Finding studies
Finding studies
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Lead
European Organisation for Research and Treatment of Cancer - EORTC
OBJECTIVES: Primary * Determine the pharmacokinetics of lapatinib ditosylate and tamoxifen citrate in patients with advanced or metastatic breast cancer. Secondary * Assess the safety of this regimen in these patients. * Determine any relationship between drug exposure and adverse events or biological modifications of this regimen in these patients. * Assess the antitumor activity of this regimen in patients with measurable disease. OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral tamoxifen citrate on days 1-28 of course 1. In all subsequent courses, patients receive oral tamoxifen citrate and oral lapatinib ditosylate on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive oral lapatinib ditosylate on days 1-14 of course 1. In all subsequent courses, patients receive oral lapatinib ditosylate and oral tamoxifen citrate on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. In both treatment arms, blood is collected periodically during courses 1 and 2 for pharmacokinetic studies. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted