NCT00692289

Brief Summary

This is an open label, non-interventional quality of life analysis for Arimidex treated postmenopausal patients in early breast cancer by investigator's questionnaire

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,510

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

June 6, 2012

Status Verified

June 1, 2012

Enrollment Period

2.1 years

First QC Date

June 5, 2008

Last Update Submit

June 5, 2012

Conditions

Breast Cancer

Keywords

Quality of Life

Outcome Measures

Primary Outcomes (1)

  • Elements of the investigator questionnaire SF RAND-36 questionnaire

    Quarterly (plus or minus 3 days )

Secondary Outcomes (1)

  • Investigator Assessment Report

    Yearly (plus or minus 1 week )

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Postmenopausal, hormonreceptor positive patients with early breast cancer treated with Arimidex (in accordance with the local SmPC).

You may qualify if:

  • Provision of informed consent
  • Postmenopausal, hormon receptor positive patients with early breast cancer treated with Arimidex
  • Investigators are requested to recruit patients only with at least 1 month prior Arimidex treatment.

You may not qualify if:

  • Allergy to substance of medication
  • Pre-perimenopausal woman
  • Woman not eligible for treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Research Site

Budapest, Hungary

Location

Research Site

Komló, Hungary

Location

Research Site

Miskolc, Hungary

Location

Research Site

Mohács, Hungary

Location

Research Site

Vác, Hungary

Location

Research Site

Zalaegerszeg, Hungary

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Zsolt Horváth, M.D.

    National Institute of Oncology

    PRINCIPAL INVESTIGATOR

  • Csaba Csongvai

    AstraZeneca Hungary

    STUDY DIRECTOR

  • Éva Gulyás

    AstraZeneca Hungary

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2008

First Posted

June 6, 2008

Study Start

June 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

June 6, 2012

Record last verified: 2012-06

Locations

HU(6)