Liposomal Doxorubicin-Investigational Chemotherapy-Tissue Doppler Imaging Evaluation (LITE) Randomized Pilot Study
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Comparison of changes of PW-TDI systolic function parameters. The co-primary end-point ill be the comparison of changes from baseline to 12-month follow-up of PW-TDI diastolic function parameters.
Up to 12 months
Marzia Lotrionte, MD
Italy: Ministry of Health
LITE Randomized Pilot Study