Multicenter randomized controlled clinical trial to evaluate cardioprotection of dexrazoxane versus no cardioprotection in women receiving epirubicin chemotherapy for advanced breast cancer.

162 women with advanced breast cancer receiving epirubicin-based chemotherapy.

Dexrazoxane given at a dexrazoxane:epirubicin dose ratio of 10:1 added to epirubicin-based chemotherapy (either cyclophosphamide 600 mg/m2 IV, epirubicin 60 mg/m2 IV, and fluorouracil 600 mg/m2 IV, or epirubicin 120 mg/m2 IV on day 1 every 3 weeks).

No dexrazoxane (epirubicin-based chemotherapy alone).

Cardiac toxicity (composite of clinical signs of congestive heart failure, a decrease in resting left ventricular ejection fraction (LVEF) to <= 45%, or a decrease from baseline resting LVEF of >= 20 EF units).composite