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Drug Use Investigation for TYKERB Tablet (All Case Investigation)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01332396
First received: April 7, 2011
Last updated: July 3, 2014
Last verified: June 2014

April 7, 2011
July 3, 2014
June 2009
February 2016   (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 ] [ Designated as safety issue: Yes ]
ADRs and SAEs [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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
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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.
 
Active, not recruiting
3000
July 2016
February 2016   (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
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01332396
113092
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2014

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