|[December 04, 2012]
AstraZeneca to Present Key New Data for Hormone Receptor-Positive Metastatic Breast Cancer at the 35th CTRC-AACR Annual San Antonio Breast Cancer Symposium
WILMINGTON, Del. --(Business Wire)--
(NYSE: AZN) today announced the presentation of important new data from
studies of FASLODEX® (fulvestrant) Injection at the 2012
CTRC-AACR San Antonio Breast Cancer Symposium taking place from 4-8
December at the Henry B. Gonzalez Convention Center, San Antonio, Texas.
This will include final analysis of overall survival from the Phase III
CONFIRM trial (COmparisoN of Faslodex In Recurrent or Metastatic breast
cancer) comparing fulvestrant 500 mg vs 250 mg.
FASLODEX 500 mg is 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. Please see additional Important Safety Information below.1
"The study data and research findings that will be presented are a
further addition to AstraZeneca's ongoing commitment to the continued
study and evaluation of treatment options for metastatic breast cancer.
While some of the data and research are investigational, it highlights
AstraZeneca's ongoing pursuit to developing and optimizing breast cancer
treatments for patients," said Yuri Rukazenkov, MD, Medical Science
Highlighted study results to be presented:
Final overall survival analysis of CONFIRM, a Phase III, randomized,
double-blind, parallel-group, multicenter trial comparing FASLODEX 500
mg (n=362) and 250 mg (n=374) in postmenopausal women with estrogen
receptor-positive advanced breast cancer whose disease progressed or
recurred following prior endocrine therapy, will be presented by
Angelo Di Leo, MD, Head of the Sandro Pitigliani Medical Oncology
Unit. Study results will also be featured in a SABCS press briefing.
Final analysis of overall survival for the Phase III CONFIRM trial:
fulvestrant 500 mg versus 250 mg. (Abstract #S1-4). SABSC press
briefing, Wednesday, December 5, 7:30 AM CDT (News - Alert). Oral presentation, General
Session 1, Wednesday, December 5, 9:15 AM CDT, Exhibit Hall D.
Data will be presented from a study on overcoming PTEN loss-related
endocrine therapy resistance through strategic combinations with mTOR,
AKT, or MEK inhibitors.
Overcoming endocrine therapy resistance related to PTEN loss by
strategic combinations with mTOR, AKT, or MEK inhibitors. (Abstract
#PD01-01). Poster Discussion 1, Endocrine Resistance, Wednesday,
December 5, 5:00 - 7:00 PM CDT, Ballroom A.
Results from a meta-analysis of the EFECT and SoFEA studies of
fulvestrant and exemestane in metastatic breast cancer patients with
acquired resistance to non-steroidal aromatase inhibitors. The SoFEA
trial is a Phase III study evaluating safety and efficacy of
fulvestrant plus concomitant anastrozole in postmenopausal women with
advanced hormone receptor-positive breast cancer compared with
fulvestrant or exemestane alone. Results of the EFECT trial, a
randomized, double-blind,placebo controlled, multicenter phase III
trial of fulvestrant versus exemestane in postmenopausal women with
hormone receptor-positive advanced breast cancer progressing or
recurring after nonsteroidal aromatase inhibitors, were published in
2008 in the Journal of Clinical Oncology.
Fulvestrant vs exemestane for treatment of metastatic breast cancer
in patients with acquired resistance to non-steroidal aromatase
inhibitors - a meta-analysis of EFECT and SoFEA (CRUKE/03/021 and
CRUK/09/007). (Abstract #P2-14-01). Poster Session 2, Treatment:
Endocrine Therapy - Advanced Disease, Thursday, December 6: 7:00 - 9:00
AM CDT: Exhibit Halls A - B.
A randomized Phase II neoadjuvant trial evaluating anastrozole and
fulvestrant efficiency for post-menopausal ER-positive, HER2-negative
Breast Cancer patients: first results of the UNICANCER CARMINA 02 French
trial. (Abstract #PD07-04). Poster Discussion 7, Neoadjuvant Endocrine
Therapy & Bisphosphonates, Friday, December 7: 7:00 - 9:00 AM CDT:
First results from the UNICANCER CARMINA 02 French Trial, a randomized
Phase II neoadjuvant trial evaluating anastrozole and fulvestrant in
post-menopausal estrogen receptor-positive, HER2-negative breast
cancer will be presented. The UNICANCER CARMINA study focuses on the
neo-adjuvant treatment of operable breast cancer in postmenopausal
women with stage II or stage III disease.
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
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 Class C)
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, and constipation
Increased hepatic enzymes (ALT, AST, ALP) occurred in >15% of FASLODEX
users and were non dose-dependent
Indication for FASLODEX® (fulvestrant)
FASLODEX is indicated for the treatment of hormone receptor-positive
metastatic breast cancer in postmenopausal women with disease
progression following antiestrogen therapy.
Please see full Prescribing
Information for FASLODEX.
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
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
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
Indications for ARIMIDEX® (anastrozole)
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.
Please see full Prescribing
Information for ARIMIDEX.
NOTES TO EDITORS
About Metastatic Breast Cancer
Metastatic breast cancer occurs when cancer cells spread beyond the
initial tumor site to other parts of the breast or body; it is the most
advanced stage of breast cancer (stage four).2,3 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.4,5 There is no cure for metastatic
breast cancer; the goal of treatment is to delay the progression of the
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 United States or our
AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com
or call 1-800-AZandMe (292-6363).
1 Prescribing Information for FASLODEX. AstraZeneca
Pharmaceutical LP, Wilmington, DE.
2 National Cancer
Institute. Treatment Option Overview, Patient Version. Available
online. Last accessed July 26, 2012.
Cancer Institute. Metastatic Cancer: Questions and Answers. Available
online. Last accessed July 26, 2012.
4 Dawood S,
Broglio K, Ensor J, Hortobagyi GN, Giordano SH. Survival differences
among women with de novo stage IV and relapsed breast cancer. Annals
5 American Cancer Society.
Treatment of invasive breast cancer, by stage. Last revised: August 23,
Online. Last accessed September 17, 2012.
Last Updated 12/12
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