Regulatory TYKERB® Tablets PMS

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Cancer

Treatments: Drug: TYKERB® tablets

Study type: Observational

Funder types: Industry

Identifiers

NCT00975988

112477

Details and patient eligibility

About

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.

Full 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

Enrollment: 750 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

750 participants in 1 patient group

TYKERB® tablets

Description:

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

Treatment:

Drug: TYKERB® tablets