Breast CancerNCT02553850
An Observational Study in Patients With Breast Cancer and Bone Metastases Receiving Ibandronate (Bondronat)
An observational study of Breast Cancer, run by Hoffmann-La Roche at 19 sites in Hungary.
Trial summary
This open non-randomized, single-arm, multicenter, observational study is designed to evaluate the correlation between bone turnover markers and the response to treatment in patients with breast cancer and bone metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 442 participants
- Where
- 19 sitesHungary
- Study dates
- Apr 2007to Jan 2010
- 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: Patients with breast cancer and bone metastases who have been prescribed ibandronate (Bondronat) will be evaluated in the routine oncological setting for 12 months.
Who may be able to join
- All criteria in accordance with the Summary of Product Characteristics of Bondronat (ibandronate)
- Adult patients greater than (>) 18 years of age
- Histologically confirmed breast cancer
- Confirmed bone metastasis (by bone scintigraphy, X-ray, computed tomography or magnetic resonance imaging)
- Life expectancy >6 months
- No previous bisphosphonate therapy
- Patients signed written informed consent form before study start
Who cannot join
- All criteria in accordance with the Summary of Product Characteristics of Bondronat(ibandronate)
- Hypersensitivity to the active substance or any of the excipients of Bondronat (ibandronate)
- Hypersensitivity to bisphosphonates
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Hungary19 sites
Study site
Budapest, 1106
Study site
Budapest, 1125
Study site
Budapest, 1145
Study site
Budapest, 1441
Study site
Debrecen, 4032
Study site
Győr, 9023
Study site
Gyula, 5700
Study site
Kaposvár, 7400
Study site
Nyíregyháza, 4400
Study site
Pécs, 7623
Study site
Szeged, 6720
Study site
Szeged, 6725
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-Pozva, 8900
About this study
Official title: A SURVEY TO STUDY THE CORRELATION BETWEEN THE SERUM LEVELS OF BONE TURNOVER MARKERS AND THE CLINICAL PICTURE IN PATIENTS WITH BREAST CANCER AND BONE METASTASES RECEIVING IBRADONIC ACID TREATMENT
This open non-randomized, single-arm, multicenter, observational study is designed to evaluate the correlation between bone turnover markers and the response to treatment in patients with breast cancer and bone metastases. In this observational study, ibandronate (Bondronat) will be prescribed and used in accordance with the standards of care. Data will be collected for 12 months.
- Conditions
- 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 |
|---|---|---|
| Ibandronate | Patients receiving ibandronate will be evaluated for bone turnover markers for 12 months. Ibandronate is not an investigational medicinal product (IMP) in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta C-terminal telopeptide (B-CTx) level
Measured: 12 months
Treatment response rate
Measured: 12 months
Secondary outcomes (2)
Number of patients who died due to progression of breast cancer
Measured: 12 months
Safety: Incidence of adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startApr 2007
- Primary completionJan 2010
- Study completionJan 2010
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 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
- 442 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
- NCT02553850
- Sponsor's protocol ID
- ML20416
- Status last verified
- Oct 2016
- First submitted
- 8 Sep 2015
- Last updated
- 1 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A SURVEY TO STUDY THE CORRELATION BETWEEN THE SERUM LEVELS OF BONE TURNOVER MARKERS AND THE CLINICAL PICTURE IN PATIENTS WITH BREAST CANCER AND BONE METASTASES RECEIVING IBRADONIC ACID TREATMENT
- ClinicalTrials.gov ID
- NCT02553850
- Acronym / sponsor ID
- ML20416
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 18 Sep 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 open non-randomized, single-arm, multicenter, observational study is designed to evaluate the correlation between bone turnover markers and the response to treatment in patients with breast cancer and bone metastases. In this observational study, ibandronate (Bondronat) will be prescribed and used in accordance with the standards of care. Data will be collected for 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ibandronate | – | –Patients receiving ibandronate will be evaluated for bone turnover markers for 12 months. Ibandronate is not an investigational medicinal product (IMP) in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer and bone metastases who have been prescribed ibandronate (Bondronat) will be evaluated in the routine oncological setting for 12 months.
Key inclusion criteria (7 listed)
- All criteria in accordance with the Summary of Product Characteristics of Bondronat (ibandronate)
- Adult patients greater than (>) 18 years of age
- Histologically confirmed breast cancer
- Confirmed bone metastasis (by bone scintigraphy, X-ray, computed tomography or magnetic resonance imaging)
- Life expectancy >6 months
Key exclusion criteria (3 listed)
- All criteria in accordance with the Summary of Product Characteristics of Bondronat(ibandronate)
- Hypersensitivity to the active substance or any of the excipients of Bondronat (ibandronate)
- Hypersensitivity to bisphosphonates
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
Beta C-terminal telopeptide (B-CTx) level
Time frame: 12 months
Treatment response rate
Time frame: 12 months
2 secondary outcomes
Number of patients who died due to progression of breast cancer
Time frame: 12 months
Safety: Incidence of adverse events
Time frame: 12 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 1 Nov 2016.
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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
19 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 Hoffmann-La Roche at 19 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 7 inclusion and 3 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 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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?
Beta C-terminal telopeptide (B-CTx) level (time frame: 12 months). 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 1 Nov 2016.