ID

34149

Description

PET/CT Guided Fulvestrant Therapy for Patients With Recurrent or Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00816582

Link

https://clinicaltrials.gov/show/NCT00816582

Keywords

  1. 1/14/19 1/14/19 -
Copyright Holder

GSK group of companies

Uploaded on

January 14, 2019

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Breast Cancer NCT00816582

Eligibility Breast Cancer NCT00816582

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
post-menopausal (≥ 60 years old, or age ≥ 45 years with amenorrhea for > 12 months or follicle stimulating hormone and estrogen levels within post-menopausal range, or prior bilateral oophorectomy)
Description

ID.1

Data type

boolean

hormone receptor positive (er and/or pgr) disease as determined locally
Description

ID.2

Data type

boolean

who performance status 0-2
Description

ID.3

Data type

boolean

life expectancy of ≥ 3 months
Description

ID.4

Data type

boolean

the presence of at least one measurable or evaluable (non-measurable) lesion
Description

ID.5

Data type

boolean

informed consent prior to any study procedures
Description

ID.6

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
life threatening metastatic visceral disease
Description

ID.7

Data type

boolean

brain or leptomeningeal metastases
Description

ID.8

Data type

boolean

prior exposure to fulvestrant
Description

ID.9

Data type

boolean

history of bleeding diathesis or need for long term anti-coagulation
Description

ID.10

Data type

boolean

Similar models

Eligibility Breast Cancer NCT00816582

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
post-menopausal (≥ 60 years old, or age ≥ 45 years with amenorrhea for > 12 months or follicle stimulating hormone and estrogen levels within post-menopausal range, or prior bilateral oophorectomy)
boolean
ID.2
Item
hormone receptor positive (er and/or pgr) disease as determined locally
boolean
ID.3
Item
who performance status 0-2
boolean
ID.4
Item
life expectancy of ≥ 3 months
boolean
ID.5
Item
the presence of at least one measurable or evaluable (non-measurable) lesion
boolean
ID.6
Item
informed consent prior to any study procedures
boolean
Item Group
C0680251 (UMLS CUI)
ID.7
Item
life threatening metastatic visceral disease
boolean
ID.8
Item
brain or leptomeningeal metastases
boolean
ID.9
Item
prior exposure to fulvestrant
boolean
ID.10
Item
history of bleeding diathesis or need for long term anti-coagulation
boolean

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