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Study E7389-M044-504 is an observational, post-authorization, single-arm, prospective, multicenter cohort study conducted to characterize and determine the incidence of eribulin-induced peripheral neuropathy (PN), and the frequency and time to resolution of eribulin-induced PN in adult participants treated with eribulin in a real-life setting with locally advanced or metastatic breast cancer (MBC) who have progressed following at least one and up to three chemotherapeutic regimens for advanced disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eribulin-treated participants | Participants treated with eribulin according to Fachinformation and managed according to clinical practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eribulin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing eribulin-induced peripheral neuropathy (PN) | Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first | |
| Percentage of participants experiencing eribulin-induced PN | Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first | |
| Number of participants with the indicated grade of eribulin-induced PN, as determined by Common Terminology Criteria for Adverse Events (CTCAE), grade version 4.0 | Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first | |
| Percentage of participants who experienced dose modifications of eribulin treatment due to eribulin-induced PN | Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first | |
| Percentage of participants who discontinued eribulin treatment due to eribulin-induced PN | Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first | |
| Time to eribulin treatment discontinuation due to eribulin-induced PN | Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first | |
| Number of resolved cases in participants who experience eribulin-induced PN | A resolved case is defined as one that ended or returned to baseline as determined by CTCAE grade version 4.0 |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life scores measured using the Patient Neurotoxicity Questionnaire | Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first | |
| Health-related quality of life scores measured using the EuroQOl-5 Dimensions-3 Levels (EQ-5D-3L) questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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Female participants greater than or equal to (>=) 18 years with locally advanced or MBC
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eisai Trial Site 1 | Amberg | Germany | ||||
| Eisai Trial Site 1 |
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| Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first |
| Percentage of resolved cases in participants who experience eribulin-induced PN | A resolved case is defined as one that ended or returned to baseline as determined by CTCAE grade version 4.0 | Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first |
| Time to resolution of eribulin-induced PN | Time to resolution is defined as the time from onset (or worsening from baseline) to the date of resolution (defined as stop of PN or return to baseline), as determined by CTCAE grade version 4.0. | Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first |
| Number of therapeutic interventions (e.g., analgesics) being used to treat eribulin-induced PN | Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first |
| Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first |
| Time to disease progression | Time to disease progression is defined as the time from the start of eribulin treatment to Investigator assessment of disease progression (clinical or radiological) | Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first |
| Number of participants with any serious adverse event (SAE) and number of participants with any non-serious AE | Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first |
| Percentage of participants with any SAE and percentage of participants with any non-serious AE | Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first |
| Aschaffenburg |
| Germany |
| Eisai Trial Site 2 | Aschaffenburg | Germany |
| Eisai Trial Site 1 | Augsburg | Germany |
| Eisai Trial Site 2 | Augsburg | Germany |
| Eisai Trial Site 1 | Aurich | Germany |
| Eisai Trial Site 1 | Berlin | Germany |
| Eisai Trial Site 2 | Berlin | Germany |
| Eisai Trial Site 3 | Berlin | Germany |
| Eisai Trial Site 1 | Bonn | Germany |
| Eisai Trial Site 2 | Bonn | Germany |
| Eisai Trial Site 1 | Cologne | Germany |
| Eisai Trial Site 2 | Cologne | Germany |
| Eisai Trial Site 1 | Darmstadt | Germany |
| Eisai Trial Site 1 | Donauwörth | Germany |
| EISAI Trial Site 1 | Dresden | Germany |
| Eisai Trial Site 1 | Düren | Germany |
| Eisai Trial Site 1 | Essen | Germany |
| Eisai Trial Site 1 | Esslingen am Neckar | Germany |
| Eisai Trial Site 1 | Eutin | Germany |
| Eisai Trial Site 1 | Freiburg im Breisgau | Germany |
| Eisai Trial Site 1 | Fürstenwalde | Germany |
| Eisai Trial Site 1 | Gelsenkirchen | Germany |
| Eisai Trial Site 1 | Georgsmarienhütte | Germany |
| Eisai Trial Site 1 | Greifswald | Germany |
| Eisai Trial Site 1 | Hanover | Germany |
| Eisai Trial Site 2 | Hanover | Germany |
| Eisai Trial Site 1 | Hof | Germany |
| Eisai Trial Site 1 | Homburg | Germany |
| Eisai Trial Site 1 | Ilsede | Germany |
| Eisai Trial Site 1 | Karlsruhe | Germany |
| Eisai Trial Site 1 | Kassel | Germany |
| Eisai Trial Site 1 | Kiel | Germany |
| Eisai Trial Site 2 | Kiel | Germany |
| Eisai Trial Site 1 | Koblenz | Germany |
| Eisai Trial Site 1 | Lahr | Germany |
| Eisai Trial Site 1 | Landshut | Germany |
| Eisai Trial Site 1 | Lemgo | Germany |
| Eisai Trial Site 1 | Lübeck | Germany |
| Eisai Trial Site 1 | Magdeburg | Germany |
| Eisai Trial Site 1 | Mainz | Germany |
| Eisai Trial Site 1 | Mannheim | Germany |
| Eisai Trial Site 1 | Marktredwitz | Germany |
| Eisai Trial Site 1 | München | Germany |
| Eisai Trial Site 2 | München | Germany |
| Eisai Trial Site 3 | München | Germany |
| Eisai Trial Site 1 | Münster | Germany |
| Eisai Trial Site 1 | Naunhof | Germany |
| Eisai Trial Site 1 | Nuremberg | Germany |
| Eisai Trial Site 1 | Oberhausen | Germany |
| Eisai Trial Site 1 | Offenbach | Germany |
| Eisai Trial Site 1 | Offenburg | Germany |
| Eisai Trial Site 1 | Oldenburg | Germany |
| Eisai Trial Site 1 | Potsdam | Germany |
| Eisai Trial Site 1 | Püttlingen | Germany |
| Eisai Trial Site 1 | Quedlinburg | Germany |
| Eisai Trial Site 1 | Rodgau | Germany |
| Eisai Trial Site 1 | Rotenburg (Wümme) | Germany |
| Eisai Trial Site 1 | Saarlouis | Germany |
| Eisai Trial Site 1 | Stolberg | Germany |
| Eisai Trial Site 1 | Stuttgart | Germany |
| Eisai Trial Site 2 | Stuttgart | Germany |
| Eisai Trial Site 1 | Tübingen | Germany |
| Eisai Trial Site 1 | Villingen-Schwenningen | Germany |
| Eisai Trial Site 1 | Worms | Germany |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C490954 | eribulin |
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