April 2005

Herceptin Combined With Chemotherapy Improves Disease-Free Survival for Patients With Early-Stage Breast Cancer

Results from two large randomized clinical trials for patients with HER-2 positive invasive breast cancer show that those patients with early-stage breast cancer who received trastuzumab (Herceptin) in combination with chemotherapy had a significant decrease in risk for breast cancer recurrence compared with patients who received the same chemotherapy without trastuzumab. Patients are considered "HER-2 positive" if their cancer cells "overexpress" — make too much of — a protein called HER-2, which is found on the surface of cancer cells. Trastuzumab slows or stops the growth of these cells, and it is only used to treat cancers that overexpress the HER-2 protein. Approximately 20 percent to 30 percent of breast cancers overexpress HER-2. These tumors tend to grow faster and are generally more likely to recur than tumors that do not overproduce HER-2.

The clinical trials, which were conducted in Atlanta at Emory University's Winship Cancer Institute, were sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and conducted by a network of researchers led by the National Surgical Adjuvant Breast and Bowel Project (NSABP). Toncred Styblo, MD, associate professor of the division of surgical oncology at Emory, was the principal investigator on the Emory Winship trial. Genentech, Inc., which manufactures trastuzumab, provided the drug for the trials under the Cooperative Research and Development Agreement (CRADA) with NCI for the clinical development of trastuzumab.

"We need to congratulate the women who chose to participate in this ground-breaking study," Dr. Styblo stated. "All too often when important trial results are announced, the focus is on the treatment and not the heroes who made the data possible."

The Data Monitoring Committees overseeing the combined analysis of these trials (known as NSABP-B-31 and NCCTG-N9831) recommended that the results of a recent combined interim analysis be made public because the studies had met their primary endpoints of increasing disease-free survival (the amount of time patients live without return of the cancer) in patients receiving trastuzumab in combination with chemotherapy. The improvement in overall survival also was statistically significant for women receiving a combination of chemotherapy and trastuzumab. These patients had a 52 percent decrease in disease recurrence compared to patients treated with chemotherapy alone.

Information from over 3,300 patients enrolled in these studies was used for analysis. Patients with operable breast cancer whose tumors over-expressed HER-2 were enrolled in these studies between February 2000 and April 2005. Patients were randomized to receive chemotherapy with doxorubicin and cyclophosphamide followed by paclitaxel, or doxorubicin and cyclophosphamide followed by paclitaxel and trastuzumab. Most patients had lymph node-positive breast cancer, or breast cancer that had spread to the lymph nodes, with only a minority having lymph node-negative disease. The limited information in the node-negative group did not allow for a separate analysis of this group.

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