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

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

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 of Clinical Oncology (20:3386-3395;3396-3403, 2002). The findings demonstrate the effectiveness and tolerability of fulvestrant compared with anastrozole (Arimidex) in these patients.

Publication of these articles follow the recent approval of fulvestrant by the US Food and Drug Administration for the treatment of hormone-receptor-positive metastatic breast cancer in postmenopausal women with disease progression following 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 following tamoxifen therapy," said lead author C. Kent Osborne, md, Baylor College of Medicine, Houston. "These published data, comparing Faslodex to an aromatase inhibitor, allows physicians to become better informed about Faslodex as a viable treatment option for postmenopausal women with advanced breast cancer."

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

 
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