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University of Cincinnati Academic Health Center
Publish Date: 10/10/00
Media Contact: AHC Public Relations, (513) 558-4553
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UC Joins Clinical Trial to Evaluate Herceptin as Therapy for Early Stage Breast Cancer

Cincinnati--The University of Cincinnati (UC) Barrett Cancer Center is participating in a new phase III clinical trial launched by the National Surgical Adjuvant Breast and Bowel Project (NSABP), a network of medical professionals funded by the National Cancer Institute (NCI). The study, Protocol B-31, will evaluate Herceptin as a breast cancer treatment to be used with traditional chemotherapy and Taxol. At more than 100 sites across the United States and Canada, Protocol B-31 will assess the safety and efficacy of the combination of Herceptin and chemotherapy in the treatment of 2,700 breast cancer patients who have cancer cells found in the lymph nodes and whose tumors overexpress the HER2 (human epidermal growth factor receptor-2) protein.

The HER2 gene (also referred to as erbB-2 or HER2/ neu) produces a protein that stimulates normal cell growth. It also seems to play a significant role in the biology of breast cancer. An abundance of the HER2 protein is found in about 25-30 percent of malignant breast tumors and is associated with more aggressive cancer growth and shorter patient survival. Based on this knowledge, researchers are now testing therapies that are aimed at tumors with HER2.

"Herceptin is on the forefront of biologic warfare against breast cancer and UC is excited to be on the frontline bringing these potential advancements to the women of the Tristate area," said Elizabeth Shaughnessy, MD, principal investigator, assistant professor, UC Department of Surgery. "The results of this study may improve treatment for women with early stage breast cancer tumors that overexpress HER2 and we look towards the future with anticipation."

Herceptin, a humanized monoclonal antibody, was approved by the U.S. Food and Drug Administration (FDA) to treat women with metastatic breast cancer with HER2-associated tumors. In a previous clinical trial, women with HER2 positive metastatic breast cancer who received Herceptin in combination with chemotherapy achieved a 50 percent response rate compared to 32 percent for women receiving chemotherapy alone. These women who received Herceptin in addition to chemotherapy lived longer than those who received chemotherapy alone. Few therapies have demonstrated such a survival benefit in this patient population. In the the new trial, the role of Herceptin will be tested in women with breast cancers having HER2 overexpression and whose tumors have spread to the underarm lymph nodes but not to other organs. They will be given either chemotherapy alone, or chemotherapy plus Herceptin.

Side effects most commonly associated with Herceptin include fever and chills, infusion-related reactions that are generally treatable. In some patients, previous research has shown that Herceptin alone, or in combination with standard chemotherapy, can increase a patient's risk for developing serious heart problems. As a result, B-31 was designed to closely monitor patients for serious heart problems.

NSABP Protocol B-31 will be conducted in two stages. Stage 1 will evaluate 1,000 patients for cardiac safety and compare the toxicities of adding weekly Herceptin to chemo treatments with Taxol, Adriamycin, and cyclophosphamide. If researchers determine the potential benefits of Herceptin therapy are greater than the drug-related side effects, the study will proceed to Stage 2. This second stage will accrue an additional 1,700 patients to study the efficacy of adding Herceptin to the standard chemotherapy regimen followed by Taxol in prolonging patient survival and disease-free survival.

In women with metastatic breast cancer, Herceptin may also be associated with increased shortness of breath, or problems breathing. Rarely, these reactions can be severe or life threatening. Patients with pre-existing lung disease or breast cancer that has spread to their lungs may be more susceptible to these reactions. Since B-31 is designed to evaluate the potential safety and efficacy of Herceptin in women with early stage breast cancer, these pulmonary reactions are rare. Women with existing heart disease are not eligible to participate.

Herceptin was discovered and developed and is manufactured and marketed in the U.S. by Genentech. It is currently indicated as a first line therapy in combination with Taxol and alone as a second and third line therapy for women with metastatic breast cancer who have tumors that overexpress the HER2 protein. For more information on protocol B-31, please call the UC Barrett Cancer Center at 513/584-2951. Or, call the NCI Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) to locate a participating site near you. Additional information can be obtained by visiting the NSABP Web site at or NCI clinical trials Web site at

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