Breast CancerNCT00660803
Retrospective Brazilian Study of Fulvestrant in Advanced Breast Cancer
An observational study of Breast Cancer, run by AstraZeneca at 4 sites in Brazil.
Trial summary
Characterize the demographic and clinical features, as well as the main treatment results, among patients with advanced breast cancer treated with fulvestrant in Brazil. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Fulvestrant
- How many people
- 200 participants
- Where
- 4 sitesBrazil
- Study dates
- May 2008to Apr 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: hospitals and primary care clinics
Who may be able to join
- Positive HR or ER by immunohistochemistry
- Postmenopausal status at the time of treatment with fulvestrant
- Failure of at least one previous endocrine therapy before treatment with fulvestrant.
Who cannot join
- Patients who are still undergoing treatment with fulvestrant will not be eligible to participate in the study
Trial locations and contacts
4 sites in 1 country.
Brazil4 sites
Research Site
Porto Alegre, Rio Grande do Sul
Research Site
Recife, Pernambuco
Research Site
Rio de Janeiro, Rio de Janeiro
Research Site
São Paulo, São Paulo
About this study
Characterize the demographic and clinical features, as well as the main treatment results, among patients with advanced breast cancer treated with fulvestrant in Brazil.
- Conditions
- Breast Cancer
- Being tested
- Fulvestrant
- Keywords
- Advanced Breast Cancer, Hormone Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FulvestrantDrug
Also called Faslodex
| Study group | Role | What they receive |
|---|---|---|
| 1 | Postmenopausal women with hormone-receptor positive, advanced breast cancer who have failed at least one previous endocrine therapy and who have been treated at any one of the participating centres with fulvestrant. Receives: Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to tumour progression
Objective response
Secondary outcomes (3)
Duration of treatment with fulvestrant
Time and duration of response
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionApr 2009
- Study completionApr 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
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dendrix - Scientific Information Architecture
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660803
- Sponsor's protocol ID
- NIS-OBR-FAS-2007/1
- Status last verified
- Jan 2010
- First submitted
- 15 Apr 2008
- Last updated
- 21 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Brazilian Study of Fulvestrant in Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00660803
- Acronym / sponsor ID
- NIS-OBR-FAS-2007/1
- Conditions
- Breast Cancer
- Keywords
- Advanced Breast Cancer, Hormone Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Dendrix - Scientific Information Architecture
- Study start
- May 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 17 Apr 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.
Characterize the demographic and clinical features, as well as the main treatment results, among patients with advanced breast cancer treated with fulvestrant in Brazil.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: FulvestrantPostmenopausal women with hormone-receptor positive, advanced breast cancer who have failed at least one previous endocrine therapy and who have been treated at any one of the participating centres with fulvestrant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospitals and primary care clinics
Key inclusion criteria (3 listed)
- Positive HR or ER by immunohistochemistry
- Postmenopausal status at the time of treatment with fulvestrant
- Failure of at least one previous endocrine therapy before treatment with fulvestrant.
Key exclusion criteria (1 listed)
- Patients who are still undergoing treatment with fulvestrant will not be eligible to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FulvestrantAlso: Faslodex | Drug | 1 |
Primary outcome
Time to tumour progression
Objective response
3 secondary outcomes
Duration of treatment with fulvestrant
Time and duration of response
Overall survival
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 21 Jan 2010.
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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.
4 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 4 sites in Brazil.
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 3 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 21 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil. 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?
Time to tumour progression. 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 21 Jan 2010.