Halaven Post-Marketing Surveillance (PMS)

Post-Marketing Surveillance of Halaven Injection in Korean Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02441764

Enrollment

3000

Registered

2015-05-12

Start date

2013-03-31

Completion date

2018-08-31

Last updated

2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Halaven, Eribulin Mesylate, locally advanced or metastatic breast cancer

Brief summary

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

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

Measure	Time frame
Tumor response to Halaven treatment	Up to 12 weeks

Countries

South Korea

Outcome results