AstraZeneca Begins a New Global Study of FASLODEX® (Fulvestrant) 500 mg Injection in Patients With Hormone Receptor-Positive Advanced Breast Cancer

LONDON, October 29, 2012 /PRNewswire/ --

FALCON (Fulvestrant and AnastrozoLe COmpared in hormonal therapy Naïve advanced breast cancer) trial to compare fulvestrant to anastrozole (ARIMIDEX^®) tablets in hormonal therapy-naïve, postmenopausal patients with hormone receptor-positive locally advanced or metastatic breast cancer.

AstraZeneca today 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.^[1]

"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 Dr John Robertson, 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 Dr Matthew Ellis, Professor of Medicine, Washington University School of Medicine and Siteman Cancer Center Breast Cancer Program.

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

The design of FALCON is based on safety and efficacy results from the Phase II FIRST (Fulvestrant First-Line Study Comparing Endocrine Treatments) study.^[2] FALCON is a randomised, 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 a 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 randomised 1:1 to receive either fulvestrant (500 mg/day intramuscular injection) on days 0, 14 (±3), 28 (±3) 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.

The FALCON study is still opening global clinical trial sites and patient recruitment and enrollment has begun. Additional information about the FALCON clinical trial is available by visiting http://www.clinicaltrials.gov

"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 optimising breast cancer therapies for patients."

Approved Use for FASLODEX^® (fulvestrant) Injection

FASLODEX is 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.^[1]

FASLODEX is a registered trademark of the AstraZeneca group of companies.

For more information on FASLODEX please see the Summary of Product Characteristics.

Approved Uses for ARIMIDEX^® (anastrozole)

ARIMIDEX is approved for adjuvant treatment (treatment following surgery with or without radiation) of postmenopausal women with hormone receptor-positive early breast cancer.

ARIMIDEX is approved for the initial treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and for the treatment of postmenopausal women with advanced breast cancer that has progressed following treatment with tamoxifen. Patients with hormone receptor-negative disease and patients who did not previously respond to tamoxifen therapy rarely responded to ARIMIDEX.

For more information on ARIMIDEX please see the Summary of Product Characteristics.

NOTES TO EDITORS

About FALCON

FALCON (Fulvestrant and AnastrozoLe COmpared in hormonal therapy Naïve advanced breast cancer) is a randomised, double-blind, parallel group, multi-center, Phase III study evaluating the efficacy and tolerability of FASLODEX 500 mg (monotherpy) compared to ARIMIDEX 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.^[4,5]

The primary objective of the Phase III FALCON study is to compare the progression-free survival (PFS) in patients treated with FASLODEX 500 mg with those treated with ARIMIDEX 1 mg.^[4,5]

The secondary objectives of the FALCON study include overall survival (OS); objective response rate (ORR), duration of response (DoR) and expected duration of response (EDoR); clinical benefit rate (CBR), duration of clinical benefit (DoCB), and expected duration of clinical benefit (EDoCB); quality of life (QoL); safety and tolerability.^[4,5]

The FALCON study is due to complete in 2017.^[4]  

About CONFIRM

CONFIRM (COmparisoN of FASLODEX In Recurrent or Metastatic breast cancer) was a Phase III, randomised, double-blind, parallel-group, multi-center trial comparing fulvestrant 500 mg (n=362) and 250 mg (n=374) in postmenopausal women with oestrogen receptor-positive advanced breast cancer, who progressed or recurred following one prior endocrine therapy (antioestrogen or aromatase inhibitor). Eligible patients were randomised 1:1 to fulvestrant 500 mg or 250 mg, and assessed for tumour 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 clinical benefit (DoCB), overall survival and quality of life (QoL). Safety and tolerability were also assessed.

About Metastatic Breast Cancer

Metastatic breast cancer occurs when cancer cells have spread beyond the initial tumour site to other parts of the breast or body, forming secondary tumours; it is the most advanced stage of breast cancer (stage four).^[6,7] 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.^[8],[9] There is no cure for metastatic breast cancer; the goal of treatment is to delay the progression of the cancer.^[6]

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. AstraZeneca is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines. For more information please visit: http://www.astrazeneca.com.

1. FASLODEX Prescribing Information Available online [http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000540/WC500021174.pdf Last accessed October 05 ]. Last accessed October 05, 2012.

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

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 [http://globocan.iarc.fr/factsheet.asp ]. Last accessed September 19, 2012.

4. Robertson J, Ellis M. A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and  Tolerability of Fulvestrant (FASLODEXTM) 500 mg with Anastrozole (ARIMIDEXTM) 1 mg 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 (FALCON). Clinical Study Protocol Synopsis. Study Code D699BC00001. May 1, 2012.

5. ClinicalTrials.gov. A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer. (FALCON) Available online. [http://www.clinicaltrials.gov/ct2/show/NCT01602380?term=FALCON&rank=1 ] Last accessed September 2012.

6. National Cancer Institute. Treatment Option Overview, Patient Version. Available online [http://www.cancer.gov/cancertopics/pdq/treatment/breast/Patient/page5 ]. Last accessed September 19, 2012.

7. National Cancer Institute. Metastatic Cancer: Questions and Answers. Available online [http://www.cancer.gov/cancertopics/factsheet/Sites-Types/metastatic ]. Last accessed September 19, 2012.

8. Dawood S et al. Survival differences among women with de novo stage IV and relapsed breast cancer. Annals of Oncology. 2010. 21: 2169-2174.

9. American Cancer Society. Treatment of invasive breast cancer, by stage. Last revised: November 22, 2010. Available Online [http://www.cancer.org/Cancer/BreastCancer/DetailedGuide/breast-cancer-treating-by-stage ]. Last accessed September 19, 2012.

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