ID

26053

Description

A Study of Herceptin (Trastuzumab) in Combination With 2nd-Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.; ODM derived from: https://clinicaltrials.gov/show/NCT00444587

Link

https://clinicaltrials.gov/show/NCT00444587

Keywords

  1. 10/5/17 10/5/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 5, 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 Cancer NCT00444587

Eligibility Breast Cancer NCT00444587

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients, >= 18 years of age;
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
metastatic breast cancer;
Description

Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C0346993
her2 overexpression (ihc 3+ and/or fish positive);
Description

HER2 Overexpression Immunohistochemistry Positive | HER2 Overexpression FISH Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0069515
UMLS CUI [1,2]
C1514559
UMLS CUI [1,3]
C0021044
UMLS CUI [1,4]
C1514241
UMLS CUI [2,1]
C0069515
UMLS CUI [2,2]
C1514559
UMLS CUI [2,3]
C0162789
UMLS CUI [2,4]
C1514241
disease progression during or after previous 1st line chemotherapy + herceptin;
Description

Disease Progression | First line Chemotherapy | Herceptin

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C0392920
UMLS CUI [3]
C0338204
scheduled to receive 2nd line chemotherapy.
Description

Second line Chemotherapy Scheduled

Data type

boolean

Alias
UMLS CUI [1,1]
C1710038
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0205539
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
concurrent immunotherapy or hormonal therapy;
Description

Immunotherapy | Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0021083
UMLS CUI [2]
C0279025
anthracyclines as part of previous 1st line chemotherapy or planned 2nd line chemotherapy;
Description

Anthracyclines | Part First line Chemotherapy | Second line Chemotherapy Planned

Data type

boolean

Alias
UMLS CUI [1]
C0282564
UMLS CUI [2,1]
C0449719
UMLS CUI [2,2]
C1708063
UMLS CUI [2,3]
C0392920
UMLS CUI [3,1]
C1710038
UMLS CUI [3,2]
C0392920
UMLS CUI [3,3]
C1301732
cardiac toxicity during previous 1st line chemotherapy + herceptin;
Description

Cardiotoxicity | First line Chemotherapy | Herceptin

Data type

boolean

Alias
UMLS CUI [1]
C0876994
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C0392920
UMLS CUI [3]
C0338204
history of other malignancy within last 5 years.
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826

Similar models

Eligibility Breast Cancer NCT00444587

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
female patients, >= 18 years of age;
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Secondary malignant neoplasm of female breast
Item
metastatic breast cancer;
boolean
C0346993 (UMLS CUI [1])
HER2 Overexpression Immunohistochemistry Positive | HER2 Overexpression FISH Positive
Item
her2 overexpression (ihc 3+ and/or fish positive);
boolean
C0069515 (UMLS CUI [1,1])
C1514559 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C1514241 (UMLS CUI [1,4])
C0069515 (UMLS CUI [2,1])
C1514559 (UMLS CUI [2,2])
C0162789 (UMLS CUI [2,3])
C1514241 (UMLS CUI [2,4])
Disease Progression | First line Chemotherapy | Herceptin
Item
disease progression during or after previous 1st line chemotherapy + herceptin;
boolean
C0242656 (UMLS CUI [1])
C1708063 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0338204 (UMLS CUI [3])
Second line Chemotherapy Scheduled
Item
scheduled to receive 2nd line chemotherapy.
boolean
C1710038 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Immunotherapy | Hormone Therapy
Item
concurrent immunotherapy or hormonal therapy;
boolean
C0021083 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
Anthracyclines | Part First line Chemotherapy | Second line Chemotherapy Planned
Item
anthracyclines as part of previous 1st line chemotherapy or planned 2nd line chemotherapy;
boolean
C0282564 (UMLS CUI [1])
C0449719 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
C1710038 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C1301732 (UMLS CUI [3,3])
Cardiotoxicity | First line Chemotherapy | Herceptin
Item
cardiac toxicity during previous 1st line chemotherapy + herceptin;
boolean
C0876994 (UMLS CUI [1])
C1708063 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0338204 (UMLS CUI [3])
Malignant Neoplasms
Item
history of other malignancy within last 5 years.
boolean
C0006826 (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