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

NCT ID: NCT03437083

Last Updated: 2019-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

340 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-25

Study Completion Date

2018-06-30

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.

Detailed Description

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Conditions

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Locally Advanced or Metastatic Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Eribulin mesylate

Intervention Type DRUG

intravenous infusion

Interventions

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Eribulin mesylate

intravenous infusion

Intervention Type DRUG

Other Intervention Names

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Halaven E7389

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Korea Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eisai Trial site_03

Ansan, , South Korea

Site Status

Eisai Trial site_04

Busan, , South Korea

Site Status

Eisai Trial site_05

Busan, , South Korea

Site Status

Eisai Trial site_06

Busan, , South Korea

Site Status

Eisai Trial site_09

Daegu, , South Korea

Site Status

Eisai Trial site_13

Daejeon, , South Korea

Site Status

Eisai Trial site_14

Gwangju, , South Korea

Site Status

Eisai Trial site_01

Seoul, , South Korea

Site Status

Eisai Trial site_02

Seoul, , South Korea

Site Status

Eisai Trial site_07

Seoul, , South Korea

Site Status

Eisai Trial site_10

Seoul, , South Korea

Site Status

Eisai Trial site_11

Seoul, , South Korea

Site Status

Eisai Trial site_12

Seoul, , South Korea

Site Status

Eisai Trial site_08

Suwon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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E7389-M082-602

Identifier Type: -

Identifier Source: org_study_id

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