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AstraZeneca PLC Begins New Global Study Of FASLODEX (Fulvestrant) 500 Mg Injection In Patients With Hormone Receptor-Positive Advanced Breast Cancer

Monday, 29 Oct 2012 08:02am EDT 

AstraZeneca PLC announced the start of a Phase III registration study (FALCON), a global clinical trial involving 450 postmenopausal women 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. Fulvestrant 500 mg is currently indicated for the treatment of postmenopausal women with oestrogen receptor-positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on therapy with an anti-oestrogen. In the FALCON study, eligible patients will be randomised 1:1 to receive either fulvestrant (500 mg/day intramuscular injection) on days 0, 14 (plus or minus3), 28 (plus or minus3) and every 28 days thereafter plus a placebo to match the anastrozole administration schedule, or anastrozole (1 mg/day orally) plus a placebo to match the fulvestrant administration. 

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