Herceptin, a drug used for metastatic breast cancer, being tested for early stage tumors
The University of Maryland Greenebaum Cancer Center is participating in one of the largest international clinical trials ever conducted to study the potential benefit of a targeted drug called Herceptin for women with early stage breast cancer.
"This innovative study gives women with an aggressive form of breast cancer the opportunity to get Herceptin much earlier than it has ever been available," explains Kate Tkaczuk, M.D., an oncologist at the University of Maryland Greenebaum Cancer Center and associate professor of medicine at the University of Maryland School of Medicine.
Herceptin is currently approved by the U.S. Food and Drug Administration only for use in treating advanced breast cancer that has spread to other parts of the body. Earlier studies have shown that Hercpetin boosts the effectiveness of traditional chemotherapy agents. This study will enroll women with a particularly aggressive type of breast cancer to determine if they may also benefit from Herceptin when it is administered earlier in treatment.
The Greenebaum Cancer Center is one of about 600 institutions on five continents -- and the only site in Maryland -- taking part in the landmark study. It was initiated by the Breast Cancer International Research Group (BCIRG), a non-profit organization comprised of more than 2,000 academic investigators who are dedicated to the strategic development of promising new therapies for women with breast cancer.
Preliminary studies suggest Herceptin may block the effect of the HER2 gene and slow the growth of cancer. Herceptin is a monoclonal antibody, which is a new type of targeted biological therapy. Unlike antibodies that are made by the human immune system to fight foreign and infectious invaders, monoclonal antibodies are manufactured in a laboratory and are designed to fight specific types of cancer cells. Herceptin finds and attaches to the HER2 gene on breast cancer cells and has been shown to shrink or stop cancer cells from growing.
The HER2 gene is normally involved in regulating cell growth and cell death, but overexpression of the HER2 gene is linked to rapid cancer growth. These defective genes are found in about 25 percent of malignant breast tumors. A recent study published in The New England Journal of Medicine stated that Herceptin, combined with chemotherapy, extended survival for women with advanced breast cancer by 24 percent. Researchers hope the drug will work even better in patients with newly diagnosed breast cancer.
"We are pleased to be a part of this international, cutting-edge study," says Dr. Tkaczuk. "It is based on the most current scientific findings in breast cancer treatment and, if this approach is successful, it may lead to a completely new standard of treatment for breast cancer patients who are HER2 positive. We are hopeful this regimen may slow cancer growth and delay or even prevent a relapse."
The 10-year study will enroll 3,150 patients worldwide. The Greenebaum Cancer Center is enrolling HER2-positive breast cancer patients whose lymph nodes test positive for cancer cells; patients whose lymph nodes test negative but have tumors larger than 2 centimeters; those whose cancers are estrogen receptor negative; and patients younger than 35 years old.
The objective of the study is to determine which of three treatment regimens is the most effective in keeping patients free of disease and prolonging patient survival.
"We have seen a dramatic increase in promising new treatments for breast cancer, and we need to prove their effectiveness through studies such as this," adds Jean-Marc Nabholtz, M.D., chairman of BCIRG, study co-chairman, and professor of medicine and director of the Cancer Therapy Development Program at UCLA. "Our focus on new therapies now undergoing clinical evaluation is intended to increase the number of women who may be cured of breast cancer."
More than 780,000 new cases of breast cancer are reported worldwide annually. In the United States, it is the second most common cancer among women, after skin cancer, and the second leading cause of cancer death among women. The American Cancer Society estimates that 182,800 new cases of breast cancer will be diagnosed among women this year, and more than 40,000 women will die from the disease.
The goal of using medicines, such as chemotherapy or biological drugs, after a tumor has been surgically removed is to eradicate any remaining tumor cells that may be too small to be seen, but that might cause a recurrence of disease.
The Greenebaum Cancer Center also will be evaluating whether there is a difference when Herceptin is administered simultaneously with chemotherapy or afterward; the effect of Herceptin administered by injection under the skin as compared to into a vein; and whether another drug (Zinecard) can help reduce the occurrence and severity of side effects to the heart that have been noted in earlier studies.
The interest in these types of therapy in breast cancer is important, since women whose disease has spread to the lymph glands under the armpit have a high probability of cancer resurfacing in other parts of the body within a decade after surgery.
The University of Maryland Greenebaum Cancer Center brings together expert researchers and clinicans to collaborate on preventing, detecting and treating cancer. The Greenebaum Cancer Center currently has more than 200 clinical trials designed to offer and evaluate the latest approaches in cancer care.