Swiss drug major Roche says that a fourth large-scale Phase III study of Herceptin (trastuzumab) in early-stage HER2-positive breast cancer, a particularly aggressive form of the disease, has demonstrated that adding the agent to chemotherapy significantly cuts the risk of cancer recurrence versus chemotherapy alone.

The BCIRG 006 trial, which is supported by French drugmaker Sanofi-Aventis and US biotechnology giant Genentech and is being conducted by Breast Cancer International Research Group, has enrolled 3,200 patients in 43 countries. The randomised, controlled evaluation is designed to assess the combination of doxorubicin and cyclophosphamide followed by docetaxel (AC), with or without Herceptin, and carboplatin plus docetaxel and Herceptin (TCH) in women with early-stage HER2-positive breast cancer.

Interim analysis showed statistically significant improvements in disease-free survival for both Herceptin-containing arms. Furthermore, the reduction in the risk of the cancer returning versus chemotherapy alone was 51% in the arm adding Herceptin to docetaxel following AC, and 39% in the TCH arm. The secondary endpoint of overall survival had not yet been attained at this stage, but an improvement in overall survival is possible as the data mature, the group noted.

These results further support the positive results of three earlier Phase III trials, which also showed that Herceptin substantially reduces the risk of cancer recurrence by about 50%.

Commenting on these latest findings, William Burns, chief executive of Roche Pharmaceuticals, claimed that “the results from Herceptin’s development programme in early breast cancer have been nothing less than remarkable. Four large trials in the past five months have delivered outstanding efficacy and safety from a vast patient pool and with a variety of treatment regimens, more than two years earlier than planned. Roche, the medical community and regulatory authorities around the world are urgently working together to secure access to Herceptin for early-stage HER2-positive breast cancer patients as soon as possible, and filing in Europe could happen as early as the beginning of 2006.”