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

NCT03437083 | Completed

• 1 other identifier: E7389-M082-602
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 14

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.

Conditions

Locally Advanced or Metastatic Breast Cancer

Keywords

Breast neoplasms; Metastatic breast cancer; E7389

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• 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)

• 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)

• 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)

• Number of participants with any treatment-emergent adverse event (TEAE)

  6 months

Study Arms (1)

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

Interventions

Eribulin mesylate DRUG

intravenous infusion

Also known as: Halaven, E7389

Eribulin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Confirmed diagnosis of locally advanced or metastatic breast cancer
• Participants who were treated with Eribulin between 01 June, 2014 and 31 December, 2016

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Eisai Korea Inc.: lead

Study Sites (14)

Eisai Trial site_03

Ansan, South Korea

Location

Eisai Trial site_04

Busan, South Korea

Location

Eisai Trial site_05

Busan, South Korea

Location

Eisai Trial site_06

Busan, South Korea

Location

Eisai Trial site_09

Daegu, South Korea

Location

Eisai Trial site_13

Daejeon, South Korea

Location

Eisai Trial site_14

Gwangju, South Korea

Location

Eisai Trial site_01

Seoul, South Korea

Location

Eisai Trial site_02

Seoul, South Korea

Location

Eisai Trial site_07

Seoul, South Korea

Location

Eisai Trial site_10

Seoul, South Korea

Location

Eisai Trial site_11

Seoul, South Korea

Location

Eisai Trial site_12

Seoul, South Korea

Location

Eisai Trial site_08

Suwon, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eribulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: February 19, 2018
• Study Start: January 25, 2018
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: January 25, 2019

Record last verified: 2018-06

Locations

KR (14)