Herceptin for Early Stage Breast Cancer

A major new clinical trial is underway to determine if Herceptin, a drug now used to treat metastatic breast cancer, may be equally effective for treating women with early stage tumors. Herceptin is currently approved by the U.S. Food and Drug Administration only for use in treating advanced breast cancer that has spread (metastasized) to other parts of the body.

This new study, initiated by the Breast Cancer International Research Group (BCIRG), 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. BCIRG is a non-profit organization comprised of more than 2,000 academic breast cancer researchers.

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 cancerous breast tumors.

Earlier studies have shown that Herceptin boosts the effectiveness of traditional chemotherapy agents, extending survival for women with advanced breast cancer. Researchers hope the drug will work even better in patients with newly diagnosed breast cancer.

"If this approach is successful, it may lead to a completely new standard of treatment for breast cancer patients who are HER2 positive," said Dr. Kate Tkaczuk of the University of Maryland Medical Center. "We are hopeful this regimen will slow cancer growth and delay or even prevent a relapse."

The 10-year study will eventually enroll 3,150 patients worldwide. To qualify, women must be 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.

SOURCES:
Breast Cancer International Research Group (www.bcirg.org)
University of Maryland Medical Center (www.umm.edu)

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