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) and the targeted therapy trastuzumab (Herceptin), 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) 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.
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.