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Completed

NCT Number: NCT02441764

Halaven Post-Marketing Surveillance (PMS)

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Busan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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.
  • Participants who have verbal or written consent for use of personal and medical information.

Investigators will refer to indications regarding inclusion criteria.

Exclusion criteria

  • Hypersensitivity to the active substance or to any of the excipients
  • Breast feeding
  • Pregnancy

Investigators will refer to indications and contraindications regarding exclusion criteria.

Treatment and study plan

Primary outcomes

  1. Safety of Halaven as a measure of number of participants with adverse events/serious adverse events/adverse drug reactions

    Time frame: Up to 1 year

Secondary outcomes

  1. Tumor response to Halaven treatment

    Time frame: Up to 12 weeks

Sponsors and collaborators

Lead sponsor

Eisai Korea Inc.

Industry

Registry information

Official study title

Post-Marketing Surveillance of Halaven Injection in Korean Patients

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
May 12, 2015
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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