Quality Of Life While Receiving Faslodex

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00643513
• Other study ID #: NIS-ORU-FAS-2007/1
• Status: Completed
• Phase: N/A
• First received: March 20, 2008
• Last updated: April 21, 2009
• Start date: June 2007
• Est. completion date: January 2009

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Pharmacological Committee, Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Russian Federation	Research Site	?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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study QoL related response, symptom spectrum and severity in disseminated breast cancer patients receiving Faslodex hormonal therapy.