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FDA Approves Herceptin to Treat Early-Stage Disease

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Herceptin (chemical name: trastuzumab) is a very effective treatment against HER2-positive breast cancer in women with stage II, III, and IV disease (medium to large cancers or cancers with lymph nodes involved or metastatic disease). Since 2005, research has shown that Herceptin also can benefit women with early-stage, HER2-positive disease that has spread to the lymph nodes. Adding Herceptin to the typical treatment plan (surgery, chemotherapy, and possibly radiation therapy) for women with early-stage, HER2-positive disease can significantly reduce the risk of recurrence (the cancer coming back).

Based on these results, many doctors began offering women with early-stage, HER2-positive breast cancer the option of receiving Herceptin. Now the U.S. Food and Drug Administration (FDA) officially has approved the use of Herceptin for early-stage disease.

The FDA based its decision on research showing that women with early-stage, HER2-positive, node-positive breast cancer had a significant reduction in the risk of recurrence compared to women who didn't receive Herceptin. After more than three years, 87% of the women receiving Herceptin were cancer-free compared to 71% of women who didn't receive Herceptin.

Herceptin is called a targeted therapy because it targets breast cancers that make too much of the HER2/neu gene or HER2 protein found in some breast cancers. Herceptin also is called an immune treatment because it is made of an immune system-like antibody that blocks the HER2 protein in cancer cells. Blocking this protein helps stop the growth of HER2-positive cancer cells. About one out of every four breast cancers is HER2-positive. HER2-positive breast cancers tend to be more aggressive than HER2-negative breast cancers.

If you've been diagnosed with early-stage, HER2-positive, node-positive breast cancer, you already may have taken Herceptin as part of your treatment. If you haven't, you might want to talk to your doctor about this newly-approved use of Herceptin for women like you.

To learn more about Herceptin, including related research results, visit our Herceptin pages.

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