A Study to Investigate the Efficacy and Safety of Eribulin in Korean Breast Cancer Participants

Study Overview
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Brief Summary
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The primary objective of the study is to observe efficacy in terms of progression-free survival rate at 6 months in eribulin-treated breast cancer participants retrospectively.

Official Title
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A Nationwide, Multi-institutional Retrospective Study of Efficacy and Safety of Eribulin in Korean Breast Cancer Patients

Conditions
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Locally Advanced or Metastatic Breast Cancer

Intervention / Treatment
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* Drug: Eribulin mesylate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of locally advanced or metastatic breast cancer Participants who were treated with Eribulin between 01 June, 2014 and 31 December, 2016 Exclusion Criteria: Not applicable
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eribulin<br>Eribulin was administered at a dose of 1.4 milligrams per meters squared (mg/m^2) (as eribulin 1.23 mg/m^2) by a 2- to 5-minute intravenous infusion or as a diluted solution on Day 1 and Day 8 every 21 days. | Drug: Eribulin mesylate<br>* intravenous infusion<br>* Other names: E7389;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) rate at 6 months | PFS rate at 6 months is estimated based on the tumor response evaluation and is defined as the proportion of participants alive and progression-free at 6 months from the initial treatment of eribulin. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) | PFS is defined as the time from the start date of therapy with eribulin to the date of disease progression or death from any cause. Participants without progression will be censored, progression free at the date of late follow-up. | From the start date of therapy with eribulin to the date of disease progression or death from any cause (1 day to up to approximately 2 years) | 
| Overall Survival (OS) | OS is defined as the time from the start date of therapy with eribulin to the date of death from any cause or last follow-up. | From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years) | 
| Time to treatment failure (TTF) | TTF is defined as a time from first treatment with eribulin to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death. | From the first treatment with eribulin to discontinuation of treatment for any reason (1 day to up to approximately 2 years) | 
| Tumor response rate (TRR) | TRR will be evaluated by medical records. ORR is defined as the sum of obtained PR and CR and the clinical benefit rate (CBR) is defined as the sum of PR, CR and stable disease (SD) maintained for at least six months. Disease control rate (DCR) is defined as the sum of PR, CR and SD. | From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years) | 
| Number of participants with any treatment-emergent adverse event (TEAE) | An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. | 6 months | 
| PFS in eribulin-treated breast cancer participants according to line of treatment for advanced disease and tumor subtype (receptor status and molecular subtype) | PFS is defined as the time from the start date of therapy with eribulin to the date of disease progression or death from any cause. Participants without progression will be censored, progression free at the date of late follow-up. | From the start date of therapy with eribulin to the date of disease progression or death from any cause (1 day to up to approximately 2 years) | 
| OS in eribulin-treated breast cancer participants according to line of treatment for advanced disease and tumor subtype (receptor status and molecular subtype) | OS is defined as the time from the start date of therapy with eribulin to the date of death from any cause or last follow-up. | From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years) | 
| TTF in eribulin-treated breast cancer participants according to line of treatment for advanced disease and tumor subtype (receptor status and molecular subtype) | TTF is defined as a time from first treatment with eribulin to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death. | From the first treatment with eribulin to discontinuation of treatment for any reason (1 day to up to approximately 2 years) | 
| TRR in eribulin-treated breast cancer participants according to line of treatment for advanced disease and tumor subtype (receptor status and molecular subtype) | TRR will be evaluated by medical records. ORR is defined as the sum of obtained PR and CR and the CBR is defined as the sum of PR, CR and SD maintained for at least six months. DCR is defined as the sum of PR, CR and SD. | From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years) | 
| PFS rate in eribulin-treated breast cancer participants comparing early (≤ third line) to late (≥ fourth line) use | PFS is defined as the time from the start date of therapy with eribulin to the date of disease progression or death from any cause. Participants without progression will be censored, progression free at the date of late follow-up. | From the start date of therapy with eribulin to the date of disease progression or death from any cause (1 day to up to approximately 2 years) | 
| OS in eribulin-treated breast cancer participants comparing early (≤ third line) to late (≥ fourth line) use | OS is defined as the time from the start date of therapy with eribulin to the date of death from any cause or last follow-up. | From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years) | 
| TTF in eribulin-treated breast cancer participants comparing early (≤ third line) to late (≥ fourth line) use | TTF is defined as a time from first treatment with eribulin to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death. | From the first treatment with eribulin to discontinuation of treatment for any reason (1 day to up to approximately 2 years) | 
| TRR in eribulin-treated breast cancer participants comparing early (≤third line) to late (≥ fourth line) use | TRR will be evaluated by medical records. ORR is defined as the sum of obtained (PR) and CR and the CBR is defined as the sum of PR, CR and SD maintained for at least 6 months. DCR is defined as the sum of PR, CR and SD. | From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years) | 
| Number of participants with the indicated action to TEAEs | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. | 6 months | 
| Number of participants with TEAEs resulting in discontinuation of eribulin | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. | 6 months | 
| Number of participants using supportive drugs to treat AEs | Treatment of adverse events will be collected retrospectively. | 6 months | 
| Median number of eribulin cycles | Data will be collected to observe a treatment pattern of eribulin in the real world. | 6 months | 
| Number of participants experiencing a dose reduction | Data will be collected to observe a treatment pattern of eribulin in the real world. | 6 months | 
| Mean duration of treatment | Duration of treatment is defined as the time from documentation of the start of eribulin treatment to the date of permanent discontinuation. | 6 months | 
| Mean duration of response | Duration of response is defined as the time from the first documented evidence of CR or PR (whichever status is recorded first) until the first documented sign of disease progression or death due to any cause. | 6 months | 
| Mean dose intensity | Dose intensity is defined as the amount of drug milligrams per meters squared (mg/m^2) delivered to a participant in a week of treatment. | 6 months | 
| Number of participants with the indicated reason for treatment discontinuation | Data will be collected to observe a treatment pattern of eribulin in the real world. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast neoplasms, Metastatic breast cancer, E7389