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

London (ots/PRNewswire) -

FALCON (Fulvestrant and AnastrozoLe COmpared in hormonal therapy
Naïve advanced breast cancer) trial to compare fulvestrant to
anastrozole (ARIMIDEX(R)) tablets in hormonal therapy-naïve,
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/documen
t_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/documen
t_library/Referrals_document/Arimidex_30/WC500109490.pdf ]

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/NC
T01602380?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/tre
atment/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-treati
ng-by-stage ]. Last accessed September 19, 2012.

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