ID

16370

Description

A Study of Epothilone D in Combination With Herceptin (Trastuzumab) in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer.; ODM derived from: https://clinicaltrials.gov/show/NCT00337649

Link

https://clinicaltrials.gov/show/NCT00337649

Keywords

  1. 7/13/16 7/13/16 -
Uploaded on

July 13, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00337649

Eligibility Breast Cancer NCT00337649

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women >=18 years;
Description

Gender | Age

Data type

boolean

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

Locally advanced breast cancer | Carcinoma breast stage IV

Data type

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2]
C0278488
her-2 overexpression (fish + or ihc 3+);
Description

HER2-positive carcinoma of breast | Fluorescent in situ hybridisation positive | Immunohistochemistry Score

Data type

boolean

Alias
UMLS CUI [1]
C1960398
UMLS CUI [2]
C3495875
UMLS CUI [3,1]
C0021044
UMLS CUI [3,2]
C0449820
>=1 measurable lesion;
Description

Measurable lesion Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
up to one prior anthracycline-based chemotherapy regimen in a metastatic setting.
Description

Anthracycline | Metastatic Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0003234
UMLS CUI [2]
C2939420
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pre-existing neuropathy >=grade 2;
Description

Neuropathy Pre-existing

Data type

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C2347662
known cns metastases;
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
congestive heart failure, or myocardial infarction within the last 6 months;
Description

Congestive heart failure | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0027051
previous malignancies in last 5 years, except for cured basal cell cancer of the skin, or cancer in situ of the cervix.
Description

Malignant Neoplasms | Basal cell carcinoma Cured | Carcinoma in situ of uterine cervix Cured

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1880198
UMLS CUI [3,1]
C0851140
UMLS CUI [3,2]
C1880198

Similar models

Eligibility Breast Cancer NCT00337649

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women >=18 years;
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Locally advanced breast cancer | Carcinoma breast stage IV
Item
locally advanced or metastatic breast cancer;
boolean
C3495949 (UMLS CUI [1])
C0278488 (UMLS CUI [2])
HER2-positive carcinoma of breast | Fluorescent in situ hybridisation positive | Immunohistochemistry Score
Item
her-2 overexpression (fish + or ihc 3+);
boolean
C1960398 (UMLS CUI [1])
C3495875 (UMLS CUI [2])
C0021044 (UMLS CUI [3,1])
C0449820 (UMLS CUI [3,2])
Measurable lesion Quantity
Item
>=1 measurable lesion;
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Anthracycline | Metastatic Neoplasm
Item
up to one prior anthracycline-based chemotherapy regimen in a metastatic setting.
boolean
C0003234 (UMLS CUI [1])
C2939420 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Neuropathy Pre-existing
Item
pre-existing neuropathy >=grade 2;
boolean
C0442874 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
CNS metastases
Item
known cns metastases;
boolean
C0686377 (UMLS CUI [1])
Congestive heart failure | Myocardial Infarction
Item
congestive heart failure, or myocardial infarction within the last 6 months;
boolean
C0018802 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
Malignant Neoplasms | Basal cell carcinoma Cured | Carcinoma in situ of uterine cervix Cured
Item
previous malignancies in last 5 years, except for cured basal cell cancer of the skin, or cancer in situ of the cervix.
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1880198 (UMLS CUI [2,2])
C0851140 (UMLS CUI [3,1])
C1880198 (UMLS CUI [3,2])

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