Halaven Post-Marketing Surveillance (PMS)

Eisai

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT02441764

EKI-PMS-1201

Details and patient eligibility

About

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

Enrollment: 3,000 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

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.

Trial design

3,000 participants in 1 patient group

Halaven

Description:

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