Drug Use Investigation for TYKERB Tablet (All Case Investigation)

Sponsor
Novartis
Study ID
NCT01332396
Status
Completed

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lapatinib — DRUG

Study Details

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.

Key Dates

Start date
Jun 30, 2009
Status verified
Apr 2017
Primary completion
Mar 13, 2017
Completion
Mar 13, 2017

Study Design

Enrollment
4,054 participants (actual)

Arms

  • Arm: Patients prescribed TYKERB
    Patients with HER2 overexpressing inoperable or recurrent breast cancer

Primary Outcome Measure

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 ]

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