Breast Cancer Nos Metastatic RecurrentNCT01711502
Epidemiology and Management of Metastatic Breast Cancer
An observational study of Breast Cancer Nos Metastatic Recurrent, run by AstraZeneca at 15 sites in Romania.
Trial summary
This is a multicenter, national, retrospective chart-review study that will be based on the collection of data from electronical or paper-based medical records with available data on female patients diagnosed with metastatic brest cancer . Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Nos Metastatic Recurrent
- How many people
- 128 participants
- Where
- 15 sitesRomania
- Study dates
- Jan 2013to 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: Female patients diagosed with metastatic breast cance, age > 18 years
Who may be able to join
- Female aged 18 years and over Diagnosis of breast cancer according to ICD-10 diagnostic criteria with confirmed metastasis
- Confirmed diagnosis between 1st July 2010 - 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
15 sites in 1 country.
15 sites in 1 country
Romania15 sites
Doina Coste Gherasim
Baia Mare
Daniel Ciurescu
Brasov
Dana Lucia Stanculeanu
Bucharest
Dragos Median
Bucharest
Mircea Dediu
Bucharest
Rodica Tudor
Bucharest
Alexandru Eniu
Cluj-Napoca
Gabriela Morar Bolba
Cluj-Napoca
Bena Sandra
Craiova
Nelly Cherciu
Craiova
Diana Petroiu
Iași
Simona Angelescu
Targoviste
Cristina Oprean
Timișoara
Stefan Curescu
Timișoara
Cristina Elen Pirau
Vaslui
About this study
Official title: Epidemiology and Therapeutic Management of Metastatic Breast Cancer in Romania: A Retrospective Cohort Study
This is a multicenter, national, retrospective chart-review study that will be based on the collection of data from electronical or paper-based medical records with available data on female patients diagnosed with metastatic brest cancer . The main purpose of this study is to provide accurate, evidence based description on the incidence of progression of metastatic breast cancer and its clinical management.
Read the detailed description
Epidemiology and Therapeutic Management of Metastatic Breast Cancer in Romania: A retrospective cohort study
- Conditions
- Breast Cancer Nos Metastatic Recurrent
- Keywords
- metastatic breast cancer,, epidemiology,, retrospective cohort
- 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 |
|---|---|---|
| Female patients diagosed with metastatic breast cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of progression of disease in a cohort of patients newly diagnosed with MBC, either De Novo or having progressed from a non-metastatic stage
Measured: At 12 and 18 months after diagnosis
Secondary outcomes (6)
The progression free survival (PFS) rates
Measured: At 12 and 18 months after diagnosis
The progression free survival (PFS) time
Measured: At 18 months after diagnosis
Time to progression (TTP)
Measured: At 18 months after diagnosis
The clinical and pathological characteristics of newly diagnosed MBC patients
Measured: At 18 months after diagnosis
The socio-demographic and anthropometric characteristics of newly diagnosed MBC patients
Measured: At 18 months after diagnosis
Health care utilization associated with the disease in Romania
Measured: At 18 months after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startJan 2013
- 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 Breast Cancer Nos Metastatic RecurrentStudies 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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dediu Mrcea, SENIOR PHYSICIAN, Principal investigator, Bucharest Institute of OncologyAlexandru Eniu, SENIOR PHYSICIAN, Principal investigator, Cluj Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711502
- Sponsor's protocol ID
- NIS-ORO-XXX-2012/1
- Status last verified
- Jan 2014
- First submitted
- 18 Oct 2012
- Last updated
- 30 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Therapeutic Management of Metastatic Breast Cancer in Romania: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT01711502
- Acronym / sponsor ID
- NIS-ORO-XXX-2012/1
- Conditions
- Breast Cancer Nos Metastatic Recurrent
- Keywords
- metastatic breast cancer,, epidemiology,, retrospective cohort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 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.
This is a multicenter, national, retrospective chart-review study that will be based on the collection of data from electronical or paper-based medical records with available data on female patients diagnosed with metastatic brest cancer . The main purpose of this study is to provide accurate, evidence based description on the incidence of progression of metastatic breast cancer and its clinical management.
Detailed description
Epidemiology and Therapeutic Management of Metastatic Breast Cancer in Romania: A retrospective cohort study
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female patients diagosed with metastatic breast cancer | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients diagosed with metastatic breast cance, age > 18 years
Key inclusion criteria (3 listed)
- Female aged 18 years and over Diagnosis of breast cancer according to ICD-10 diagnostic criteria with confirmed metastasis
- Confirmed diagnosis between 1st July 2010 - 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
The incidence rate of progression of disease in a cohort of patients newly diagnosed with MBC, either De Novo or having progressed from a non-metastatic stage
Time frame: At 12 and 18 months after diagnosis
6 secondary outcomes
The progression free survival (PFS) rates
Time frame: At 12 and 18 months after diagnosis
The progression free survival (PFS) time
Time frame: At 18 months after diagnosis
Time to progression (TTP)
Time frame: At 18 months after diagnosis
The clinical and pathological characteristics of newly diagnosed MBC patients
Time frame: At 18 months after diagnosis
The socio-demographic and anthropometric characteristics of newly diagnosed MBC patients
Time frame: At 18 months after diagnosis
Health care utilization associated with the disease in Romania
Time frame: At 18 months after diagnosis
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 30 Jan 2014.
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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.
Dediu Mrcea, SENIOR PHYSICIAN principal investigator
Bucharest Institute of Oncology
Alexandru Eniu, SENIOR PHYSICIAN principal investigator
Cluj Institute of Oncology
15 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 Nos Metastatic Recurrent, run by AstraZeneca at 15 sites in Romania.
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 30 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Romania. 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?
The incidence rate of progression of disease in a cohort of patients newly diagnosed with MBC, either De Novo or having progressed from a non-metastatic stage (time frame: At 12 and 18 months after diagnosis). 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 30 Jan 2014.