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

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

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.

Study Overview

• Status: Completed
• Conditions: Locally Advanced or Metastatic Breast Cancer
• Intervention / Treatment: Drug: Eribulin mesylate

• Study Type: Observational
• Enrollment (Actual): 340

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ansan, Korea, Republic of
    • Eisai Trial site_03
  • Busan, Korea, Republic of
    • Eisai Trial site_04
  • Busan, Korea, Republic of
    • Eisai Trial site_05
  • Busan, Korea, Republic of
    • Eisai Trial site_06
  • Daegu, Korea, Republic of
    • Eisai Trial site_09
  • Daejeon, Korea, Republic of
    • Eisai Trial site_13
  • Gwangju, Korea, Republic of
    • Eisai Trial site_14
  • Seoul, Korea, Republic of
    • Eisai Trial site_01
  • Seoul, Korea, Republic of
    • Eisai Trial site_02
  • Seoul, Korea, Republic of
    • Eisai Trial site_07
  • Seoul, Korea, Republic of
    • Eisai Trial site_10
  • Seoul, Korea, Republic of
    • Eisai Trial site_11
  • Seoul, Korea, Republic of
    • Eisai Trial site_12
  • Suwon, Korea, Republic of
    • Eisai Trial site_08

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Male and female participants diagnosed with locally advanced or metastatic breast cancer, who had experience with eribuin-treatment

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Eribulin; 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; intravenous infusion; Other Names: Halaven; E7389

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eisai Korea Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2018
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 25, 2019
• Last Update Submitted That Met QC Criteria: January 24, 2019
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Metastatic breast cancer; Breast neoplasms; E7389
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: E7389-M082-602

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No