Multicenter phase II trial of gemcitabine plus liposomal doxorubicin in chemotherapeutically pretreated patients with advanced breast cancer (ABC

696 Background: To evaluate the safety and efficacy of gemcitabine in combination with lioposomal doxorubicin in pretreated patients with ABC. Methods: Thirty-four patients (pts) with ABC were entered in this multicenter phase II trial in order to investigate the efficacy and tolerance of a combination regimen consisting of gemcitabine (800 mg/m2, days 1 + 8) and liposomal doxorubicin (24 mg/m2 day 1) ± granulocyte colony-stimulating factor (GCSF; 5mcg/kg/d x 5 s.c.), depending on ANCs on the days of scheduled drug administration. Treatment courses were repeated every 3 weeks. Thirty-one pts (91%) are presently evaluable for response and all pts for toxicity assessment. Seven pts were pre- and 27 pts post-menopausal. Their median age was 64 (37–80) years, and the median WHO performance status 1(0–2). Predominant tumor sites were visceral in 26 pts, bone in 6 pts, and soft-tissue in 2 pts, respectively. Twenty-six patients (76%) had 2 or multiple tumor sites. Twenty-seven pts received this regimen as 2nd l...