Breast CancerFRAMENCT00878930
Parameters of Acceptability, Compliance and Efficacy of Fulvestrant in Post-menopausal Patients With Advance Breast Cancer
An observational study of Breast Cancer, run by AstraZeneca at 16 sites in Argentina.
Trial summary
The objectives of this study is to obtain information of Faslodex use in the treatment of breast cancer in the clinical practice in Argentina. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 500 participants
- Where
- 16 sitesArgentina
- Study dates
- Apr 2009to Dec 2010
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Post-menopausal women with advanced breast cancer hormone receptor-positive who have progressed to a one prior hormone therapy.
Who may be able to join
- Postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer with recurrence during or after adjuvant anti-estrogen therapy or disease progression during anti-estrogen treatment, currently receiving Faslodex
- Signature of the informed consent
Who cannot join
- Any contraindication to Faslodex administration
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Argentina16 sites
Research Site
Bahía Blanca, Buenos Aires
Research Site
Campana, Buenos Aires
Research Site
Ciudad de Buenos Aires, Buenos Aires
Research Site
Córdoba, Córdoba Province
Research Site
La Plata, Buenos Aires
Research Site
Mar del Plata, Buenos Aires
Research Site
Mendoza, Mendoza Province
Research Site
Morón, Buenos Aires
Research Site
Pergamino, Buenos Aires
Research Site
Rio Grande, Tierra del Fuego Province
Research Site
Rosario, Santa Fe Province
Research Site
San Martín, Buenos Aires
Research Site
San Miguel de Tucumán, Tucumán Province
Research Site
Santa Rosa, La Pampa Province
Research Site
Tandil, Buenos Aires
Research Site
Vicente López, Buenos Aires
About this study
Official title: Non-interventional Report on Parameters of Acceptability, Efficacy and Compliance of Fulvestrant in Post-menopausal Patients With Advanced Breast Cancer HR Positive Who Progresses to One Prior Endocrine Therapy With Antiestrogens
The objectives of this study is to obtain information of Faslodex use in the treatment of breast cancer in the clinical practice in Argentina.
Read the detailed description
In Argentina, Faslodex is indicated for treating postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer with recurrence during or after adjuvant anti-oestrogen therapy or disease progression during anti-oestrogen treatment. This study will provide information regarding the acceptability and compliance of Argentina patients to Faslodex and will provide information regarding the efficacy of this treatment in local population.
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Fulvestrant, Faslodex, Acceptability, Compliance, Efficacy
- Medical subject headings
- Breast Neoplasms, Patient Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
To collect real life data of acceptability and compliance on the use of Faslodex in the Argentine population.
Measured: monthly
To collect real life data of efficacy on the use of Faslodex in the Argentine population.
Measured: monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2010
- Study completionDec 2010
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878930
- Sponsor's protocol ID
- NIS-OAR-FAS-2008/1
- Acronym
- FRAME
- Status last verified
- Jan 2011
- First submitted
- 8 Apr 2009
- Last updated
- 5 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Report on Parameters of Acceptability, Efficacy and Compliance of Fulvestrant in Post-menopausal Patients With Advanced Breast Cancer HR Positive Who Progresses to One Prior Endocrine Therapy With Antiestrogens
- ClinicalTrials.gov ID
- NCT00878930
- Acronym / sponsor ID
- FRAME / NIS-OAR-FAS-2008/1
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Fulvestrant, Faslodex, Acceptability, Compliance, Efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 9 Apr 2009 (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.
The objectives of this study is to obtain information of Faslodex use in the treatment of breast cancer in the clinical practice in Argentina.
Detailed description
In Argentina, Faslodex is indicated for treating postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer with recurrence during or after adjuvant anti-oestrogen therapy or disease progression during anti-oestrogen treatment. This study will provide information regarding the acceptability and compliance of Argentina patients to Faslodex and will provide information regarding the efficacy of this treatment in local population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post-menopausal women with advanced breast cancer hormone receptor-positive who have progressed to a one prior hormone therapy.
Key inclusion criteria (2 listed)
- Postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer with recurrence during or after adjuvant anti-estrogen therapy or disease progression during anti-estrogen treatment, currently receiving Faslodex
- Signature of the informed consent
Key exclusion criteria (1 listed)
- Any contraindication to Faslodex administration
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 collect real life data of acceptability and compliance on the use of Faslodex in the Argentine population.
Time frame: monthly
To collect real life data of efficacy on the use of Faslodex in the Argentine population.
Time frame: monthly
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 5 Jan 2011.
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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.
16 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 16 sites in Argentina.
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 2 inclusion and 1 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 5 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Argentina. 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 collect real life data of acceptability and compliance on the use of Faslodex in the Argentine population. (time frame: monthly). The study lists 2 primary outcomes in all. 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 5 Jan 2011.