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

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Catholic University, Italy
• Collaborator: Cephalon
• Treatments: Doxorubicin; Epirubicin; Liposomal doxorubicin

Criteria

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