Results of this trial were presented at the San Antonio Breast Cancer Symposium by lead investigator Nicholas Robert, M.D., of Inova Fairfax Hospital, Fairfax, Virginia.
"This study shows that the addition of carboplatin may provide clinical benefit and demonstrates improvement in response rate and time to disease progression in HER2-positive metastatic breast cancer patients," said Dr. Robert
."In addition, the preliminary analysis of survival is encouraging."Median survival in the Herceptin and paclitaxel arm was 33.5 months and has not been reached at 36 months of follow-up in the Herceptin, paclitaxel and carboplatin arm.
The study (abstract # 35) enrolled 194 women who had evidence of HER2 protein overexpression by immunohistochemistry (IHC); 191 patients wereevaluable for the primary endpoint of time to progression.Results of the randomized study showed that women receiving Herceptin, paclitaxel and carboplatin had a median time to progression of 11.2 months, compared to 6.9 months for those receiving standard treatment of Herceptin and paclitaxel alone.In women with IHC scores of 3+, those treated with all three agents had a median time to progression of 13.5 months, compared to 7.2 months in the group receiving Herceptin and paclitaxel.Investigators are in the process of retrospectively testing tumor samples in this study by FISH (fluorescence in-situ hybridization), a gene-based HER2 diagnostic test.