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

Phase 4

• Conditions: Breast Cancer
• Interventions: Drug: liposomal doxorubicin; Drug: epirubicin

• Registration Number: NCT00531973
• Lead Sponsor: Catholic University, Italy

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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-09-18
• Study First Submitted QC: 2007-09-18
• Study First Posted: 2007-09-19
• Primary Completion: 2008-08
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-17
• Last Update Posted: 2009-02-18
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	liposomal doxorubicin	Liposomal doxorubicin
B	epirubicin	epirubicin

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Changes of standard 2-dimensional echocardiography parameters, including LV ejection fraction, peak values of biochemical markers of cardiac damage and heart failure, ie cardiac troponin T and BNP.	12 months

Trial Locations

Locations (1)

Catholic University; 🇮🇹 Rome, RM, Italy