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Objectives: To determine if there is an association between overall and breast cancer specific-survival and participation in clinical trials (CT’s) in patients with invasive non-metastatic breast cancer.
Materials and Methods: All women (6,794) diagnosed between 1982 and 2008 with invasive non-metastatic breast cancer from our database were used. Survival data was compared between women diagnosed with invasive nonmetastatic breast cancer who participated in a CT and with those who did not.
Results: A total of 1,137 (16.7%) patients participated in a CT. These patients were younger and exhibited more unfavourable prognostic factors compared to non-participant. The crude hazard ratio for the overall survival rate for those who participated in a CT was 0.84 (95% CI [0.73-0.97]; p=0.02), and was 0.90 (CI 95% [0.78-1.04]; p=0.16) after an adjustment for body mass index (BMI), hormone receptors, treatments and histological grade.
Conclusion: Breast cancer patients who participate in a CT exhibit different baseline characteristics. Assuming that difference, trial participation in itself did not improve survival rate in breast cancer patients. However, it can be concluded that the CTs does not have a deleterious effect on the participants.