Cancer
Conditions
Keywords
PMS (post-marketing surveillance), TYKERB® tablets
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
Interventions
DRUGTYKERB® tablets
Patients administrated TYKERB® tablets according to the prescribing information
Sponsors
GlaxoSmithKline
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events after TYKERB® tablets administration | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness of TYKERB® tablets and Occurrence of unexpected adverse drug reaction and serious adverse event after TYKERB® tablets administration | 12 months |
Countries
South Korea
Outcome results
None listed