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First Patient Enrolled in Global Phase III Study of Bevacizumab and Trastuzumab in Early Breast Cancer

Wednesday, May 28, 2008 General News J E 4
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PARIS, May 27 A new international study for women withHER2-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 thebenefits 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 stageHER2-positive breast cancer.

"Trastuzumab is already the standard of care across all stages ofHER2-positive breast cancer and has a proven survival benefit. Bevacizumab hasbeen shown to be of benefit when given in combination with chemotherapy forthe treatment of metastatic breast cancer," said Dennis Slamon, MD, directorof clinical/translational research at the University of California, LosAngeles' (UCLA) Jonsson Comprehensive Cancer Center and principalinvestigator, Cancer International Research Group. "The design of the BETHclinical trial is based on the preclinical and early clinical work from theSlamon/TRIO Laboratories at UCLA. We are looking forward to investigating theadditional benefit to patients of combining these two treatments withchemotherapy in the treatment of early breast cancer."

"Despite treatment advances, over 400,000 women worldwide still die frombreast cancer every year, so striving to improve treatment outcomes remainscritical," said Norman Wolmark, MD, chairman of the Department of HumanOncology at the Allegheny General Hospital, and principal investigator, NSABPFoundation, Inc., Pittsburgh, Pennsylvania, USA, who welcomes the start of thestudy.

In BETH, patients will be randomized to a regimen of chemotherapy (either6 cycles of docetaxel/carboplatin or 3 cycles of docetaxel, followed by 3cycles 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 (CancerInternational Research Group). The study will be led by the two groups andwill recruit approximately 3,500 patients. The primary outcome measure of BETHwill be invasive disease-free survival. Secondary endpoints for the studyinclude disease-free survival, overall survival, safety, and tolerability.

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

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

CIRG is a not-for-profit research organization with offices based inParis, France and Alberta, Canada. With an international network of 2000investigators and 450 cancer centers in over 45 different countries, CIRG hasconducted a number of new and innovative global studies evaluating systemictherapy for cancer. The BCIRG 001 study led to the registration of docetaxelin the early breast cancer setting. The BCIRG 006 study showed that anon-anthracycline Herceptin-containing regimen was as efficacious as ananthracycline- and Herceptin-containing regimen in the early HER2-positivebreast cancer setting, thus providing an equally effective, less cardiotoxicalternative to women with this type of breast cancer.

Recently, CIRG has partnered with the UCLA-based investigator network ofTranslational Oncology Research International, to form TRIO (TranslationalResearch in Oncology). In addition to a network of dedicated investigatorsand clinical trial services, TRIO also includes the Slamon/TRIO Laboratoriesat UCLA. Slamon and fellow scientists have developed and adapted preclinicalmodels which allow for the validation of molecular markers,
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