Quality Of Life While Receiving Faslodex

April 21, 2009 updated by: AstraZeneca

Quality Of Life And Symptoms In Postmenopausal Women With Hormone Receptor Positive Disseminated Breast Cancer While Receiving Faslodex.

To study QoL related response, symptom spectrum and severity in disseminated breast cancer patients receiving Faslodex hormonal therapy.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • ?rasnodar, Russian Federation
        • Research Site
      • Astrahan, Russian Federation
        • Research Site
      • Blagoveshenk, Russian Federation
        • Research Site
      • Chita, Russian Federation
        • Research Site
      • Igevsk, Russian Federation
        • Research Site
      • Kemerovo, Russian Federation
        • Research Site
      • Kursk, Russian Federation
        • Research Site
      • Magadan, Russian Federation
        • Research Site
      • Moscow, Russian Federation
        • Research Site
      • Obninsk, Russian Federation
        • Research Site
      • Penza, Russian Federation
        • Research Site
      • Petropavlovsk, Russian Federation
        • Research Site
      • Rostov, Russian Federation
        • Research Site
      • Salehard, Russian Federation
        • Research Site
      • Samara, Russian Federation
        • Research Site
      • Sankt-Petersburg, Russian Federation
        • Research Site
      • Shahti, Russian Federation
        • Research Site
      • Surgut, Russian Federation
        • Research Site
      • Tiva, Russian Federation
        • Research Site
      • Tomsk, Russian Federation
        • Research Site
      • Tver, Russian Federation
        • Research Site
      • Ufa, Russian Federation
        • Research Site
      • Volgodonsk, Russian Federation
        • Research Site
      • Yakutsk, Russian Federation
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologic and/or cytological proven breast cancer.
  • Patients with metastases of breast cancer ± postmenopausal primary tumor ≥12 months.
  • Positive oestrogen receptors (ER+), positive progesterone receptors (PgR+) or unknown hormonal receptors (if duration between surgery and metastasis occurring is not less 2 years) which are indirect confirmation of hormone sensitive tumor.
  • ECOG performance status of ≤ 2
  • Patient willingness to take part in the programm
  • Life expectancy of more than 6 months.
  • Patient ability to complete a questionnaire.

Exclusion Criteria:

  • Contraindications for Faslodex therapy
  • Other anticancer therapy (chemotherapy, hormonal therapy with other drugs, radiotherapy), except for radiotherapy of sites which are not only measurable or evaluable manifestation of disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To study QoL related response, symptom spectrum and severity in disseminated breast cancer patients receiving Faslodex hormonal therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

March 20, 2008

First Submitted That Met QC Criteria

March 20, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

April 22, 2009

Last Update Submitted That Met QC Criteria

April 21, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-ORU-FAS-2007/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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