Lapatinib and Temozolomide for the Treatment of Progressive Brain Disease in HER-2 Positive Breast Cancer
Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
Objectives:
Primary - Determine the maximum tolerated dose (MTD) and evaluate the dose limiting
toxicities (DLT) of combining lapatinib and temozolomideSecondary - Obtain preliminary
information on the clinical anti-tumor activity of lapatinib plus temozolomide on brain
metastases secondary to HER-2 positive breast cancer including Objective Response Rate (ORR),
Clinical Benefit (CB) and Duration of Response (DR)
Methodology:
Phase I, single-centre, open-label, dose-escalation study of combining lapatinib and
temozolomide in HER-2 positive breast cancer patients with progressive brain metastases after
surgery or radiotherapy or radiosurgery
Treatment:
Temozolomide will be given orally for 5 days of every 28 days, at doses of either
100mg/m2/day or 150mg/m2/day or 200mg/m2/day AND Lapatinib will be given orally every day at
either 1000mg/day or 1250mg/day or 1500mg/day.Sequential cohorts will be escalated in
increments according to the dose escalation scheme, and determined by dose limiting
toxicities.