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

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

  PR Newswire

  LONDON, October 29, 2012

LONDON, October 29, 2012 /PRNewswire/ --

FALCON ( F ulvestrant and  A nastrozo L e  CO mpared in hormonal therapy  N
aïve 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 ( F ulvestrant and A nastrozo L e CO mpared in hormonal therapy N aïve
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 ( CO mpariso N of F ASLODEX I n R ecurrent or M etastatic 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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