Use of Fulvestrant for Advanced Breast Cancer Supported by Pivotal Phase III Data

October 1, 2002

The results of two clinical trials evaluating fulvestrant (Faslodex) for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy were published in a recent issue of the Journal

The results of two clinical trials evaluating fulvestrant (Faslodex) for thetreatment of advanced breast cancer in postmenopausal women with diseaseprogression following antiestrogen therapy were published in a recent issue ofthe Journal of Clinical Oncology (20:3386-3395;3396-3403, 2002). The findingsdemonstrate the effectiveness and tolerability of fulvestrant compared withanastrozole (Arimidex) in these patients.

Publication of these articles follow the recent approval of fulvestrant bythe US Food and Drug Administration for the treatment of hormone-receptor-positivemetastatic breast cancer in postmenopausal women with disease progressionfollowing antiestrogen therapy. Approval was based on data from the studies(trials 20 and 21) discussed in the articles.

Viable Treatment Option

"Faslodex provides a new choice for patients progressing followingtamoxifen therapy," said lead author C. Kent Osborne, md, Baylor College ofMedicine, Houston. "These published data, comparing Faslodex to anaromatase inhibitor, allows physicians to become better informed about Faslodexas a viable treatment option for postmenopausal women with advanced breastcancer."

Trial 21 was a randomized, double-blind, double-dummy, phase III studyconducted in North America. Trial 20 was an open label, randomized, multicenter,phase III study conducted in Europe, Australia, and South Africa. The trialswere designed to compare fulvestrant, 250 mg per month administered as anintramuscular injection, with oral anastrozole, 1 mg daily. A total of 851postmenopausal women with disease progression following antiestrogen therapy(usually tamoxifen) were enrolled in the trial.