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.
Results from the 1-year arm of the study, showcased at ECCO 13, show that Herceptin is associated with a significant improvement in DFS in this group of patients. The difference in Herceptin treated women was 85.8% compared to 77.4% of women on observati
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Contact: Kirsten Mason
kirsten.mason@toniclc.com
44-077-969-55353
Federation of European Cancer Societies
31-Oct-2005