Quality Of Life While Receiving Faslodex

NCT ID: NCT00643513

Last Updated: 2009-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-01-31

Brief Summary

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

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Clinical Study Information

Locations

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Research Site

?rasnodar, , Russia

Site Status

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Astrakhan, , Russia

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Blagoveshenk, , Russia

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Chita, , Russia

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Igevsk, , Russia

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Kemerovo, , Russia

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Kursk, , Russia

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Magadan, , Russia

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Moscow, , Russia

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Obninsk, , Russia

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Penza, , Russia

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Petropavlovsk, , Russia

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Rostov, , Russia

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Saint Petersburg, , Russia

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Salekhard, , Russia

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Samara, , Russia

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Shahti, , Russia

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Surgut, , Russia

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Tiva, , Russia

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Tomsk, , Russia

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Tver', , Russia

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Ufa, , Russia

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Volgodonsk, , Russia

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Yakutsk, , Russia

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Countries

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Russia

Other Identifiers

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NIS-ORU-FAS-2007/1

Identifier Type: -

Identifier Source: org_study_id

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