ID

30576

Description

A Phase II Combination of Trastuzumab and Ixabepilone Versus Trastuzumab and Docetaxel in Patients With Advanced and/or Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00490646

Link

https://clinicaltrials.gov/show/NCT00490646

Keywords

Versions (1)
  1. 6/16/18 6/16/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 16, 2018

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.

Back to model comments
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 Metastatic Breast Cancer NCT00490646

English

Eligibility Metastatic Breast Cancer NCT00490646

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
locally advanced or metastatic her2+ breast cancer not previously treated with chemotherapy or trastuzumab.
Description

Locally advanced breast cancer | Secondary malignant neoplasm of female breast HER2 Positive | Chemotherapy Absent | Trastuzumab Absent

Data type

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2,1]
C0346993
UMLS CUI [2,2]
C2348909
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0728747
UMLS CUI [4,2]
C0332197
subjects who had received prior (neo)adjuvant chemotherapy or trastuzumab were eligible except if they relapsed within 12 months after the last dose of a taxane or trastuzumab given as (neo)adjuvant therapy.
Description

Chemotherapy, Adjuvant | Chemotherapy Neoadjuvant | Trastuzumab Adjuvant | Trastuzumab Neoadjuvant | Exception Recurrent disease Post Taxane | Exception Recurrent disease Post Trastuzumab

Data type

boolean

Alias
UMLS CUI [1]
C0085533
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0600558
UMLS CUI [3,1]
C0728747
UMLS CUI [3,2]
C1522673
UMLS CUI [4,1]
C0728747
UMLS CUI [4,2]
C0600558
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0277556
UMLS CUI [5,3]
C0687676
UMLS CUI [5,4]
C0215136
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0277556
UMLS CUI [6,3]
C0687676
UMLS CUI [6,4]
C0728747
measurable disease
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
left ventricular ejection fraction (lvef) ≥50%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior chemotherapy or trastuzumab for metastatic breast cancer (mbc)
Description

Chemotherapy Secondary malignant neoplasm of female breast | Trastuzumab Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0346993
UMLS CUI [2,1]
C0728747
UMLS CUI [2,2]
C0346993
relapse within 1 year after (neo)adjuvant taxane or trastuzumab
Description

Recurrent disease | Status post Taxane Adjuvant | Status post Taxane Neoadjuvant | Status post Trastuzumab Adjuvant | Status post Trastuzumab Neoadjuvant

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0215136
UMLS CUI [2,3]
C1522673
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0215136
UMLS CUI [3,3]
C0600558
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0728747
UMLS CUI [4,3]
C1522673
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0728747
UMLS CUI [5,3]
C0600558
neuropathy > grade 1
Description

Neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
significant cardiovascular disease
Description

Cardiovascular Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0007222
any brain metastases
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
Back to the top of the page

Similar models

Eligibility Metastatic Breast Cancer NCT00490646

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Locally advanced breast cancer | Secondary malignant neoplasm of female breast HER2 Positive | Chemotherapy Absent | Trastuzumab Absent
Item
locally advanced or metastatic her2+ breast cancer not previously treated with chemotherapy or trastuzumab.
boolean
C3495949 (UMLS CUI [1])
C0346993 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0728747 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Chemotherapy, Adjuvant | Chemotherapy Neoadjuvant | Trastuzumab Adjuvant | Trastuzumab Neoadjuvant | Exception Recurrent disease Post Taxane | Exception Recurrent disease Post Trastuzumab
Item
subjects who had received prior (neo)adjuvant chemotherapy or trastuzumab were eligible except if they relapsed within 12 months after the last dose of a taxane or trastuzumab given as (neo)adjuvant therapy.
boolean
C0085533 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C0728747 (UMLS CUI [3,1])
C1522673 (UMLS CUI [3,2])
C0728747 (UMLS CUI [4,1])
C0600558 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0277556 (UMLS CUI [5,2])
C0687676 (UMLS CUI [5,3])
C0215136 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0277556 (UMLS CUI [6,2])
C0687676 (UMLS CUI [6,3])
C0728747 (UMLS CUI [6,4])
Measurable Disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
Left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) ≥50%
boolean
C0428772 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Secondary malignant neoplasm of female breast | Trastuzumab Secondary malignant neoplasm of female breast
Item
prior chemotherapy or trastuzumab for metastatic breast cancer (mbc)
boolean
C0392920 (UMLS CUI [1,1])
C0346993 (UMLS CUI [1,2])
C0728747 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
Recurrent disease | Status post Taxane Adjuvant | Status post Taxane Neoadjuvant | Status post Trastuzumab Adjuvant | Status post Trastuzumab Neoadjuvant
Item
relapse within 1 year after (neo)adjuvant taxane or trastuzumab
boolean
C0277556 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0215136 (UMLS CUI [2,2])
C1522673 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C0215136 (UMLS CUI [3,2])
C0600558 (UMLS CUI [3,3])
C0231290 (UMLS CUI [4,1])
C0728747 (UMLS CUI [4,2])
C1522673 (UMLS CUI [4,3])
C0231290 (UMLS CUI [5,1])
C0728747 (UMLS CUI [5,2])
C0600558 (UMLS CUI [5,3])
Neuropathy CTCAE Grades
Item
neuropathy > grade 1
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Cardiovascular Diseases
Item
significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
any brain metastases
boolean
C0220650 (UMLS CUI [1])
Back to the top of the page 

Contact

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

Fields marked with * are required.

Help

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