Halaven Post-Marketing Surveillance (PMS)

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02441764
• Lead Sponsor: Eisai Korea Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2015-05-08
• Study First Submitted QC: 2015-05-08
• Study First Posted: 2015-05-12
• Status Verified: 2018-06
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Tumor response to Halaven treatment	Up to 12 weeks