Breast CancerNCT00860561
Faslodex Post Marketing Surveillance
An observational study of Breast Cancer, run by AstraZeneca at 7 sites in South Korea.
Trial summary
This PMS aims to assess the efficacy, the safety and tolerability profile of Faslodex in everyday practice. Secondary objective of this PMS is to identify the frequency of serious adverse events or any unknown adverse events of Faslodex. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 42 participants
- Where
- 7 sitesSouth Korea
- Study dates
- Jan 2009to Oct 2013
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Postmenopausal women with locally advanced or metastatic breast cancer who have failed 2 or more prior hormone therapies, or were intolerant to prior hormone therapy and have no endocrine therapeutic options.
Who may be able to join
- Postmenopausal women
- Patients who have failed 2 or more prior hormone therapies (The prior hormone therapies should contain both antiestrogen and non-steroidal Aromatase inhibitor)
- Patients who were intolerant to prior hormone therapy and have no endocrine therapeutic options (The prior hormone therapies should contain both antiestrogen and non-steroidal Aromatase inhibitor)
Who cannot join
- The patients who received Faslodex treatment before
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Research Site
Cheonan
Research Site
Daegu
Research Site
Daejeon
Research Site
Iksan
Research Site
Jeonju
Research Site
Seoul
Research Site
Suwon
About this study
This PMS aims to assess the efficacy, the safety and tolerability profile of Faslodex in everyday practice. Secondary objective of this PMS is to identify the frequency of serious adverse events or any unknown adverse events of Faslodex.
- Conditions
- Breast Cancer
- Keywords
- Efficacy profile, Safety profile, Faslodex
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Postmenopausal women with locally advanced or metastatic breast cancer who have failed 2 or more prior hormone therapies, or were intolerant to prior hormone therapy and have no endocrine therapeutic options. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events are confirmed by investigator through asking to patients or patients' voluntary reporting.
Measured: 5 years
Efficacy of Faslodex is assessed by proper method among CT scan, MRI, Ultrasound, etc. The RECIST criteria for target and non-target lesions will be used to evaluate efficacy.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionOct 2013
- Study completionOct 2013
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
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860561
- Sponsor's protocol ID
- D6997L00018
- Status last verified
- Oct 2014
- First submitted
- 11 Mar 2009
- Last updated
- 10 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faslodex Post Marketing Surveillance
- ClinicalTrials.gov ID
- NCT00860561
- Acronym / sponsor ID
- D6997L00018
- Conditions
- Breast Cancer
- Keywords
- Efficacy profile, Safety profile, Faslodex
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 12 Mar 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.
This PMS aims to assess the efficacy, the safety and tolerability profile of Faslodex in everyday practice. Secondary objective of this PMS is to identify the frequency of serious adverse events or any unknown adverse events of Faslodex.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Postmenopausal women with locally advanced or metastatic breast cancer who have failed 2 or more prior hormone therapies, or were intolerant to prior hormone therapy and have no endocrine therapeutic options. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Postmenopausal women with locally advanced or metastatic breast cancer who have failed 2 or more prior hormone therapies, or were intolerant to prior hormone therapy and have no endocrine therapeutic options.
Key inclusion criteria (3 listed)
- Postmenopausal women
- Patients who have failed 2 or more prior hormone therapies (The prior hormone therapies should contain both antiestrogen and non-steroidal Aromatase inhibitor)
- Patients who were intolerant to prior hormone therapy and have no endocrine therapeutic options (The prior hormone therapies should contain both antiestrogen and non-steroidal Aromatase inhibitor)
Key exclusion criteria (1 listed)
- The patients who received Faslodex treatment before
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
Adverse events are confirmed by investigator through asking to patients or patients' voluntary reporting.
Time frame: 5 years
Efficacy of Faslodex is assessed by proper method among CT scan, MRI, Ultrasound, etc. The RECIST criteria for target and non-target lesions will be used to evaluate efficacy.
Time frame: 5 years
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 10 Oct 2014.
- CSR\_Synopsis\_D6997L00018Link provided by the sponsor.
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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.
7 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 7 sites in South Korea.
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 10 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. 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?
Adverse events are confirmed by investigator through asking to patients or patients' voluntary reporting. (time frame: 5 years). 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 10 Oct 2014.