drugset / Trial / NCT00531973

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

NCT00531973

Phase 4 Unknown 80 enrolled Catholic University, Italy Cephalon · collab
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2007-01
Primary completion
2008-08
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxorubicin Other / unclassified 50 mg/m2
Comparator Epirubicin Small molecule 90 mg/m2
Comparator Cyclophosphamide Other / unclassified 500 mg/m2
Comparator fluorouracil Small molecule 500 mg/m2