Clinical trial NCT00643513: Quality Of Life While Receiving Faslodex
Official title: Quality Of Life And Symptoms In Postmenopausal Women With Hormone Receptor Positive Disseminated Breast Cancer While Receiving Faslodex.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: QUALITY OF LIFE
POSTMENOPAUSAL WOMEN
HORMONE RECEPTOR POSITIVE DISSEMINATED BREAST CANCER
FASLODEX
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE

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


Eligibility criteria: 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.

Primary outcomes:
measure: To study QoL related response, symptom spectrum and severity in disseminated breast cancer patients receiving Faslodex hormonal therapy.
Secondary outcomes:
Other outcomes:
Locations:
city: ?rasnodar
country: Russian Federation
facility: Research Site
city: Astrahan
country: Russian Federation
facility: Research Site
city: Blagoveshenk
country: Russian Federation
facility: Research Site
city: Chita
country: Russian Federation
facility: Research Site
city: Igevsk
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Kursk
country: Russian Federation
facility: Research Site
city: Magadan
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Obninsk
country: Russian Federation
facility: Research Site
city: Penza
country: Russian Federation
facility: Research Site
city: Petropavlovsk
country: Russian Federation
facility: Research Site
city: Rostov
country: Russian Federation
facility: Research Site
city: Salehard
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
facility: Research Site
city: Sankt-Petersburg
country: Russian Federation
facility: Research Site
city: Shahti
country: Russian Federation
facility: Research Site
city: Surgut
country: Russian Federation
facility: Research Site
city: Tiva
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Tver
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Volgodonsk
country: Russian Federation
facility: Research Site
city: Yakutsk
country: Russian Federation
facility: Research Site
Study officials:
References: