Drug Use Investigation for TYKERB Tablet (All Case Investigation)

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.

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Key information

Conditions

Cancer Neoplasms

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lapatinib

Drug

Primary outcomes

The incidence of adverse events in Japanese patients treated with TYKERB based on prescribing information under the conditions of general clinical practice

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2017
Study completion: 2017
First posted: Apr 11, 2011
Registry last updated: Apr 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed