First Patient Enrolled In Global Phase III Study Of Bevacizumab And Trastuzumab In Early Breast Cancer

A new international study for women with
HER2-positive breast cancer is open for enrollment. The pivotal BETH
(BEvacizumab and Trastuzumab Adjuvant Therapy in HER2-positive Breast
Cancer) study is a Phase III clinical research trial that is investigating
the benefits of combining two monoclonal antibodies, the anti-angiogenic,
bevacizumab (Avastin(R)) and the targeted therapy trastuzumab
(Herceptin(R)), together with chemotherapy for the treatment of patients
with early stage HER2-positive breast cancer.


"Trastuzumab is already the standard of care across all stages of
HER2-positive breast cancer and has a proven survival benefit. Bevacizumab
has been shown to be of benefit when given in combination with chemotherapy
for the treatment of metastatic breast cancer," said Dennis Slamon, MD,
director of clinical/translational research at the University of
California, Los Angeles' (UCLA) Jonsson Comprehensive Cancer Center and
principal investigator, Cancer International Research Group. "The design of
the BETH clinical trial is based on the preclinical and early clinical work
from the Slamon/TRIO Laboratories at UCLA. We are looking forward to
investigating the additional benefit to patients of combining these two
treatments with chemotherapy in the treatment of early breast cancer."



"Despite treatment advances, over 400,000 women worldwide still die
from breast cancer every year, so striving to improve treatment outcomes
remains critical," said Norman Wolmark, MD, chairman of the Department of
Human Oncology at the Allegheny General Hospital, and principal
investigator, NSABP Foundation, Inc., Pittsburgh, Pennsylvania, USA, who
welcomes the start of the study.



In BETH, patients will be randomized to a regimen of chemotherapy
(either 6 cycles of docetaxel/carboplatin or 3 cycles of docetaxel,
followed by 3 cycles of FEC(1)) plus trastuzumab with or without
bevacizumab.



BETH was developed through the collaborative efforts of the NSABP
(National Surgical Adjuvant Breast and Bowel Project) and CIRG (Cancer
International Research Group). The study will be led by the two groups and
will recruit approximately 3,500 patients. The primary outcome measure of
BETH will be invasive disease-free survival. Secondary endpoints for the
study include disease-free survival, overall survival, safety, and
tolerability.



Bevacizumab and trastuzumab are used in the treatment of women with
breast cancer; bevacizumab for metastatic breast cancer and trastuzumab for
both early and late HER2-positive breast cancer. This is the first Phase
III trial to evaluate combining the two therapies in treating early stage
breast cancer.



ABOUT THE CANCER INTERNATIONAL RESEARCH GROUP (CIRG) AND TRANSLATIONAL
RESEARCH IN ONCOLOGY (TRIO)
















CIRG is a not-for-profit research organization with offices based in
Paris, France and Alberta, Canada. With an international network of 2000
investigators and 450 cancer centers in over 45 different countries, CIRG
has conducted a number of new and innovative global studies evaluating
systemic therapy for cancer. The BCIRG 001 study led to the registration of
docetaxel in the early breast cancer setting. The BCIRG 006 study showed
that a non-anthracycline Herceptin-containing regimen was as efficacious as
an anthracycline- and Herceptin-containing regimen in the early
HER2-positive breast cancer setting, thus providing an equally effective,
less cardiotoxic alternative to women with this type of breast cancer.



Recently, CIRG has partnered with the UCLA-based investigator network
of Translational Oncology Research International, to form TRIO
(Translational Research in Oncology). In addition to a network of dedicated
investigators and clinical trial services, TRIO also includes the
Slamon/TRIO Laboratories at UCLA. Slamon and fellow scientists have
developed and adapted preclinical models which allow for the validation of
molecular markers, the preclinical assessment of new biologic agents and
the characterization of an agent's mechanisms of action. This preclinical
work, in turn, generates the clinical hypotheses for the group's future
cancer trials in patients. This translational approach has been used in the
BCIRG 006 study and the newly-launched BETH clinical trial.



TRIO is dedicated to advancing translational cancer research by
bringing innovative and targeted therapeutics to clinical practice.
Additional information is available on the Internet at
trioncology.



ABOUT THE NATIONAL SURGICAL ADJUVANT BREAST AND BOWEL PROJECT (NSABP)



Headquartered in Pittsburgh, Pennsylvania, USA, the National Surgical
Adjuvant Breast and Bowel Project (NSABP) is a clinical trials cooperative
group. The NSABP has a 50-year history of designing and conducting clinical
research trials that have changed the way breast cancer is treated and,
more recently, prevented.



With research sites at nearly 1,000 major medical centers, university
hospitals, large oncology practice groups, and health maintenance
organizations in the United States, Canada, Puerto Rico, and Ireland, the
NSABP has enrolled more than 110,000 women and men in clinical trials in
breast and colorectal cancer. More than 5,000 physicians, nurses, and other
medical professionals conduct NSABP treatment and prevention trials.



NSABP breast cancer studies led to the establishment of lumpectomy plus
radiation over radical mastectomy as the standard surgical treatment for
breast cancer. In addition, the NSABP was the first to demonstrate that
adjuvant therapy could alter the natural history of breast cancer, thereby
increasing survival rates. The group was also the first to conduct large
scale breast cancer prevention studies that showed that the drugs tamoxifen
and raloxifene could reduce the risk of developing invasive breast cancer
by about 50 percent in women at increased risk for the disease; more than
33,000 women participated in the Breast Cancer Prevention Trial (BCPT) and
Study of Tamoxifen and Raloxifene (STAR).



Additional information about the NSABP is available on the Internet at
nsabp.



(1) FEC refers to 5-Fluorouracil, Epirubicin, Cyclophosphamide


National Surgical Adjuvant Breast and Bowel Project

nsabp