Rationale and design of a phase III trial of adjuvant sequential epirubicin/ cyclophosphamide and taxane versus concurrent epirubicin/taxane in operable node-positive breast cancer.

The sequential use of a doxorubicin combination followed by paclitaxel has been reported to improve disease-free and overall survival in patients with node-positive breast cancer beyond that obtained with doxorubicin/cyclophosphamide combinations. Epirubicin is associated with less cardiotoxicity than doxorubicin and can be used at cumulative dose levels or intensities that cannot be safely achieved with doxorubicin. Epirubicin/taxane combinations have exhibited significant activity when used in the treatment of metastatic breast cancer. Based on these safety and efficacy data, a phase III adjuvant trial will compare the efficacy of a concurrent epirubicin/taxane regimen with sequential epirubicin/cyclophosphamide followed by taxane treatment in patients with operable node-positive breast cancer.