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AstraZeneca Begins A New Global Study Of FASLODEX® (fulvestrant) Injection In Patients With Hormone Receptor-Positive Advanced Breast Cancer

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.

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.

The FALCON design is based on safety and efficacy results from the phase II FIRST (Fulvestrant First-Line Study Comparing Endocrine Treatments) study. 1 FALCON is a randomized, double-blind, parallel group, multicenter, Phase III study evaluating the efficacy and tolerability of fulvestrant 500 mg (monotherapy) compared to anastrozole 1 mg (monotherapy) as hormonal treatment for postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer who have not previously been treated with any hormonal therapy.

In the FALCON study, eligible patients will be randomized 1:1 to receive either fulvestrant (500 mg/day intramuscular injection) on Days 0, 14 (±3), 28 (±3), and every 28 (±3) 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. 2

The FALCON study is still opening US clinical trial sites and patient recruitment and enrollment has begun. Additional information about the FALCON clinical trial is available by visiting www.clinicaltrials.gov and searching under the term FALCON.

“Despite advances in treatment and detection, breast cancer remains the leading cause of cancer death in women around the world,” said Yuri Rukazenkov, MD, Medical Science Director, AstraZeneca. 3 “The FALCON trial is part of AstraZeneca’s commitment to the continued study and evaluation of treatment options for metastatic breast cancer, and developing and optimizing breast cancer therapies for all patient groups.”

Approved Use for FASLODEX ® (fulvestrant) Injection

The pivotal study supporting fulvestrant 500 mg is the CONFIRM ( COmpariso N of FASLODEX In Recurrent or Metastatic breast cancer) Trial.

FASLODEX is indicated for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

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