ID

20195

Beschrijving

Open Label Study Of SU011248 In Combination With Trastuzumab For Patients With Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00243503

Link

https://clinicaltrials.gov/show/NCT00243503

Trefwoorden

  1. 11-02-17 11-02-17 -
Geüploaded op

11 februari 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Neoplasms NCT00243503

Eligibility Breast Neoplasms NCT00243503

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
a diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease.
Beschrijving

Unresectable or metastatic breast cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519810
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C0278488
her2 positive disease (3+ by immunohistochemistry [ihc] or fish-positive)
Beschrijving

Her2 positive disease

Datatype

boolean

Alias
UMLS CUI [1]
C1960398
candidate for treatment with trastuzumab. prior treatment with trastuzumab and or/
Beschrijving

Trastuzumab

Datatype

boolean

Alias
UMLS CUI [1]
C0728747
lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted.
Beschrijving

Lapatinib or hormone therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1506770
UMLS CUI [2]
C0279025
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with >1 regimen of cytotoxic therapy in the advanced disease setting. adjuvant chemotherapy is permitted
Beschrijving

Prior chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C1514457
prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions.
Beschrijving

Hypersensitivity to trastuzumab

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0728747
prior treatment on a su11248 clinical trial.
Beschrijving

Study status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
uncontrolled brain metastases.
Beschrijving

Brain metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0220650

Similar models

Eligibility Breast Neoplasms NCT00243503

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Unresectable or metastatic breast cancer
Item
a diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease.
boolean
C1519810 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0278488 (UMLS CUI [2])
Her2 positive disease
Item
her2 positive disease (3+ by immunohistochemistry [ihc] or fish-positive)
boolean
C1960398 (UMLS CUI [1])
Trastuzumab
Item
candidate for treatment with trastuzumab. prior treatment with trastuzumab and or/
boolean
C0728747 (UMLS CUI [1])
Lapatinib or hormone therapy
Item
lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted.
boolean
C1506770 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Prior chemotherapy
Item
prior treatment with >1 regimen of cytotoxic therapy in the advanced disease setting. adjuvant chemotherapy is permitted
boolean
C1514457 (UMLS CUI [1])
Hypersensitivity to trastuzumab
Item
prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions.
boolean
C0020517 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
Study status
Item
prior treatment on a su11248 clinical trial.
boolean
C2348568 (UMLS CUI [1])
Brain metastases
Item
uncontrolled brain metastases.
boolean
C0220650 (UMLS CUI [1])

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