Herceptin: the future in adjuvant breast cancer therapy

New drugs for the treatment of breast cancer are generally introduced into clinical practice in the metastatic setting. However, it is well known that therapeutic response improves when drugs are used earlier in the disease. Therefore, once drugs have shown a major therapeutic impact in the metastatic setting, investigation in the adjuvant setting should be prioritized. Herceptin has shown significant efficacy and an ability to extend survival in human epidermal growth factor receptor-2 (HER2)-positive metastatic breast cancer patients and is well tolerated. Four major randomized, multicenter adjuvant clinical trials of Herceptin in patients with HER2-positive primary breast cancer have been started or are planned. The designs of these trials are described. With a total of over 12 000 patients, these studies should provide the information necessary to confirm the clinical potential of Herceptin as adjuvant therapy. The inclusion of a variety of regimens, including different durations of Herceptin therapy in the Herceptin Adjuvant (HERA) Trial, will allow the optimal therapeutic approach to be identified, and the size and generally pragmatic designs should encourage clinicians to enroll patients. The establishment of the role of Herceptin in the adjuvant setting will offer women with HER2-positive primary breast cancer the chance for improved survival. This is particularly important given that HER2-positive breast cancer patients form a high-risk group with a poor overall prognosis.