NCT00643513

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

24 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, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

April 22, 2009

Status Verified

April 1, 2009

First QC Date

March 20, 2008

Last Update Submit

April 21, 2009

Conditions

Keywords

QUALITY OF LIFEPOSTMENOPAUSAL WOMENHORMONE RECEPTOR POSITIVE DISSEMINATED BREAST CANCERFASLODEX

Outcome Measures

Primary Outcomes (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Research Site

?rasnodar, Russia

Location

Research Site

Astrakhan, Russia

Location

Research Site

Blagoveshenk, Russia

Location

Research Site

Chita, Russia

Location

Research Site

Igevsk, Russia

Location

Research Site

Kemerovo, Russia

Location

Research Site

Kursk, Russia

Location

Research Site

Magadan, Russia

Location

Research Site

Moscow, Russia

Location

Research Site

Obninsk, Russia

Location

Research Site

Penza, Russia

Location

Research Site

Petropavlovsk, Russia

Location

Research Site

Rostov, Russia

Location

Research Site

Saint Petersburg, Russia

Location

Research Site

Salekhard, Russia

Location

Research Site

Samara, Russia

Location

Research Site

Shahti, Russia

Location

Research Site

Surgut, Russia

Location

Research Site

Tiva, Russia

Location

Research Site

Tomsk, Russia

Location

Research Site

Tver', Russia

Location

Research Site

Ufa, Russia

Location

Research Site

Volgodonsk, Russia

Location

Research Site

Yakutsk, Russia

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 20, 2008

First Posted

March 26, 2008

Study Start

June 1, 2007

Study Completion

January 1, 2009

Last Updated

April 22, 2009

Record last verified: 2009-04

Locations