Metastatic Breast CancerNCT02528747
A Survey of Breast Cancer Patients With Metastatic Bone Disease Receiving Oral Ibandronate
An observational study of Metastatic Breast Cancer, run by Hoffmann-La Roche at 25 sites in Hungary.
Trial summary
This observational, multicenter survey is designed to assess the efficacy of oral ibandronate in adults with breast cancer and metastatic bone disease. Data on the use of ibandronate in clinical practice will be collected from Hungarian patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- How many people
- 582 participants
- Where
- 25 sitesHungary
- Study dates
- Jan 2009to Dec 2011
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients with metastatic bone disease who are receiving oral ibandronate will be followed for approximately 1 year.
Who may be able to join
- Adults at least 18 years of age
- Histologically confirmed breast cancer with bone metastasis
- Receiving or indicated for the tablet formulation of ibandronate according to the summary of product characteristics (SmPC) and local labeling
Who cannot join
- Contraindication to ibandronate according to SmPC
- Ongoing participation in any trial evaluating the efficacy and/or safety of ibandronate
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Hungary25 sites
Study site
Budapest, 1031
Study site
Budapest, 1067
Study site
Budapest, 1083
Study site
Budapest, 1106
Study site
Budapest, 1125
Study site
Budapest, 1145
Study site
Budapest, 1441
Study site
Debrecen, 4032
Study site
Debrecen, H-4031
Study site
Győr, 9023
Study site
Gyula, 5700
Study site
Kaposvár, 7400
Study site
Kecskemét, 6000
Study site
Kistarcsa, 2143
Study site
Miskolc, 3501
Study site
Nyíregyháza, 4400
Study site
Pécs, 7623
Study site
Szeged, 6720
Study site
Székesfehérvár, 8000
Study site
Szekszárd, 7100
Study site
Szolnok, 5004
Study site
Szombathely, 9700
Study site
Tatabánya, 2800
Study site
Veszprém, 8200
Study site
Zalaegerszeg, 8900
About this study
Official title: A Multi-Center Observational Survey of Breast Cancer Patients With Metastatic Bone Disease Receiving Oral Ibandronate (BONDORAL)
This observational, multicenter survey is designed to assess the efficacy of oral ibandronate in adults with breast cancer and metastatic bone disease. Data on the use of ibandronate in clinical practice will be collected from Hungarian patients.
- Conditions
- Metastatic Breast Cancer
- 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 |
|---|---|---|
| Study population | Breast cancer patients with metastatic bone disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone pain according to Visual Analog Scale (VAS) score
Measured: From Baseline to the end of 1 year
Secondary outcomes (2)
Compliance with tablet formulation of ibandronate according to Case Report Form (CRF) questionnaire
Measured: Up to approximately 1 year
Incidence of adverse events
Measured: Up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionDec 2011
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 Hoffmann-La RocheThe 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
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528747
- Sponsor's protocol ID
- ML22421
- Status last verified
- Aug 2015
- First submitted
- 6 Aug 2015
- Last updated
- 19 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Observational Survey of Breast Cancer Patients With Metastatic Bone Disease Receiving Oral Ibandronate (BONDORAL)
- ClinicalTrials.gov ID
- NCT02528747
- Acronym / sponsor ID
- ML22421
- Conditions
- Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Aug 2015 (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 observational, multicenter survey is designed to assess the efficacy of oral ibandronate in adults with breast cancer and metastatic bone disease. Data on the use of ibandronate in clinical practice will be collected from Hungarian patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | –Breast cancer patients with metastatic bone disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients with metastatic bone disease who are receiving oral ibandronate will be followed for approximately 1 year.
Key inclusion criteria (3 listed)
- Adults at least 18 years of age
- Histologically confirmed breast cancer with bone metastasis
- Receiving or indicated for the tablet formulation of ibandronate according to the summary of product characteristics (SmPC) and local labeling
Key exclusion criteria (2 listed)
- Contraindication to ibandronate according to SmPC
- Ongoing participation in any trial evaluating the efficacy and/or safety of ibandronate
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
Change in bone pain according to Visual Analog Scale (VAS) score
Time frame: From Baseline to the end of 1 year
2 secondary outcomes
Compliance with tablet formulation of ibandronate according to Case Report Form (CRF) questionnaire
Time frame: Up to approximately 1 year
Incidence of adverse events
Time frame: Up to approximately 1 year
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 19 Aug 2015.
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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.
Clinical Trials study director
Hoffmann-La Roche
25 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 Hoffmann-La Roche at 25 sites in Hungary.
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 2 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 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Hungary. 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?
Change in bone pain according to Visual Analog Scale (VAS) score (time frame: From Baseline to the end of 1 year). 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 19 Aug 2015.