Breast CancerNCT00643513
Quality Of Life While Receiving Faslodex
An observational study of Breast Cancer, run by AstraZeneca at 24 sites in Russia.
Trial summary
To study QoL related response, symptom spectrum and severity in disseminated breast cancer patients receiving Faslodex hormonal therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 120 participants
- Where
- 24 sitesRussia
- Study dates
- Jun 2007to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Russia24 sites
Research Site
?rasnodar
Research Site
Astrakhan
Research Site
Blagoveshenk
Research Site
Chita
Research Site
Igevsk
Research Site
Kemerovo
Research Site
Kursk
Research Site
Magadan
Research Site
Moscow
Research Site
Obninsk
Research Site
Penza
Research Site
Petropavlovsk
Research Site
Rostov-on-Don
Research Site
Saint Petersburg
Research Site
Salekhard
Research Site
Samara
Research Site
Shahti
Research Site
Surgut
Research Site
Tiva
Research Site
Tomsk
Research Site
Tver'
Research Site
Ufa
Research Site
Volgodonsk
Research Site
Yakutsk
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Keywords
- QUALITY OF LIFE, POSTMENOPAUSAL WOMEN, HORMONE RECEPTOR POSITIVE DISSEMINATED BREAST CANCER, FASLODEX
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To study QoL related response, symptom spectrum and severity in disseminated breast cancer patients receiving Faslodex hormonal therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startJun 2007
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643513
- Sponsor's protocol ID
- NIS-ORU-FAS-2007/1
- Status last verified
- Apr 2009
- First submitted
- 20 Mar 2008
- Last updated
- 22 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Of Life And Symptoms In Postmenopausal Women With Hormone Receptor Positive Disseminated Breast Cancer While Receiving Faslodex.
- ClinicalTrials.gov ID
- NCT00643513
- Acronym / sponsor ID
- NIS-ORU-FAS-2007/1
- Conditions
- Breast Cancer
- Keywords
- QUALITY OF LIFE, POSTMENOPAUSAL WOMEN, HORMONE RECEPTOR POSITIVE DISSEMINATED BREAST CANCER, FASLODEX
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Study completion
- Jan 2009 (actual)
- First posted
- 26 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study QoL related response, symptom spectrum and severity in disseminated breast cancer patients receiving Faslodex hormonal therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To study QoL related response, symptom spectrum and severity in disseminated breast cancer patients receiving Faslodex hormonal therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by AstraZeneca at 24 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study QoL related response, symptom spectrum and severity in disseminated breast cancer patients receiving Faslodex hormonal therapy.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2009.