U.S. National Institutes of Health
Last Updated: 04/06/07

Trastuzumab Combined with Chemotherapy Improves Disease-Free Survival for Patients with Early-Stage Breast Cancer

The combination of the targeted agent trastuzumab (Herceptin®) and standard chemotherapy cuts the risk of Her2-positive breast cancer recurrence by more than half compared with chemotherapy alone. The result comes from two large, CTEP-sponsored, randomized trials testing, as adjuvant therapy, a trastuzumab/chemotherapy combination against chemotherapy alone in women with invasive, early stage, Her2-positive breast cancer.

Trastuzumab, manufactured by Genentech, Inc., specifically targets the HER2 protein, which is overexpressed in approximately 20 to 30 percent of breast cancers. Her2-positive tumors are not only more aggressive than tumors that do not overproduce HER2 protein, but also they are more likely to recur. Trastuzumab is approved by FDA for use in women with Her2-positive metastatic breast cancer. These are the first trials to show a benefit for trastuzumab as breast cancer adjuvant therapy.

Additional analyses will allow the trial leaders to perform a more thorough risk/benefit analysis. In the interim analysis, the likelihood of congestive heart failure (CHF) in women receiving the trastuzumab/chemotherapy combination was increased by 3 to 4 percent, compared with a less than 1 percent CHF rate in those treated with chemotherapy alone.

Romond EH, Perez EA, Bryant J, Suman V, Geyer CE, Davidson N, Tan-Chiu E, Martino S, Swain SM, Kaufman P, Fehrenbacher L, Pisansky T, Vogel V, Kutteh LA, Yothers G, Visscher D, Brown AM, Jen¬kins R, Seay TE, Mamounas E, Abrams J, Wolmark N. Joint analysis of NSABP-B-31 and NCCTG-N9831. Presented at: Advances in Monoclonal Antibody Therapy for Breast Cancer Scientific Symposium, ASCO Annual Meeting. May 13–17, 2005. Orlando, FL.