease
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
contraindication to the use of corticosteroids as premedication
Description

Medical contraindication Adrenal Cortex Hormones Premedication

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C0033045
acute infectious diseases
Description

Communicable Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0009450
insulin-dependent diabetes
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
history of other cancers except for adequately treated basal cell skin cancer or in situ carcinoma of the cervix
Description

Malignant Neoplasms | Basal cell carcinoma Treated Adequate | Carcinoma in situ of uterine cervix Treated Adequate

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C0205411
UMLS CUI [3,1]
C0851140
UMLS CUI [3,2]
C1522326
UMLS CUI [3,3]
C0205411
concurrent treatment with any other cancer therapy
Description

cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0920425
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Similar models

Eligibility Metastatic Breast Cancer NCT00250874

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
HER2/Neu Overexpression | Fluorescent in Situ Hybridization | Immunohistochemistry
Item
her-2/neu overexpression assessed by fish test or with immunohistochemical methods: dako(the result must be 3+ with dakotest); if the immunohistochemical test results 2+
boolean
C1512413 (UMLS CUI [1,1])
C1514559 (UMLS CUI [1,2])
C0162789 (UMLS CUI [2])
C0021044 (UMLS CUI [3])
Fluorescent in Situ Hybridization Positive
Item
it is needed a positive fish test
boolean
C0162789 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Gender | Age
Item
female < 70yrs
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast Carcinoma
Item
histologically or cytologically proven breast cancer.
boolean
C0678222 (UMLS CUI [1])
Carcinoma breast stage IV | Locally advanced breast cancer | TNM clinical staging
Item
metastatic or locally advanced breast cancer (clinical stage: iii-iv)
boolean
C0278488 (UMLS CUI [1])
C3495949 (UMLS CUI [2])
C3258246 (UMLS CUI [3])
Hematologic function | Liver function | Renal function | Cardiac function | Echocardiography | FEV1
Item
adequate hematological, hepatic, renal and cardiac function, the latter confirmed by echocardiography with fevs ≥50%
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0232164 (UMLS CUI [4])
C0013516 (UMLS CUI [5])
C0429706 (UMLS CUI [6])
Chemotherapy, Adjuvant | Doxorubicin Cumulative Dose | Epirubicin Cumulative Dose
Item
prior adjuvant chemotherapy if doxorubicin total dose ≤300 mg/m2, epirubicin total dose ≤450 mg/m2
boolean
C0085533 (UMLS CUI [1])
C0013089 (UMLS CUI [2,1])
C2986497 (UMLS CUI [2,2])
C0014582 (UMLS CUI [3,1])
C2986497 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Heart Diseases
Item
history of cardiopathy
boolean
C0018799 (UMLS CUI [1])
Liver disease Severe | Kidney Disease Severe
Item
severe hepatic and renal diseases
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Metastatic malignant neoplasm to brain
Item
brain metastases as the only parameter of disease
boolean
C0220650 (UMLS CUI [1])
Medical contraindication Adrenal Cortex Hormones Premedication
Item
contraindication to the use of corticosteroids as premedication
boolean
C1301624 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C0033045 (UMLS CUI [1,3])
Communicable Diseases
Item
acute infectious diseases
boolean
C0009450 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
insulin-dependent diabetes
boolean
C0011854 (UMLS CUI [1])
Malignant Neoplasms | Basal cell carcinoma Treated Adequate | Carcinoma in situ of uterine cervix Treated Adequate
Item
history of other cancers except for adequately treated basal cell skin cancer or in situ carcinoma of the cervix
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
C0851140 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0205411 (UMLS CUI [3,3])
cancer treatment
Item
concurrent treatment with any other cancer therapy
boolean
C0920425 (UMLS CUI [1])
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