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
  Purpose

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 Intervention
Cancer
Drug: Lapatinib

Study Type: Observational
Official Title: Drug Use Investigation for TYKERB Tablet (All Case Investigation)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 3000
Study Start Date: June 2009
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients prescribed TYKERB
Patients with HER2 overexpressing inoperable or recurrent breast cancer
Drug: Lapatinib

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332396

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01332396     History of Changes
Other Study ID Numbers: 113092
Study First Received: April 7, 2011
Last Updated: July 3, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

ClinicalTrials.gov processed this record on September 30, 2014