An Open-Label Phase I Study of Fixed Dose Lapatinib in Combination With an Escalating Dose of Epirubicin in Metastatic Breast Cancer
- To assess the safety and tolerability of fixed-dose lapatinib ditosylate in combination
with epirubicin hydrochloride in patients with metastatic breast cancer.
- To determine the optimally-tolerated regimen in these patients.
- To determine the clinical efficacy of this regimen in these patients.
- To analyze pharmacokinetic data of this regimen.
- To determine biomarkers that correlate with clinical benefit or response to lapatinib
ditosylate in these patients.
- To identify tumor-derived or blood-derived biomarkers that correlate with or are
predictive of clinical response or benefit to lapatinib ditosylate in these patients.
- To determine the levels of IGF-IR and phosphorylated IGF-IR in tumor tissue.
- To determine the expression pattern of the proteins associated with drug resistance
that may be clinically active in these patients.
OUTLINE: This is a multicenter, dose-escalation study of epirubicin hydrochloride.
Patients receive oral lapatinib ditosylate followed by epirubicin hydrochloride IV over
15-30 minutes on day 1. Treatment repeats every 3 weeks for up to 7 courses in the absence
of disease progression or unacceptable toxicity.
Blood samples are collected periodically for pharmacokinetic analysis via liquid
chromatography-mass spectometry (LC-MS).
After completion of study therapy, patients are followed at 28 days and then every 3 months
Masking: Open Label, Primary Purpose: Treatment
Optimally-tolerated regimen of lapatinib ditosylate in combination with epirubicin hydrochloride
John Crown, MD
St. Vincent's University Hospital
United States: Food and Drug Administration