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.
In BETH, patients will be randomized to a regimen of chemotherapy (either six cycles of docetaxel/carboplatin or three cycles of docetaxel, followed by three cycles of FEC(1)) plus trastuzumab with or without bevacizumab.
BETH was developed through the collaborative efforts of the National Surgical Adjuvant Breast and Bowel Project (NSABP) and Cancer International Research Group (CIRG). 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.