Effects of fulvestrant 250 mg in premenopausal women with oestrogen receptor-positive primary breast cancer

Fulvestrant (Faslodex (TM)) reduces markers of hormone sensitivity and proliferation in postmenopausal women. This Phase 11 double-blind, randomised, multicentre study compared the effects of a single 250 mg intramuscular dose of fulvestrant and placebo 14-21 days prior to surgery of curative intent on the oestrogen receptor (ER), progesterone receptor and Ki67 levels in 66 premenopausal women with ER-positive primary breast cancer. There were no statistically significant differences between fulvestrant and placebo with respect to any of the three markers analysed. The most common adverse events in both groups were nausea, headache and pyrexia. Fulvestrant 250 mg had no effects on markers of hormone-sensitivity and proliferation in premenopausal women with primary breast cancer when measured at 14-21 days after injection. These findings suggest that a higher fulvestrant dose may be required in this patient population. Further clinical trials are necessary to evaluate the efficacy of fulvestrant in premenopausal women. (c) 2006 Elsevier Ltd. All rights reserved.