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

AsiaNet 51193

LONDON, Oct. 29, 2012 /PRN=KYODO JBN/ --

     FALCON (Fulvestrant and AnastrozoLe COmpared in hormonal therapy Naive

advanced breast cancer) trial to compare fulvestrant to anastrozole

(ARIMIDEX(R)) tablets in hormonal therapy-naive, postmenopausal patients with

hormone receptor-positive locally advanced or metastatic breast cancer.

    AstraZeneca [http://www.astrazeneca.com ] 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 [http://jco.ascopubs.org/content/27/27/4530.full.pdf ] (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 (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.

    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(R) (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. [

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000540/WC500021174.pdf

]

    Approved Uses for ARIMIDEX(R) (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. [

http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Arimidex_30/WC500109490.pdf

]

    NOTES TO EDITORS

    About FALCON

    FALCON (Fulvestrant and AnastrozoLe COmpared in hormonal therapy Naive

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.

    CONTACTS

    Media enquiries

    David Ginivan

    Tel: +44-1625-516973

    mob: +44(0)-7775-412-619

    Elizabeth Lockett

    Tel: +44(0)20-3047-2078

    SOURCE: AstraZeneca