AstraZeneca commences FASLODEX Phase III study for hormone receptor-positive metastatic breast cancer

Published on October 29, 2012 at 12:22 PM · No Comments

AstraZeneca (NYSE:AZN) today announced the start of a Phase III study (FALCON), a global clinical trial which will involve 450 postmenopausal patients with hormone receptor-positive locally advanced or metastatic breast cancer who have not previously been treated with any hormonal therapy. The Phase III study is designed to evaluate the efficacy and tolerability of fulvestrant 500 mg compared to anastrozole 1 mg in this patient population.

“The FALCON study is the first Phase III study designed to investigate the potential role of the 500 mg dose of fulvestrant in the treatment of hormone receptor positive advanced breast cancer in patients who have not been previously treated with any hormonal therapy”

Fulvestrant 500 mg is currently indicated for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy. FASLODEX is contraindicated in patients with known hypersensitivity to the drug or to any of its components. Hypersensitivity reactions, including urticaria and angioedema have been reported in association with FASLODEX.

"The FALCON study is the first Phase III study designed to investigate the potential role of the 500 mg dose of fulvestrant in the treatment of hormone receptor positive advanced breast cancer in patients who have not been previously treated with any hormonal therapy," said John Robertson, MD, Professor of Medicine, Graduate Entry Medicine and Health School, University of Nottingham Royal Derby Hospital.

"The FALCON study has the potential to impact clinical practice concerning endocrine treatment options for women with hormone receptor positive locally advanced or metastatic breast cancer," said Matthew Ellis, MB BChir PhD, Professor of Medicine, Washington University School of Medicine and Siteman Cancer Center Breast Cancer Program.

Dr. Ellis and Dr. Robertson are the International Co-ordinating investigators for the FALCON Study.

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