Influence of clinical trial participation with regard to overall survival (OS) and progression-free survival (PFS) for patients with advanced breast cancer.

1144 Background: According to several reports in literature a survival benefit for patients with early breast cancer can been seen only due to the fact that women participate in clinical trials. This is based on the hypothesis that participation in clinical studies includes controlled trial conditions and the introduction of new medication which results in a survival benefit. However the data in literature regarding this question is inconsistent. Concerning advanced breast cancer no analysis has been published so far. Methods: 152 women with advanced breast cancer who were treated in our clinic from 2002 to 2006 were included in this retrospective analysis. 72 women were treated within a clinical trial, whereas 80 patients received guideline therapy. No significant differences in the two study populations regarding significant prognostic markers such as age, disease-free survival, or type of metastases were existent. Patients from eleven different clinical trials were considered for this analysis. Results: With regard to PFS and OS no significant difference was seen in the two groups. The median time of progression-free survival was 11 months in the group of study participants in comparison to 12 months in the standard therapy group. Only the univariate analysis showed a not significant trend towards a longer PFS in the clinical trial group. Furthermore no significant difference for the OS in both groups could be detected. 95 months was the median time of survival after progression in both groups. The 2-year and 5-year survival rate also showed no significant difference. Conclusions: In comparison to guideline therapy, clinical trial participation does not account for a benefit in PFS or OS in women with advanced breast cancer. No significant financial relationships to disclose.