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
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
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
*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,
*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
– ENDS –
NOTES TO EDITORS
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
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
^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,
Media Inquiries US
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