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Drug Use Investigation for TYKERB Tablet (All Case Investigation)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01332396
First received: April 7, 2011
Last updated: April 25, 2017
Last verified: April 2017

April 7, 2011
April 25, 2017
June 2009
March 13, 2017   (Final data collection date for 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 ]
ADRs and SAEs [ Time Frame: 1 year ]
Complete list of historical versions of study NCT01332396 on ClinicalTrials.gov Archive Site
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Drug Use Investigation for TYKERB Tablet (All Case Investigation)
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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Observational
Observational Model: Other
Time Perspective: Other
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Probability Sample
All patients who have "HER2 overexpressing inoperable or recurrent breast cancer" and have received TYKERB for the first time
Cancer
Drug: Lapatinib
Patients prescribed TYKERB
Patients with HER2 overexpressing inoperable or recurrent breast cancer
Intervention: Drug: Lapatinib
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4054
March 13, 2017
March 13, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Japan
 
NCT01332396
113092
No
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Novartis
Novartis
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP