ID

20195

Description

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

Keywords

  1. 2/11/17 2/11/17 -
Uploaded on

February 11, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Breast Neoplasms NCT00243503

Eligibility Breast Neoplasms NCT00243503

Inclusion Criteria
Description

Inclusion Criteria

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

Unresectable or metastatic breast cancer

Data type

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)
Description

Her2 positive disease

Data type

boolean

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

Trastuzumab

Data type

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.
Description

Lapatinib or hormone therapy

Data type

boolean

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

Exclusion Criteria

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

Prior chemotherapy

Data type

boolean

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

Hypersensitivity to trastuzumab

Data type

boolean

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

Study status

Data type

boolean

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

Brain metastases

Data type

boolean

Alias
UMLS CUI [1]
C0220650

Similar models

Eligibility Breast Neoplasms NCT00243503

Name
Type
Description | Question | Decode (Coded Value)
Data type
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial