Dr. De Censi Discusses the Results of the Phase III TAM-01 Trial in Breast Cancer

Andrea De Censi, MD, director of the medical oncology unit at the National Hospital E.O. Ospedali Galliera—SC Oncologia Medica in Genoa, Italy, discusses the results of the phase III TAM-01 trial in breast cancer.

This trial randomized 500 women with operated hormone sensitive breast ductal or lobular carcinoma in situ to receive either low-dose tamoxifen or placebo to assess the potential recurrence risk reduction. After a median follow-up of 5 years, results showed a 52% reduction in the risk of recurrence with low-dose tamoxifen compared with placebo, says De Censi, meeting the criteria for statistical significance.

Moreover, there were 14 (5.5%) events of disease recurrence in the tamoxifen arm versus 28 (11.3%) in the placebo arm (HR, 0.48; 95% CI, 0.26-0.92; P = .024). The number of events has been relatively low, he adds. More follow-up is needed to assess the benefit of low-dose tamoxifen in this patient population.