Breast Cancer
Conditions
Keywords
Breast Cancer
Brief 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.
Interventions
None listed
Sponsors
Eisai Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The participants have to meet all of the following criteria to be eligible to enter into the prospective registry: 1. Participants older than 18 years of age 2. Willing and able to provide informed consent 3. Diagnosis of locally advanced or metastatic breast cancer 4. 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 5. Adequate bone marrow, liver, and renal function 6. Life expectancy greater than 12 weeks
Exclusion criteria
Participants meeting the following criteria will not be permitted to enter the study: 1. Prior treatment with eribulin 2. Participants who have received more than two prior chemotherapeutic regimens for advanced disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AEs) and serious adverse events (SAEs) | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | From date of first administration of study drug to date of death or up to approximately 2 years |
| Demographic and clinical characteristics | Up to approximately 2 years |
| Duration of treatment | Historical data collected at Baseline |
| Tumour response | From date of enrollment, Day 1 and Day 8 of every 21 day cycle or up to approximately 2 years |
| Incidence of dose reductions | From date of first administration up to approximately 2 years |
| Relative dose intensity (RDI) of eribulin | From date of first administration up to approximately 2 years |
| Treatment patterns for locally advanced or metastatic breast cancer | Historical data collected at Baseline |
| Incidence of dose delays | From date of first administration up to approximately 2 years |
Countries
Denmark, Ireland, United Kingdom
Outcome results
None listed