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Trials Show Herceptin Aids Breast Cancer Recovery

April 26, 2005

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The drug Herceptin has produced promising results in trials for the treatment of breast cancer. The drug, developed by Genentech, is used to treat women with the early stage of the disease, and who have undergone surgery.

The National Cancer Institute, one of the test's two sponsors, said it concluded the clinical trials early after Herceptin and chemotherapy showed such strong promise as a treatment. The patients who received Herceptin and chemotherapy had a 52 percent decrease in disease recurrence, compared with women treated only with chemotherapy.

The trials compared Herceptin plus chemotherapy to chemotherapy alone as adjuvant therapy following initial treatment with surgery for women with early-stage, or cancer that has not spread beyond the breast and associated lymph nodes, human epidermal growth factor receptor 2 (HER2) positive breast cancer.

"The data from these very important Phase III trials suggest for the first time that a therapy that targets women whose tumors have a specific genetic mutation has the potential to reduce the recurrence of disease in early-stage breast cancer patients," said Susan Desmond-Hellmann, M.D., M.P.H., Genentech's president of Product Development.

"While further follow-up is necessary, the results of this joint interim analysis suggest that adjuvant therapy with Herceptin plus chemotherapy for women with early-stage HER2-positive breast cancer may increase the chance of long-term survival."

The NCCTG study enrolled its first patient in June 2000 and has enrolled 3,406 patients to date; the NSABP study began enrollment in March 2000 and has enrolled 2,085 patients to date. The interim analysis was based on information from 3,300 patients. These studies will stop enrolling new patients and the cooperative groups will continue to monitor patients for longer-term data. Each of the studies was a randomized, controlled trial that evaluated the combination of anthracycline and cyclophosphamide (AC) followed by paclitaxel, with or without Herceptin using different treatment schedules of paclitaxel in women with HER2-positive breast cancer.

Adverse events in these studies were consistent with those seen in previous Herceptin clinical trials. Each of these studies has an independent, external Data Monitoring Committee (DMC) that reviewed data from the studies, including cardiac safety data. The DMCs monitored safety data on a regular basis and there were three to four percent more cases of serious or life-threatening (and in rare cases, fatal) cardiac events, most commonly congestive heart failure (weakening of the heart muscle) in patients receiving the combination of Herceptin plus chemotherapy. Patients in these studies will continue to be followed for any additional side effects.

Herceptin is a targeted therapeutic antibody treatment for women with HER2-positive metastatic breast cancer, an especially aggressive form of the disease that affects approximately one-fourth of women with breast cancer. Special testing is required to identify women who are HER2-positive and candidates for treatment with Herceptin.

Herceptin received U.S. Food and Drug Administration (FDA) approval in September 1998 for use in women with metastatic breast cancer who have tumors that overexpress the HER2 protein. It is indicated for weekly treatment of patients both as first-line therapy in combination with paclitaxel and as a single agent in second- and third-line therapy.

Genentech says Herceptin therapy does involve risks. Serious side effects have occurred in patients treated with Herceptin in metastatic breast cancer. Herceptin administration can result in the development of ventricular dysfunction and cardiac failure. Severe hypersensitivity reactions (including anaphylaxis), infusion reactions, and pulmonary events have been infrequently reported. Rarely, these were fatal.

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