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

Eisai Korea Inc.14 sites in 1 country340 target enrollmentJanuary 25, 2018

ConditionsLocally Advanced or Metastatic Breast Cancer

InterventionsEribulin mesylate

DrugsEribulin mesylate

Overview

Phase: Not Applicable
Intervention: Eribulin mesylate
Conditions: Locally Advanced or Metastatic Breast Cancer
Sponsor: Eisai Korea Inc.
Enrollment: 340
Locations: 14
Primary Endpoint: Progression-free survival (PFS) rate at 6 months
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 25, 2018

End Date

June 30, 2018

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Eisai Korea Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: Eribulin mesylate

Outcomes

Primary Outcomes

Progression-free survival (PFS) rate at 6 months

Time Frame: 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.

Secondary Outcomes

Tumor response rate (TRR)(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 in eribulin-treated breast cancer participants according to line of treatment for advanced disease and tumor subtype (receptor status and molecular subtype)(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))
TRR in eribulin-treated breast cancer participants according to line of treatment for advanced disease and tumor subtype (receptor status and molecular subtype)(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))
Progression-Free Survival (PFS)(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))
Number of participants with any treatment-emergent adverse event (TEAE)(6 months)
Overall Survival (OS)(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)(From the first treatment with eribulin to discontinuation of treatment for any reason (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)(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(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(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(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(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(6 months)
Number of participants with TEAEs resulting in discontinuation of eribulin(6 months)
Number of participants using supportive drugs to treat AEs(6 months)
Median number of eribulin cycles(6 months)
Number of participants experiencing a dose reduction(6 months)
TTF in eribulin-treated breast cancer participants according to line of treatment for advanced disease and tumor subtype (receptor status and molecular subtype)(From the first treatment with eribulin to discontinuation of treatment for any reason (1 day to up to approximately 2 years))
Mean duration of treatment(6 months)
Mean duration of response(6 months)
Mean dose intensity(6 months)
Number of participants with the indicated reason for treatment discontinuation(6 months)