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OpenTrials
Completed

NCT Number: NCT00975988

Regulatory TYKERB® Tablets PMS

Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of TYKERB® tablets administered in Korean patients according to the prescribing information TYKERB® is a registered trademark of the GlaxoSmithKline group of companies.

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Key information

Conditions

Cancer Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Seoul, South Korea

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About this study

Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of TYKERB® tablets administered in Korean patients according to the prescribing information

TYKERB® tablets will be administered with capecitabine for HER2 overexpressing advanced or metastatic breast cancer treatment or with letrozole for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 as described the prescribing information of TYKERB® tablets

Who can participate

Healthy volunteers accepted: No

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

All subjects must satisfy the following criteria at PMS entry according to MFDS PMS regulation:

  • Subjects with indication in the locally approved prescribing information
  • Subjects with no contraindication according to the prescribing information

Treatment and study plan

TYKERB® tablets

Drug

Patients administrated TYKERB® tablets according to the prescribing information

Primary outcomes

  1. Occurrence of adverse events after TYKERB® tablets administration

    Time frame: 12 months

Secondary outcomes

  1. Effectiveness of TYKERB® tablets and Occurrence of unexpected adverse drug reaction and serious adverse event after TYKERB® tablets administration

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Effectiveness of TYKERB® Tablets Administered in Korean Patients According to the Prescribing Information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 14, 2009
Registry last updated
Oct 27, 2014

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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