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

Catholic University, Italy

Status and phase: Unknown; Phase 4

Conditions: Breast Cancer

Treatments: Drug: epirubicin; Drug: liposomal doxorubicin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00531973

LITE Randomized Pilot Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

A

Experimental group

Description:

Liposomal doxorubicin

Treatment:

Drug: liposomal doxorubicin

B

Active Comparator group

Description:

epirubicin

Treatment:

Drug: epirubicin