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

January 24, 2019 updated by: Eisai Korea Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
340

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: 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)
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)
Time Frame: 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)
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)
Time Frame: From the first treatment with eribulin to discontinuation of treatment for any reason (1 day to up to approximately 2 years)
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)
Time Frame: 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)
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)
Time Frame: 6 months
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)
Time Frame: 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)
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)
Time Frame: 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)
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)
Time Frame: From the first treatment with eribulin to discontinuation of treatment for any reason (1 day to up to approximately 2 years)
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)
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: From the first treatment with eribulin to discontinuation of treatment for any reason (1 day to up to approximately 2 years)
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
Time Frame: 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)
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
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
Treatment of adverse events will be collected retrospectively.
6 months
Median number of eribulin cycles
Time Frame: 6 months
Data will be collected to observe a treatment pattern of eribulin in the real world.
6 months
Number of participants experiencing a dose reduction
Time Frame: 6 months
Data will be collected to observe a treatment pattern of eribulin in the real world.
6 months
Mean duration of treatment
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
Data will be collected to observe a treatment pattern of eribulin in the real world.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eisai Korea Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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