Metastatic Breast CancerNCT01715155
Management of Metastatic Breast Cancer in Clinical Practice - Retrospective Study
An observational study of Metastatic Breast Cancer, run by AstraZeneca at 6 sites in Bulgaria.
Trial summary
The purpose of this study is to evaluate the incidence rate of progression of disease, to describe the diagnostic and clinical management in patients with Metastatic Breast Cancer in the clinical practice in Bulgaria. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- How many people
- 171 participants
- Where
- 6 sitesBulgaria
- Study dates
- Dec 2012to Jun 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients newly diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.
Who may be able to join
- New diagnosis of breast cancer according to ICD-10 with confirmed metastasis
- Confirmed diagnosis between 1st July 2010 and 30th June 2011.
- Female patient managed for her disease at the same setting where final diagnosis of MBC was performed.
Who cannot join
- History of concurrent or other primary malignancies (except curatively resected non-melanoma skin cancer or in situ cervical cancer).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Bulgaria6 sites
Research Site
Pleven
Research Site
Plovdiv
Research Site
Rousse
Research Site
Sofia
Research Site
Stara Zagora
Reaseach Site
Varna
About this study
Official title: A Retrospective Cohort Study on Therapeutic Management of Metastatic Breast Cancer in Clinical Practice in Bulgaria
The purpose of this study is to evaluate the incidence rate of progression of disease, to describe the diagnostic and clinical management in patients with Metastatic Breast Cancer in the clinical practice in Bulgaria.
Read the detailed description
A Retrospective Cohort Study on Therapeutic Management of Metastatic Breast Cancer in Clinical Practice in Bulgaria
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer,, retrospective study,, disease progression,, clinical management
- Medical subject headings
- Breast Neoplasms, Disease Progression
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 |
|---|---|---|
| Female patients diagnosed with metastatic breast cancer | Patients newly diagnosed with metastatic breast cancer, either De Novo or having progressed from a non-metastatic stage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of progression events on a per patient-year-basis
Measured: Up to 2 years 5 months
Secondary outcomes (3)
Proportion of patients among study population who have not progressed at 12 and 18 months after they were diagnosed
Measured: Up to 2 years 5 months
Median and mean time interval that elapsed between diagnosis and first objective tumor progression (TTP) event and subsequent events
Measured: Up to 2 years 5 months
Median and mean time from the date of diagnosis to the date of breast cancer progression or death whichever occurred first
Measured: Up to 2 years 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Retrospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715155
- Sponsor's protocol ID
- NIS-OBG-XXX-2012/1
- Status last verified
- Aug 2013
- First submitted
- 22 Oct 2012
- Last updated
- 22 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cohort Study on Therapeutic Management of Metastatic Breast Cancer in Clinical Practice in Bulgaria
- ClinicalTrials.gov ID
- NCT01715155
- Acronym / sponsor ID
- NIS-OBG-XXX-2012/1
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer,, retrospective study,, disease progression,, clinical management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 26 Oct 2012 (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 purpose of this study is to evaluate the incidence rate of progression of disease, to describe the diagnostic and clinical management in patients with Metastatic Breast Cancer in the clinical practice in Bulgaria.
Detailed description
A Retrospective Cohort Study on Therapeutic Management of Metastatic Breast Cancer in Clinical Practice in Bulgaria
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female patients diagnosed with metastatic breast cancer | – | –Patients newly diagnosed with metastatic breast cancer, either De Novo or having progressed from a non-metastatic stage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients newly diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.
Key inclusion criteria (3 listed)
- New diagnosis of breast cancer according to ICD-10 with confirmed metastasis
- Confirmed diagnosis between 1st July 2010 and 30th June 2011.
- Female patient managed for her disease at the same setting where final diagnosis of MBC was performed.
Key exclusion criteria (1 listed)
- History of concurrent or other primary malignancies (except curatively resected non-melanoma skin cancer or in situ cervical cancer).
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
Number of progression events on a per patient-year-basis
Time frame: Up to 2 years 5 months
3 secondary outcomes
Proportion of patients among study population who have not progressed at 12 and 18 months after they were diagnosed
Time frame: Up to 2 years 5 months
Median and mean time interval that elapsed between diagnosis and first objective tumor progression (TTP) event and subsequent events
Time frame: Up to 2 years 5 months
Median and mean time from the date of diagnosis to the date of breast cancer progression or death whichever occurred first
Time frame: Up to 2 years 5 months
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 Aug 2013.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by AstraZeneca at 6 sites in Bulgaria.
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 22 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Bulgaria. 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?
Number of progression events on a per patient-year-basis (time frame: Up to 2 years 5 months). 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 Aug 2013.