Regulatory TYKERB® Tablets PMS

Completed

• Conditions: Cancer
• Interventions: Drug: TYKERB® tablets

• Registration Number: NCT00975988
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2009-09-11
• Study First Submitted QC: 2009-09-11
• Study First Posted: 2009-09-14
• Study Start: 2010-01
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-23
• Last Update Posted: 2014-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TYKERB® tablets	TYKERB® tablets	There is only one group. This group includes patients administrated TYKERB® tablets

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events after TYKERB® tablets administration	12 months

Secondary Outcome Measures

Name	Time	Method
Effectiveness of TYKERB® tablets and Occurrence of unexpected adverse drug reaction and serious adverse event after TYKERB® tablets administration	12 months

Trial Locations

Locations (1)

GSK Investigational Site; 🇰🇷 Seoul, Korea, Republic of