Drug Use Investigation for TYKERB Tablet (All Case Investigation)
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer
Intervention: Lapatinib (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: Drug Use Investigation for TYKERB Tablet (All Case Investigation)
Study design: N/A
Primary outcome: The incidence of adverse events in Japanese patients treated with TYKERB based on prescribing information under the conditions of general clinical practice
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: June 2009
Last updated: July 9, 2015
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