An open label phase II trial of glufosfamide: A {beta}-D-glucose-linked isophosphoramide mustard given as 1-hour infusion in patients with advanced breast cancer

646 Background: Glufosfamide (Glufo) is a new alkylating agent in which the active metabolite is linked to β-D-glucose to target the glucose transporter system and increase intracellular uptake in tumor cells. The aim of this study was to evaluate the activity and the safety profile of Glufo administered as 2nd line chemotherapy in patients (pts) with metastatic and inoperable breast cancer. Methods: Pts received 5000 mg/m2 of Glufo as a 1-hour infusion every 3 weeks. Anti-tumor activity was assessed according to RECIST criteria and toxicity according to CTC 2.0. The study was approved by the appropriate ethical committees and pts gave written informed consent. Results: Twenty-two pts were included over a 20-month period and all pts received treatment (median age 51 years, WHO performance status 0/1/2: 1/9/12 pts). A total of 42 treatment cycles were administered in 22 pts. Anti-tumor activity: Partial response was observed in 3 of 22 pts (14%) for the ITT population (PP population 3 of 11 pts). Eight of ...