Trial Information
Assessment of Physician Compliance to Recommended Liver Function Test Monitoring for Tykerb Patients
Inclusion Criteria:
- Female aged >= 19 years
- A diagnosis of breast cancer with documented metastatic disease (as defined by stage
at diagnosis, evidence of disease progression, and/or line of therapy);
- Documented order/prescription for lapatanib from January 1, 2007 - December 31, 2009;
- Received care at a practice utilizing the full electronic medical record capabilities
of US Oncology's iKnowMed system
Exclusion Criteria:
- Patients participating in clinical trials
- Patients receiving care for another cancer during the study time period
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Retrospective
Outcome Measure:
The change in proportion of patients that receive liver function tests prior to the initiation of lapatanib
Outcome Time Frame:
Within 30 days, 60 days, or 90 days prior to (and including) the day that lapatanib was initiated
Safety Issue:
Yes
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United Kingdom: No Health Authority
Study ID:
115270
NCT ID:
NCT01462552
Start Date:
December 2010
Completion Date:
August 2011
Related Keywords:
- Metastatic Breast Cancer
- Cancer
- lapatanib
- liver function testing
- Breast cancer
- Breast Neoplasms