Mass. General leading international trial of novel breast cancer drug

December 13, 2006

A clinical trial of a new targeted breast cancer drug, led by physicians at Massachusetts General Hospital (MGH) Cancer Center, has begun enrolling patients. The TEACH (Tykerb Evaluation After CHemotherapy) trial will investigate the experimental drug Tykerb (lapatinib) in patients with early-stage, HER2-positive breast cancer who have not been treated with Herceptin, another targeted drug used for the same type of tumor. The MGH is the lead institution for the international trial, which is being sponsored by GlaxoSmithKline, the manufacturer of Tykerb.

"This trial represents another step toward understanding the role of targeted therapies in extending disease-free survival," said Paul Goss, MD, PhD, director of Breast Cancer Research at the MGH Cancer Center, who proposed the TEACH study and chairs the International Steering Committee.

About one quarter of breast cancer patients have tumors that overexpress or produce too many copies of a receptor molecule called HER2. Because cellular growth is stimulated by the overactivity of this molecule, which also is called ErbB2, these tumors are more likely to recur and are less responsive to hormone-based treatments. Herceptin, a monoclonal antibody that blocks the HER2 receptor, is approved by the FDA as an adjuvant treatment - given along with chemotherapy after surgical removal and/or radiation therapy - for early-stage, node-positive and HER2-positive tumors as well as for metastatic tumors.

Tykerb blocks both the HER2/ErbB2 receptor and a related molecule called ErbB1. Earlier clinical trials have indicated that it may have advantages over Herceptin in a number of settings related to treatment of HER2-positive breast cancer without significant side effects. Tykerb has not yet received approval from the U.S. Food and Drug Administration, and the TEACH study is a Phase III trial of its use in patients with early-stage HER2-positive tumors. To enroll in the study - which is being conducted at 450 sites around the world - patients must have completed adjuvant chemotherapy but not have received Herceptin. Study participants will be randomized to receive a daily oral dose of either Tykerb or a placebo for up to one year.

"The TEACH study will be the first to investigate the use of a dual ErbB1 and ErbB2 inhibitor as an adjuvant treatment for women with HER2-positive breast cancer, who are at a high risk of their disease recurring," says Goss.

"The concept of the TEACH study arose from our clinics," says Beverly Moy, MD, a medical oncologist at the MGH Breast Center and a member of the TEACH International Steering Committee."We have patients with HER2-positive breast cancer who had never received Herceptin because they were diagnosed before we knew about the benefits of Herceptin in early-stage breast cancer. The results of this study could reveal whether the targeted therapy Tykerb could benefit women several years after the initial diagnosis of breast cancer."
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U.S. patients interested in enrolling in the TEACH trial should call toll-free (877) 379-3718. Those interested in enrolling at the MGH can call (617) 643-3555. Additional information on the study is available at http://www.clinicaltrials.gov/ct/show/NCT00374322"order=27.

An integral part of one of the world's most distinguished medical centers, the Massachusetts General Hospital Cancer Center is chosen by more cancer patients than any other hospital in New England. Known for providing individualized, compassionate care to both adults and children, the MGH Cancer Center is comprised of 16 fully integrated, multidisciplinary clinical programs and a vast network of support and educational services. Scientific investigations are conducted as part of the largest hospital-based research program in the United States, and a powerful synergy between physicians and laboratory scientists fosters innovation in basic, translational and clinical research. The MGH is consistently ranked as one of the best cancer treatment centers in the country by US News and World Report, and MGH nurses were the first in the state to achieve Magnet status for exceptional nursing care.

Massachusetts General Hospital

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