WALT trial (Phase I-II): Weekly non-pegylated liposomal anthracycline and taxane combination in first-line breast cancer chemotherapy

1097 Background: Weekly administration of proved efficacy agents, through different pharmacodynamic-kinetic interactions, overcomes resistance with lower toxicities and greater benefits and preservation of quality of life. Based on this assumption we designed wALT (weekly liposomal-anthracycline and taxane) trial. Methods: Patients (pts) with previously untreated metastatic breast cancer were eligible. Prior adjuvant anthracycline or taxane exposure was permitted. We designed a phase I multicenter, open lable dose-finding study to examine the safety and efficacy of weekly combination (d 1,8,15 q4w) of paclitaxel (n=28 pts) or docetaxel (n=20 pts) with non-pegylated liposomal anthracycline; a phase II trial followed and a total of 48 patients was enrolled from January 2002. All Her2(+) pts received trastuzumab after 6 cycles until progression. Primary endpoint of phase I study was dose limiting toxicity (DLT) and safety assessment; phase II trial primary endpoint was overall response rate (ORR) while secon...