New Studies Of First Successful Targeted Therapy Launched; Volunteers Sought.(Herceptin)

2001 JUL 12 - (NewsRx Network) -- University of California, Los Angeles, physicians are seeking more than 3,000 women with early-stage breast cancer for a new study of the breakthrough drug Herceptin, the first successful targeted therapy for breast cancer.

The study, headquartered at UCLA's Jonsson Cancer Center, will be the largest international clinical trial to investigate Herceptin in women with early-stage breast cancer. Up to 600 institutions on five continents may participate in the clinical trial through the Breast Cancer International Research Group (BCIRG), a global network that spans 35 countries, 850 medical centers, and involves 1,500 clinical investigators who test new therapies for breast cancer.

The most recent and comprehensive research on Herceptin, published in the March 15, 2001, issue of the New England Journal of Medicine, proved the drug's effectiveness in women with a particular kind of breast cancer that has metastasized, or spread, beyond the breast and local lymph nodes. The data show that combining Herceptin with chemotherapy as a first-line treatment offers the best chance at increasing survival for those with a fast-growing form of late-stage breast cancer.

By investigating Herceptin in women with aggressive breast cancer that has been diagnosed early - before it has spread from the breast to other parts of the body - researchers hope to demonstrate significant improvements in patient survival and cure rates, said Dr. Dennis Slamon, director of the Revlon/UCLA Women's Cancer Research Program at the Jonsson Cancer Center and leader of the UCLA team whose scientific and clinical research in the 1980s laid the foundation for Herceptin's development.

"The Herceptin-chemotherapy combinations have been shown to decrease breast cancer deaths by 27% in women whose metastatic breast cancer is characterized by an alteration in the HER-2/neu gene. This is significant because the life expectancy of patients who have the genetic alteration can be as low as half the life expectancy of patients who don't have it," said Slamon, who also is director of Clinical/Translational Research at the Jonsson Cancer Center and chief of the Division of Hematology/Oncology at the UCLA School of Medicine. "By giving Herceptin and chemotherapy at an earlier stage, we hope to help patients who have the genetic alteration live longer and ultimately have the best chance of being cured. Our lab studies demonstrate that this stage of the disease is likely to be where we can have our greatest impact on cure rates. However, this has to be proven first in a clinical trial."

Approved by the U.S. Food and Drug Administration in September 1998, Herceptin is the first breast cancer treatment to successfully attack a specific genetic mutation that causes an aggressive form of the disease. The drug can be effective for breast cancer patients who have a mutation in a gene called HER-2/neu in their tumor cells, an abnormality that causes their cancer to grow and spread quickly. About 25% to 30% of women with breast cancer - or about 125,000 to 150,000 cases a year worldwide - fall into that category.

The new study will test standard chemotherapy combinations for early-stage breast cancer with and without Herceptin.