Fulvestrant in postmenopausal women with metastatic breast cancer progressing on prior endocrine therapy -results from a compassionate use progra

730 Background: Fulvestrant (Faslodex) is an estrogen receptor (ER) antagonist with no agonist effects. Here we report results from a compassionate use/named patient program in which postmenopausal women with metastatic breast cancer progressing on at least two prior endocrine therapies were treated with fulvestrant 250 mg. Methods: Fulvestrant 250 mg was given as a single 5 mL intramuscular injection, once-monthly until disease progression (PD). Tumor response was assessed monthly using UICC criteria. Time to progression (TTP) and duration of response (DOR; responding patients only) were defined from start of treatment until PD. Results: Between August 2001 and October 2003, 44 patients (median age 63 years [range 39–91 years]) were treated and followed-up for a median of 28 weeks (range 12–104 weeks). All had received prior endocrine treatment for advanced disease and 50% had received adjuvant endocrine treatment. Thirty patients (68%) had received prior chemotherapy. Most patients (75%) received fulves...