Halaven Post-Marketing Surveillance (PMS)

Breast Cancer Clinical Trial

Official title:

Post-Marketing Surveillance of Halaven Injection in Korean Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02441764
• Other study ID #: EKI-PMS-1201
• Status: Completed
• Start date: March 2013
• Est. completion date: August 2018

Study information

• Verified date: June 2018
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Halaven as a measure of number of participants with adverse events/serious adverse events/adverse drug reactions		Up to 1 year
Secondary	Tumor response to Halaven treatment		Up to 12 weeks