Halaven Post-Marketing Surveillance (PMS)

Post-Marketing Surveillance of Halaven Injection in Korean Patients

This is a PMS to observe the safety profile of Halaven in normal clinical practice setting.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Actual): 3000

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
  • Chuncheongnam-do, Korea, Republic of
  • Chungcheongbuk-do, Korea, Republic of
  • Chungcheongnam-do, Korea, Republic of
  • Daegu, Korea, Republic of
  • Gwangju, Korea, Republic of
  • Gyeonggi-do, Korea, Republic of
  • Gyeongsanbuk-do, Korea, Republic of
  • Gyeongsannam-do, Korea, Republic of
  • Jeollabuk-do, Korea, Republic of
  • Jeollanam-do, Korea, Republic of
  • Seoul, Korea, Republic of

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Participants who are prescribed with Halaven per approved prescribing information of Halaven will be enrolled in the study.

Description

Participants who are prescribed with Halaven per approved prescribing information of Halaven will be enrolled in the study. This study will be conducted as complete surveillance method; participants who meet the inclusion/exclusion criteria and administrate Halaven for the first time after conclusion of agreement will be enrolled after consent.

Inclusion Criteria:

Participants who meet all of the following criteria will be eligible for inclusion in the study:

1. Participants with following indication: Participants with locally advanced or metastatic breast cancer who have previously received at least two chemotherapeutic regimens which should have included an anthracycline and a taxane.
2. Participants who have verbal or written consent for use of personal and medical information.

Investigators will refer to indications regarding inclusion criteria.

Exclusion Criteria:

1. Hypersensitivity to the active substance or to any of the excipients
2. Breast feeding
3. Pregnancy

Investigators will refer to indications and contraindications regarding exclusion criteria.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Halaven; Participants who are prescribed with Halaven per approved prescribing information of Halaven.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety of Halaven as a measure of number of participants with adverse events/serious adverse events/adverse drug reactions	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Tumor response to Halaven treatment	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Eisai Korea Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: May 8, 2015
• First Submitted That Met QC Criteria: May 8, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Eribulin Mesylate; Halaven; locally advanced or metastatic breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: EKI-PMS-1201