Results from the first and only interim analysis of an important trial assessing the potential of Herceptin (trastuzumab) to improve disease-free survival (DFS) in HER-2 positive breast cancer patients after adjuvant chemotherapy, have shown that Herceptin affords a significant survival advantage. These new findings were released at the 13th European Cancer Conference (ECCO) on the recommendation of the Independent Data Monitoring Committee.
The study in question, an international, multicentre, randomised, 3-arm trial is being conducted by the Breast International Group (BIG) in collaboration with the pharmaceutical company Roche AG, manufacturers of Herceptin. In total, 5,090 early breast cancer patients have been enrolled into this trial by the 478 participating institutions from Europe, Canada, South Africa, Israel, the Asia Pacific Region, Japan and Latin America. All women accrued had HER-2 positive breast cancer (either node negative or positive) and had completed at least four cycles of an acceptable (neo) adjuvant chemotherapy regimen. For women with hormone receptor positive disease, adjuvant endocrine therapy (most commonly tamoxifen) followed chemotherapy. The average age of study participants is 49 years.
The aim of this trial is to compare the effect of 1 year of Herceptin infusions, given every 3 weeks, with one year of simple observation, on survival – primarily DFS but also overall survival (OS), relapse-free survival (RFS) and distant disease free survival (DDFS), as well as comparable assessment of overall and cardiac safety. The study also consists of a 2-year arm – where 2 years of 3-weekly Herceptin is being compared with observation.
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