Halaven Post-Marketing Surveillance (PMS)

NCT ID: NCT02441764

Last Updated: 2020-03-10

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

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2018-08-31

Brief Summary

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

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Halaven

Participants who are prescribed with Halaven per approved prescribing information of Halaven.

No interventions assigned to this group

Eligibility Criteria

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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.

Exclusion Criteria

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

Site Status

Chuncheongnam-do, , South Korea

Site Status

Chungcheongbuk-do, , South Korea

Site Status

Chungcheongnam-do, , South Korea

Site Status

Daegu, , South Korea

Site Status

Gwangju, , South Korea

Site Status

Gyeonggi-do, , South Korea

Site Status

Gyeongsanbuk-do, , South Korea

Site Status

Gyeongsannam-do, , South Korea

Site Status

Jeollabuk-do, , South Korea

Site Status

Jeollanam-do, , South Korea

Site Status

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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EKI-PMS-1201

Identifier Type: -

Identifier Source: org_study_id

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