ID

12964

Beschrijving

Weekly Gemcitabine and Trastuzumab in the Treatment of Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00193063

Link

https://clinicaltrials.gov/show/NCT00193063

Trefwoorden

  1. 07-01-16 07-01-16 -
Geüploaded op

7 januari 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00193063

Eligibility Breast Cancer NCT00193063

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
her-2 positive metastatic breast cancer confirmed by biopsy
Beschrijving

biopsy metastasis, her2

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0027627
UMLS CUI [2]
C0242957
measurable disease
Beschrijving

measurable disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
able to perform activities of daily living without considerable
Beschrijving

performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1518965
no previous chemotherapy with gemcitabine
Beschrijving

gemcitabine

Datatype

boolean

Alias
UMLS CUI [1]
C0045093
no more than one prior chemotherapy regimen for metastatic breast cancer
Beschrijving

chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
adequate bone marrow, liver and renal function
Beschrijving

bone marrow, liver and renal function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0005953
UMLS CUI [3]
C0232804
normal heart function
Beschrijving

cardiac function

Datatype

boolean

Alias
UMLS CUI [1]
C0232164
give written informed consent prior to entering this study.
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
received previous treatment with gemcitabine
Beschrijving

gemcitabine

Datatype

boolean

Alias
UMLS CUI [1]
C0045093
history of brain metastases
Beschrijving

brain metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
serious underlying medical conditions
Beschrijving

comorbidity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Beschrijving

additional inclusion/exclusion criteria

Datatype

boolean

Similar models

Eligibility Breast Cancer NCT00193063

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
biopsy metastasis, her2
Item
her-2 positive metastatic breast cancer confirmed by biopsy
boolean
C0005558 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0242957 (UMLS CUI [2])
measurable disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
performance status
Item
able to perform activities of daily living without considerable
boolean
C1518965 (UMLS CUI [1])
gemcitabine
Item
no previous chemotherapy with gemcitabine
boolean
C0045093 (UMLS CUI [1])
chemotherapy
Item
no more than one prior chemotherapy regimen for metastatic breast cancer
boolean
C0392920 (UMLS CUI [1])
bone marrow, liver and renal function
Item
adequate bone marrow, liver and renal function
boolean
C0232741 (UMLS CUI [1])
C0005953 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
cardiac function
Item
normal heart function
boolean
C0232164 (UMLS CUI [1])
informed consent
Item
give written informed consent prior to entering this study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
gemcitabine
Item
received previous treatment with gemcitabine
boolean
C0045093 (UMLS CUI [1])
brain metastases
Item
history of brain metastases
boolean
C0220650 (UMLS CUI [1])
comorbidity
Item
serious underlying medical conditions
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
additional inclusion/exclusion criteria
Item
please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
boolean

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