Drug Use Investigation for TYKERB Tablet (All Case Investigation)

NCT ID: NCT01332396

Last Updated: 2017-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4054 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2017-03-13

Brief Summary

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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

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Conditions

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Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Patients prescribed TYKERB

Patients with HER2 overexpressing inoperable or recurrent breast cancer

Lapatinib

Intervention Type DRUG

Interventions

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Lapatinib

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

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113092

Identifier Type: -

Identifier Source: org_study_id

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