AstraZeneca Begins a New Global Study of FASLODEX® (fulvestrant) Injection in Patients with Hormone Receptor-Positive Advanced Breast Cancer FALCON (Fulvestrant and AnastrozoLe COmpared in hormonal therapy Naïve advanced breast cancer) trial to compare fulvestrant to ARIMIDEX^® (anastrozole) Tablets in hormonal therapy-naïve, postmenopausal patients with hormone receptor-positive locally advanced or metastatic breast cancer Business Wire WILMINGTON, Del. -- October 29, 2012 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 (COmparisoN 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. Important Safety Information About FASLODEX *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 *Because FASLODEX^® (fulvestrant) Injection is administered intramuscularly, it should be used with caution in patients with bleeding diatheses, thrombocytopenia, or in patients on anticoagulants *FASLODEX is metabolized primarily in the liver. A 250-mg dose is recommended in patients with moderate hepatic impairment. FASLODEX has not been evaluated in patients with severe hepatic impairment (Child-Pugh Class C) *Fetal harm can occur when administered to a pregnant woman. Women should be advised of the potential hazard to the fetus and to avoid becoming pregnant while receiving FASLODEX *The most common, clinically significant adverse reactions occurring in ≥5% of patients receiving FASLODEX were: injection site pain, nausea, bone pain, arthralgia, headache, back pain, fatigue, pain in extremity, hot flash, vomiting, anorexia, asthenia, musculoskeletal pain, cough, dyspnea, and constipation *Increased hepatic enzymes (ALT, AST, ALP) occurred in >15% of FASLODEX users and were non dose-dependent Please see full Prescribing Information for FASLODEX. Approved Uses for ARIMIDEX^® (anastrozole) Tablets 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. Important Safety Information About ARIMIDEX *ARIMIDEX is only for postmenopausal women. ARIMIDEX can cause fetal harm when administered to a pregnant woman. Before starting treatment with ARIMIDEX, pregnancy must be excluded. ARIMIDEX is contraindicated in patients with demonstrated hypersensitivity to ARIMIDEX or any of its excipients. Observed reactions include anaphylaxis, angioedema, and urticaria. (see CONTRAINDICATIONS section of full Prescribing Information) *In women with preexisting ischemic heart disease 465/6186 (7.5%), an increased incidence of ischemic cardiovascular events occurred with ARIMIDEX (17%) vs tamoxifen (10%). In this patient population, angina pectoris was reported in 25/216 (11.6%) vs 13/249 (5.2%) and myocardial infarction was reported in 2/216 (0.9%) vs 8/249 (3.2%) in patients receiving ARIMIDEX and tamoxifen, respectively *Compared to baseline, ARIMIDEX showed a mean decrease in both lumbar spine and total hip bone mineral density. Tamoxifen showed a mean increase in these measurements. Nine percent of patients receiving ARIMIDEX had an elevated serum cholesterol vs 3.5% of patients receiving tamoxifen *Common side effects seen with ARIMIDEX vs tamoxifen in the early breast cancer trial after 5 years of treatment include hot flashes (36% vs 41%), joint disorders (including arthritis, arthrosis, arthralgia) (36% vs 29%), asthenia (19% vs 18%), mood disturbances (19% vs 18%), pain (17% vs 16%), pharyngitis (14% vs 14%), nausea and vomiting (13% vs 12%), rash (11% vs 13%), depression (13% vs 12%), hypertension (13% vs 11%), osteoporosis (11% vs 7%), peripheral edema (10% vs 11%), lymphedema (10% vs 11%), back pain (10% vs 10%), insomnia (10% vs 9%), and headache (10% vs 8%). Fractures, including fractures of the spine, hip, and wrist, occurred more often with ARIMIDEX vs tamoxifen (10% vs 7%) *In the advanced breast cancer studies, the most common (occurring with an incidence of >10%) side effects occurring in women taking ARIMIDEX included hot flashes, nausea, asthenia, pain, headache, back pain, bone pain, increased cough, dyspnea, pharyngitis, and peripheral edema. Joint pain/stiffness has been reported in association with the use of ARIMIDEX *Clinical and pharmacokinetic results suggest that tamoxifen should not be administered with ARIMIDEX. Estrogen-containing therapies should not be used with ARIMIDEX as they may diminish its pharmacologic action Please see full Prescribing Information for ARIMIDEX. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. FASLODEX ^ and ARIMIDEX ^ are registered trademarks of the AstraZeneca group of companies. – ENDS – NOTES TO EDITORS About CONFIRM CONFIRM (COmparisoN of FASLODEX In Recurrent or Metastatic 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). About Metastatic Breast Cancer 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).^4,5 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.^6,7 There is no cure for metastatic breast cancer; the goal of treatment is to delay the progression of the cancer.^5 About AstraZeneca 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: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363). ^1 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. J Clin Oncol. 2009;27(27):4530-4535. ^2 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. Available Online. Last accessed October 19, 2012. ^3 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 Available online. Last accessed August 19, 2012. ^4 National Cancer Institute. Treatment Option Overview, Patient Version. Available online. Last accessed July 26, 2012. ^5 National Cancer Institute. Metastatic Cancer: Questions and Answers. Available online. Last accessed July 26, 2012. ^6 Dawood S, Broglio K, Ensor J, Hortobagyi GN, Giordano SH. Survival differences among women with de novo stage IV and relapsed breast cancer. Annals Oncol. 2010;21:2169-2174. ^7 American Cancer Society. Treatment of invasive breast cancer, by stage. Last revised: August 23, 2012. Available Online. Last accessed September 17, 2012. 2154905 10/12 Contact: Media Inquiries US AstraZeneca Rachelle Benson +1 302-885-5853 mob: +1 302-559-5861
AstraZeneca Begins a New Global Study of FASLODEX® (fulvestrant) Injection in Patients with Hormone Receptor-Positive Advanced
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