Drug Use Investigation for TYKERB Tablet (All Case Investigation)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01332396

Enrollment

4054

Registered

2011-04-11

Start date

2009-06-30

Completion date

2017-03-13

Last updated

2017-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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.

Interventions

DRUGLapatinib

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The incidence of adverse events in Japanese patients treated with TYKERB based on prescribing information under the conditions of general clinical practice	1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026