Avastin + Herceptin HER2 study initiated

The international BETH study for women with HER2-positive breast cancer is open for enrollment. The pivotal Phase III clinical trial is investigating the benefits of combining two blockbuster antibody drugs made by Swiss drug major Roche. The study will evaluate the anti-angiogenic Avastin (bevacizumab) and the targeted therapy Herceptin (trastuzumab) together with chemotherapy for 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, principal investigator of the Cancer International Research Group.

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 a regimen of 5-fluorouracil, epirubicin and cyclophosphamide plus trastuzumab with or without bevacizumab.