New Data On Pfizer's Aromasin and Ellence to Be Presented at San Antonio Breast Cancer Symposium
15 December 2006 - 5:09AM
PR Newswire (US)
Pfizer Begins a Phase III Trial to Study Sutent(R) in Patients with
Advanced Breast Cancer NEW YORK, Dec. 14 /PRNewswire-FirstCall/ --
Results of two studies evaluating the hormonal therapy Aromasin(R)
(exemestane tablets) and the chemotherapy Ellence(R) (epirubicin
hydrochloride injection) will be presented at the San Antonio
Breast Cancer Symposium (SABCS) December 14 - 17, 2006. In
addition, Pfizer announced the initiation of a phase III clinical
trial to study Sutent(R) (sunitinib malate) in patients with
advanced (or metastatic) breast cancer -- cancer that originated in
the breast and has spread to other parts of the body. "New data are
showing that Aromasin and Ellence can improve the outcomes for
women with breast cancer," said Dr. Charles Baum, vice president of
Pfizer Global Research and Development and oncology clinical
leader. "Looking forward, we are pleased to begin studying patients
with Sutent in combination with a taxane in a Phase III trial for
the first-line treatment of advanced breast cancer." * Aromasin:
Efficacy in the Treatment of Early Breast Cancer Data from the
National Surgical Adjuvant Breast and Bowel Project (NSABP) B-33
study evaluates postmenopausal women with hormone receptor-
positive breast cancer who, after five years of tamoxifen therapy,
received either Aromasin or placebo. * Ellence: Interim Analysis of
Women with High Risk Node Negative Breast Cancer A study comparing
the efficacy of several common chemotherapy regimens, including
Ellence, cyclophosphamide, and fluorouracil (CEF), Ellence and
cyclophosphamide followed by paclitaxel (ECT) and a combination of
doxorubicin and cyclophosphamide followed by paclitaxel (AC/T). *
Sutent: Clinical Trials in Breast Cancer A phase III randomized
open-label study of sunitinib malate in combination with paclitaxel
versus bevacizumab with paclitaxel as a first-line treatment for
patients with advanced breast cancer is now open and enrolling
patients. The trial will enroll more than 700 patients at 20 sites
across the United States. The initiation of a second phase III
trial is expected in early 2007. In addition, a phase II
randomized, open-label study of sunitinib malate versus
standard-of- care for patients with previously treated advanced
triple receptor negative (ER-, PR- and HER2-) breast cancer is
currently enrolling patients at 44 international sites, including
more than 25 U.S. sites. For more information about this trial,
visit http://www.pfizeroncology.com/clinicaltrialpo.aspx or call
1-877-369- 9753. Key data presentations include: PRODUCT TIME
ABSTRACT TITLE AROMASIN(R) Benefit from exemestane as extended
(exemestane Dec. 15 adjuvant therapy after five years of tablets)
9:30 am tamoxifen: intent-to-treat analysis of NSABP B-33
ELLENCE(R) A Randomized Trial of CEF versus Dose (epirubicin Dec.
17 Dense EC followed by Paclitaxel hydrochloride 8:45 am versus AC
followed by Paclitaxel in injection) women with node positive or
high risk node negative breast cancer, NCIC CTG MA.21: Results of
an interim analysis Background information on studies and trials
will be posted on http://www.pfizer.com/ after each presentations
is made at SABCS. About Aromasin(R) Aromasin is indicated for the
adjuvant treatment of postmenopausal women with hormone
receptor-positive early breast cancer who have received two to
three years of tamoxifen and are switched to AROMASIN for
completion of a total of 5 consecutive years of adjuvant hormonal
therapy. Aromasin is also indicated for the treatment of advanced
breast cancer in women with natural or induced postmenopausal
status whose disease has progressed following tamoxifen therapy.
Important Safety Information: Aromasin should not be used in women
who are premenopausal, are nursing or pregnant, have a known
hypersensitivity to the drug, or are taking estrogen- containing
agents. About Ellence(R) Ellence (epirubicin hydrochloride
injection) is part of a chemotherapy regimen used to treat the
early stages of breast cancer when the cancer has spread to the
lymph nodes. It is administered after women have undergone surgery
for their cancer. This kind of chemo is called "adjuvant" therapy.
Important Safety Information: Tissue necrosis due to extravasation
could occur. Not to be given by IM or subcutaneous route;
cardiotoxicity, CHF in most severe cases, may occur during or after
therapy; secondary leukemia has been reported in anthracycline-
treated patients. Certain factors can increase the risk for
developing these conditions; dosage should be reduced in
hepatically impaired patients; severe myelosuppression may occur.
DISCLOSURE NOTICE: The information contained in this release is as
of December 14, 2006. Pfizer assumes no obligation to update any
forward-looking statements contained in this release as the result
of new information or future events or developments. This release
contains forward-looking information about a potential additional
indication for Sutent that involves substantial risks and
uncertainties. Such risks and uncertainties include, among other
things, the uncertainties inherent in research and development;
decisions by regulatory authorities regarding whether and when to
approve any drug applications that may be filed for this additional
indication as well as their decisions regarding labeling and other
matters that could affect its availability or commercial potential;
and competitive developments. A further description of risks and
uncertainties can be found in Pfizer's Annual Report on Form 10-K
for the fiscal year ended December 31, 2005 and in its reports on
Form 10-Q and Form 8-K. DATASOURCE: Pfizer Inc CONTACT: Betsy
Raymond, +1-212-733-6572, or Vanessa Aristide, +1-212-733-3784 Web
site: http://www.pfizer.com/
http://www.pfizeroncology.com/clinicaltrialpo.aspx Company News
On-Call: http://www.prnewswire.com/comp/688250.html Company News
On-Call: Pfizer's press releases are available through PR
Newswire's Company News On-Call service on PRN's Web Site. Visit
http://www.prnewswire.com/comp/688250.html
Copyright