Promising Results on Horizon for Early-Stage Breast Cancer Patients

Thursday, April 28, 2005

SCOTTSDALE, Ariz. - A promising major advance for thousands of women with an aggressive type of breast cancer has been announced by the National Cancer Institute (NCI) - based on results of two large randomized clinical trials involving treatment with drugs and chemotherapy.

"These findings confirm that we now have a very potent weapon against the recurrence of cancer cells that over-express HER-2," said Edith A. Perez, M.D., Mayo Clinic in Jacksonville, Fla., who chaired the trials that extended from February 2000 to April 2005. Physicians at Mayo Clinic in Arizona also helped conduct the study - providing the opportunity for patients in Arizona to participate and benefit from this research.

HER-2 is a protein found on the surface of cancer cells. If these cells over-express, or make too much of the protein, patients are said to be HER-2 positive. Results of the trials show that HER-2 positive breast cancer patients who received a combination of a drug that targets HER-2, combined with chemotherapy, had a significant decrease in risk for breast cancer recurrence compared with patients who received chemotherapy without the drug.

The drug is Herceptin (trastuzumab), a drug that was approved for treatment of advanced breast cancer in 1998. When administered in the early stages of the disease, Herceptin stops or slows the growth of the cancer cells. (The drug is used only to treat cancers that over-express the HER-2 protein.) (MORE)

Leaders of the study are reacting very positively to the results, citing the collaborative efforts involved.

Several leading research and clinical organizations participated in the studies. Noted NCI director Andres von Eschenback, M.D., "These results are one more example that we are at a major turning point in the use of targeted therapies to eliminate suffering and death from cancer."

Donald W. Northfelt, M.D., F.A.C.P., medical oncologist and Co-Director of the Breast Clinic at Mayo Clinic in Arizona, confirmed the positive findings announced by the study leaders, acknowledging, "For women with this type of aggressive breast cancer, this combination of Herceptin and chemotherapy appears to virtually reverse prognosis from 'unfavorable' to 'good.'"

More than 3,300 patients were enrolled in the studies, most of whom had breast cancer with lymph node involvement. Patients were randomized, with some receiving chemotherapy with one specific set of drugs and others receiving a drug combination that included Herceptin.

The Data Monitoring Committees overseeing the analysis of the trials recommended that the results be made public because of the promising results that indicate significantly lower risk for relapse in women receiving Herceptin in combination with chemotherapy. According to the NCI, about 30 percent of women diagnosed with breast cancer have lymph node involvement - and about 20 to 30 percent of these tumors over-express the HER-2 protein, the target for Herceptin.

Mayo Clinic Cancer Center
Mayo Clinic Cancer Center is one of only 38 U.S. medical centers that have been named as a National Cancer Institute (NCI) Comprehensive Cancer Center. To receive this designation, an institution must meet rigorous standards demonstrating clinical excellence in treating cancer patients and scientific excellence in its research programs. Mayo Clinic Cancer Center is ranked by the NCI as one of the top 10 cancer centers in the nation, and is the only national, multi-site center with the NCI's Comprehensive Cancer Center designation. In Arizona, Mayo's clinical and research experts work together to address the complex needs of cancer patients, with a dedication to understanding the biology of cancer; discovering new ways to predict, prevent, diagnose and treat cancer; and transforming the quality of life for cancer patients today and in the future.

Mayo Clinic is a private group practice of medicine dedicated to providing diagnosis and treatment of patient illnesses through a systematic focus on individual patient needs. As a leading academic medical center in the Southwest, Mayo Clinic focuses on providing specialty and surgical care in more than 65 disciplines at its outpatient facility in north Scottsdale and at Mayo Clinic Hospital. The 208-licensed bed hospital is located at 56th Street and Mayo Boulevard (north of Bell Road) in northeast Phoenix, and provides inpatient care to support the medical and surgical specialties of the clinic, which is located at 134th Street and Shea Boulevard in Scottsdale.

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