The present study protocol: Supported by "in-vitro" and preliminary "in-vivo" data, briefly summarized above, this study is designed to test prospectively the value of topo II alpha gene amplification and protein overexpression in predicting the efficacy of anthracyclines. To our knowledge this is the only prospective trial worldwide which is attempting to prospectively clarify the predictive value of this interesting biological marker. This study could have important practical implications in the daily clinical management of early breast cancer patients because, if the trial confirms that topo II a gene amplification and/or protein overexpression are associated with high efficacy of anthracyclines, while topo II a normal/deleted gene and low protein content are associated with modest efficacy, an important step forward in the direction of anthracycline "tailoring" would be accomplished.