An observational study in Breast Cancer, sponsored by Eisai Limited. Completed at 12 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-15.
Sponsored by Eisai Limited · Observational
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 77 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Eisai Limited is the lead sponsor of 44 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
The participants have to meet all of the following criteria to be eligible to enter into the prospective registry:
Exclusion Criteria
Participants meeting the following criteria will not be permitted to enter the study:
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.
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.
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
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
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Eisai Limited