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Drug Use Investigation for TYKERB Tablet (All Case Investigation)

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ClinicalTrials.gov Identifier: NCT01332396
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

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.

Condition or disease Intervention/treatment
Cancer Drug: Lapatinib

Study Type : Observational
Actual Enrollment : 4054 participants
Observational Model: Other
Time Perspective: Other
Official Title: Drug Use Investigation for TYKERB Tablet (All Case Investigation)
Study Start Date : June 2009
Actual Primary Completion Date : March 13, 2017
Actual Study Completion Date : March 13, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Patients prescribed TYKERB
Patients with HER2 overexpressing inoperable or recurrent breast cancer
Drug: Lapatinib



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients who have "HER2 overexpressing inoperable or recurrent breast cancer" and have received TYKERB for the first time
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332396


Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01332396     History of Changes
Other Study ID Numbers: 113092
First Posted: April 11, 2011    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Lapatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action