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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
  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
Study Design: Observational Model: Other
Time Perspective: Other
Official Title: Drug Use Investigation for TYKERB Tablet (All Case Investigation)

Resource links provided by NLM:


Further study details as provided by Novartis:

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 ]

Enrollment: 4054
Study Start Date: June 2009
Study Completion Date: March 13, 2017
Primary Completion Date: March 13, 2017 (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

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
  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
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01332396     History of Changes
Other Study ID Numbers: 113092
Study First Received: April 7, 2011
Last Updated: April 25, 2017

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

ClinicalTrials.gov processed this record on July 21, 2017