ID

12964

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00193063

Nyckelord

  1. 2016-01-07 2016-01-07 -
Uppladdad den

7 januari 2016

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00193063

Eligibility Breast Cancer NCT00193063

Inclusion Criteria
Beskrivning

Inclusion Criteria

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

biopsy metastasis, her2

Datatyp

boolean

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

measurable disease

Datatyp

boolean

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

performance status

Datatyp

boolean

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

gemcitabine

Datatyp

boolean

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

chemotherapy

Datatyp

boolean

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

bone marrow, liver and renal function

Datatyp

boolean

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

cardiac function

Datatyp

boolean

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

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
received previous treatment with gemcitabine
Beskrivning

gemcitabine

Datatyp

boolean

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

brain metastases

Datatyp

boolean

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

comorbidity

Datatyp

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.
Beskrivning

additional inclusion/exclusion criteria

Datatyp

boolean

Similar models

Eligibility Breast Cancer NCT00193063

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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