Nationwide clinical trial, led by IU Simon Cancer Center physician/researcher, tests effectiveness of drug that slows cancer growth

INDIANAPOLIS – (Nov. 26, 2007) -- A drug that slows the growth of cancer in women with metastatic breast cancer will soon be tested in newly diagnosed patients across the country to determine if it will have a similar effect.


            Kathy Miller, M.D., associate professor of medicine and the Sheila D. Ward Scholar at the Indiana University School of Medicine and a physician/researcher at the Indiana University Melvin and Bren Simon Cancer Center, is the principal investigator of the phase III trial called E5103 coordinated by the Eastern Cooperative Oncology Group, a network of cancer researchers, physicians and health-care professionals at public and private institutions around the nation. 


            The clinical study, which will enroll 4,950 women and men at sites across the country over the next 2½ years, is the first to add the drug bevacizumab (Avastin®) to the current standard chemotherapy treatment in patients with newly diagnosed breast cancer.


            In 2005, Miller discovered that adding Avastin to the standard chemotherapy treatment nearly doubled the time it took for cancer to grow in women whose breast cancer had metastasized to other parts of the body, compared with women who received standard treatment alone.

            Because of that discovery, Miller and her colleagues believe that adding Avastin to chemotherapy for newly diagnosed women – those women without metastasized cancer – may also be successful in treating breast cancer.


            “What we hope and think will happen is the women treated with Avastin in addition to chemotherapy will have fewer recurrences of their breast cancer and more of them will be alive and well,” Dr. Miller said. “They’ll essentially be cured of their disease.”


How does Avastin work?

            Tumors need an increased blood supply to grow. The process of growing new blood vessels is called angiogenesis; tumors have the ability to trigger that growth process. Avastin appears to block signals to the blood vessels that tell them to grow. The drug is currently FDA approved for treatment of metastatic colorectal cancer and non-small cell lung cancer.


            Participants of the breast cancer study will be randomized into three groups: 


  • Group 1 will receive standard chemotherapy -- Doxorubicin and Cyclophosphamide -- for 12 weeks followed by 12 weeks of Paclitaxel.


  • Group 2 will receive the same therapy as Group 1, but it will also receive Avastin at three-week intervals throughout the two 12-week treatment periods.


  • Group 3 will receive the same treatments as Group 2. After completion of the two 12-week treatment periods, Group 3 will continue to receive Avastin every three weeks for 30 weeks.


              The trial is open in the United States, Canada, Peru, South Africa and Ireland. Women or men with newly diagnosed breast cancer are eligible to participate. To learn more about the trial, talk with your physician.


            Researchers at the IU Simon Cancer Center have been the leaders in anti-angiogenic research for breast cancer. George Sledge, M.D., the Ballve Lantero Professor of Oncology at the IU School of Medicine, was the principal investigator of the first nationwide phase I and phase II trials with the drug in 1997 and 1999, respectively.