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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From date of first administration of study drug up to 30 days after last administration of study drug or until approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Tumour response | From date of enrollment, Day 1 and Day 8 of every 21 day cycle or up to approximately 2 years | |
| Overall survival (OS) | From date of first administration of study drug to date of death or up to approximately 2 years |
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Inclusion Criteria
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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Hartmut Kristeleit | Guy's Hospital, Great Maze Pond | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus | Denmark | |||||
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| Demographic and clinical characteristics | Up to approximately 2 years |
| Duration of treatment | Historical data collected at Baseline |
| Incidence of dose delays | From date of first administration 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 |
| Copenhagen |
| Denmark |
| Dublin | Ireland |
| Bath | United Kingdom |
| Cottingham | United Kingdom |
| Derby | United Kingdom |
| London | United Kingdom |
| Maidstone | United Kingdom |
| Manchester | United Kingdom |
| Norwich | United Kingdom |
| Oxford | United Kingdom |
| Plymouth | United Kingdom |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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