Breast CancerNCT02443428
Eribulin Use for the Treatment of Advanced Breast Cancer: A Prospective Observational Registry
An observational study of Breast Cancer, run by Eisai Limited at 12 sites in 3 countries.
Trial summary
The purpose of this prospective observational registry is to monitor safety of eribulin in routine clinical practice. Additionally, this study will also assess the effectiveness of eribulin in real-life settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- Type of treatment
- Injection or infusion
- How many people
- 77 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Aug 2013to Oct 2015
- 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: Participants with locally advanced or metastatic breast cancer who have progressed after up to two chemotherapeutic regimens for advanced disease will be prospectively included in the registry. Prior therapy should have included an anthracycline and a taxanes unless the patient was not suitable for these treatments.
Who may be able to join
- The participants have to meet all of the following criteria to be eligible to enter into the prospective registry:
- Participants older than 18 years of age
- Willing and able to provide informed consent
- Diagnosis of locally advanced or metastatic breast cancer
- Progression after up to two previous chemotherapy regimens for advanced disease. Prior therapy should have included an anthracycline and a taxanes in either the adjuvant or advanced setting unless not suitable
- Adequate bone marrow, liver, and renal function
- Life expectancy greater than 12 weeks
Who cannot join
- Participants meeting the following criteria will not be permitted to enter the study:
- Prior treatment with eribulin
- Participants who have received more than two prior chemotherapeutic regimens for advanced disease
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United Kingdom9 sites
Study site
Bath
Study site
Cottingham
Study site
Derby
Study site
London
Study site
Maidstone
Study site
Manchester
Study site
Norwich
Study site
Oxford
Study site
Plymouth
About this study
Official title: Eribulin (HALAVEN) Use for the Treatment of Advanced Breast Cancer: A Prospective Observational Registry
The purpose of this prospective observational registry is to monitor safety of eribulin in routine clinical practice. Additionally, this study will also assess the effectiveness of eribulin in real-life settings.
- Conditions
- Breast Cancer
- Keywords
- 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 |
|---|---|---|
| Eribulin Mesilate | Participants will be treated in accordance with normal clinical practice. The recommend dose of eribulin is 1.23 mg/m2 administered intravenously on days 1 and 8 of every 21-day cycle. Treatment with eribulin is continued until disease progression, onset of unacceptable drug toxicities, or participant/physician's request to discontinue. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Safety assessment will consist of monitoring of all AEs, including SAEs at every visit. All participants will be evaluable for safety from the time of their first treatment with eribulin.
Measured: From date of first administration of study drug up to 30 days after last administration of study drug or until approximately 2 years
Secondary outcomes (8)
Tumour response
Measured: From date of enrollment, Day 1 and Day 8 of every 21 day cycle or up to approximately 2 years
Overall survival (OS)
Measured: From date of first administration of study drug to date of death or up to approximately 2 years
Demographic and clinical characteristics
Measured: Up to approximately 2 years
Duration of treatment
Measured: Historical data collected at Baseline
Incidence of dose delays
Measured: From date of first administration up to approximately 2 years
Incidence of dose reductions
Measured: From date of first administration up to approximately 2 years
Relative dose intensity (RDI) of eribulin
Measured: From date of first administration up to approximately 2 years
Treatment patterns for locally advanced or metastatic breast cancer
Measured: Historical data collected at Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startAug 2013
- Primary completionOct 2015
- Study completionOct 2015
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.
- 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
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hartmut Kristeleit, Study director, Guy's Hospital, Great Maze Pond
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443428
- Sponsor's protocol ID
- OBU-N-H-01
- Status last verified
- Apr 2016
- First submitted
- 11 May 2015
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eribulin (HALAVEN) Use for the Treatment of Advanced Breast Cancer: A Prospective Observational Registry
- ClinicalTrials.gov ID
- NCT02443428
- Acronym / sponsor ID
- OBU-N-H-01
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Eisai LimitedIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 May 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.
The purpose of this prospective observational registry is to monitor safety of eribulin in routine clinical practice. Additionally, this study will also assess the effectiveness of eribulin in real-life settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eribulin Mesilate | – | –Participants will be treated in accordance with normal clinical practice. The recommend dose of eribulin is 1.23 mg/m2 administered intravenously on days 1 and 8 of every 21-day cycle. Treatment with eribulin is continued until disease progression, onset of unacceptable drug toxicities, or participant/physician's request to discontinue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with locally advanced or metastatic breast cancer who have progressed after up to two chemotherapeutic regimens for advanced disease will be prospectively included in the registry. Prior therapy should have included an anthracycline and a taxanes unless the patient was not suitable for these treatments.
Key inclusion criteria (7 listed)
- The participants have to meet all of the following criteria to be eligible to enter into the prospective registry:
- Participants older than 18 years of age
- Willing and able to provide informed consent
- Diagnosis of locally advanced or metastatic breast cancer
- Progression after up to two previous chemotherapy regimens for advanced disease. Prior therapy should have included an anthracycline and a taxanes in either the adjuvant or advanced setting unless not suitable
Key exclusion criteria (3 listed)
- Prior treatment with eribulin
- Participants who have received more than two prior chemotherapeutic regimens for advanced disease
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 participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: From date of first administration of study drug up to 30 days after last administration of study drug or until approximately 2 years
Safety assessment will consist of monitoring of all AEs, including SAEs at every visit. All participants will be evaluable for safety from the time of their first treatment with eribulin.
8 secondary outcomes
Tumour response
Time frame: From date of enrollment, Day 1 and Day 8 of every 21 day cycle or up to approximately 2 years
Overall survival (OS)
Time frame: From date of first administration of study drug to date of death or up to approximately 2 years
Demographic and clinical characteristics
Time frame: Up to approximately 2 years
Duration of treatment
Time frame: Historical data collected at Baseline
Incidence of dose delays
Time frame: From date of first administration up to approximately 2 years
Incidence of dose reductions
Time frame: From date of first administration up to approximately 2 years
Relative dose intensity (RDI) of eribulin
Time frame: From date of first administration up to approximately 2 years
Treatment patterns for locally advanced or metastatic breast cancer
Time frame: Historical data collected at Baseline
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 15 Apr 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.
Hartmut Kristeleit study director
Guy's Hospital, Great Maze Pond
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Eisai Limited at 12 sites in 3 countries.
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 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom, Denmark, Ireland. 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 participants with adverse events (AEs) and serious adverse events (SAEs) (time frame: From date of first administration of study drug up to 30 days after last administration of study drug or until approximately 2 years). 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 15 Apr 2016.