ID

37737

Beschrijving

Phase 2 Trial Of CP-751,871 And Docetaxel In Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00678626

Link

https://clinicaltrials.gov/show/NCT00678626

Trefwoorden

Versies (1)
  1. 20-08-19 20-08-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

20 augustus 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00678626

Engels

Eligibility Breast Cancer NCT00678626

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed diagnosis with evidence of either metastatic disease (stage iv) of locally recurrent disease not amenable to curative resection or radiation therapy (stage iiib).
Beschrijving

Neoplasm Metastasis TNM Breast tumor staging | Recurrent disease Locally TNM Breast tumor staging | Excision Curative Unsuccessful | Therapeutic radiology procedure Unsuccessful

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C1517927
UMLS CUI [2,3]
C0474926
UMLS CUI [3,1]
C0728940
UMLS CUI [3,2]
C1276305
UMLS CUI [3,3]
C1272705
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C1272705
her-2negative breast cancer or unknown her-2 status.
Beschrijving

Breast Carcinoma HER2 Negative | HER2 Status Unknown

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C2348908
UMLS CUI [2]
C2348910
at least 1 measurable lesion as defined by recist.
Beschrijving

Measurable Disease Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
ecog status 0-1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow, hepatic and renal function.
Beschrijving

Bone Marrow function | Liver function | Renal function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
left ventricular ejection fraction of greater than or equal to 50%.
Beschrijving

Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
willingness to discontinue hormonal therapy.
Beschrijving

Hormone Therapy Discontinue Willing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0600109
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
any previous chemotherapy for advanced disease.
Beschrijving

Prior Chemotherapy Advanced disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0679246
prior exposure to taxanes as (neo) adjuvant treatment less than 12 months prior to randomization.
Beschrijving

Exposure to Taxanes Adjuvant therapy | Exposure to Taxanes Neoadjuvant Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0796419
UMLS CUI [1,3]
C0677850
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0796419
UMLS CUI [2,3]
C0600558
symptomatic brain metastases.
Beschrijving

Metastatic malignant neoplasm to brain Symptomatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
prior anti-igf-1r based investigational therapy.
Beschrijving

IGF1R inhibitors Investigational Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C4044495
UMLS CUI [1,2]
C0243077
UMLS CUI [1,3]
C0949266
peripheral neuropathy greater than grade 2.
Beschrijving

Peripheral Neuropathy CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
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Similar models

Eligibility Breast Cancer NCT00678626

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Neoplasm Metastasis TNM Breast tumor staging | Recurrent disease Locally TNM Breast tumor staging | Excision Curative Unsuccessful | Therapeutic radiology procedure Unsuccessful
Item
histologically or cytologically confirmed diagnosis with evidence of either metastatic disease (stage iv) of locally recurrent disease not amenable to curative resection or radiation therapy (stage iiib).
boolean
C0027627 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
C0474926 (UMLS CUI [2,3])
C0728940 (UMLS CUI [3,1])
C1276305 (UMLS CUI [3,2])
C1272705 (UMLS CUI [3,3])
C1522449 (UMLS CUI [4,1])
C1272705 (UMLS CUI [4,2])
Breast Carcinoma HER2 Negative | HER2 Status Unknown
Item
her-2negative breast cancer or unknown her-2 status.
boolean
C0678222 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
C2348910 (UMLS CUI [2])
Measurable Disease Quantity
Item
at least 1 measurable lesion as defined by recist.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
ECOG performance status
Item
ecog status 0-1
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, hepatic and renal function.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Left ventricular ejection fraction
Item
left ventricular ejection fraction of greater than or equal to 50%.
boolean
C0428772 (UMLS CUI [1])
Hormone Therapy Discontinue Willing
Item
willingness to discontinue hormonal therapy.
boolean
C0279025 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Advanced disease
Item
any previous chemotherapy for advanced disease.
boolean
C1514457 (UMLS CUI [1,1])
C0679246 (UMLS CUI [1,2])
Exposure to Taxanes Adjuvant therapy | Exposure to Taxanes Neoadjuvant Therapy
Item
prior exposure to taxanes as (neo) adjuvant treatment less than 12 months prior to randomization.
boolean
C0332157 (UMLS CUI [1,1])
C0796419 (UMLS CUI [1,2])
C0677850 (UMLS CUI [1,3])
C0332157 (UMLS CUI [2,1])
C0796419 (UMLS CUI [2,2])
C0600558 (UMLS CUI [2,3])
Metastatic malignant neoplasm to brain Symptomatic
Item
symptomatic brain metastases.
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
IGF1R inhibitors Investigational Therapy
Item
prior anti-igf-1r based investigational therapy.
boolean
C4044495 (UMLS CUI [1,1])
C0243077 (UMLS CUI [1,2])
C0949266 (UMLS CUI [1,3])
Peripheral Neuropathy CTCAE Grades
Item
peripheral neuropathy greater than grade 2.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
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