The Breast International Group (BIG), a Belgian nonprofit research-sharing network, in collaboration with pharmaceutical giant Roche has announced the release of research indicating that the drug Herceptin (generic name trastuzumab) may give survivors of HER2-positive early breast cancer a 25 percent reduction in the risk of their cancer’s recurring. Furthermore, according to BIG, “women with HER2-positive early breast cancer continue to benefit from Herceptin (trastuzumab) several years after treatment completion and as a result enjoy a longer life disease free.”
The data was derived from the HERA (HERceptin Adjuvant) study, an international phase III study conducted as a collaboration between BIG and Roche. The study, with over 5000 patients enrolled, is still currently assessing the benefits of adjuvant Herceptin treatment in women with HER2 positive early breast cancer. The HERA study’s primary endpoint is disease-free survival (DFS); its secondary endpoint is overall survival (OS) and cardiac safety.
In the study, patients were treated for one year with Herceptin and followed up for four years. In data presented at the Primary Therapy in Early Breast Cancer conference in St. Gallen, Switzerland, women treated with Herceptin had a 25 percent reduction in the risk of their cancer coming back compared to women who did not receive Herceptin, and after four years of medical observation on average, almost 90 percent of the Herceptin-treated women were still alive. In addition to the significant treatment benefit, this analysis confirmed the long-term safety profile of Herceptin, with good cardiac safety and tolerability maintained throughout the four-year follow-up period.
“These data are extremely important for the treatment of breast cancer,” commented Martine Piccart, MD, PhD, lead investigator of the HERA study and chair of BIG. “HERA is the first of the four large Herceptin studies in early HER2-positive breast cancer to substantiate the long-term benefit derived from one year of treatment.”
“These important long-term results from the HERA trial reinforce that women with this aggressive type of cancer have the best chance of cure with Herceptin,” said William M. Burns, CEO of Roche’s Pharmaceuticals Division.
Historically, HER2-positive breast cancer has been associated with a poor prognosis, but the first analysis of the HERA trial, released in 2005, established significant benefits in terms of lowering the risk of cancer returning (disease-free survival).
