The randomized LITE study will compare liposomal doxorubin versus standard epirubicin in the treatment of female breast cancer. In order to detect as early as possible post-chemotherapy cardiotoxicity, tissue Doppler imaging parameters elicited at transthoracic echocardiography will be used and will constitute the primary and co-primary end-points.

The randomized LITE study will compare liposomal doxorubin versus standard epirubicin within a comprehensive adjuvant or neo-adjuvant chemotherapy regimen in women undergoing treatment for breast cancer. The study will enrol a total of 80 patients, randomized 1:1 to liposomal doxorubin vs epirubicin. Standard and tissue Doppler imaging parameters will be appraised at transthoracic echocardiography will be used and will constitute the primary and co-primary end-points. In addition, other efficacy and safety end-points will be appraised, including disease free progression.

Inclusion Criteria:

• women with age ≥18 and ≤65 years
• histological and/or cytological diagnosis of clinically non-metastatic breast cancer (c/pTall, c/pNall, cM0)
• indication for integrated treatment with surgical intervention associated with adjuvant or neo-adjuvant chemotherapy, endocrinological and radiation therapy, including adjuvant or neo-adjuvant chemotherapy with anthracycline
• ECOG (Eastern Cooperative Oncology Group) performance status ≤2
• normal kidney, hepatic and hematological function
• normal LV ejection fraction at baseline (≥50%)
• negative pregnancy test in fecund women

Exclusion Criteria:

• metastatic breast cancer
• past radiation therapy and chemotherapy
• hypertension and other cardiovascular risk factors
• prior valvular heart disease
• cardiomyopathy
• chronic or acute congestive heart failure
• LV systolic dysfunction (ejection fraction<50%)
• abnormal complete blood count
• pregnancy
• breast-feeding