AstraZeneca Begins a New Global Study of FASLODEX® (fulvestrant) Injection in Patients with Hormone Receptor-Positive Advanced Breast Cancer

(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. 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.

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 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. “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.”

The pivotal study supporting fulvestrant 500 mg is the CONFIRM (mpariso of ASLODEX n ecurrent or etastatic 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.

Please see full for FASLODEX.

ARIMIDEX is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.

ARIMIDEX is indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with estrogen receptor-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to ARIMIDEX.

Please see full for ARIMIDEX.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.

FASLODEXand ARIMIDEXare registered trademarks of the AstraZeneca group of companies.

CONFIRM (mpariso of ASLODEX n ecurrent or etastatic breast cancer) was a Phase III, randomized, double-blind, parallel-group, multicenter trial comparing fulvestrant 500 mg (n=362) and 250 mg (n=374) in postmenopausal women with estrogen receptor-positive advanced breast cancer, who progressed or recurred following prior endocrine therapy. Eligible patients were randomized 1:1 to fulvestrant 500 mg or 250 mg, and assessed for tumor progression every 12 weeks. The primary objective was to compare the efficacy of both treatment groups in terms of progression free survival. Secondary objectives included: objective response rate (ORR), clinical benefit rate (CBR), duration of response, duration of clinical benefit (DoCB), overall survival, tolerability, and quality of life (QoL).

Metastatic breast cancer occurs when cancer cells have spread beyond the initial tumor site to other parts of the breast or body, forming secondary tumors; it is the most advanced stage of breast cancer (stage four).Metastatic breast cancer may be diagnosed as an initial diagnosis, as a distant recurrence after treatment of early breast cancer, or as a progression of earlier stage disease. There is no cure for metastatic breast cancer; the goal of treatment is to delay the progression of the cancer.

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

For more information about AstraZeneca in the U.S. or our AZ&Me™ Prescription Savings programs, please visit: or call 1-800-AZandMe (292-6363).

Robertson JFR, Llombart-Cussac A, et al. Activity of Fulvestrant 500 mg Versus Anastrozole 1 mg As First-Line Treatment for Advanced Breast Cancer: Results From the FIRST Study. 2009;27(27):4530-4535.

ClinicalTrials.gov. A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer. (FALCON). US National Institutes of Health. . Last accessed October 19, 2012.

Ferlay J et al. GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide: IARC Cancer Base No. 10 [Internet]. Lyon, France, International Agency for Research on Cancer, 2010 . Last accessed August 19, 2012.

National Cancer Institute. Treatment Option Overview, Patient Version. . Last accessed July 26, 2012.

National Cancer Institute. Metastatic Cancer: Questions and Answers. . Last accessed July 26, 2012.

Dawood S, Broglio K, Ensor J, Hortobagyi GN, Giordano SH. Survival differences among women with de novo stage IV and relapsed breast cancer. 2010;21:2169-2174.

American Cancer Society. Treatment of invasive breast cancer, by stage. Last revised: August 23, 2012. . Last accessed September 17, 2012.

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