Spots Global Cancer Trial Database for A Study of Liposomal Doxorubicin in Women With Breast Cancer Exploiting Tissue Doppler Imaging

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Trial Identification

Brief Title: A Study of Liposomal Doxorubicin in Women With Breast Cancer Exploiting Tissue Doppler Imaging

Official Title: Liposomal Doxorubicin-Investigational Chemotherapy-Tissue Doppler Imaging Evaluation (LITE) Randomized Pilot Study

Study ID: NCT00531973

Conditions

Breast Cancer

Interventions

liposomal doxorubicin

epirubicin

Study Description

Brief Summary: 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.

Detailed Description: 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.