Drug Use Investigation for TYKERB Tablet (All Case Investigation)
- Registration Number
- NCT01332396
- Lead Sponsor
- Novartis
- Brief Summary
Data on the safety and efficacy of TYKERB shall be collected from the patients in order to grasp the actual conditions of post-marketing use and assess background information on the patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4054
Inclusion Criteria
- Patients with HER2 overexpressing inoperable or recurrent breast cancer
Exclusion Criteria
- Patients with hypersensitivity to lapatinib or any components
- Pregnant women and women suspected of being pregnant
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients prescribed TYKERB Lapatinib Patients with HER2 overexpressing inoperable or recurrent breast cancer
- Primary Outcome Measures
Name Time Method The incidence of adverse events in Japanese patients treated with TYKERB based on prescribing information under the conditions of general clinical practice 1 year
- Secondary Outcome Measures
Name Time Method